The data of the current Leaflet concern the approved ones by the National Organization for Medicines (E.O.F.

) in Greece.

LEAFLET ZINGUL injectable solution

FOR ANIMAL TREATMENT ONLY

1. NAME AND ADDRESS OF THE MARKETING AUTHORIZATION HOLDER AND OF THE MANUFACTURING AUTHORIZATION HOLDER RESPONSIBLE FOR BATCH RELEASE, 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: vet@provet.gr 2. NAME OF THE VETERINARY MEDICINAL PRODUCT ZINGUL 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 ADMINISTRATION None

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 PACKAGES Vials 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