البلد: إسرائيل
اللغة: الإنجليزية
المصدر: Ministry of Health
OXYTETRACYCLINE AS DIHYDRATE
COMEX LTD
SOLUTION FOR INJECTION
OXYTETRACYCLINE AS DIHYDRATE 200 MG/ML
I.M
Required
NORBROOK LABORATORIES LTD, IRELAND
Antibiotic, treatment of sensitive microorganisms in cattle, pigs and sheep.
2014-07-31
VETERINARY MEDICINE USER LEAFLET Veterinarian Prescription only medicine For animal use only 1. NAME, FORM AND STRENGTH OF THE VETERINARY MEDICINE: _ALAMYCIN LA VETERINARY, SOLUTION FOR INJECTION, 200 MG/ML_ 2. ACTIVE INGREDIENT: Each 1 ml of the medicine contains: _Oxytetracycline (as Dihydrate) _ _200 mg _ The medicine also contains the excipient: Sodium Formaldehyde Sulphoxylate 2 mg For a full list of excipients, see section 13 “further information” . 3. INDICATIONS FOR USE: Antibiotic treatment of sensitive microorganisms in cattle, pigs and sheep. THERAPEUTIC GROUP: Antibiotic. 4. CONTRAINDICATIONS: Do not use in animals suffering from hepatic or renal damage. Do not use in animals with known hypersensitivity to Oxytetracycline. 5. ADVERSE REACTIONS: Although well tolerated, occasionally a slight local reaction of a transient nature has been observed. Hypersensitivity reactions, including anaphylaxis (sometimes fatal), have been reported very rarely. 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, pigs and sheep 7. AMOUNTS TO BE ADMINISTERED AND ADMINISTRATION ROUTE: The recommended dose rate is 20 mg/kg bodyweight (i.e., 1 ml per 10 kg bodyweight) administered by deep intramuscular injection. 8. HOW TO USE THE PRODUCT: Maximum recommended dose at any one site: Cattle: 20 ml Pigs: 5.5 ml Sheep: 5 ml Piglets: 1 day 0.2 ml 7 days 0.3 ml 14 days 0.4 ml 21 days 0.5 ml over 21 days 1.0 ml/10 kg 9. WITHDRAWAL PERIOD: CATTLE: Meat and offal: 35 days Milk: 8 days PIGS: Meat and offal: 20 days SHEEP: Meat and offal:20 days Milk: 8 days 10. WARNINGS: • Special precautions regarding the use of the medicine for the target animal: None. • Special safety precautions regarding the use of the medicine in animals: D اقرأ الوثيقة كاملة
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Alamycin L.A. Veterinary 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: Active substance Oxytetracycline (as Dihydrate) 200 mg Excipient Sodium Formaldehyde Sulphoxylate 2 mg For a full list of excipients see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection. A clear amber solution 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle, pigs and sheep. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Antibiotic, treatment of sensitive microorganisms in cattle, pigs and sheep. 4.3 CONTRAINDICATIONS Do not use in animals suffering from hepatic or renal damage. Do not use in animals with known hypersensitivity to Oxytetracycline. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS Do not dilute Alamycin LA. If concurrent treatment is administered, use a separate injection site. SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE MEDICINAL PRODUCT TO ANIMALS In case of contact with eyes or skin, wash immediately with water as irritation may occur. Wash hands after use. Take care to avoid accidental injection. 4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS) Although well tolerated, occasionally a slight local reaction of a transient nature has been observed. Hypersensitivity reactions, including anaphylaxis (sometimes fatal), have been reported very rarely. Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation by using an online form: https://sideeffects.health.gov.il 4.7 USE DURING PREGNANCY, LACTATION OR LAY The use of tetracycline during the period of tooth and bone development, including late pregnancy may lead to tooth discoloration. Alamycin LA can be safe اقرأ الوثيقة كاملة