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

Zinc Oxide

For full list of excipients see section 6.1

Quantitative composition

100% ^w/_w

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 pigs

4.3

Contraindications

None known

4.4

Special warnings for each target species

None known

4.5

Special precautions for use

i.

Special precautions for use in animals

None known

ii.

Special precautions for the person administering the veterinary medicinal product to animals

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 EN143 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 ingestion, drink plenty of water and seek medical attention.

Wash hands after use.

iii.

Other precautions

None known

4.6

Adverse reactions (frequency and seriousness)

None known

4.7

Use during pregnancy, lactation or lay

Not applicable

4.8

Interaction with other medicinal products and other forms of interaction

None known

4.9

Amount(s) to be administered and administration route

For oral administration only

For incorporation into dry feed at a registered/licensed mill. For more information:

• In the UK refer to VMGN No 3, Guidance for Retailers,

• In Ireland seek advice from the Department of Agriculture, Food and the Marine.

Administer 2900-3100 mg/kg Pigzin Premix (which provides 2320 - 2489 mg/kg elemental zinc) so that the amount of zinc already present in the feed (naturally occurring zinc plus added nutritional zinc) is taken account of to ensure that the final feed contains 2500 mg/kg of elemental zinc.

To ensure adequate distribution of the product in the final feed it is recommended that it be premixed with a suitable quantity of feed ingredients before blending into the final feed. The final feed should be fed as the only feed for up to 14 days.

4.10

Overdose (symptoms, emergency procedures, antidotes), if necessary

No known problems.

4.11

Withdrawal period(s)

Animals must not be slaughtered for human consumption during treatment. Animals may be slaughtered for human consumption only after 28 days after the end of treatment.

5.

PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group:

Anti-diarrhoeal

ATC Vet Code: QA07XA91

5.1

Pharmacodynamic properties

The mode of action of zinc oxide in the treatment and control of diarrhoea has not been determined. It has been shown to have a favourable effect on the gut microflora by helping to prevent the reduction in diversity of microflora that occurred in the intestines of control pigs during the second week after weaning.

5.2

Pharmacokinetic properties

Absorption – Zinc is an essential trace element for livestock required for the maintenance of daily bodily function. Zinc oxide is known to be relatively poorly absorbed and therapeutic levels have increased blood levels by a factor of two.

Distribution – Therapeutic levels of zinc oxide fed for four weeks after weaning have been shown to increase zinc levels in the liver and kidney of pigs by a factor of approximately five and two respectively. No increases in muscle levels were noted.

Biotransformation – Zinc is a trace element essential for daily metabolism in the body. Since therapeutic levels are poorly absorbed, it is believed that most is voided unchanged in the faeces.

Elimination – Most zinc from zinc oxide is excreted without absorption.

6.

PHARMACEUTICAL PARTICULARS

6.1

List of excipients

None

6.2

Incompatibilities

None known

6.3

Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 2 Years.

Shelf life after incorporation into meal or pelleted feed: 3 Months

6.4

Special precautions for storage

• Store in a clean dry place. Do not store above 25°C

• Store in tightly closed original container.

• Store away from food, drink and animal feedingstuffs

• Close the bag securely after use.

• The shelf life after incorporation into feed is three months.

6.5

Nature and composition of immediate packaging

Three-ply paper sacks containing 25kg of a soft, white or yellowish white amorphous powder.

Sacks are filled via a side valve, which is tucked in and glued to form a closure.

6.6

Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products, if appropriate

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

7.

MARKETING AUTHORISATION HOLDER

DSM Nutritional Products (UK) Limited

Delves Road

Heanor Gate Industrial Estate

Heanor

Derbyshire

DE75 7SG

8.

MARKETING AUTHORISATION NUMBER

Vm 19108/4000

9.

DATE OF FIRST AUTHORISATION

05 May 2000

10.

DATE OF REVISION OF THE TEXT

May 2013