Albex 2.5% (Albendazole)

Click Here To Download Data Sheet Summary of Product Characteristics 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Albex 2.5% Oral Suspension 2 QUALITATIVE AND QUANTITATIVE COMPOSITION For a full list of excipients, see section 6.1 Active Substance: Albendazole 2.5 % w/v Excipients: Chlorophyll WS1, E141 0.3 % w/v Methyl parahydroxybenzoate E218 0.2 % w/v Propyl parahydroxybenzoate E216 0.02 % w/v 3 PHARMACEUTICAL FORM Oral suspension. A pale green, free flowing suspension. 4 CLINICAL PARTICULARS 4.1 Target Species Cattle and sheep Active Substance: Albendazole 2.5 % w/v Excipients: Chlorophyll WS1, E141 0.3 % w/v Methyl parahydroxybenzoate E218 0.2 % w/v Propyl parahydroxybenzoate E216 0.02 % w/v 4.2 Indications for use, specifying the target species Albex 2.5% is a broad spectrum multi-purpose anthelmintic for the control of mature and developing immature forms of gastrointestinal roundworms, lungworms, tapeworms and adult liver fluke in cattle and sheep. The product is also ovicidal against fluke and roundworm eggs. In cattle it is active against the following species: Roundworms: Ostertagia, Haemonchus, Trichostrongylus, Nematodirus, Oesophagostomum, Bunostomum, Cooperia and Strongyloides spp.. It is usually effective against inhibited larvae of Cooperia and Ostertagia. Lungworms: Dictyocaulus viviparus Tapeworm: Moniezia spp. Adult liver fluke: Fasciola hepatica In sheep it is active against benzimidazole susceptible strains of the following species: Roundworms: Ostertagia, Haemonchus, Trichostrongylus, Nematodirus (including N. Battus), Chabertia and Oesophagostomum. It is usually effective against inhibited larvae of Ostertagia. Lungworms: Dictyocaulus filaria Tapeworms: Moniezia spp. Adult Liver Fluke: Fasciola hepatica Albex 2.5% is ovicidal and will kill fluke and roundworm eggs, thus reducing pasture contamination. 4.3 Contraindications Do not use in cases of known hypersensitivity to the active ingredient. 4.4 Special warnings for each target species Not for use in sheep producing milk for human consumption. Cattle suffering from severe lung damage due to heavy lungworm infestation may continue to cough for some weeks after infection. Intensive use or misuse of anthelmitics can give rise to resistance. To reduce this risk, dosing programmes should be discussed with your veterinary surgeon. Care must be taken not to damage the pharyngeal region when dosing, particularly in sheep. 4.5 Special precautions for use Special precautions for use in animals Not to be diluted or mixed with other products. Avoid the introduction of contamination during use. Special precautions to be taken by the person administering the veterinary medicinal product to animals Direct contact with the skin should be kept to a minimum. Wear suitable protective clothing including impermeable rubber gloves. Wash hands after use. 4.6 Adverse reactions (frequency and seriousness) None known. 4.7 Use during pregnancy, lactation or lay Do not dose ewes at the 'fluke and worm' dose rate, (7.5 mg/kg), during tupping or for 1 month after removing the rams. Albex 2.5% can be safely used during lactation. The use of Albex 2.5% in breeding bulls or pregnant cattle is not expected to interfere with their reproductive performance. 4.8 Interaction with other medicinal products and other forms of interaction None known. 4.9 Amounts to be administered and administration route For oral administration only using properly calibrated dosing equipment. Estimate bodyweight accurately. One ml of Albex 2.5% contains 25 mg Albendazole. Shake the container before use. Cattle: Worm dose: For the control of roundworms, lungworms, tapeworms and fluke and roundworm eggs. Dosage: Approximately 7.5 mg albendzole per kg bodyweight. Fluke and worm dose: For the additional treatment of adult liver fluke (chronic fascioliasis) in cattle. Dosage: Approximately 10 mg albendazole per kg bodyweight. Sheep: Worm dose: For the control of roundworms, lungworms, tapeworms, and fluke and roundworm eggs. Dosage: Approximately 5 mg albendazole per kg bodyweight. Fluke and Worm Dose: For the additional treatment of adult liver fluke (chronic fascioliasis) in sheep. Dosage: Approximately 7.5 mg albendazole per kg bodyweight. 4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary Not applicable. 4.11Withdrawal Period(s) Animals intended for human consumption should not be slaughtered during treatment. Cattle must not be slaughtered for human consumption until after 14 days after last treatment. Sheep must not be slaughtered for human consumption until after 4 days after last treatment. Milk intended for human consumption may be taken from cows only after 60 hours after the last treatment. 5 PHARMACOLOGICAL or IMMUNOLOGICAL PROPERTIES Albex 2.5% is a broad spectrum multi-purpose anthelmintic for the control of mature and developing immature forms of gastrointestinal roundworms, lungworms, tapeworms and adult liver fluke in cattle and sheep. The product is also ovicidal against fluke and roundworm eggs. Benzimidazoles bind to nematode tubulin, a protein necessary for the formation and viability of microtubules. This occurs primarily in absorptive intestinal cells resulting in the absence of microtubules in the intestinal cells of the nematode, with the result that these cells cannot absorb nutrients, thus causing a consequent reduction in glycogen and effective starvation of the parasites. Structural differences have been shown to exist between tubulin from mammalian and helminth sources, resulting in the preferential toxicity of albendazole to the helminth and not to the host. Benzimidazoles have also been shown to inhibit the fumarate reductase system of helminths and impair energy production. 6 PHARMACEUTICAL PARTICULARS 6.1 List of excipients Methyl Parahydroxybenzoate Propyl Parahydroxybenzoate Citric Acid Monohydrate Sodium Citrate Chlorophyll WS 1 (E141) Xanthan Gum Povidone 90 Polysorbate 20 Propylene Glycol Simethicone Emulsion Purified Water 6.2 Incompatibilities None known. 6.3 Shelf-life Shelf life of the veterinary medicinal product as packaged for sale: 3 years. 6.4 Special precautions for storage This veterinary medicinal product does not require any special storage conditions. 6.5 Nature and composition of immediate packaging 1.0 L, 2.5 L, 5.0 L and 10 L white standard containers or 1 L, 2.5 L and 5 L flexi-packs. Standard Pack Container: HDPE Closure: HDPE Cap liner: Expanded polyethylene Tamper evidence: Closure is tamper evident Flexi pack (vaccine pack) Container: HDPE Closure: Homo polymer polypropylene Cap liner: Polyfaced steran wad Tamper evidence: Aluminium foil seal Flexi pack (flat bottomed stand alone) Container: HDPE Closure: Copolymer polypropylene Cap liner: Polyfaced steran wad Tamper evidence: Closure is tamper evident Not all pack sizes may be marketed. 6.6 Special precautions for the disposal of unused veterinary medicinal products or waste materials Do not contaminate ponds, waterways or ditches with the product or used containers. Dispose of used containers safely. Unused product should be disposed of in accordance with current practice for pharmaceutical waste under national waste disposal regulations. 7 MARKETING AUTHORISATION HOLDER Chanelle Animal Health Limited, 7 Rodney Street, Liverpool, L1 9HZ, United Kingdom. 8 MARKETING AUTHORISATION NUMBER(S) VPA 10879/5/1 9 DATE OF THE FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 22nd April 2001 10 DATE OF REVISION OF THE TEXT 4th April 2008