Nazione: Spagna
Lingua: inglese
Fonte: HMA (Heads of Medicines Agencies)
zinc oxide 1000 mg
Laboratorios Calier
QA07XA91
Premix for medicated feed
zinc oxide
Pigs
2012-01-25
1 LABELLING AND PACKAGE LEAFLET 21. NAME OF THE VETERINARY MEDICINAL PRODUCT OXIDO DE ZINC CALIER premix for medicated feeding stuff for pigs 2. STATEMENT OF ACTIVE AND OTHER SUBSTANCES Each gram contains: Active substance Zinc Oxide……………….1000 mg Excipients: None 3. PHARMACEUTICAL FORM Premix for medicated feeding stuff 4. PACKAGE SIZE Bags of 25 Kg 5. TARGET SPECIES Pigs (piglets) between 1 week and 11 weeks of age 6. INDICATION(S) Prevention of post weaning diarrhoea. 7. METHOD AND ROUTE(S) OF ADMINISTRATION Oral route mixed with feed. Piglets: 85 mg of zinc oxide / kg b.w. per day, for 14 days post-weaning (equivalent to 3.1 kg of Oxido Zinc Calier for Veterinary use/Tn of feed or equivalent to 2500 g of Zinc / Tn of feed). To ensure adequate distribution of Zinc Oxide in the final feed it is recommended that the product be premixed with a suitable quantity of feed ingredients before blending into the final feed. The medicated feed must be the only source of feed for not more than the 14 days post- weaning. 3 8. WITHDRAWAL PERIOD Pigs (piglets) Meat and offal: 9 days 9. SPECIAL WARNING(S), IF NECESSARY Contraindications: Do not use in case of hypersensitivity to the active substance Adverse reactions: The use of the premix for medicated feeding stuff can cause a white-yellow coloration of the faeces that remits once the treatment is withdrawn Interaction: Oral bioavailability of Zinc can Leggi il documento completo
Page 1 of 10 SUMMARY OF PRODUCT CHARACTERISTICS Page 2 of 10 1. NAME OF THE VETERINARY MEDICINAL PRODUCT: OXIDO DE ZINC CALIER premix for medicated feeding stuff for pigs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION: Each gram contains: Active substance Zinc Oxide……………….1000 mg Excipients: None 3. PHARMACEUTICAL FORM: Premix for medicated feeding stuff White or faintly yellowish-white, powder 4. CLINICAL PARTICULARS: 4.1. TARGET SPECIES: Pigs (piglets) between 1 week and 11 weeks of age 4.2 INDICATIONS FOR USE, SPECIFYING TARGET SPECIES: Piglets: Prevention of post weaning diarrhoea. _ _ 4.3 CONTRAINDICATIONS: Do not use in case of hypersensitivity to the active substance 4.4 SPECIAL WARNINGS: The administration of the premix for medicated feeding stuff can alter some biological parameters (alkaline phosphate, -amilasa activity) that remit after withdrawing the treatment. 4.5 SPECIAL PRECAUTIONS FOR USE Given that zinc can accumulate in soil, it is recommended to rotate the lands to which applies/incorporates the pig slurry at least every two years. _ _ Page 3 of 10 Granulation of medicated feed has to be carried out at temperature not exceeding 55º C. Special precautions for use in animals Not for use in breeding animals and animals older than the 11 weeks of age. Special precautions to be taken by the person administering the veterinary medicinal product to animals Avoid direct contact with skin and mucosa and inhalation of the prod Leggi il documento completo