Nazione: Irlanda
Lingua: inglese
Fonte: HPRA (Health Products Regulatory Authority)
Bismuth subnitrate, heavy
FATRO S.p.A.
QG52X
Bismuth subnitrate, heavy
Intramammary suspension
LR: Licensed Retailer as defined in national legislation
VARIOUS PRODUCTS FOR TEATS AND UDDER
2022-04-01
_ _ 1/5 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT FATROSEAL 2.6 g intramammary suspension for dry cows 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) EXCIPIENT(S): For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Intramammary suspension. White to greyish homogeneous suspension. 4. CLINICAL PARTICULARS 4.1. TARGET SPECIES Cattle (dairy cows at drying-off). 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 can be used alone in dry cow management and mastitis control. 4.3. CONTRAINDICATIONS Do not use in lactating cows. See section 4.7. 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 known cases of hypersensitivity to the active substance or to any of the excipients. 4.4. SPECIAL WARNINGS FOR EACH TARGET SPECIES Selection of cows for treatment 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. _ _ 2/5 4.5. SPECIAL PRECAUTIONS FOR USE 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 minimize 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 a Leggi il documento completo