NOAH Compendium

Printed from NOAH Compendium (http://www.noahcompendium.co.uk). (c) Copyright NOAH Compendium 2019. All Rights Reserved.
Date: Saturday, August 24, 2019 8:47

Description: Chanelle Animal Health combined 2012
Release 2.87
Albex 2.5% w/v SC Oral Suspension
 
Species: Sheep, Cattle
Therapeutic indication: Pharmaceuticals: Endoparasiticides: Anthelmintics for cattle, Anthelmintics for sheep, Combination fluke/wormers, Tapeworm products
Active ingredient: Albendazole, Cobalt, Selenium
Product:Albex™ 2.5% w/v SC Oral Suspension
Product index: Albex 2.5% SC 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 green free flowing suspension for oral administration. Each ml contains 25 mg Albendazole. Each ml also contains 0.27 mg selenium (as sodium selenite and 0.63 mg cobalt (as cobalt sulphate).
Uses
Albex 2.5% SC 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 sheep and cattle. The product is also ovicidal against fluke and roundworm eggs. The product also contains selenium and cobalt as nutritional supplements.
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.
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.
Albex 2.5% SC is ovicidal and will kill fluke and roundworm eggs, thus reducing pasture contamination.
Dosage and administration
For oral administration only. To ensure administration of a correct dose, body weight should be determined as accurately as possible; accuracy of the dosing device should be checked. Estimate bodyweight accurately.
Sheep
For the control of roundworms, lungworms, tapeworms and fluke and roundworm eggs, 5 mg albendazole per kg bodyweight which is equivalent to 2.0 ml Albex 2.5% SC per 10 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 3 ml Albex 2.5% SC per 10 kg bodyweight.
Dosage Guide Sheep
Bodyweight
Worm dose
(5.0 mg/kg)
Fluke & worm
(7.5 mg/kg)
Up to 10 kg
 2 ml
 3 ml
11–20 kg
 4 ml
 6 ml
21–30 kg
 6 ml
 9 ml
31–40 kg
 8 ml
12 ml
41–50 kg
10 ml
15 ml
51–60 kg
12 ml
18 ml
61–70 kg
14 ml
21 ml
71-80 kg
16 ml
24 ml
Sheep over 80 kg - give a further 2 ml (worm dose) or 3 ml (fluke and wom dose) for each additional 10 kg bodyweight.
Cattle
For the control of roundworms, lungworms, tapeworms and fluke and roundworm eggs, 7.5 mg albendazole per kg bodyweight which is equivalent to 15 ml Albex 2.5% SC per 50 kg bodyweight.
For the additional treatment of adult liver fluke (chronic fascioliasis) in cattle, 10 mg albendazole per kg bodyweight, which is equivalent to 20 ml Albex 2.5% SC per 50 kg bodyweight.
Dosage Guide Cattle
Bodyweight
Worm dose
(7.5 mg/kg)
Fluke & worm
(10 mg/kg)
 50 kg
 15 ml
 20 ml
100 kg
 30 ml
 40 ml
150 kg
 45 ml
 60 ml
200 kg
 60 ml
 80 ml
250 kg
 75 ml
100 ml
300 kg
 90 ml
120 ml
350 kg
105 ml
140 ml
400 kg
120 ml
160 ml
Cattle over 400 kg - give a further 15 ml (worm dose) or 20 ml (fluke and worm dose) for each additional 50 kg bodyweight.
Contra-indications, warnings, etc
Known hypersensitivity to the active ingredient.
Special warnings
Selenium and cobalt are included as nutritional supplements and are not intended to be used therapeutically. Administration of ionophores to lambs has been shown to enhance selenium bioavailability. Concurrent administration of ionophores and Albex 2.5% SC may therefore lead to an increased risk of selenium toxicity. Cattle suffering from severe lung damage due to heavy lungworm infestation may continue to cough for some weeks after treatment.
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 an extended period of time
∙ Underdosing, which may be due to underestimation 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 of the test(s) strongly suggest resistance to a particular anthelmintic, an anthelmintic belonging to a different pharmacological class and 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
Care must be taken not to damage the pharyngeal region when dosing, particularly in sheep. Do not administer other cobalt and selenium supplements concurrently with this product unless specifically advised by your veterinary surgeon. Not to be diluted or mixed with other products. Avoid the introduction of contamination during use. Intensive use or misuse of anthelmintics can give rise to resistance. To reduce the risk, dosing programmes should be discussed with a veterinary surgeon.
The product should only be used in areas where deficiencies of selenium and cobalt are likely to occur. In cases of doubt, consult 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 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. The 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
No special precautions for storage.
Shake container before use. Avoid the introduction of contamination during use. Do not 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 the 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.
Packaging quantities
1 L, 2.5 L, 5 L and 10 L.
Legal category
Legal category: POM-VPS
Further information
Selenium and cobalt are included in Albex 2.5% SC as nutritional supplements and are not intended to be used therapeutically. Administration of ionophores to lambs has been shown to enhance selenium bioavailability. Concurrent administration of ionophores and Albex 2.5% SC may therefore lead to an increased risk of selenium toxicity.
The use of Albex 2.5% SC 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. The product should only be used in areas where deficiencies of selenium and cobalt are likely to occur. In cases of doubt, consult a veterinary surgeon.
Marketing Authorisation Number
Vm 11990/4015.
Significant changes