Ülke: Portekiz
Dil: İngilizce
Kaynak: HMA (Heads of Medicines Agencies)
zinc oxide 1000 mg/g
ANDRÉS PINTALUBA S.A.
QA07XA91
Premix for medicated feed
zinc oxide
Pigs Food
2011-04-10
1/3 LABELLING AND PACKAGE LEAFLET APSAMIX ZINC 1000 MG/G PREMIX FOR MEDICATED FEEDING STUFF FOR PIGS 1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT Marketing authorisation holder and manufacturer responsible for batch release: ANDRÉS PINTALUBA, S.A. Polígono Industrial Agro-Reus C/ Prudenci Bertrana, 5 43206 Reus (TARRAGONA) SPAIN 2. NAME OF THE VETERINARY MEDICINAL PRODUCT APSAMIX ZINC 1000 mg/g premix for medicated feeding stuff for pigs Zinc Oxide 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Each gram contains: Active substance: Zinc oxide 1000 mg 4. INDICATION(S) Piglets: Prevention of the post-weaning diarrhoea. 5. CONTRAINDICATIONS None. 6. ADVERSE REACTIONS The administration of the medicated premix may lead to a white-yellowish colouring in faeces, which remits following the withdrawal of treatment. If you notice any serious effects or other effects not mentioned in this package leaflet, please inform your veterinary surgeon. 7. TARGET SPECIES Pigs (piglets). 8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION Oral administration mixed with the feed. Piglets: 100 mg of zinc oxide/kg of body weight and day, for 14 post weaning days (equivalent to 3.1 kg of the product / ton of feed or equivalent to 2500 g of zinc / ton of feed). 2/3 Considering that the treatment should begin at weaning (21 days o Belgenin tamamını okuyun
1/5 SUMMARY OF PRODUCT CHARACTERISTICS (SPC) 1. NAME OF THE VETERINARY MEDICINAL PRODUCT APSAMIX ZINC 1000 mg/g premix for medicated feeding stuff for pigs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each gram contains Active substance : Zinc oxide .......................................... 1000 mg Excipients: “For a full list of excipients, see section 6.1.” 3. PHARMACEUTICAL FORM Premix for medicated feeding stuff. Light, white or yellowish-white powder. 4. CLINICAL PARTICULARS 4.1. TARGET SPECIES Pigs (piglets). 4.2. INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Piglets: Prevention of the post-weaning diarrhoea. 4.3. CONTRAINDICATIONS None. 4.4. SPECIAL WARNINGS FOR EACH TARGET SPECIES The administration of the medicated premix may alter certain biological parameters (alkaline phosphatase, -amylase activity), which remits following withdrawal of the treatment. 2/5 4.5. SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals 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. Special precautions to be taken by the person administering the veterinary medicinal product to animals The veterinary medicinal product should not come into contact with the skin or mucous membranes and should not be inhaled. Use a disposable mask in accordance with the EN 140 European Standard with EN 143 filter when mixing or Belgenin tamamını okuyun