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Meds A-Z

Tulathromycin

Detailed information about Tulathromycin

Official label facts Owner quick guide first Marketing clearly labeled
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Pet Owner Quick Guide

Start here: what this medicine is for, what it does, and when it's usually needed.

Usually used for:

BRD – Tulathromycin Injection is indicated for the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica , Pasteurella multocida , Histophilus somni , and Mycoplasma bovis ; and for the con...

What it does:

For the treatment of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae , Pasteurella multocida , Bordetella bronchiseptica , Haemophilus parasuis , and Mycoplasma hyopneumoniae ; and for the...

When it's needed:

Do not inject more than 4 mL per injection site. For use in suckling calves, dairy calves, veal calves, and swine. Not for use in ruminating cattle. Not for use in Chickens or Turkeys. Federal (USA) law restricts this dr...

Call your vet sooner if you notice:

  • Do not inject more than 4 mL per injection site. For use in suckling calves, dairy calves, veal calves, and swine. Not for use in ruminating cattle. Not for use in Chickens or Turkeys. Federal (USA) law restricts this drug to useby or on the order of a licensed veterinarian. Do not inject more than 11.5 mL per injection site. For use in suckling calves, dairy calves, veal calves, and swine. Not for use in ruminating cattle. Not for use in Chickens or Turkeys. Federal (USA) law restricts this drug to useby or on the order of a licensed veterinarian.

Commonly reported reactions:

  • (2 reports)
  • (2 reports)
  • (1 reports)

What to ask your vet today:

  • Is this medicine the right fit for my pet’s current symptoms?
  • Which warning signs mean I should call back right away?
  • How should I handle missed doses or refusal to take the medicine?
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Tulathromycin

Tulathromycin

Drug type: Generic ingredient • Branded profile FDA branded products available

Species: Both

Manufacturer: MSK

Quick Facts

Official label facts first, then secondary summaries. Marketing content is separated below.

Species: Both
Manufacturer: MSK
Form: Injectable Solution
Identifiers:
ANADA: 200657 ANADA: 200665 ANADA: 200666 ANADA: 200668 ANADA: 200669 ANADA: 200711 ANADA: 200712 ANADA: 200715 ANADA: 200723 ANADA: 200730 ANADA: 200742 ANADA: 200745 ANADA: 200773 ANADA: 200774 NADA: 141349 NADA: 141543 NDC Package: 0061-6607-02 NDC Package: 0061-6607-03 NDC Package: 0061-6607-04 NDC Package: 0061-6607-05
Source metadata:

Warnings / Contraindications

Do not inject more than 4 mL per injection site. For use in suckling calves, dairy calves, veal calves, and swine. Not for use in ruminating cattle. Not for use in Chickens or Turkeys. Federal (USA) law restricts this drug to useby or on the order of a licensed veterinarian. Do not inject more than 11.5 mL per injection site. For use in suckling calves, dairy calves, veal calves, and swine. Not for use in ruminating cattle. Not for use in Chickens or Turkeys. Federal (USA) law restricts this drug to useby or on the order of a licensed veterinarian.

  • High: Do not inject more than 4 mL per injection site. For use in suckling calves, dairy calves, veal calves, and swine. Not for use in ruminating cattle. Not for use in Chickens or Turkeys. Federal (USA) law restricts this drug to useby or on the order of a licensed veterinarian. Do not inject more than 11.5 mL per injection site. For use in suckling calves, dairy calves, veal calves, and swine. Not for use in ruminating cattle. Not for use in Chickens or Turkeys. Federal (USA) law restricts this drug to useby or on the order of a licensed veterinarian.
Source metadata:

Adverse Reactions

Snapshot first, detailed rows second. This section summarizes signal data and is not a diagnosis.

Tap or hover a reaction to see what it means in plain language.

Tracked signals
32
Reported cases
20
Serious reports
15
Species represented
2
Most Reported Reactions
Reaction Cases Species Serious cases
2 Cat, Dog 2
2 Cat, Dog 0
1 Cat 1
1 Dog 1
1 Dog 1
1 Dog 1
1 Dog 1
1 Cat 1

Species coverage: Dog (18) Cat (14)

View detailed reaction table
Reaction Species Seriousness Frequency Reports
Cat Serious - 1
Dog Serious - 1
Dog Serious - 1
Dog Serious - 1
Cat Serious - 1
Cat Serious - 1
Cat Serious - 1
Cat Serious - 1
Dog Serious - 1
Dog Non-serious - 1
Dog Non-serious - 1
Cat Non-serious - 1
Dog Serious - 1
Dog Serious - 1
Cat Serious - 1
Dog Non-serious - 1
Dog Non-serious - 1
Dog Serious - 1
Dog Serious - 1
Cat Serious - 1
Cat Unknown - -
Dog Unknown - -
Dog Unknown - -
Dog Unknown - -
Cat Unknown - -
Cat Unknown - -
Cat Unknown - -
Cat Unknown - -
Dog Unknown - -
Dog Unknown - -
Dog Unknown - -
Cat Unknown - -
Source metadata:

Storage & Handling

No storage/handling guidance is linked yet.

Source metadata: No source yet.

Documents

Official label facts are separated from secondary summaries.

Official documents: 33 • Secondary summaries: 0

Secondary summaries

No source yet.

Promotional Materials (Marketing)

This content is marketing material and not clinical guidance.

No marketing assets are linked yet.

No source yet.

Source metadata: No source yet.
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Technical appendix (vet reference)

Canonical medication sections are above. This legacy block remains available for deeper cross-reference without cluttering the primary workflow.

At a Glance

Quick facts and links to official labeling and safety signals.

