Država: Irska
Jezik: engleski
Izvor: HPRA (Health Products Regulatory Authority)
Bismuth subnitrate, heavy
Zoetis Belgium S.A.
QG52X
Bismuth subnitrate, heavy
2.6 gram(s)
Intramammary suspension
LR: Licensed Retailer as defined in national legislation
VARIOUS PRODUCTS FOR TEATS AND UDDER
Authorised
2020-11-20
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Orbeseal Dry Cow 2.6 g intramammary suspension for cattle [AT, BE, BG, HR, CY, DE, FI, EL, IT, LU, NL, NO, PT, RO, SI, ES, SE, United Kingdom (NI)] Orbesealer Vet – 2.6 g intramammary suspension for cattle [DK] Boviseal Dry cow intramammary suspension for cattle [IE] Orbeseal Dry cow intramammary suspension for cattle [FR] 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 4 g intramammary syringe contains: ACTIVE SUBSTANCE: Bismuth subnitrate, heavy 2.6 g (equivalent to Bismuth, heavy 1.858 g) EXCIPIENTS: QUALITATIVE COMPOSITION OF EXCIPIENTS AND OTHER CONSTITUENTS Liquid paraffin Aluminium Di Tri Stearate Silica, Colloidal Anhydrous Greyish white, smooth, unctuous intramammary suspension. 3. CLINICAL INFORMATION 3.1 TARGET SPECIES Cattle (dairy cow at drying-off). 3.2 INDICATIONS FOR USE FOR EACH TARGET SPECIES Prevention of new intramammary infections throughout the dry period. In cows considered likely to be free of sub-clinical mastitis, the veterinary medicinal product can be used on its own in dry cow management and mastitis control. 3.3 CONTRAINDICATIONS See section 3.7 “Use during pregnancy, lactation or lay”. Do not use the veterinary medicinal 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. 3.4 SPECIAL WARNINGS Selection of cows for treatment with the veterinary medicinal 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 subclinical mastitis or bacteriology sampling. 3.5 SPECIAL PRECAUTIONS FOR USE Special precautions for safe use in the target species: 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 st Pročitajte cijeli dokument