国: アイルランド
言語: 英語
ソース: HPRA (Health Products Regulatory Authority)
Procaine benzylpenicillin
Norbrook Laboratories (Ireland) Limited
QJ01CE01
Procaine benzylpenicillin
300 milligram(s)/millilitre
Suspension for injection
POM: Prescription Only Medicine as defined in relevant national legislation
benzylpenicillin
Authorised
1987-10-01
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Norocillin 300 mg/ml Suspension for Injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: ACTIVE SUBSTANCE: Procaine Benzylpenicillin 300 mg EXCIPIENTS: *Hydroxybenzoate esters 1.5 mg (*containing Ethyl Parahydroxybenzoate (E214), Propyl Parahydroxybenzoate (E216), Methyl Parahydroxybenzoate (E218) For a full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Suspension for injection. White/off-white suspension. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Horses, Cows, Sheep, Pigs. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the treatment of systemic infections caused by or associated with organisms sensitive to penicillin. _ In vitro_ tests have shown the following organisms to be sensitive: _Corynebacterium pyogenes _ _ _ _Erysipelothrix rhusiopathiae _ _Listeria _spp. _Pasteurella haemolytica _ _ _ _Pasteurella multocida _ _Staphylococcus_ spp (non penicillinase producing) _Streptococcus_ spp. 4.3 CONTRAINDICATIONS Do not inject intravenously. Do not use in known cases of hypersensitivity to penicillins. Do not use in sheep producing milk for human consumption. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Occasionally in suckling and fattening pigs, administration of Norocillin may cause a transient pyrexia, vomiting, shivering, listlessness and inco-ordination. 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTION(S) FOR USE IN ANIMALS Administer by deep injection only. SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE VETERINARY MEDICINAL PRODUCT TO ANIMALS Penicillin and cephalosporins may cause hypersensitivity (allergy) following injection, inhalation, ingestion or skin contact. Hypersensitivity to penicillin may lead to cross sensitivity to cephalosporins and vice versa. Allergic reaction to these substances may occasionally be serious. 1. Do not handle this product if you know you are sensitised, or if you have been advised not to work with such preparations. 2. Handle this p 完全なドキュメントを読む