Data freshness
  • Medication catalog: Source PetWisePlus | Refreshed Feb 12, 2026, 10:44 PM UTC
  • Animal Drugs @ FDA: Source FDA | Refreshed Feb 16, 2026, 11:00 AM UTC
    Applications/products are imported from FDA export data.
  • Animal Drugs @ FDA previews: Source FDA | Refreshed Feb 9, 2026, 3:05 AM UTC
    Label highlights/doc links are fetched from FDA preview endpoints.
  • Animal Drug Product Listing Directory (NDC): Source FDA | Refreshed Feb 16, 2026, 11:00 AM UTC
    Package/product NDCs from FDA’s electronic listing directory (XLS).
  • openFDA reaction terms: Source FDA openFDA | Refreshed Feb 9, 2026, 3:13 AM UTC
  • openFDA case summaries: Source FDA openFDA | Refreshed Feb 9, 2026, 3:20 AM UTC
Official (FDA)
Identity: Generic ingredient • FDA branded products available
Official FDA brands: AROVYN™ Draxxin® 25 Injectable Solution Draxxin® KP Increxxa™ Increxxa™ 25 MACROSYN™ RESPIRmycin™ RESPIRmycin™ 25 TULAVEN™ 100 TULAVEN™ 25 Tulaject™ Tulaject™ 100 Tulathromycin Injection Tulieve® Tulissin® 100 Tulissin® 25
Case-reported brands (openFDA): MSK
Catalog species: Both FDA-labeled species: Beef And Non-Lactating Dairy, Beef bulls, Beef calves 2 months of age and older, Beef heifers, Beef steers, Dairy bulls, Dairy calves, No use class stated or implied, Replacement Dairy Heifers, Suckling Calves, Suckling calves, Veal calves
Rx/OTC: RX
Form/route: Injectable Solution Intramuscular, Subcutaneous
Applications: ANADA 200-742 • ANADA 200-774 • ANADA 200-773 • ANADA 200-745 • ANADA 200-730 • ANADA 200-723 • ANADA 200-715 • ANADA 200-665 • ANADA 200-711 • ANADA 200-712 • ANADA 200-669 • ANADA 200-668 • NADA 141-543 • ANADA 200-666 • ANADA 200-657 • NADA 141-349
Documents: 17 (FOI: 17) • SPL: 16 Label highlights Official documents
Safety (openFDA)
Top reactions: Dog 8 Cat 8 View
Case summaries: 10 (showing 8) View
openFDA reports are unverified and do not prove causation.

Explore
Linked using: Fda_Label (0.95), Fda_Label (0.95)

Diagnosis Codes

Diagnosis-code mappings are not available for this medication yet.

Counseling and Monitoring Highlights

Global Pet owner/Vet mode is controlled in the header. This section avoids duplicate in-page persona tabs.

Owner-facing counseling points
  • Do not inject more than 4 mL per injection site. For use in suckling calves, dairy calves, veal calves, and swine. Not for use in ruminating cattle. Not for use in Chickens or Turkeys. Federal (USA) law restricts this drug to useby or on the order of a licensed veterinarian. Do not inject more than 11.5 mL per injection site. For use in suckling calves, dairy calves, veal calves, and swine. Not for use in ruminating cattle. Not for use in Chickens or Turkeys. Federal (USA) law restricts this drug to useby or on the order of a licensed veterinarian. (Contraindication, High)
Top reaction signals
Blindness (1) Coughing up blood (1) Cutaneous emphysema (1) Dyspnoea (1) Elevated alanine aminotransferase (ALT) (1) Elevated aspartate aminotransferase (AST) (1) Elevated blood urea nitrogen (BUN) (1) Head bobbing (1) Injection site reaction NOS (1) Lack of efficacy (bacteria) - NOS (1) Lack of efficacy - NOS (1) Lack of efficacy - NOS (1) Lethargy (see also Central nervous system depression in 'Neurological') (1) Neurological signs NOS (1) Neurological signs NOS (1) Oral cavity disorder NOS (1)

Identifiers & Packages

Normalized identifiers (NDC/NADA/ANADA) and package metadata from regulator listings.

Identifiers
ANADA: 200657 ANADA: 200665 ANADA: 200666 ANADA: 200668 ANADA: 200669 ANADA: 200711 ANADA: 200712 ANADA: 200715 ANADA: 200723 ANADA: 200730 ANADA: 200742 ANADA: 200745 ANADA: 200773 ANADA: 200774 NADA: 141349 NADA: 141543 NDC Package: 0061-6607-02 NDC Package: 0061-6607-03 NDC Package: 0061-6607-04 NDC Package: 0061-6607-05 NDC Package: 23243-2825-1 NDC Package: 23243-2825-2 NDC Package: 23243-5282-1 NDC Package: 23243-5282-2
Package NDC Product NDC Form / Route Status
0061-6607-02 0061 -
0061-6607-03 0061 -
0061-6607-04 0061 -
0061-6607-05 0061 -
23243-2825-1 23243 -
23243-2825-2 23243 -
23243-5282-1 23243 -
23243-5282-2 23243 -
23243-5282-5 23243 -
23243-5282-6 23243 -
51311-002-10 51311 -
51311-002-25 51311 -
51311-006-10 51311 -
51311-006-25 51311 -
51311-006-50 51311 -
51311-006-51 51311 -
54771-2155-1 54771 -
54771-2155-2 54771 -
54771-2155-3 54771 -
54771-2155-4 54771 -

Enriched Documents

Documents are tiered by source trust: Official, Clinical, Manufacturer, Marketing.

Data Sources & Revision History

Every non-trivial field is expected to include provenance and update timestamps.

Official 20 Clinical 0 Manufacturer 0 Marketing 0
Current Field Facts
  • contraindications: Do not inject more than 4 mL per injection site. For use in suckling calves, dairy calves, veal calves, and swine. Not for use in ruminating cattle. Not for us… (Official, 2026-02-12)
  • side_effects: Top reported reactions (openFDA): Coughing up blood, Cutaneous emphysema, Dyspnoea, Injection site reaction NOS, Lack of efficacy (bacteria) - NOS, Lack of eff… (Official, 2026-02-12)
  • usage: For the treatment of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae , Pasteurella multocida , Bordetella bronchiseptica , Haem… (Official, 2026-02-12)
Recent Revisions
  • side_effects updated 2026-02-12 22:44 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-02-12 22:44 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-02-12 22:44 by etl_backfill • Backfilled from existing medication fields

FDA Products & Applications (Animal Drugs @ FDA)

Official sponsor/proprietary-name/application-status records linked by active ingredient.

