STATEMENT OF ACTIVE AND OTHER SUBSTANCES
Oral suspension containing 10% w/v
Albendazole
PHARMACEUTICAL FORM
Oral suspension containing:
Albendazole Ph. Eur.
PACKAGE SIZE
1L, 2.5L & 5L
TARGET SPECIES
Cattle & Sheep
INDICATION(S)
Fluke and worm drench for Sheep and Cattle.
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.
METHOD AND ROUTE(S) OF ADMINISTRATION
DOSAGE AND ADMINISTRATION:
Shake container before use.
For oral administration only .To ensure administration of correct dose, body weight should be determined as accurately as possible, accuracy of the dosing device should be checked.
1 ml of Albex 10% w/v contains 100 mg Albendazole.
Cattle For the control of roundworms, lungworms, tapeworms and fluke and roundworm eggs, 7.5 mg albendazole per kg bodyweight which is equivalent to 7.5 ml Albex 10% per 100 kg bodyweight.
For the additional treatment of adult liver fluke (chronic fascioliasis) in cattle, 10 mg albendazole per kg bodyweight, which is equivalent to 10 ml Albex 10% per 100 kg bodyweight.
Sheep: For the control of roundworms, lungworms, tapeworms and fluke and roundworm eggs, 5 mg albendazole per kg bodyweight which is equivalent to 1.0 ml Albex 10% per 20 kg bodyweight. For the additional treatment of adult liver fluke (chronic fascioliasis) in sheep, 7.5 mg albendazole per kg bodyweight, which is equivalent to 1.5 ml Albex 10% per 20 kg bodyweight.
| Cattle | Sheep | ||||
| Bodyweight |
Worm dose (7.5 mg/kg) |
Fluke & worm dose (10 mg/kg) |
Bodyweight |
Worm dose (5.0 mg/kg) |
Fluke & worm dose (7.5 mg/kg) |
|
50 kg 100 kg 200 kg 300 kg 400 kg |
3.75 ml 7.50 ml 15.00 ml 22.50 ml 30.00 ml |
5.0 ml 10.0 ml 20.0 ml 30.0 ml 40.0 ml |
Up to 10 kg 11 - 20 kg 21 - 30 kg 31 - 40 kg 41 - 50 kg 51 - 60 kg 61 - 70 kg 71 - 80 kg |
0.5 ml 1.0 ml 1.5 ml 2.0 ml 2.5 ml 3.0 ml 3.5 ml 4.0 ml |
0.75 ml 1.50 ml 2.25 ml 3.00 ml 3.75 ml 4.50 ml 5.25 ml 6.00 ml |
Sheep over 80 kg give a further 0.5 or 0.75 ml for each additional 10 kg bodyweight.
WITHDRAWAL PERIOD
Meat and offal (cattle): 8 days
(sheep-goats): 5 days
Milk (cattle): 96 hours
(sheep-goats): 96 hours
SPECIAL WARNING(S), IF NECESSARY
Do not dose ewes at the 'fluke and worm dose' (7.5 mg/kg) during tupping or for 1 month after removing the rams. Care must be taken not to damage the pharyngeal region, particularly in sheep, when dosing. Assess bodyweight as accurately as possible before calculating the dosage. 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 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 and extended period of time.
• Under dosing, which may be due to undersestimation 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 strongly suggest resistance to a particular anthelmintic, an anthelmintic belonging to another pharmacological class having a different mode of action should be used.
Resistance, to benzimidazoles has been reported in Teladorsagia Haemonchus, Cooperia and Trichostrongylus species in small ruminants. Therefore, the use of this product should be based on local (regional, farm) epidemiological information about susceptibility of nematodes and recommendations on how to limit further selection for resistance to anthelminics.
User Warnings: Wash hands after use. Avoid direct contact with the product. Wear suitable protective clothing including impermeable rubber gloves.
In the event of accidental eye exposure, flush eye thoroughly with running water. If irritation persists, seek medical attention. In the event of accidental skin exposure, wash the effected area with soap and water. If irritation persists, seek medical attention.
Do not mix with other products.
Overdose: no treatment specified.
SPECIAL STORAGE CONDITIONS
N/A
SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE MATERIALS, IF ANY
DANGEROUS to aquatic life. Do not contaminate ponds, waterways or ditches with the product or used containers. Dispose of any unused product or containers in accordance with guidance from an appropriate waste regulation authority.
THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
For animal treatment only.
THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN”
Keep out of the sight and reach of children.
FURTHER INFORMATION
The use of Albex 10% in breeding bulls or pregnant cattle is not expected to interfere with their reproductive performance. Cattle suffering from severe lung damage due to heavy lungworm infestation may continue to cough for some weeks after treatment.
To be supplied only on a veterinary prescription.
