Oral suspension for cattle and sheep.
MANUFACTURING AUTHORIZATION HOLDER: S.C. Delos Impex ’96 S.R.L., 81, Horia, Closca si Crisan Street, Otopeni, Ilfov District, Romania
Tel. +0040-372 714 433 Fax: +0040-0372 871 445
NAME OF THE VETERINARY MEDICINAL PRODUCT: VERMICID 2,5, 25 mg/g albendazole, oral suspension for cattle and sheep.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENTS: Albendazole 25 mg, Excipients: Benzoic acid 5 mg
The product VERMICID 2,5 is indicated for the control of albendazole susceptible mature and developing immature forms of the following internal parasites of cattle and sheep:
|Control of adult liver flukes||Fasciola hepatica, Dicrocelium lanceolatum||Fasciola hepatica, Dicrocelium lanceolatum|
|Control of tapeworms||Moniezia benedeni,M. expansa||Moniezia expansa|
|Gastro-intestinal roundworms(L4 larvae and adults)||Ostertagia ostertagi (including inhibited larvae L4),Haemonchus contortus,Trichostrongylus axei||Ostertagia circumcincta (including inhibited larvae L4), Coopperia oncophora, Haemonchus contortus,Trichostrongylus axei|
|Gastro-intestinal roundworms(L4 larvae and adults)||Nematodirus spathiger,Cooperia oncophora (including inhibited larvae L4)||Nematodirus spathiger,N. filicolis,Cooperia oncophora,Trichostrongylus colubriformis,Oesophagostomum columbianum,Chabertia ovina|
|Gastro-intestinal adult roundworms||Bunostomum phlebotomum,Trichostrongylus colubriformis,Oesophagostomum radiatum|
|Lungworms (larva and adults)||Dictiocaulus viviparus||Dictiocaulus filaria|
The product has also ovicidal activity. As prophylactic purposes, the deworming program should consist in 3-4 administrations: before entering to pasture, in July and September and after housing the animals.
CONTRAINDICATIONS : Do not administer to animals with known hypersensitivity to benzimidazoles or the excipients.
ADVERSE REACTIONS: Adverse reactions are not to be expected following treatment.
TARGET SPECIES: Cattle and sheep.
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
To ensure administration of a correct dose, body weight should be determined as accurately as possible; accuracy of the dosing device should be checked. If animals are to be treated collectively rather than individually, they should be grouped according to their bodyweight and dosed accordingly, in order to avoid under- or overdosing. No special control of diet is necessary before or after treatment. The therapeutically dosage is approximately 10 – 12.5 mg albendazole per kg bodyweight.
Cattle: 20 ml / 40 kg b.w. (12.5 mg albendazole/kg bw); Sheep: 16 ml/ 40kg b.w. (10 mg albendazole/kg bw).
ADVICE ON CORRECT ADMINISTRATION: Where a dosing device is used, care must be taken to avoid causing injury to the mouth and pharynx when dosing lambs and sheep. Care must be taken also, to avoid choking and ab-ingestis pneumonia.
WITHDRAWAL PERIOD: Cattle: 28 days for meat; Sheep: 14 days for meat.; Milk: 3 days. Animals must not be slaughtered for human consumption during treatment. Milk for human consumption must not be taken during treatment.
SPECIAL PRECAUTIONS FOR STORAGE
Keep away from reach and sight of children! Shelf life of the veterinary medicinal product as packaged for sale: 2 years.
Shelf-life of the veterinary medicinal product after opening the package the product should be used within 28 days. Do not use after expiry date which is stated on the label.
People with known hypersensitivity to albendazole or to the product’s excipients should avoid contact with the veterinary medicinal product. To prevent any unpleasant effects, personal protective equipment consisting in rubber gloves and goggles should be worn when administering the product. Wash hands and exposed skin after use. In case of accidental ingestion or the occurrence of symptoms characterized by skin rash, seek medical advice. Serious symptoms such as swelling of face, lips or eye lids, accompanied by breath difficulties, are life-threatening symptoms and need immediate medical attention. Care should be taken to avoid the following practices because they increase the risk of development of resistance and could ultimately result in ineffective therapy:
- Too frequent and repeated use of anthelmintics from the same class, over an extended period of time.
- Underdosing, that may be due to underestimation of body weight, misadministration of the product, or lack of calibration of the dosing device (if any).
Suspected clinical cases of resistance to anthelmintics should be further investigated using appropriate tests (e.g. Faecal Egg Count Reduction Test). Where the results of the test(s) strongly suggest resistance to a particular anthelmintic, an anthelmintic belonging to another pharmacological class and having a different mode of action should be used. Do not administer the product during the first month of pregnancy in ewes and cows.
Moderate overdosage is unlikely to cause adverse reactions in healthy animals. If adverse reactions occur animals should be clinically monitorized and administered symptomatic treatment to support vital functions, if necessary. Liver damage could occur if animals are highly overdosed and for a long period of time.
SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY
For the environmental protection, medicines should not be disposed of via wastewater or household waste. Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
100 ml, 500 ml, 1 litre, 2.5 litre, 5 litre, 10 litre and 20 litre white high density polyethylene containers. Not all pack sizes may be marketed.
For any information regarding this veterinary medicinal product, please contact the local representative of the marketing authorization holder.