Product Sponsor Application Status Published
Tulathromycin Injection
RX
Tulathromycin
Injectable Solution Intramuscular, Subcutaneous
Hikma Pharmaceuticals USA, Inc. ANADA 200-742 Approved Feb 26, 2025
Tulaject™
RX
Tulathromycin
Injectable Solution Intramuscular, Subcutaneous
Cronus Pharma Specialities India Private Ltd. ANADA 200-774 Approved Oct 1, 2024
Tulaject™ 100
RX
Tulathromycin
Injectable Solution Subcutaneous, Intramuscular
Cronus Pharma Specialities India Private Ltd. ANADA 200-773 Approved Oct 1, 2024
RESPIRmycin™ 25
RX
Tulathromycin
Injectable Solution Subcutaneous, Intramuscular
Parnell Technologies Pty. Ltd. ANADA 200-745 Approved Apr 3, 2023
RESPIRmycin™
RX
Tulathromycin
Injectable Solution Subcutaneous, Intramuscular
Parnell Technologies Pty. Ltd. ANADA 200-730 Approved Dec 1, 2022
Tulieve®
RX
Tulathromycin
Injectable Solution Subcutaneous, Intramuscular
Norbrook Laboratories, Ltd. ANADA 200-723 Approved Apr 1, 2022
AROVYN™
RX
Tulathromycin
Injectable Solution Subcutaneous, Intramuscular
Intervet, Inc. ANADA 200-715 Approved Mar 1, 2022
Increxxa™ 25
RX
Tulathromycin
Injectable Solution Subcutaneous, Intramuscular
Elanco US Inc. ANADA 200-665 Approved Mar 1, 2022
TULAVEN™ 100
RX
Tulathromycin
Injectable Solution Subcutaneous, Intramuscular
Ceva Sante Animale ANADA 200-711 Approved Dec 1, 2021
TULAVEN™ 25
RX
Tulathromycin
Injectable Solution Intramuscular, Subcutaneous
Ceva Sante Animale ANADA 200-712 Approved Dec 1, 2021
Tulissin® 100
RX
Tulathromycin
Injectable Solution Subcutaneous, Intramuscular
Virbac AH, Inc. ANADA 200-669 Approved Dec 1, 2021
Tulissin® 25
RX
Tulathromycin
Injectable Solution Subcutaneous, Intramuscular
Virbac AH, Inc. ANADA 200-668 Approved Dec 1, 2021
Draxxin® KP
RX
Ketoprofen Tulathromycin
Injectable Solution Subcutaneous
Zoetis Inc. NADA 141-543 Approved Jul 1, 2021
Increxxa™
RX
Tulathromycin
Injectable Solution Subcutaneous, Intramuscular
Elanco US Inc. ANADA 200-666 Approved Mar 1, 2021
MACROSYN™
RX
Tulathromycin
Injectable Solution Intramuscular, Subcutaneous
Bimeda Animal Health Limited ANADA 200-657 Approved Mar 1, 2021
Draxxin® 25 Injectable Solution
RX
Tulathromycin
Injectable Solution Intramuscular, Subcutaneous
Zoetis Inc. NADA 141-349 Approved Apr 1, 2019

Data source: FDA Animal Drugs @ FDA (public search export).

What It's For (FDA Label Highlights)

Extracted from FDA Animal Drugs @ FDA product labeling. Always confirm details with your veterinarian.

Species: Suckling Calves, Dairy Calves, Veal Calves • Beef And Non-Lactating Dairy
Composition / specifications
100 mg of tulathromycin/mL
Beef cattle, non-lactating dairy cattle, suckling calves, dairy calves and veal calves
Indication

BRD – Tulathromycin Injection is indicated for the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis; and for the control of respiratory disease in cattle at high risk of developing BRD associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis.

IBK – Tulathromycin Injection is indicated for the treatment of infectious bovine keratoconjunctivitis (IBK) associated with Moraxella bovis.

Foot Rot – Tulathromycin Injection is indicated for the treatment of bovine foot rot (interdigital necrobacillosis) associated with Fusobacterium necrophorum and Porphyromonas levii.

Suckling Calves, Dairy Calves, and Veal Calves

BRD – Tulathromycin Injection is indicated for the treatment of BRD associated with M. haemolytica, P. multocida, H. somni, and M. bovis.

Dosage

Inject subcutaneously as a single dose in the neck at a dosage of 2.5 mg/kg (1.1 mL/100 lb) body weight (BW). Do not inject more than 10 mL per injection site.

Limitations
Swine
Indication

Tulathromycin Injection is indicated for the treatment of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Bordetella bronchiseptica, Haemophilus parasuis, and Mycoplasma hyopneumoniae; and for the control of SRD associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, and Mycoplasma hyopneumoniae in groups of pigs where SRD has been diagnosed.

Dosage

Inject intramuscularly as a single dose in the neck at a dosage of 2.5 mg/kg (0.25 mL/22 lb) BW. Do not inject more than 2.5 mL per injection site.

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: Suckling Calves, Dairy Calves, Veal Calves
Composition / specifications
25 mg of tulathromycin/mL
Swine
Indication

For the treatment of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Bordetella bronchiseptica, Haemophilus parasuis, and Mycoplasma hyopneumoniae; and for the control of SRD associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, and Mycoplasma hyopneumoniae in groups of pigs where SRD has been diagnosed.

Dosage

Inject intramuscularly as a single dose in the neck at a dosage of 2.5 mg/kg (1 mL/22lb) body weight (BW). Do not inject more than 4 mL per injection site.

Limitations
Suckling Calves, Dairy Calves, and Veal Calves
Indication

For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis.

Dosage

Inject subcutaneously as a single dose in the neck at a dosage of 2.5 mg/kg (1 mL/22lb) BW. Do not inject more than 11.5 mL per injection site.

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: Suckling Calves, Dairy Calves, Veal Calves • Beef And Non-Lactating Dairy
Composition / specifications
100 mg of tulathromycin/mL
Beef and Non-Lactating Dairy Cattle
Indication

BRD- For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis; and for the control of respiratory disease in cattle at high risk of developing BRD associated with Mannheimia haemolyticaPasteurella multocidaHistophilus somni, and Mycoplasma bovis.
IBK- For the treatment of infectious bovine keratoconjunctivitis (IBK) associated with Moraxella bovis
Foot Rot- For the treatment of bovine foot rot (interdigital necrobacillosis) associated with Fusobacterium necrophorum and Porphyromonas levii

Dosage

Inject subcutaneously as a single dose in the neck at a dosage of 2.5 mg/kg (1.1 mL/100 lb) body weight (BW). Do not inject more than 10 mL per injection site.

Limitations
Suckling Calves, Dairy Calves, and Veal Calves
Indication

For the treatment of BRD associated with M. haemolytica, P. multocida, H. somni, and M. bovis.

Dosage

Inject subcutaneously as a single dose in the neck at a dosage of 2.5 mg/kg (1.1 mL/100 lb) body weight (BW). Do not inject more than 10 mL per injection site.

Limitations
Swine
Indication

For the treatment of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Bordetella bronchiseptica, Haemophilus parasuis, and Mycoplasma hyopneumoniae; and for the control of SRD associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, and Mycoplasma hyopneumoniae in groups of pigs where SRD has been diagnosed.

Dosage

Inject intramuscularly as a single dose in the neck at a dosage of 2.5 mg/kg (0.25 mL/22 lb) BW. Do not inject more than 2.5 mL per injection site.

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: No use class stated or implied • Suckling Calves, Dairy Calves, Veal Calves
Composition / specifications
25 mg of tulathromycin/mL
Swine
Indication

For the treatment of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Bordetella bronchiseptica, Haemophilus parasuis, and Mycoplasma hyopneumoniae; and for the control of SRD associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, and Mycoplasma hyopneumoniae in groups of pigs where SRD has been diagnosed.

Dosage

Inject intramuscularly as a single dose in the neck at a dosage of 2.5 mg/kg (1 mL/22 lb) body weight (BW). Do not inject more than 4 mL per injection site.

Limitations
Suckling Calves, Dairy Calves, and Veal Calves
Indication

For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis.

Dosage

Inject subcutaneously as a single dose in the neck at a dose of 2.5 mg/kg (1 mL/22 lb BW. Do not inject more than 11.5 mL per injection site.

