Country: Իռլանդիա
language: անգլերեն
source: HPRA (Health Products Regulatory Authority)
Oxytetracycline dihydrate; Flunixin meglumine
Norbrook Laboratories (Ireland) Limited
QJ01AA56
Oxytetracycline dihydrate; Flunixin meglumine
300,20 milligram(s)/millilitre
Solution for injection
POM: Prescription Only Medicine as defined in relevant national legislation
oxytetracycline, combinations
Authorised
1999-02-05
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Hexasol LA Solution for Injection (IE) Hexasol Solution for Injection for Cattle (AT, PT) Covunil (FR) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: _Active substance: _ Oxytetracylcine (as oxytetracycline dehydrate) 300mg Flunixin (as flunixin meglumine) 20 mg _Excipients: _ Sodium Formaldehyde Sulphoxylate 4.0 mg For a full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Solution for injection. A clear dark amber solution. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the treatment of acute respiratory disease caused by oxytetracycline sensitive _ Mannheimia _ _(Pasteurella) haemolytica _ and _Pasteurella multocida _ where an anti-inflammatory and anti-pyretic effect is required. 4.3 CONTRAINDICATIONS Use is contraindicated in animals suffering from cardiac, hepatic or renal disease, where there is a possibility of gastrointestinal ulceration or bleeding or where there is hypersensitivity to one of the ingredients of the product. Avoid use in dehydrated hyopyolaemic or hypotensive animals as there is a potential risk of increased renal toxicity. Do not use in cases of known resistance to tetracyclines. Refer to section 4.11 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. 4.5 SPECIAL PRECAUTIONS FOR USE Special Precautions for use in animals: Use in any animals less than 6 weeks of age or in aged animals may involve additional risk due to the anti-prostaglandin effects of flunixin on renal function. If such use cannot be avoided, animals may require careful clinical management. Use of the product should be based on susceptibility testing of the bacteria isolated from the animal. If this is not possible, therapy should be based on local (regional, farm level) epidemiological information about susceptibility of the target bacteria. Flunixin is toxic to avian scavengers. Do not administer to animals susceptible to enter wild fauna food chain. In read_full_document