Country: Romania
Language: English
Source: HMA (Heads of Medicines Agencies)
zinc oxide 1000 mg/g
ANDRÉS PINTALUBA S.A.
QA07XA91
Premix for medicated feed
zinc oxide
Pigs Food
2011-06-17
Page 1 of 3 PROPOSAL FOR LABELLING AND PACKAGE LEAFLET ZINCOPREMIX 1000 MG/G PREMIX FOR MEDICATED FEEDING STUFF FOR PIGS ZINC OXIDE QUALITATIVE AND QUANTITATIVE COMPOSITION OF ACTIVE AND OTHER SUBSTANCES Each gram contains: ACTIVE SUBSTANCE: Zinc oxide 1000 mg INDICATIONS FOR USE Piglets: Prevention of the post-weaning diarrhoea. CONTRAINDICATIONS None. 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. TARGET SPECIES Pigs (piglets). AMOUNTS TO BE ADMINISTERED AND ADMINISTRATION ROUTE Oral use, in-feed use. The recommended dose is 100 mg of zinc oxide/kg of bw/day for 14 days. The period of administration is from weaning until the animal is 10 weeks old. Considering that the treatment begins at weaning (21 days old), and that the average weight of piglets is approximately 7 kg bw, with an average daily feed consumption of approximately 0.225 kg, the recommended dose of ZINCOPREMIX 1000 mg/g in the final feed is 3100 mg of zinc oxide/kg of feed (equivalent to 2500 mg of zinc/kg of feed). This dose corresponds to 3.1 kg of ZINCOPREMIX 1000 mg/g per Tm of feed. Feed intake depends on the clinical condition of the animal, thus the concentration in the feed should be adjusted to assure the correct dosage. Mix well to ensure homogeneous distribution. WITHDRAWAL PERIOD Meat: 9 days. Page 2 of 3 SPECIAL STORAGE PRECAUTIONS Keep o Read the complete document
Page 1 of 4 SUMMARY OF PRODUCT CHARACTERISTICS (SPC) 1. NAME OF THE VETERINARY MEDICINAL PRODUCT ZINCOPREMIX 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 feedingstuff. 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 The administration of the medicated premix may alter certain biological parameters (alkaline phosphatase, -amylase activity), which remits following withdrawal of the treatment. 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 Page 2 of 4 140 European Standard with EN 143 filter when mixing or handling the feed. In the case of substantial inhalation of dust or powder, leave the contaminated Read the complete document