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: No use class stated or implied • Beef And Non-Lactating Dairy • Dairy calves • Suckling calves • Veal calves
Composition / specifications
100 mg of tulathromycin/mL
Beef and non-lactating dairy cattle
Indication

BRD – For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis; and for the control of respiratory disease in cattle at high risk of developing BRD associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis.

IBK – For the treatment of infectious bovine keratoconjunctivitis (IBK) associated with Moraxella bovis.

Foot Rot – For the treatment of bovine foot rot (interdigital necrobacillosis) associated with Fusobacterium necrophorum and Porphyromonas levii.

Dosage

Inject subcutaneously as a single dose in the neck at a dosage of 2.5 mg/kg (1.1 mL/100 lb) body weight (BW). Do not inject more than 10 mL per injection site.

Limitations
Suckling calves, dairy calves, and veal calves
Indication

For the treatment of BRD associated with M. haemolytica, P. multocida, H. somni, and M. bovis.

Dosage

Inject subcutaneously as a single dose in the neck at a dosage of 2.5 mg/kg (1.1 mL/100 lb) body weight (BW). Do not inject more than 10 mL per injection site.

Limitations
Swine
Indication

For the treatment of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Bordetella bronchiseptica, Haemophilus parasuis, and Mycoplasma hyopneumoniae; and for the control of SRD associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, and Mycoplasma hyopneumoniae in groups of pigs where SRD has been diagnosed.

Dosage

Inject intramuscularly as a single dose in the neck at a dosage of 2.5 mg/kg (0.25 mL/22 lb) BW. Do not inject more than 2.5 mL per injection site.

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: No use class stated or implied • Suckling Calves, Dairy Calves, Veal Calves • Beef And Non-Lactating Dairy
Composition / specifications
100 mg of tulathromycin/mL
Beef and Non-Lactating Dairy Cattle
Indication

For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis; and for the control of respiratory disease in cattle at high risk of developing BRD associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis.

For the treatment of infectious bovine keratoconjunctivitis associated with Moraxella bovis.

For the treatment of bovine foot rot (interdigital necrobacillosis) associated with Fusobacterium necrophorum and Porphyromonas levii.

Dosage

Inject subcutaneously as a single dose in the neck at a dosage of 2.5 mg/kg (1.1 mL/100 lb) body weight (BW). Do not inject more than 10 mL per injection site.

Limitations
Suckling Calves, Dairy Calves, and Veal Calves
Indication

For the treatment of BRD associated with M. haemolytica, P. multocida, H. somni, and M. bovis.

Dosage

Inject subcutaneously as a single dose in the neck at a dosage of 2.5 mg/kg (1.1 mL/100 lb) body weight (BW). Do not inject more than 10 mL per injection site.

Limitations
Swine
Indication

For the treatment of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Bordetella bronchiseptica, Haemophilus parasuis, and Mycoplasma hyopneumoniae; and for the control of SRD associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, and Mycoplasma hyopneumoniae in groups of pigs where SRD has been diagnosed.

Dosage

Inject intramuscularly as a single dose in the neck at a dosage of 2.5 mg/kg (0.25 mL/22 lb) BW. Do not inject more than 2.5 mL per injection site.

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: No use class stated or implied • Suckling Calves, Dairy Calves, Veal Calves • Beef And Non-Lactating Dairy
Composition / specifications
100 mg of tulathromycin/mL
Beef and Non-Lactating Dairy Cattle
Indication

For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis; and for the control of respiratory disease in cattle at high risk of developing BRD associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis.

For the treatment of infectious bovine keratoconjunctivitis associated with Moraxella bovis.

For the treatment of bovine foot rot (interdigital necrobacillosis) associated with Fusobacterium necrophorum and Porphyromonas levii.


Dosage

Inject subcutaneously as a single dose in the neck at a dosage of 2.5 mg/kg (1.1 mL/100 lb) body weight (BW). Do not inject more than 10 mL per injection site.

Limitations
Suckling Calves, Dairy Calves, and Veal Calves
Indication

For the treatment of BRD associated with M. haemolytica, P. multocida, H. somni, and M. bovis.

Dosage

Inject subcutaneously as a single dose in the neck at a dosage of 2.5 mg/kg (1.1 mL/100 lb) body weight (BW). Do not inject more than 10 mL per injection site.

Limitations
Swine
Indication

For the treatment of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Bordetella bronchiseptica, Haemophilus parasuis, and Mycoplasma hyopneumoniae; and for the control of SRD associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, and Mycoplasma hyopneumoniae in groups of pigs where SRD has been diagnosed.

Dosage

Inject intramuscularly as a single dose in the neck at a dosage of 2.5 mg/kg (0.25 mL/22 lb) BW. Do not inject more than 2.5 mL per injection site.

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: No use class stated or implied • Suckling Calves, Dairy Calves, Veal Calves
Composition / specifications
25 mg tulathromycin/mL
Swine
Indication

For the treatment of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Bordetella bronchiseptica, Haemophilus parasuis, and Mycoplasma hyopneumoniae; and for the control of SRD associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, and Mycoplasma hyopneumoniae in groups of pigs where SRD has been diagnosed.

Dosage

Inject intramuscularly as a single dose in the neck at a dosage of 2.5 mg/kg (1mL/22 lb) body weight (BW). Do not inject more than 4 mL per injection site.

Limitations
Suckling Calves, Dairy Calves, and Veal Calves
Indication

For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis.

Dosage

Inject subcutaneously as a single dose in the neck at a dosage of 2.5 mg/kg (1mL/22 lb) BW. Do not inject more than 11.5 mL per injection site.

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: No use class stated or implied • Suckling Calves, Dairy Calves, Veal Calves • Beef And Non-Lactating Dairy • Dairy calves
Composition / specifications
100 mg of tulathromycin/mL
Beef and Non-Lactating Dairy Cattle
Indication

BRD: For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis; and for the control of respiratory disease in cattle at high risk of developing BRD associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis.

IBK: For the treatment of infectious bovine keratoconjunctivitis (IBK) associated with Moraxella bovis.

Foot Rot: For the treatment of bovine foot rot (interdigital necrobacillosis) associated with Fusobacterium necrophorum and Porphyromonas levii.

Dosage

Inject subcutaneously as a single dose in the neck at a dosage of 2.5 mg/kg (1.1 mL/100 lb) body weight (BW). Do not inject more than 10 mL per injection site.

Limitations
Suckling Calves, Dairy Calves, and Veal Calves
Indication

For the treatment of BRD associated with M. haemolytica, P. multocida, H. somni, and M. bovis.

Dosage

Inject subcutaneously as a single dose in the neck at a dosage of 2.5 mg/kg (1.1 mL/100 lb) body weight (BW). Do not inject more than 10 mL per injection site.

