الحصن الحصين البيطرية
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ZUPREVO | Tildipirosin | For bovine respiratory disease
For Veterinary Use Only.
ZUPREVO For the treatment and prevention of bovine respiratory disease (BRD) associated with Mannheimia , Pasteurella and Histophilus sensitive to tildipirosin.
COMPOSITION
ZUPREVO contains:
Active substance:
Tildipirosin 180 mg/ml
Excipients:
Citric acid monohydrate
Propylene glycol
Water for injections
PHARMACEUTICAL FORM
ZUPREVO is a clear yellowish solution for injection containing 180 mg/ml of tildipirosin.
TARGET SPECIES
Cattle.
INDICATIONS
For the treatment and prevention of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida and Histophilus somni sensitive to tildipirosin.
The presence of the disease in the herd should be confirmed before preventive treatment.
DOSAGE FOR EACH SPECIES
Administer 4 mg tildipirosin/kg body weight (equivalent to 1 ml/45 kg body weight) once only.
METHOD AND ROUTE OF ADMINISTRATION
Subcutaneous use.
ADVICE ON CORRECT ADMINISTRATION
ZUPREVO is used for treatment of cattle over 450 kg body weight, divide the dose so that no more than 10 ml are injected at one site.
The rubber stopper of the vial may be safely punctured up to 20 times.
Otherwise, the use of a multiple-dose syringe is recommended.
To ensure correct dosage and to avoid underdosing, body weight should be determined as accurately as possible.
It is recommended to treat animals in the early stages of the disease and to evaluate the response to treatment within 2 to 3 days after injection. If clinical signs of respiratory disease persist or increase, treatment should be changed using another antibiotic and continued until clinical signs have resolved.
CONTRAINDICATIONS
Do not use ZUPREVO in case of hypersensitivity to macrolide antibiotics, citric acid monohydrate or propylene glycol.
ADVERSE REACTIONS
Pain on injection and injection site swellings are very common in treated animals.
Following the maximum recommended injection site volume of 10 ml, injection site swellings may be associated with pain on palpation for about one day in individual animals.
The swellings are transient and will usually resolve within 7 to 16 days; in individual animals swellings may persist for 21 days.
Pathomorphological injection site reactions will largely resolve within 35 days.
If you notice any serious effects or other effects not mentioned in this package leaflet, please inform your veterinary surgeon.
WITHDRAWAL PERIODS
Cattle (Meat and offal): 47 days.
Do not use it in lactating cattle producing milk for human consumption.
Do not use in pregnant cows or heifers within 2 months of expected parturition when the milk produced is intended for human consumption.
SPECIAL WARNINGS
Precautions for use in animals:
-There may be cross resistance with other macrolides.
-Do not administer with antimicrobials of a similar mode of action such as other macrolides or lincosamides.
-Whenever possible, the veterinary medicinal product should only be used based on susceptibility testing.
-Official, national and regional antimicrobial
policies should be taken into account when the veterinary medicinal product is used.
-The safety of the veterinary medicinal product has not been established during pregnancy and lactation of cattle. However, there was no evidence for any selective developmental or reproductive effects in any of the laboratory studies.
-Use only accordingly to the benefit/risk assessment by the responsible veterinarian.
-Overdoses of 10 times the recommended dose as well as repeated subcutaneous administration of the veterinary medicinal product only led to transient clinical signs attributed to injection site discomfort and injection site swellings associated with pain in some animals.
-In the absence of compatibility studies, ZUPREVO must not be mixed with other veterinary medicinal products.
Precautions for the person administering ZUPREVO:
-Special caution should be taken to avoid accidental self-injection.
-In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
-Do not use in automatically powered syringes which have no additional protection system.
Tildipirosin may cause sensitisation by skin contact.
-If accidental skin exposure occurs, wash the skin immediately with soap and water.
-If accidental eye exposure occurs, flush eyes immediately with clean water.
-Wash hands after use.
-Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
To report any side effect:
National pharmacovigilance Center (NPC).
SPECIAL STORAGE CONDITIONS
Keep ZUPREVO out of the reach and sight of children.
Do not store above 30 °C.
Do not use after the expiry date which is stated on the vial.
Shelf-life after first opening the vial: 28 days.
Vendor Information
- Store Name: الحصن الحصين البيطرية
- Vendor: الحصن الحصين البيطرية
- Address: Riyadh
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