Pigzin Premix, 100% w/w Premix for medicated feeding stuff

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Zinc oxide

Available from:

DSM Nutritional Products (UK) Ltd

ATC code:

QA07XA91

INN (International Name):

Zinc oxide

Dosage:

100 percent weight/weight

Pharmaceutical form:

Premix for medicated feeding stuff

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Pigs

Therapeutic area:

zinc oxide

Therapeutic indications:

Miscellaneous

Authorization status:

Authorised

Authorization date:

2013-05-17

Summary of Product characteristics

Health Products Regulatory Authority
04 December 2018
CRN000X1C
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SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Pigzin Premix, 100% w/w Premix for medicated feeding stuff
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
QUALITATIVE COMPOSITION
​
1g contains:
​
Zinc oxide 1000.0 mg/g
​
(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 faintly yellowish white, amorphous powder.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Pigs up to 10 weeks of age.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment and control of diarrhoea in young pigs.
4.3 CONTRAINDICATIONS
None known.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5 SPECIAL PRECAUTIONS FOR USE
I. SPECIAL PRECAUTIONS FOR USE IN ANIMALS
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 co-selection
of
Health Products Regulatory Authority
04 December 2018
CRN000X1C
Page 2 of 6
methicillin-resistant _Staphylococcus aureus_ (MRSA) and in increasing
the proportion
of multiresistant _Escherichia coli_.
II. SPECIAL PRECAUTIONS FOR 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 skin by wearing protective clothing, including
impermeable
gloves. In case of accidental skin contact, wash the exposed skin with
soap and water.
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.
Contaminated clothing should be removed and washed before being
reused.
In case of accidental