Limitations
Swine
Indication

For the treatment of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Bordetella bronchiseptica, Haemophilus parasuis, and Mycoplasma hyopneumoniae; and for the control of SRD associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, and Mycoplasma hyopneumoniae in groups of pigs where SRD has been diagnosed.

Dosage

Inject intramuscularly as a single dose in the neck at a dosage of 2.5 mg/kg (0.25 mL/22 lb) BW. Do not inject more than 2.5 mL per injection site.

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: No use class stated or implied • Suckling Calves, Dairy Calves, Veal Calves
Composition / specifications
25 mg/mL of tulathromycin
Swine
Indication

For the treatment of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Bordetella bronchiseptica, Haemophilus parasuis, and Mycoplasma hyopneumoniae; and for the control of SRD associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, and Mycoplasma hyopneumoniae in groups of pigs where SRD has been diagnosed.

Dosage

Inject intramuscularly as a single dose in the neck at a dosage of 2.5 mg/kg(1 mL/22 lb) body weight (BW). Do not inject more than 4 mL per injection site.

Limitations
Suckling Calves, Dairy Calves, and Veal Calves
Indication

For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis.

Dosage

Inject subcutaneously as a single dose in the neck at a dosage of 2.5 mg/kg (1 mL/22 lb) BW. Do not inject more than 11.5 mL per injection site.

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: No use class stated or implied • Suckling Calves, Dairy Calves, Veal Calves • Beef And Non-Lactating Dairy
Composition / specifications
100 mg of tulathromycin/mL
Beef and Non-Lactating Dairy Cattle
Indication

BRD: For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis; and for the control of respiratory disease in cattle at high risk of developing BRD associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis.

IBK: For the treatment of infectious bovine keratoconjunctivitis (IBK) associated with Moraxella bovis.

Foot Rot: For the treatment of bovine foot rot (interdigital necrobacillosis) associated with Fusobacterium necrophorum and Porphyromonas levii.

Dosage

Inject subcutaneously as a single dose in the neck at a dosage of 2.5 mg/kg (1.1 mL/100 lb) body weight (BW). Do not inject more than 10 mL per injection site.

Limitations
Suckling Calves, Dairy Calves, and Veal Calves
Indication

For the treatment of BRD associated with M. haemolytica, P. multocida, H. somni, and M. bovis.

Dosage

Inject subcutaneously as a single dose in the neck at a dosage of 2.5 mg/kg (1.1 mL/100 lb) body weight (BW). Do not inject more than 10 mL per injection site.

Limitations
Swine
Indication

For the treatment of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Bordetella bronchiseptica, Haemophilus parasuis, and Mycoplasma hyopneumoniae; and for the control of SRD associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, and Mycoplasma hyopneumoniae in groups of pigs where SRD has been diagnosed.

Dosage

Inject intramuscularly as a single dose in the neck at a dosage of 2.5 mg/kg (0.25 mL/22 lb) BW. Do not inject more than 2.5 mL per injection site.

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: No use class stated or implied • Suckling Calves, Dairy Calves, Veal Calves
Composition / specifications
25 mg tulathromycin/mL
Swine
Indication

For the treatment of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Bordetella bronchiseptica, Haemophilus parasuis, and Mycoplasma hyopneumoniae; and for the control of SRD associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, and Mycoplasma hyopneumoniae in groups of pigs where SRD has been diagnosed.

Dosage

Inject intramuscularly as a single dose in the neck at a dosage of 2.5 mg/kg (1 mL/22 lb) body weight (BW). Do not inject more than 4 mL per injection site.

Limitations
Suckling calves, dairy calves, and veal calves
Indication

For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis.

Dosage

Inject subcutaneously as a single dose in the neck at a dosage of 2.5 mg/kg (1 mL/22 lb) BW. Do not inject more than 11.5 mL per injection site.

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: Replacement Dairy Heifers • Beef heifers • Beef steers • Dairy bulls • Beef calves 2 months of age and older • Beef bulls
Composition / specifications
100 mg/mL tulathromycin and 120 mg/mL ketoprofen
Cattle (beef steers, beef heifers, beef calves 2 months of age and older, beef bulls, dairy bulls, and replacement dairy heifers)
Indication

For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis, and control of pyrexia associated with BRD in beef steers, beef heifers, beef calves 2 months of age and older, beef bulls, dairy bulls, and replacement dairy heifers.

Dosage

Inject subcutaneously as a single dose in the neck at a dosage of 2.5 mg tulathromycin and 3 mg ketoprofen/kg (1.1 mL/100 lb) bodyweight.

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: No use class stated or implied • Suckling Calves, Dairy Calves, Veal Calves • Beef And Non-Lactating Dairy
Composition / specifications
100 mg of tulathromycin/mL
Beef and Non-Lactating Dairy Cattle
Indication

For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis; and for the control of respiratory disease in cattle at high risk of developing BRD associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis.

For the treatment of infectious bovine keratoconjunctivitis (IBK) associated with Moraxella bovis.

For the treatment of bovine foot rot (interdigital necrobacillosis) associated with Fusobacterium necrophorum and Porphyromonas levii.

Dosage

Inject subcutaneously as a single dose in the neck at a dosage of 2.5 mg/kg (1.1 mL/100 lb) body weight (BW). Do not inject more than 10 mL per injection site.

Limitations
Suckling Calves, Dairy Calves, and Veal Calves
Indication

For the treatment of BRD associated with M. haemolytica, P. multocida, H. somni, and M. bovis.

Dosage

Inject subcutaneously as a single dose in the neck at a dosage of 2.5 mg/kg (1.1 mL/100 lb) body weight (BW). Do not inject more than 10 mL per injection site.

Limitations
Swine
Indication

For the treatment of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Bordetella bronchiseptica, Haemophilus parasuis, and Mycoplasma hyopneumoniae; and for the control of SRD associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, and Mycoplasma hyopneumoniae in groups of pigs where SRD has been diagnosed.

Dosage

Inject intramuscularly as a single dose in the neck at a dosage of 2.5 mg/kg (0.25 mL/22 lb) BW. Do not inject more than 2.5 mL per injection site.

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: No use class stated or implied • Suckling Calves, Dairy Calves, Veal Calves • Beef And Non-Lactating Dairy
Composition / specifications
100 mg of tulathromycin/mL
Beef and Non-Lactating Dairy Cattle
Indication

For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis; and for the control of respiratory disease in cattle at high risk of developing BRD associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis.

For the treatment of infectious bovine keratoconjunctivitis (IBK) associated with Moraxella bovis.

For the treatment of bovine foot rot (interdigital necrobacillosis) associated with Fusobacterium necrophorum and Porphyromonas levii.

Dosage

Inject subcutaneously as a single dose in the neck at a dosage of 2.5 mg/kg (1.1 mL/100 lb.) bodyweight (BW). Do not inject more than 10 mL per injection site.

