Land: Israel
Språk: engelsk
Kilde: Ministry of Health
DIHYDROSTREPTOMYCIN AS SULFATE; NAFCILLIN AS SODIUM; PROCAINE BENZYLPENICILLIN
INTERVET ( ISRAEL) LTD
OINTMENT
PROCAINE BENZYLPENICILLIN 300 MG / 3 G; DIHYDROSTREPTOMYCIN AS SULFATE 100 MG / 3 G; NAFCILLIN AS SODIUM 100 MG / 3 G
INTRAMAMMARY
Required
INTERVET INTERNATIONAL B.V. (MSD ANIMAL HEALTH), NETHERLANDS
Treatment of mastitis in cows during the dry period caused by penicillin, nafcillin and streptomycin sensitive microorganisms.
2017-10-31
CONSUMER PACKAGE INSERT FOR VETERINARY MEDICINAL PRODUCT THE MEDICINE IS DISPENSED WITH A VETERINARIAN’S PRESCRIPTION ONLY FOR USE IN ANIMALS ONLY 1. NAME OF THE MEDICINE: Nafpenzal DC Veterinary Intramammary Ointment 2. COMPOSITION: Each 3 g syringe contains the following active ingredients: Procaine benzylpenicillin 300 mg (300,000 I.U.) Dihydrostreptomycin (as sulfate) 100 mg Nafcillin (as sodium) 100 mg A list of the inactive ingredients is detailed in section 13 – “Further information”. 3. WHAT THE MEDICINE IS INTENDED FOR: For treatment of cows during the dry period, for mastitis caused by bacteria susceptible to penicillin, streptomycin or nafcillin. Therapeutic group: A combination of antibacterial agents for intramammary use; combinations of procaine benzylpenicillin with other antibacterial agents. 4. CONTRAINDICATIONS: Do not use in cases of hypersensitivity to penicillin, nafcillin or dihydrostreptomycin, or to the inactive ingredients. Do not use in lactating cows. 5. SIDE EFFECTS: In very rare cases (less than one animal in 10,000 animals, including isolated reports), hypersensitivity (allergic) reactions have been observed. If you have noticed any serious effects or other effects not mentioned in this consumer leaflet, please inform your veterinarian. Side effects can be reported to the Ministry of Health by clicking on the link “Reporting Side Effects due to Drug Treatment” found on the Ministry of Health homepage (www.health.gov.il), that directs you to the online form for reporting side effects, or by entering the link: HTTP://SIDEEFFECTS.HEALTH.GOV.IL 6. TARGET ANIMALS: Cows during the dry period 7. METHOD OF ADMINISTRATION AND DOSAGE: An ointment for intramammary administration. The content of one syringe is infused into each quarter of an udder via the teat canal when the cow is dried off at the end of the lactation period. 8. HOW TO USE THE MEDICINAL PRODUCT: Before administration, milk the udder completely dry and thoroughly clean the end of the teat. Break off the tip of the ca Les hele dokumentet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Nafpenzal DC Veterinary 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 3 g syringe contains: ACTIVE SUBSTANCES: Procaine benzylpenicillin 300 mg Dihydrostreptomycin (as the sulfate) 100 mg Nafcillin (as the sodium salt) 100 mg For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Intramammary ointment. White, to off-white ointment. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Dry cows 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Treatment of mastitis in cows during the dry period caused by penicillin, nafcillin and streptomycin sensitive microorganisms. _ _ 4.3 CONTRAINDICATIONS Do not use in cases of hypersensitivity to penicillin, nafcillin or dihydro-streptomycin, or to any of the excipients listed in section 6.1. Do not use in lactating animals. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals Do not transfer the syringe from one teat to another. 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 reactions to cephalosporins and _vice versa_ . Allergic reactions to these substances are occasionally 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 product with great care to avoid exposure, taking all recommended precautions. 3. If you develop symptoms following exposure, such as a skin rash, you should seek medical advice and show the doctor this warning. Swelling of the face, lips or eyes or difficulty with breathing are more serious symptoms and require urgent medical attention. 4. It is recommended to avoid contact with the active ingredient and to use gloves. 4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS) All Les hele dokumentet