ZINTESTIN
Country: Spain
Language: English
Source: HMA (Heads of Medicines Agencies)
Patient Information leaflet
(PIL)
04-05-2013
Summary of Product characteristics
(SPC)
04-05-2013
Active ingredient:
zinc oxide 1000 mg/g
Available from:
Vetpharma Animal Health S.L
ATC code:
QA07XA91
Pharmaceutical form:
Premix for medicated feed
Therapeutic group:
zinc oxide
Therapeutic area:
Pigs Food
Authorization date:
2012-07-27
Patient Information leaflet
B.2. LABEL-LEAFLET
ZINTESTIN 1000 MG/G PREMIX FOR MEDICATED FEEDING STUFF FOR PIGS
SYMBOL (PLACED ON THE UPPER RIGHT CORNER): “”
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND
OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR
BATCH RELEASE
MARKETING AUTHORIZATION HOLDER:
VETPHARMA ANIMAL HEALTH, S.L.
Les Corts, 23
08028 BARCELONA
Spain
MANUFACTURER RESPONSIBLE FOR BATCH RELEASE:
LABORATORIOS CALIER, S.A
INDUSTRIAL VETERINARIA, S.A.
C/ Barcelonés, 26
– Pla de Ramassà
Esmeralda, 19
LES FRANQUESES DEL VALLÉS
(Barcelona)
08950 ESPLUGUES DE
LLOBREGAT (Barcelona)
NAME OF THE VETERINARY MEDICINAL PRODUCT
ZINTESTIN 1000 mg/g Premix for medicated feeding stuff for pigs
Zinc oxide
STATEMENT OF ACTIVE SUBSTANCE AND OTHER INGREDIENTS
Each gram contains:
Active substance:
Zinc oxide
1000 mg
Excipients:
None
INDICATION
Piglets: Prevention of post weaning diarrhoea.
CONTRAINDICATIONS
Not described.
ADVERSE REACTIONS
The administration of the medicated premix may cause that faeces take on a white-
yellowish colour that subsides when treatment is withdrawn. If you notice any serious
effects or other effects not mentioned in this leaflet, please inform your veterinary
surgeon.
TARGET SPECIES
Pigs (piglets)
DOSAGE FOR EACH SPECIES, ROUTE AND METHOD OF ADMINISTRATION
Oral administration mixed with the feed.
Piglets: 85 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 zi
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Summary of Product characteristics
B. SUMMARY OF PRODUCT CHARACTERISTICS,
LABELLING AND PACKAGE LEAFLET
B.1. SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
ZINTESTIN
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:
None
3. PHARMACEUTICAL FORM
Premix for medicated feeding stuff.
Soft, white or faintly yellowish-white, amorphous powder.
4. CLINICAL PARTICULARS
4.1.
TARGET SPECIES
Pigs (piglets).
4.2.
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Piglets: Prevention of post weaning diarrhoea.
4.3.
CONTRAINDICATIONS
Not described.
4.4.
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Biological parameters (alkaline phosphatase, the activity of
-amylase) may be
altered by the administration of the medicated premix. This disorder subsides
when treatment is withdrawn.
4.5.
SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Zinc may accumulate in the soil. It is recommended to rotate the land to which
the slurry is applied/incorporated at least every two years.
The maximum temperature of medicated feed pelleting should be 55 ºC.
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE
VETERINARY MEDICINAL PRODUCT TO ANIMALS
Avoid direct contact with the skin and mucous membranes by wearing
appropriate protective clothing. Contaminated clothing should be removed and
washed before being reused.
Wear protective goggles and impermeable gloves
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