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1. NAME AND ADDRESS OF THE AUTHORIZATION HOLDER AND OF THE PRODUCER (IF THEY DIFFERENT)
VETPROM AD, 2400, Radomir, Bulgaria, 26, Otets Paisiy Str.
2. NAME OF THE VETERINARY MEDICINAL PRODUCT
LEVAMISOLE 7.5% Solution for Injection
3. ACTIVE SUBSTANCE AND EXCIPIENTS 100 mL contain:
Active Substance: Levamisole Hydrochloride – 7.5 g Excipients: Chlorocresol, Sodium Metabisulphite, Disodium Edetate, Citric Acid Monohydrate, Sodium Citrate, Water for injections.
4. THERAPEUTIC INDICATIONS
In invasions: in calves with Haemonchi, Ostertagi, Trichostrongyli, Nematodiri, Cooperi, Esofagostomi, Bunostomi, Trichuris worms, Dictyocaulidae: in sheep with Haemonchi, Ostertagi, Trichostrongyli, Nematodiri, Cooperi, Bunostomi, Strongyloides, Esofagostomi, Geigeri, Habertii, Trichuris worms (weaker), Dictyocaulidae, Protostrongylii; in swine with Ascarii, Hyostrongyli, Metha strongili, Esofagostomi and Trichuris worms; in carnivores with Toxocara, Ancylostoma, Uncinaria and Trichuris worms.
Not to be used in lactating animals. The product should be administered with great caution in exhausted animals or in significantly impaired kidney and liver function. Special caution is needed when levamisole is administered to cattle after vaccinations, dehorning or castration (the administration should be postponed).
6. ADVERSE REACTIONS
After levamisole administration some animals experience temporary excitation;, hypertension; salivation; diarrhea; erythema; agranulocytosis; swelling at the site of injection, which resolves in 7 to 14 days. If you notice any serious adverse effects, due to the use of this VMP not listed in this leaflet, please inform your veterinarian.
7. ANIMAL SPECIES, FOR WHICH THIS VMP IS DESIGNED
Calves, sheep, swine, dogs.
8. RECOMMENDED DOSES FOR EACH OF THE ANIMAL SPECIES, ADMINISTRATION ROUTE
Oral administration: for calves, sheep and swine – 0.0075 g/kg b.w. (1 mL/10 kg b.w.); for dogs – 0.01 g/kg b.w. (1.35 mL/10 kg b.w.); Subcutaneous administration: calves – 0.005 g/kg b.w. (0,7 mL/10 kg b.w.); sheep and swine – 0.0075 g/kg b.w. (1 mL/10 kg b.w.).
9. ADVICE FOR PROPER ADMINISTRATION
10. WITHDRAWAL PERIOD
Calves, sheep and swine: meat and internal organs – 7 days. The use of the VMP in animals which milk is designed for human use is prohibited.
11. SPECIAL PRECAUTIONS FOR STORAGE OF THE VMP
Keep the medication out of sight and reach of children! Do not store above 25ºC. Protect from light. Keep in dry place. Following withdrawal of the first dose, use the product within 28 days. Keep in a refrigerator (2 C – 8 C).
12. SPECIAL PRECAUTIONS FOR USE
Special precautions for the animals when using this product. Not to be administered to animals in the last third of pregnancy. Do not administer together with diethylcarbamazine and organophosphorus compounds. Pregnancy ad lactation: Not to be administered to animals in the last third of pregnancy. Not to be used in lactating animals. Interaction with other medicinal products and other forms of interaction: Do not administer together with diethylcarbamazine and organophosphorus compounds. Concomitant levamisole and levomycetin could be fatal. Overdose: When higher than the recommended doses are used salivation, tremor, frequent defecation and urination, excitation and ataxia develop. Antidote: Atropine. Incompatibilities: Do not administer together with diethylcarbamazine and organophosphorus compounds.
13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED VETERINARY MEDICINAL PRODUCT OR WASTE MATERIALS DERIVED FROM THE USE OF SUCH PRODUCTS The VMP should not be disposed of together with household wastes or sewage. Ask your veterinarian what to do with the no longer necessary VMPs. These measures would help environmental protection.