Albex 10% is a broad spectrum multi-purpose anthelmintic oral drench 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.
Each ml of Albex 10% contains 100 mg Albendazole.
Summary of Product Characteristics
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Albex 10 % Oral Suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance:
Albendazole 10.00 % w/v
Excipients:
Green S (E142) 0.0018 % w/v
Methyl parahydroxybenzoate (E218) 0.2 % w/v
Propyl parahydroxybenzoate (E216) 0.02 % w/v
For a full list of excipients, see Section 6.1.
3 PHARMACEUTICAL FORM
Oral suspension.
A pale blue, free flowing suspension.
4 CLINICAL PARTICULARS
4.1 Target Species
Cattle and sheep
4.2 Indications for use, specifying the target species
Albex 10% 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 Tapeworms: 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 10% 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 anthelmintics 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 10% can be safely used during lactation.
The use of Albex 10% 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 using properly calibrated dosing equipment. Estimate bodyweight accurately. One ml of Albex 10% contains 100 mg Albendazole.
Cattle:
Worm dose: For the control of roundworms, lungworms, tapeworms and fluke and roundworm eggs. Dosage: Approximately 7.5 mg albendazole 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 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.
4.11 Withdrawal 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 the last treatment.
Sheep must not be slaughtered for human consumption until after 4 days after the 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 10% 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
Green S (E142 ) Xanthan Gum Povidone 90
Polysorbate 20
Propylene Glycol
Simethicone Emulsion
Purified Water
6.2 Incompatibilities
None known.
6.3 Shelf-life
Shelf life of 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
0.5 L, 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 or waste material 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,
Rodney Street,
Liverpool, L1 9HZ, United Kingdom.
MARKETING AUTHORISATION NUMBER(S)
VPA 10879/004/001
DATE OF THE FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
21st April 2006
10 DATE OF REVISION OF THE TEXT
16th November 2011
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