Zingul Inj Sol en Leaflet

download Zingul Inj Sol en Leaflet

of 2

Transcript of Zingul Inj Sol en Leaflet

  • 8/13/2019 Zingul Inj Sol en Leaflet

    1/2

    The data of the cur rent Leaflet concern the approved ones by the National Organization f or Medicines (E.O.F.) in Greece.

    1

    LEAFLET

    ZINGULinjectable solution

    FOR ANIMAL TREATMENT ONLY

    1. NAME AND ADDRESS OF THE MARKETING AUTHORIZATION HOLDER AND OF

    THE MANUFACTURING AUTHORIZATION HOLDER RESPONSIBLE FOR BATCHRELEASE, IF DIFFERENT

    Marketing authorization holder:

    PROVET S.A.

    77, Posidonos Avenue

    174 55 Alimos, Attiki

    el.: +30 2105575770-3, +30 210 5508500

    Fax: +30 2105575830

    E-mail: [email protected]

    2. NAME OF THE VETERINARY MEDICINAL PRODUCTZINGUL

    injectable solution

    3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENTS

    1 ml of solution contains:

    Active substances: 50.000 I.U.Vitamin A (palmitate), 25.000 I.U.Vitamin D3, 50 mg Vitamin E acetate

    Excipients:Butylhydroxytoluene, Butylhydroxyanisole, Benzyl alcohol, Myritol 318

    4. INDICATION(S)

    ZINGUL inj. is recommended for the treatment of vitamin , D3 and deficiency in newborn and

    young animals. It is also indicated in cases of reduced fertility, developmental abnormalities (rickets) and

    provides supportive treatment during stressful situations, diarrhea and infectious diseases, as well as

    during pregnancy and lactation.

    5. CONTRAINDICATIONS

    There are no contraindications, when used according to instructions.

    6. ADVERSE REACTIONS

    There are no adverse reactions, when used according to instructions.

    If you notice any serious effects or other effects not mentioned in this leaflet, please inform your

    veterinary surgeon.

    7. TARGET SPECIES

    Horses, Cattle, Pigs, Sheep, Goats

    8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION

    It is administered intramuscularly.

    Horses-Cattle: 7-15 ml

    Calves-Foals: 5-7 ml

    Pigs: 5-7 ml

    Piglets: 0.5-2 ml

    Sheep-Goats: 5-7 ml

    Lambs-Kids: 3-5 ml

    In severe cases, treatment can be repeated every 10 days at the recommended doses.

    9. ADVICE ON CORRECT ADMINISTRATIONNone

  • 8/13/2019 Zingul Inj Sol en Leaflet

    2/2

    2

    10. WITHDRAWAL PERIOD

    Meat (injection site): 5 days

    11. SPECIAL STORAGE PRECAUTIONS

    Store at temperatures below 25 C.

    Shelf life after first opening of the immediate packaging: 28 days

    12. SPECIAL WARNING(S)

    In case of accidental overdose, clinical symptoms of hypervitaminosis A and D will become apparent.

    In case of overdose, the fat soluble vitamins, especially vitamin A, accumulates in the liver and this

    may be dangerous for humans (teratogenicity effects of pregnant women).

    13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE

    MATERIALS, IF ANY

    Ask your veterinary surgeon how to dispose of medicines no longer required. These measures should

    help to protect the environment.

    14. OTHER INFORMATION

    PACKAGESVials of 50 ml and 100 ml

    Not all pack sizes may be marketed.

    Marketing Authorization Number: 26494/01-09-1994/K-0003901

    For any information about this veterinary medicinal product, please contact the local representative of

    the marketing authorization holder.

    *under veterinary medical prescription*

    KEEP OUT OF THE REACH AND SIGHT OF CHILDREN