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Draxxin

Species

Cattle, pigs, sheep.

Composition Composition per ml:  
- Active substance: Tulathromycin 100 mg  
- Excipients: Monothioglycerol 5 mg
Indications

Cattle:  
- Treatment and metaphylaxis of bovine respiratory disease (BRD) caused by Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis. The presence of the disease in the herd must be confirmed before use.  
- Treatment of infectious bovine keratoconjunctivitis (IBK) caused by Moraxella bovis susceptible to tulathromycin.  

Swine:  
- Treatment and metaphylaxis of swine respiratory disease (SRD) caused by Actinobacillus pleuropneumoniae, Pasteurella multocida, Mycoplasma hyopneumoniae, Haemophilus parasuis, and Bordetella bronchiseptica. The product should be used only if pigs are expected to develop signs of disease within the next 2–3 days.  

Sheep:  
- Treatment of early-stage infectious pododermatitis (footrot) associated with virulent Dichelobacter nodosus, requiring systemic treatment.

Dosage and method of administration

Cattle  
- Subcutaneous administration: A single subcutaneous injection of 2.5 mg tulathromycin/kg body weight (equivalent to 1 ml/40 kg body weight).  
- For cattle over 300 kg, the dose should be split so that no more than 7.5 ml is administered at a single injection site.  

Swine  
- Intramuscular administration: A single intramuscular injection of 2.5 mg tulathromycin/kg body weight (equivalent to 1 ml/40 kg body weight) in the neck region.  
- For pigs over 80 kg, the dose should be split so that no more than 2 ml is administered at a single injection site.  

Sheep  
- Intramuscular administration: A single intramuscular injection of 2.5 mg tulathromycin/kg body weight (equivalent to 1 ml/40 kg body weight) in the neck region.  

Correct Administration Recommendations  
- Treatment should be administered in the early stages of respiratory disease. The response should be evaluated within 48 hours of injection.  
- If symptoms persist, worsen, or reoccur, an alternative antibiotic should be used, and treatment should continue until clinical signs resolve.  
- Body weight must be accurately determined to ensure correct dosing and avoid underdosing.  
- For multi-dose vials requiring multiple punctures, a draw-off needle or multi-dose syringe should be used to prevent excessive puncturing of the rubber stopper.

Contraindications Do not use in cases of hypersensitivity to macrolide antibiotics or any of the excipients.
Waiting period

Cattle (meat and offal): 22 days.  
Pigs (meat and offal): 13 days.  
Sheep (meat and offal): 16 days.  

Not authorized for use in animals producing milk for human consumption.  
Do not use in pregnant animals intended to produce milk for human consumption within 2 months before the expected calving date.

Release form

Type I glass vial with a chlorobutyl stopper coated with fluoropolymer and an aluminum seal.  

Packaging sizes:  
- Carton box containing one 20 ml vial.  
- Carton box containing one 50 ml vial.  
- Carton box containing one 100 ml vial.  
- Carton box containing one 250 ml vial.  
- Carton box containing one 500 ml vial.  

500 ml vials must not be used for pigs and sheep.  
*Not all packaging sizes may be marketed.

Storage conditions Store in a dark place, separate from food and feed, at T°C 5°C + 25°C, in places inaccessible to children.
Shelf life

3 years from the date of production, from the first opening – 3 months.

Do not use after the expiry date indicated on the packaging.