NOAH Compendium

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Date: Wednesday, July 8, 2020 23:56

Description: Chanelle_Phara_Logo_cmyk
Release 2.122
Albex 10% w/v Oral Suspension
 
Species: Sheep, Cattle
Therapeutic indication: Pharmaceuticals: Endoparasiticides: Anthelmintics for cattle, Anthelmintics for sheep, Combination fluke/wormers, Tapeworm products
Active ingredient: Albendazole
Product:Albex™ 10% w/v Oral Suspension
Product index: Albex 10% Oral Suspension
Cattle - milk: 60 hours
Cattle - meat: 14 days
Sheep - meat: 5 days
Withdrawal notes: Not for use in sheep producing milk for human consumption
Presentation
A pale blue free-flowing suspension for oral administration. Each ml of Albex 10% contains 100 mg Albendazole.
Uses
Albex 10% is a broad spectrum multi-purpose anthelmintic for the control of mature and developing immature forms of gastro-intestinal 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.
Dosage and administration
For oral administration only using properly calibrated dosing equipment. To ensure administration of a correct dose, body weight should be determined as accurately as possible; accuracy of the dosing device should be checked.
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.
Dosage Guide Cattle
Bodyweight
Worm dose
(7.5 mg/kg)
Fluke & worm dose
(10 mg/kg)
 50 kg
3.75 ml
5.0 ml
100 kg
7.50 ml
10.0 ml
200 kg
15.00 ml
20.0 ml
300 kg
22.50 ml
30.0 ml
400 kg
30.00ml
40.0ml
Cattle over 400kg give a further 3.75 ml (worm dose) or 5ml (fluke and worm dose) for each additional 50kg bodyweight.
Dosage Guide Sheep
Bodyweight
Worm dose
(5.0 mg/kg)
Fluke & worm dose
(7.5 mg/kg)
Up to 10 kg
 0.5 ml
0.75 ml
11–20 kg
 1.0 ml
1.50 ml
21–30 kg
 1.5 ml
2.25 ml
31–40 kg
 2.0 ml
3.00 ml
41–50 kg
 2.5 ml
3.75 ml
51–60 kg
 3.0 ml
4.50 ml
61–70 kg
 3.5 ml
5.25 ml
71-80 kg
4.0 ml
6.00 ml
Sheep over 80kg give a further 0.5 ml (worm dose) or 0.75 ml (fluke and worm dose) for each additional 10kg bodyweight.
Contra-indications, warnings, etc
Known hypersensitivity to the active ingredient.
Special warnings
Cattle suffering from severe lung damage due to heavy lungworm infestation may continue to cough for some weeks after infection.
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.
∙ Underdosing, 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 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 (which includes albendazole) has been reported in Teladorsagia Haemonchus, Cooper and Trichostrongylus species in small ruminants in a number of countries, including the EU. Resistance to albendazole has been reported in Cooperia and Teladorsagia species in cattle in developed countries such as New Zealand. 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 anthelmintics.
Special precautions for use in animals
Not to be diluted or mixed with other products.
Avoid the introduction of contamination during use.
Care must be taken not to damage the pharyngeal region during dosing, particularly in sheep.
Intensive use or misuse of anthelmintics can give rise to resistance. To reduce the risk, dosing programmes should be discussed with a veterinary surgeon.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
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.
Adverse reactions (frequency and seriousness)
None known
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. Can be safely used during lactation.
Use of the product in breeding bulls or pregnant cattle is not expected to interfere with their reproductive performance.
Interaction with other medicinal products and other forms of interaction
None known.
Overdose (symptoms, emergency procedures, antidotes), if necessary
No treatment specified.
Withdrawal period(s)
Cattle:
Meat & Offal: 14 days
Milk: 60 hours
Sheep:
Meat & Offal: 5 days
Not to be used in sheep producing milk for human consumption.
Pharmaceutical precautions
Shake container before use. Avoid the introduction of contamination during use. Do not dilute or mix with other products.
Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
DANGEROUS to fish and aquatic life. Do not contaminate ponds, waterways or ditches with product or used container. Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Legal category
Legal category: POM-VPS
Packaging quantities
1 L, 2.5 L, 5 L and 10 L.
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 infection.
Marketing Authorisation Number
Vm 11990/4016.
Significant changes