Gutal 1000 mg/g Premix for Medicated Feeding Stuff for Piglets

Summary of Product characteristics

                                Revised: September 2019
AN: 01711/2018
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Gutal 1000 mg/g premix for medicated feeding stuff for piglets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 g contains:
ACTIVE SUBSTANCE:
Zinc oxide 1000.0 mg (Corresponding to zinc 803.4 mg)
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Premix for medicated feeding stuff.
A soft, white or yellowish, dry, amorphous powder.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Piglet (weaned piglets)
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the prevention of post-weaning diarrhoea.
4.3
CONTRAINDICATIONS
None.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Studies have shown zinc oxide to be beneficial in piglets at risk of
developing mild to
moderate diarrhoea. However, there are no studies available in piglets
at risk of
developing severe/haemorrhagic forms of diarrhoea.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
The product should only be administered to animals at risk of
diarrhoea, for example
if the piglets are from sows with a history of regularly occurring
cases of post-
weaning diarrhoea.
Feeding of high zinc concentrations may stimulate the occurrence of
resistance to
zinc in the pig gut microflora and may play a role in the coselection
of MRSA and in
increasing the proportion of multiresistant E.coli.
Revised: September 2019
AN: 01711/2018
Page 2 of 5
Special precautions to be taken by the person administering the
veterinary medicinal
product to animals
Use in a well ventilated area. Avoid inhalation of the product while
preparing the
medicated feed. Wear either a disposable half-mask respirator
conforming to
European Standard EN 149 or a non-disposable respirator to European
Standard EN
140 with a filter to EN 143 when mixing or handling the feed.
Avoid contact with the eyes by wearing protective goggles or safety
glasses. In case
of accidental eye contact, irrigate thoroughly with large quantities
of water.
Avoid co
                                
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