Limitations
Suckling Calves, Dairy Calves, and Veal Calves
Indication

For the treatment of BRD associated with M. haemolytica, P. multocida, H. somni, and M. bovis.

Dosage

Inject subcutaneously as a single dose in the neck at a dosage of 2.5 mg/kg (1.1 mL/100 lb.) bodyweight (BW). Do not inject more than 10 mL per injection site.

Limitations
Swine
Indication

For the treatment of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Bordetella bronchiseptica, Haemophilus parasuis, and Mycoplasma hyopneumoniae; and for the control of SRD associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, and Mycoplasma hyopneumoniae in groups of pigs where SRD has been diagnosed.

Dosage

Inject intramuscularly as a single dose in the neck at a dosage of 2.5 mg/kg (0.25 mL/22 lb.) BW. Do not inject more than 2.5 mL per injection site.

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: No use class stated or implied • Suckling Calves, Dairy Calves, Veal Calves
Composition / specifications
25 mg/mL
Swine
Indication
For the treatment of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Bordetella bronchiseptica, Haemophilus parasuis, and Mycoplasma hyopneumoniae; and for the control of SRD associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, and Mycoplasma hyopneumoniae in groups of pigs where SRD has been diagnosed.
Dosage
Inject intramuscularly as a single dose in the neck at a dosage of 2.5 mg/ kg (1 mL/22 lb) Body Weight (BW).
Limitations
Do not inject more than 4 mL per injection site. For use in suckling calves, dairy calves, veal calves, and swine. Not for use in ruminating cattle. Not for use in Chickens or Turkeys. Federal (USA) law restricts this drug to useby or on the order of a licensed veterinarian.
Cattle (Calves)
Indication
For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis.
Dosage
Inject subcutaneously as a single dose in the neck at a dosage of 2.5 mg/kg (1 mL/22 lb) body weight (BW).
Limitations
Do not inject more than 11.5 mL per injection site. For use in suckling calves, dairy calves, veal calves, and swine. Not for use in ruminating cattle. Not for use in Chickens or Turkeys. Federal (USA) law restricts this drug to useby or on the order of a licensed veterinarian.

FDA page: Open in Animal Drugs @ FDA

Official Documents (FDA)

Direct links to FDA-hosted PDFs and SPL packages (when available).

Documents
  • Summary

    Beef cattle, non-lactating dairy cattle, suckling calves, dairy calves and veal calves

    BRD- Tulathromycin Injection is indicated for the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis; and for the control of respiratory disease in cattle at high risk of developing BRD associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis.

    IBK- Tulathromycin Injection is indicated for the treatment of infectious bovine keratoconjunctivitis (IBK) associated with Moraxella bovis.

    Foot Rot- Tulathromycin Injection is indicated for the treatment of bovine foot rot (interdigital necrobacillosis) associated with Fusobacterium necrophorum and Porphyromonas levii.

    Suckling Calves, Dairy Calves, and Veal Calves

    BRD- Tulathromycin Injection is indicated for the treatment of BRD associated with M. haemolytica, P. multocida, H. somni, and M. bovis.

    Swine

    Tulathromycin Injection is indicated for the treatment of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Bordetella bronchiseptica, Haemophilus parasuis, and Mycoplasma hyopneumoniae; and for the control of SRD associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, and Mycoplasma hyopneumoniae in groups of pigs where SRD has been diagnosed.

SPL Packages

FDA page: Open in Animal Drugs @ FDA

Documents
  • Summary

    Swine- For the treatment of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Bordetella bronchiseptica, Haemophilus parasuis, and Mycoplasma hyopneumoniae; and for the control of SRD associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, and Mycoplasma hyopneumoniae in groups of pigs where SRD has been diagnosed.
    Suckling Calves, Dairy Calves, and Veal Calves
    BRD- For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis.

SPL Packages

FDA page: Open in Animal Drugs @ FDA

Documents
  • Summary

    Beef and Non-Lactating Dairy Cattle
    BRD- For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis; and for the control of respiratory disease in cattle at high risk of developing BRD associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis.
    IBK- For the treatment of infectious bovine keratoconjunctivitis (IBK) associated with Moraxella bovis.
    Foot Rot- For the treatment of bovine foot rot (interdigital necrobacillosis) associated with Fusobacterium necrophorum and Porphyromonas levii. 
    Suckling Calves, Dairy Calves, and Veal Calves
    BRD- For the treatment of BRD associated with M. haemolytica, P. multocida, H. somni, and M. bovis.
    Swine- For the treatment of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Bordetella bronchiseptica, Haemophilus parasuis, and Mycoplasma hyopneumoniae; and for the control of SRD associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, and Mycoplasma hyopneumoniae in groups of pigs where SRD has been diagnosed.


SPL Packages

FDA page: Open in Animal Drugs @ FDA

Documents
  • Summary

    Swine: For the treatment of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Bordetella bronchiseptica, Haemophilus parasuis, and Mycoplasma hyopneumoniae; and for the control of SRD associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, and Mycoplasma hyopneumoniae in groups of pigs where SRD has been diagnosed.

    Suckling Calves, Dairy Calves, and Veal Calves: For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis.

SPL Packages

FDA page: Open in Animal Drugs @ FDA

Documents
  • Summary

    Beef and Non-Lactating Dairy Cattle

    BRD- For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis; and for the control of respiratory disease in cattle at high risk of developing BRD associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis.

    IBK- For the treatment of infectious bovine keratoconjunctivitis (IBK) associated with Moraxella bovis.

    Foot Rot- For the treatment of bovine foot rot (interdigital necrobacillosis) associated with Fusobacterium necrophorum and Porphyromonas levii.

    Suckling Calves, Dairy Calves, and Veal Calves

    BRD- For the treatment of BRD associated with M. haemolytica, P. multocida, H. somni, and M. bovis.

    Swine

    For the treatment of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Bordetella bronchiseptica, Haemophilus parasuis, and Mycoplasma hyopneumoniae; and for the control of SRD associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, and Mycoplasma hyopneumoniae in groups of pigs where SRD has been diagnosed.

SPL Packages

FDA page: Open in Animal Drugs @ FDA

Documents
  • Summary

    Beef and Non-Lactating Dairy Cattle: For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis; and for the control of respiratory disease in cattle at high risk of developing BRD associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis.

    For the treatment of infectious bovine keratoconjunctivitis associated with Moraxella bovis.

    For the treatment of bovine foot rot (interdigital necrobacillosis) associated with Fusobacterium necrophorum and Porphyromonas levii.

    Suckling Calves, Dairy Calves, and Veal Calves: For the treatment of BRD associated with M. haemolytica, P. multocida, H. somni, and M. bovis.

