Draxxin Plus

1 x 50 ml
Liquid for injection, solution
SC

Species

Cattle.

Indications

Treatment of bovine respiratory disease (BRD) associated with pyrexia due to Mannheimia haemolytica, Pasteurella multocida, Histophilus somni and Mycoplasma bovis susceptible to tulathromycin.

Dose to be administered and administration route

Subcutaneous use.

A single subcutaneous injection of 2.5 mg tulathromycin/kg bodyweight and 3 mg ketoprofen/kg bodyweight (equivalent to 1 ml/40 kg bodyweight). For treatment of cattle over 400 kg bodyweight, divide the dose so that no more than 10 ml are injected at one site.

To ensure correct dosage bodyweight should be determined as accurately as possible to avoid underdosing.

For any respiratory disease, it is recommended to treat animals in the early stages of the disease and to evaluate the response to treatment within 48 hours after injection. If clinical signs of respiratory disease persist or increase, or if relapse occurs, treatment should be changed, using another antibiotic, and continued until clinical signs have resolved.

If there is persistent elevated body temperature 24 hours after treatment initiation, the responsible veterinarian must evaluate the necessity of further anti-pyretic treatment.

The stopper may be safely punctured up to 20 times. When treating groups of animals in one run, use a draw-off needle that has been placed in the vial stopper or an automatic syringe to avoid excessive broaching of the stopper.

The draw-off needle should be removed after treatment.

Adverse reactions

Cattle:

Very common

(>1 animal / 10 animals treated):

injection site pain1

injection site swelling1,2

injection site reaction2

injection site oedema2

injection site fibrosis2

injection site haemorrhage2

Very rare

(<1 animal / 10,000 animals treated, including isolated reports):

digestive tract disorder

renal disorder

hypersensitivity reactions (e.g. anaphylaxis, dyspnoea, collapse)3

1 May persist for up to 32 days after injection

2 Pathomorphological injection site reactions are present for approximately 32 days after injection.

3  In case of such an allergic or anaphylactic reaction, appropriate symptomatic treatment should be administered immediately.


Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or its local representative or the national competent authority via the national reporting system. See also the last section of the package leaflet for respective contact details. See also section 16 of the package leaflet for respective contact details.

EMA Categorisation

C
Cattle
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Art. Nr. 42058/5100
EAN 5414736050386
PACKAGES
Draxxin Plus
Zoetis
1 x 50 ml
42058/5100
Draxxin Plus
Zoetis
1 x 100 ml
42058/5100
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