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Irish Medicines Board
IRISH MEDICINES BOARD ACT 1995
EUROPEAN COMMUNITIES (ANIMAL REMEDIES) (No. 2) REGULATIONS 2007
(S.I. No. 786 of 2007)
VPA: 10879/004/001
Case No: 7006318
The Irish Medicines Board in exercise of the powers conferred on it by Animal Remedies (No. 2) Regulations (S.I. No. 786 of 2007) herebygrants to: Chanelle Animal Health Ltd.
7 Rodney Street, Liverpool L1 9HZ, England
an authorisation, subject to the provisions of the said Regulations and the general conditions of the attached authorisation, in respect of theVeterinary Medicinal Product: Albex 10% Oral Suspension, 10 %w/v
The particulars of which are set out in Part 1 and Part 2 of the said Schedule. The authorisation is also subject to any special conditions as maybe specified in the said Schedule.
The authorisation,unless revoked, shall continue in force from 15/07/2009.
Signed on behalf of the Irish Medicines Board A person authorised in that behalf by the said Board.
(NOTE: This authorisation replaces any previous authorisation in respect of this product which is now null and void.) ______________________________________________________________________________________________________________________ Irish Medicines Board
Summary of Product Characteristics
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance:
Excipients:
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
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 ofgastrointestinal roundworms, lungworms, tapeworms and adult liver fluke in cattle and sheep. The product is alsoovicidal 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.
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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 weeksafter infection.
Intensive use or misuse of anthelmintics can give rise to resistance. To reduce this risk, dosing programmes should bediscussed 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 impermeablerubber gloves. Wash hands after use.
4.6 Adverse reactions (frequency and seriousness)
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 therams. 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 reproductiveperformance.
4.8 Interaction with other medicinal products and other forms of interaction
4.9 Amounts to be administered and administration route
For oral administration using properly calibrated dosing equipment. Estimate bodyweight accurately. One ml of Albex10% 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.
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4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
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 ofgastrointestinal roundworms, lungworms, tapeworms and adult liver fluke in cattle and sheep. The product is alsoovicidal against fluke and roundworm eggs.
Benzimidazoles bind to nematode tubulin, a protein necessary for the formation and viability of microtubules. Thisoccurs primarily in absorptive intestinal cells resulting in the absence of microtubules in the intestinal cells of thenematode, with the result that these cells cannot absorb nutrients, thus causing a consequent reduction in glycogen andeffective starvation of the parasites. Structural differences have been shown to exist between tubulin from mammalianand 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 energyproduction.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Methyl ParahydroxybenzoatePropyl ParahydroxybenzoateCitric Acid MonohydrateSodium CitrateGreen S (E142 )Xanthan GumPovidone 90Polysorbate 20Propylene GlycolSimethicone EmulsionPurified Water 6.2 Incompatibilities
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.
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6.5 Nature and composition of immediate packaging
0.5 L, 1.0 L, 2.5 L and 5.0 L white standard containers or 1 L, 2.5 L and 5 L flexi-packs.
Flexi pack (flat bottomed stand alone)Container: 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 wasteunder 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)
9 DATE OF THE FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10 DATE OF REVISION OF THE TEXT
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Source: http://www.animalfarmacy.ie/assets/products/pdf/1757_albex%2010%20percent%20oral%20suspension.pdf