情報リーフレット
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
完全なドキュメントを読む
製品の特徴
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
完全なドキュメントを読む