Pays: Israël
Langue: anglais
Source: Ministry of Health
DIHYDROSTREPTOMYCIN SULFATE; PROCAINE BENZYLPENICILLIN
COMEX LTD
SUSPENSION FOR INJECTION
PROCAINE BENZYLPENICILLIN 200 MG/ML; DIHYDROSTREPTOMYCIN SULFATE 250 MG/ML
I.M
Required
NORBROOK LABORATORIES LIMITED, NORTHERN IRELAND
Treatment of infection caused orassociated with organisms sensitive to penicillin and/or streptomycin in cattle, horses, pigs and sheep.
2021-04-30
VETERINARY MEDICINE USER LEAFLET Veterinarian Prescription Only Medicine For Animal Use Only 1. NAME AND FORM OF THE VETERINARY MEDICINE: _PEN & STREP VETERINARY, SUSPENSION FOR INJECTION _ 2. ACTIVE INGREDIENTS: Each 1 ml of the medicine contains: _Procaine Penicillin _ _200 mg _ _ _ _Dihydrostreptomycin Sulphate _ _250 mg _ The medicine also contains the excipients: Hydroxybenzoate Esters (as Nipasept Sodium) 1.5mg as antimicrobial preservative. Sodium Formaldehyde Sulphoxylate dihydrate 1.25mg as antioxidant. For a full list of excipients, see section 13 “Further Information”. 3. INDICATIONS FOR USE: Treatment of infection caused by or associated with organisms sensitive to penicillin and/or streptomycin in cattle, horses, pigs and sheep. THERAPEUTIC GROUP: Antibacterials for systemic use. 4. CONTRAINDICATIONS: Contraindicated in known cases of hypersensitivity to penicillins. 5. ADVERSE REACTIONS: In rare cases, hypersensitivity reactions can occur and very rarely, these can be fatal. Very rarely, in sucking and fattening pigs, administration may cause a transient pyrexia, vomiting, shivering, listlessness and incoordination. A palpable but transient local reaction may occur at the site of intramuscular administration in horses. Side effects can be reported to the Ministry of Health by clicking on the link “Reporting adverse events due to drug treatment” found on the home page of the Ministry of Health website (www.health.gov.il), which refers to the online form for reporting adverse events, or by entering the link: https://sideeffects.health.gov.il 6. TARGET SPECIES: Cattle, horses, pigs, sheep. 7. AMOUNT TO BE ADMINISTERED AND ADMINISTRATION ROUTE: Administer by deep intramuscular injection. Recommended dosage rate is 8 mg/kg bodyweight procaine penicillin with 10 mg/kg bodyweight dihydrostreptomycin sulphate equivalent to 1 ml / 25 kg bodyweight. Treatment should be given once daily for up to 3 consecutive days. 8. HOW TO USE THE PRODUCT: Shake the vial before use. The maximum dose volume administe Lire le document complet
Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Pen & Strep Veterinary 2. QUALITATIVE AND QUANTITATIVE COMPOSITION _ACTIVE SUBSTANCES _ Procaine Penicillin 200 mg Dihydrostreptomycin Sulphate 250 mg _EXCIPIENTS _ The product also contains 1.5mg Hydroxybenzoate Esters (as Nipasept Sodium) as antimicrobial preservative and 1.25mg sodium formaldehyde sulphoxylate dihydrate as antioxidant. For a full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Suspension for Injection A white to off-white aqueous suspension for injection. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle Horses Sheep Pigs 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the treatment of systemic infections in cattle, horses, sheep and pigs caused by or associated with organisms sensitive to penicillin and/or streptomycin including: _Arcanobacterium pyogenes _ _Erysipelothrix rhusiopathiae _ _Klebsiella pneumoniae _ _Listeria _spp _Mannheimia haemolytica _ _Pasteurella multocida _ _Staphylococcus _spp (non-penicillinase producing) Page 2 of 6 _Streptococcus _spp _Salmonella _spp 4.3 CONTRAINDICATIONS Contraindicated in known cases of hypersensitivity to penicillins. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Use with care in animals known to have kidney disease or defective renal function. Do not exceed the recommended dosage or duration of treatment. 4.5 SPECIAL PRECAUTIONS FOR USE i. Special precautions for use in animals: Care should be taken not to exceed the recommended dosage. Aminoglycosides have a narrower margin of safety than beta lactam antibiotics. ii. Special precautions to be taken by the person administering the product to the animals: Care should be taken to avoid accidental self-injection. In the case of accidental self-injection, seek medical advice immediately. Penicillins and cephalosporins may cause hypersensitivity (allergy) following injection, inhalation, ingestion or skin contact. Hypersensitivity to penicillins may lead to cross-reactions to cephalosporins Lire le document complet