Country: Ireland
Bahasa: Inggeris
Sumber: HPRA (Health Products Regulatory Authority)
Bismuth subnitrate, heavy
Norbrook Laboratories (Ireland) Limited
QG52X
Bismuth subnitrate, heavy
2.6 g/syringe
Intramammary suspension
LR: Licensed Retailer as defined in national legislation
VARIOUS PRODUCTS FOR TEATS AND UDDER
Authorised
2013-07-26
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Sureseal 2.6g Intramammary Suspension for Cattle (IE, FR, UK) Noroseal 2.6g Intramammary Suspension for Cattle (BE, ES, IT, NL, PT) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 4g Intramammary syringe contains: ACTIVE SUBSTANCE: Bismuth subnitrate, heavy 2.6g For the full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Intramammary suspension Light brown suspension. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle (dairy cows) 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Prevention of new intramammary infections throughout the dry period. In cows considered likely to be free of sub-clinical mastitis, the product may be suitable for use on its own in dry cow management for mastitis control. Selection of cows for treatment with the product should be based on veterinary clinical judgement. Selection criteria may be based on the mastitis and cell count history of individual cows, or recognised tests for the detection of sub- clinical mastitis such as bacteriological sampling. 4.3 CONTRAINDICATIONS See section 4.7. Do not use in lactating cows. Do not use the product alone in cows with sub-clinical mastitis at drying off. Do not use in cows with clinical mastitis at drying off. Do not use in cases of hypersensitivity to the active substance or to any of the excipients. 4.4 SPECIAL WARNINGS None 4.5 SPECIAL PRECAUTIONS FOR USE (i) Special precautions for use in animals It is good practice to observe dry cows regularly for signs of clinical mastitis. If a sealed quarter develops clinical mastitis, the affected quarter should be stripped out manually before appropriate therapy is instituted. To reduce the risk of contamination, do not immerse the syringe in water. Use the syringe only once. Since the product does not have antimicrobial activity, in order to minimise the risk of acute mastitis due to poor infusion technique and lack of hygiene (see section 4.6), it is crucial to follow the aseptic technique of administ Baca dokumen lengkap