    Swine: For the treatment of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Bordetella bronchiseptica, Haemophilus parasuis, and Mycoplasma hyopneumoniae; and for the control of SRD associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, and Mycoplasma hyopneumoniae in groups of pigs where SRD has been diagnosed.

SPL Packages

FDA page: Open in Animal Drugs @ FDA

Documents
  • Summary

    Beef and Non-Lactating Dairy Cattle: For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis; and for the control of respiratory disease in cattle at high risk of developing BRD associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis.

    For the treatment of infectious bovine keratoconjunctivitis associated with Moraxella bovis.

    For the treatment of bovine foot rot (interdigital necrobacillosis) associated with Fusobacterium necrophorum and Porphyromonas levii.

    Suckling Calves, Dairy Calves, and Veal Calves: For the treatment of BRD associated with M. haemolytica, P. multocida, H. somni, and M. bovis.

    Swine: For the treatment of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Bordetella bronchiseptica, Haemophilus parasuis, and Mycoplasma hyopneumoniae; and for the control of SRD associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, and Mycoplasma hyopneumoniae in groups of pigs where SRD has been diagnosed.

SPL Packages

FDA page: Open in Animal Drugs @ FDA

Documents
SPL Packages

FDA page: Open in Animal Drugs @ FDA

Documents
  • Summary

    Beef and Non-Lactating Dairy Cattle: For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis; and for the control of respiratory disease in cattle at high risk of developing BRD associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis.

    For the treatment of infectious bovine keratoconjunctivitis (IBK) associated with Moraxella bovis.

    For the treatment of bovine foot rot (interdigital necrobacillosis) associated with Fusobacterium necrophorum and Porphyromonas levii.

    Suckling Calves, Dairy Calves, and Veal Calves: For the treatment of BRD associated with M. haemolytica, P. multocida, H. somni, and M. bovis.

    Swine: For the treatment of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Bordetella bronchiseptica, Haemophilus parasuis, and Mycoplasma hyopneumoniae; and for the control of SRD associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, and Mycoplasma hyopneumoniae in groups of pigs where SRD has been diagnosed.

SPL Packages

FDA page: Open in Animal Drugs @ FDA

Documents
  • Summary

    Swine: For the treatment of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Bordetella bronchiseptica, Haemophilus parasuis, and Mycoplasma hyopneumoniae; and for the control of SRD associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, and Mycoplasma hyopneumoniae in groups of pigs where SRD has been diagnosed.

    Suckling Calves, Dairy Calves, and Veal Calves: For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis.


SPL Packages

FDA page: Open in Animal Drugs @ FDA

Documents
  • Summary

    Beef and Non-Lactating Dairy Cattle: For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis; and for the control of respiratory disease in cattle at high risk of developing BRD associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis.

    For the treatment of infectious bovine keratoconjunctivitis (IBK) associated with Moraxella bovis.

    For the treatment of bovine foot rot (interdigital necrobacillosis) associated with Fusobacterium necrophorum and Porphyromonas levii.

    Suckling Calves, Dairy Calves, and Veal Calves: For the treatment of BRD associated with M. haemolytica, P. multocida, H. somni, and M. bovis.

    Swine: For the treatment of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Bordetella bronchiseptica, Haemophilus parasuis, and Mycoplasma hyopneumoniae; and for the control of SRD associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, and Mycoplasma hyopneumoniae in groups of pigs where SRD has been diagnosed.

SPL Packages

FDA page: Open in Animal Drugs @ FDA

Documents
  • Summary

    Swine: For the treatment of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Bordetella bronchiseptica, Haemophilus parasuis, and Mycoplasma hyopneumoniae; and for the control of SRD associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, and Mycoplasma hyopneumoniae in groups of pigs where SRD has been diagnosed.

    Suckling Calves, Dairy Calves, and Veal Calves: For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis.

SPL Packages

FDA page: Open in Animal Drugs @ FDA

Documents
  • Summary

    For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis, and control of pyrexia associated with BRD in beef steers, beef heifers, beef calves 2 months of age and older, beef bulls, dairy bulls, and replacement dairy heifers.

SPL Packages

FDA page: Open in Animal Drugs @ FDA

Documents
  • Summary

    Beef and Non-Lactating Dairy Cattle

    For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis; and for the control of respiratory disease in cattle at high risk of developing BRD associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis.

    For the treatment of infectious bovine keratoconjunctivitis (IBK) associated with Moraxella bovis.

    For the treatment of bovine foot rot (interdigital necrobacillosis) associated with Fusobacterium necrophorum and Porphyromonas levii.

    Suckling Calves, Dairy Calves, and Veal Calves

    For the treatment of BRD associated with M. haemolytica, P. multocida, H. somni, and M. bovis.

    Swine

    For the treatment of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Bordetella bronchiseptica, Haemophilus parasuis, and Mycoplasma hyopneumoniae; and for the control of SRD associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, and Mycoplasma hyopneumoniae in groups of pigs where SRD has been diagnosed.

SPL Packages

FDA page: Open in Animal Drugs @ FDA

Documents
  • Summary

    Beef and Non-Lactating Dairy Cattle

    For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis; and for the control of respiratory disease in cattle at high risk of developing BRD associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis.

    For the treatment of infectious bovine keratoconjunctivitis (IBK) associated with Moraxella bovis.

    For the treatment of bovine foot rot (interdigital necrobacillosis) associated with Fusobacterium necrophorum and Porphyromonas levii.

    Suckling Calves, Dairy Calves, and Veal Calves

    For the treatment of BRD associated with M. haemolytica, P. multocida, H. somni, and M. bovis.

    Swine

    For the treatment of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Bordetella bronchiseptica, Haemophilus parasuis, and Mycoplasma hyopneumoniae; and for the control of SRD associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, and Mycoplasma hyopneumoniae in groups of pigs where SRD has been diagnosed.



SPL Packages

FDA page: Open in Animal Drugs @ FDA

Documents
  • Summary
    This supplement provides for use in suckling calves, dairy calves, and veal calves for the treatment of BRD associated with M. haemolytica, P. multocida, H. somni, and M. bovis.
  • Summary
    For the treatment of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Bordetella bronchiseptica, Haemophilus parasuis, and Mycoplasma hyopneumoniae; and for the control of SRD associated with A. pleuropneumoniae, P. multocida, and M. hyopneumoniae in groups of pigs where SRD has been diagnosed.

FDA page: Open in Animal Drugs @ FDA

Usage

For the treatment of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae , Pasteurella multocida , Bordetella bronchiseptica , Haemophilus parasuis , and Mycoplasma hyopneumoniae ; and for the control of SRD associated with Actinobacillus pleuropneumoniae , Pasteurella multocida , and Mycoplasma hyopneumoniae in groups of pigs where SRD has been diagnosed. For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica , Pasteurella multocida , Histophilus somni , and Mycoplasma bovis . For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica , Pasteurella multocida , Histophilus somni , and Mycoplasma bovis , and control of pyrexia associated with BRD in beef steers, beef heifers, beef calves 2 months of age and older, beef bulls, dairy bulls, and replacement dairy heifers.

