SUMMARY OF PRODUCTS CHARACTERISTICS

1.

NAME OF THE VETERINARY MEDICINAL PRODUCT

ZincoTec Zinc Oxide 100% Premix for Medicated Feeding Stuff

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION

Qualitative composition

Zinc Oxide

Quantitative composition

% w/w

100

3.

PHARMACEUTICAL FORM

Premix for medicated feeding stuff

A soft, white or yellowish, dry, 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 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 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 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.

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 feed 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 Zincotec (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 from the end of treatment.

5.

PHARMACOLOGICAL PROPERTIES: ATC Vet Code QA07XA91

5.1

Pharmacodynamic properties

The mode of action of Zinc Oxide in the treatment and control of diarrhoea in pigs 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 the factor of only 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 factors of approximately five and two, respectively. No increase 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.

Environmental properties

Zinc oxide is mainly excreted in the faeces with a small proportion excreted in the urine. The substance is not biotransformed and may enter the environment in the form of slurry and manure. The impact on the total environmental zinc burden has been assessed and is not expected to be great when the product is used as directed.

6.

PHARMACEUTICAL PARTICULARS

6.1

List of excipients

None

6.2

Incompatibilities

None known

6.3

Shelf life

(i) Shelf-life of the veterinary medicinal product as packaged for sale -2 years.

(ii) Shelf life of the veterinary medicinal product after incorporation into meal or pelleted feed - 3 months

6.4

Special precautions for storage

• Store in a cool, dry place

• Do not store above 25^oC

• Store in tightly closed original container

• Store away from, food, drink and animal feeding stuffs

6.5

Nature and composition of immediate packaging:

25kg multi-ply paper sacks are filled via a side valve, which is tucked in to form a closure and is glued.

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:

Provimi Limited

Eastern Avenue

Lichfield

Staffordshire

WS13 7SE

8.

MARKETING AUTHORISATION NUMBER

Vm 03941/4000

9.

DATE OF FIRST AUTHORISATION

9 July 1990

10.

DATE OF REVISION OF THE TEXT

April 2013