Bimectin Vet.
PACKAGE LEAFLET
Bimectin vet.10 mg/ml
Solution for injection
1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Bimeda (A Division of Cross Vetpharm Group Ltd)
Broomhill Road, Tallaght
Dublin 24, Ireland
NAME AND ADDRESS OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
Cross Vetpharm Group Ltd.
Broomhill Road, Tallaght
Dublin 24, Ireland
2. NAME OF THE VETERINARY MEDICINAL PRODUCT
Bimectin vet., 10 mg/ml Solution for Injection
3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
1 ml contains:
Ivermectin 10 mg
Glycerol. 100 mg
Glycerolformal to 1,0 ml (contains thiopropionic acid, N-propyl gallate and disodium edetate)
4. INDICATION(S)
Ivermectin is active against several invertebrates, such as roundworms, parasitic stages of
warbles, mange mites and lice.
Due to the ivermectin the parasites are paralyzed and killed.
Cattle:
Gastro-intestinal roundworms(adult and fourth stage larvae, L4)
Ostertagia ostertagi.(including inhibited L4)
Ostertagia lyrata
Haemonochus placei
Trichostrongylus axei
Trichostrongylus colubriformis (L4)
Cooperia spp.
Oesophagostomum radiatum
Nematodirus spathiger(adult)
Lungworms (adult and fourth stage larvae, L4)
Dictyocaulus viviparus.
Warbles (larval stages)
Hypoderma bovis
Hypoderma lineatum.
Mange mites
Sarcoptes scabiei var. bovis
Psoroptes bovis
Lice
Linognathus vituli
Haematopinus eurysternus
Reindeer
Larval stages of Hypoderma tarandi.
Pigs:
Gastro-intestinal roundworms(adult and fourth stage larvae, L4)
Ascaris suum
Hyostrongylus rubidus
Oesophagostomum spp.
Strongyloides ransomi (adult)
Lungworms
Metastrongylus spp. (adult)
Mange mites
Sarcoptes scabiei var. suis
Lice
Haematopinus suis
5. CONTRAINDICATIONS
Bimectin vet. Injection should not be given to animals with known hypersensitivity to
ivermectin. Small piglets are sensible for overdosage of ivermectin. Therefore, Bimectin vet. Injection should not be used in pigs younger than 5 days of age.
6. ADVERSE REACTIONS
Local reactions at the injection site may occur.
If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.
7. TARGET SPECIES
Cattle, reindeer and swine.
8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
Bimectin vet. should be given by subcutaneous injection.
Cattle and reindeer: 1 ml Bimectin vet, per 50 kg bodyweight, responding to 0.2 mg ivermectin per kg bodyweight.
Swine: 1 ml Bimectin vet, per 33 kg bodyweight, responding to 0.3 mg ivermectin per kg bodyweight.
9. ADVICE ON CORRECT ADMINISTRATION
Due to lack of incompatibility studies, this veterinary medicinal drug should not be mixed with other veterinary medicinal drugs.
10. WITHDRAWAL PERIOD
Slaughter: Cattle 49 days, reindeer and pigs 28 days.
Lactating cows producing milk for human consumption should not be treated. Dry cows and heifers should not be treated within 60 days prior to calving.
11. SPECIAL STORAGE PRECAUTIONS
Keep the container in the other carton, in order to protect from light.
After first opening, the product should be used within 28 days.
Do not use after the expiry date which is stated on the label.
Keep out of the reach and sight of children.
12. SPECIAL WARNING(S)
This veterinary medicinal product could be harmful for other species than cattle, reindeer and swine. (Cases of intolerance with fatal outcome are reported in dogs, especially Collies, Old English Sheepdogs and related breeds or crosses, and also in turtles/tortoises).
Use during pregnancy and lactation
Bimectin vet. can be given to beef cows and pigs at any stage of pregnancy or lactation.
Bimectin vet. should not be given to lactating cows, or heifers and dry cows within 60 days prior to calving, when the milk is intended for human consumption.
13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY
Free ivermectin is very toxic to fish and other water-borne organisms.
Medicines should not be disposed of via wastewater or household waste. Ask your veterinary surgeon how to dispose of medicines no longer required. These measures should help to protect the environment.
14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
2009-10-01.
15. OTHER INFORMATION
Information in Sweden is given by
Ceva Vetpharma AB
Annedalsvägen 9
227 64 Lund
Sweden
Information in Finland is given by
Vetcare Oy
PB 99
24101 Salo
Finland
Observe that your veterinarian could have prescribed this veterinary pharmaceutical for a different usage and/or in a different dosage than given in this information. You should always follow the veterinary prescription and the directions on the label from the pharmacy.
4
Page of 4