Source: FDA Animal Drugs @ FDA • Reference

Contraindications

Do not inject more than 4 mL per injection site. For use in suckling calves, dairy calves, veal calves, and swine. Not for use in ruminating cattle. Not for use in Chickens or Turkeys. Federal (USA) law restricts this drug to useby or on the order of a licensed veterinarian. Do not inject more than 11.5 mL per injection site. For use in suckling calves, dairy calves, veal calves, and swine. Not for use in ruminating cattle. Not for use in Chickens or Turkeys. Federal (USA) law restricts this drug to useby or on the order of a licensed veterinarian.

Side Effects

No approved side-effect narrative is linked yet.

openFDA reaction signals are available for Dog 8 and Cat 8 (view top reported reactions).

Top Reported Reactions (openFDA)

Aggregated reaction terms from FDA openFDA reports (not verified; does not prove causation).

Dog
Neurologic
Neurological signs NOS (1) Tiredness (lethargy) (1)
Effectiveness
Lack of efficacy (bacteria) - NOS (1) Lack of efficacy - NOS (1)
Other
Coughing up blood (1) Cutaneous emphysema (1) Injection site reaction NOS (1) Trouble breathing (dyspnea) (1)
Cat
Neurologic
Neurological signs NOS (2)
Effectiveness
Lack of efficacy - NOS (2)
Other
Blindness (3) Elevated alanine aminotransferase (2) Elevated aspartate aminotransferase (2) Elevated blood urea nitrogen (2) Head bobbing (2) Vocalisation (2)

Data source: FDA openFDA Animal & Veterinary adverse event reports.

Adverse Event Case Summaries (openFDA)

These are individual FDA adverse event reports. They are unverified and do not prove the medication caused the reaction.

Dog, Poodle (unspecified), Male, 16.964 kilogram • Drug: MSK, Injection, Unknown, Dose: 0.50 mL per animal • Reactions: Cutaneous emphysema, Coughing up blood, Pneumothorax • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2024-US-068637
  • Serious AE: Yes
  • Treated For AE: No
  • Sex: Male
  • Weight: 16.964 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
  • Form: Injection
  • Dose: 0.50 mL per animal
Reactions Reported:
Cutaneous emphysema Coughing up blood Pneumothorax
Outcomes: Ongoing

Cat, Cat (unknown), Male, 10 year, 4 kilogram • Drug: MSK, Subcutaneous, Dose: 0.15 mL per animal • Reactions: Blindness, Neurological signs NOS, Vocalisation, Elevated alanine aminotransferase, Elevated aspartate aminotransferase… • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2024-US-013392
  • Serious AE: Yes
  • Treated For AE: No
  • Sex: Male
  • Age: 10.00 Year
  • Weight: 4.000 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Subcutaneous
  • Dose: 0.15 mL per animal
Reactions Reported:
Blindness Neurological signs NOS Vocalisation Elevated alanine aminotransferase Elevated aspartate aminotransferase Elevated blood urea nitrogen Head bobbing
Outcomes: Ongoing

Cat, Domestic Shorthair, Male, 10 year, 4 kilogram • Drug: MSK, Injection, Subcutaneous, Dose: 0.15 mL per animal • Reactions: Blindness, Neurological signs NOS, Vocalisation, Elevated alanine aminotransferase, Elevated aspartate aminotransferase… • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2024-US-005492
  • Serious AE: Yes
  • Treated For AE: No
  • Sex: Male
  • Age: 10.00 Year
  • Weight: 4.000 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Subcutaneous
  • Form: Injection
  • Dose: 0.15 mL per animal
Reactions Reported:
Blindness Neurological signs NOS Vocalisation Elevated alanine aminotransferase Elevated aspartate aminotransferase Elevated blood urea nitrogen Head bobbing
Outcomes: Ongoing

Cat, Cat (other), Unknown • Drug: MSK, Injection, Unknown, Dose: 0.50 mL per animal • Reactions: Blindness • Outcome: Outcome Unknown

  • Report ID: USA-USFDACVM-2022-US-050395
  • Serious AE: Yes
  • Treated For AE: No
  • Sex: Unknown
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
  • Form: Injection
  • Dose: 0.50 mL per animal
Reactions Reported:
Blindness
Outcomes: Outcome Unknown

Dog, Great Pyrenees, Female, 19 week, 11.703 kilogram • Drug: MSK, Solution, Unknown • Reactions: Oral cavity disorder NOS • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2022-US-030251
  • Serious AE: No
  • Treated For AE: No
  • Sex: Female
  • Age: 19.00 Week
  • Weight: 11.703 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
  • Form: Solution
Reactions Reported:
Oral cavity disorder NOS
Outcomes: Ongoing

Dog, Deutsche Dogge, Great Dane, Unknown, 9 month, 35.834 kilogram • Drug: MSK, Injection, Subcutaneous, Dose: 1.50 mL per animal • Reactions: Lack of efficacy (bacteria) - NOS, Overdose • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2022-US-005144
  • Serious AE: No
  • Treated For AE: No
  • Sex: Unknown
  • Age: 9.00 Month
  • Weight: 35.834 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Subcutaneous
  • Form: Injection
  • Dose: 1.50 mL per animal
Reactions Reported:
Lack of efficacy (bacteria) - NOS Overdose
Outcomes: Ongoing

Cat, Domestic Mediumhair, Female, 4 year • Drug: MSK, Injection, Unknown • Reactions: Lack of efficacy - NOS • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2020-US-023278
  • Serious AE: No
  • Treated For AE: No
  • Sex: Female
  • Age: 4.00 Year
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
  • Form: Injection
Reactions Reported:
Lack of efficacy - NOS
Outcomes: Ongoing

Dog, ['Siberian Husky', 'Poodle (unspecified)'], Male, 11 week, 6.804 kilogram • Drug: MSK, Injection, Unknown • Reactions: Lack of efficacy - NOS • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2020-US-015293
  • Serious AE: No
  • Treated For AE: Yes
  • Sex: Male
  • Age: 11.00 Week
  • Weight: 6.804 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
  • Form: Injection
Reactions Reported:
Lack of efficacy - NOS
Outcomes: Ongoing

Data source: FDA openFDA Animal & Veterinary adverse event reports.

Overdose Information

No approved overdose-management text is linked yet. If overdose is suspected, contact a veterinarian or emergency clinic immediately.

Storage & Handling

No approved storage guidance is linked yet for this ingredient. Use manufacturer packaging and veterinary guidance for handling/storage.

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This medication has not been reviewed by a veterinarian yet.