Florazole 10% Oral Suspension

Presentation

A 10% suspension of fenbendazole as a ready to administer oral anthelmintic for cattle, sheep and horses. 1 ml contains 100 mg active ingredient fenbendazole.

Uses

A broad-spectrum anthelmintic for the treatment of cattle and sheep infected with mature and developing immature forms of nematodes of the gastro-intestinal and respiratory tracts.
Cattle
For the treatment of cattle infected with: Ostertagia spp. Cooperia spp. Trichostrongylus spp. Nematodirus spp. Oesophagostomum spp. Haemonchus spp. Bunostomum spp. Strongyloides spp. Trichuris spp. Dictyocaulus viviparus.Florazole is usually effective against inhibited larvae of Ostertagia spp. and against Moniezia spp. of tapeworm.
Sheep
For the treatment of sheep infected with benzimidazole susceptible: Ostertagia spp. Haemonchus spp. Trichostrongylus spp. Nematodirus spp. Oesophagostomum spp. Cooperia spp. Chabertia spp. Bunostomum spp. Strongyloides spp. Dictyocaulus filaria. Florazole is usually effective against Moniezia spp. of tapeworm and may have useful but variable efficacy against Trichuris spp.
Horses
For the treatment and control of adult and immature roundworms of the gastro-intestinal tract in horses and other equines. Florazole effectively treats and controls the following roundworm infections: Large strongyles (adults and migrating larval stages of Strongylus vulgaris; adults and tissue larval stages of S. edentatus). Benzimidazole-susceptible adult and immature small strongyles (Cyathostomes). Florazole is also effective for the treatment and control of encysted mucosal 3rd and 4th stage small strongyle larvae and is also effective against encysted inhibited 3rd stage small strongyle larvae in the mucosa. Adult and immature Oxyuris spp., Strongyloides spp. and Parascaris equorum. Florazole also has an ovicidal effect on nematode eggs.

Dosage and administration

Shake container before use. For oral administration only. No dietary control is required before or after treatment. 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 and Horses: Administer orally 1 ml of the product per 13 kg bodyweight. (= 7.5 mg fenbendazole/kg bodyweight)
Above 400 kg, an extra 3.75 ml are required for each additional 50 kg bodyweight.
Sheep: Administer orally 0.5 ml per 10 kg bodyweight (= 5 mg fenbendazole/kg bodyweight). Above 80 kg, an extra 0.5 ml is required for each additional 10 kg bodyweight. The product is best administered to cattle with the Florazole 20ml Automatic Drencher and to sheep with the 5ml Sheep Drencher, but other standard dosing guns or drenching equipment may also be used. For administration to horses, thoroughly mix the product with grain or concentrate feed and give the full dosage as one administration. Treatment should be repeated when natural re-infection of animals with parasitic worms occurs.
Horses: Recommended dosage programme. All horses should be routinely wormed with the single dose regimen every 6-8 weeks. Treatment of encysted inhibited and encysted mucosal dwelling larvae should be performed in the autumn (ideally late October/November) and again in the Spring (ideally in February). However, for horses who fail to maintain condition or bought-in horses with unknown worming history, the treatment can be given at any time of the year.
Five day course
For the treatment and control of migrating and issue larval stages of large strongyles, encysted mucosal 3rd and 4th stage small strongyle larvae and encysted inhibited 3rd stage small strongyle larvae in the mucosa administer 5 ml of the product per 64 kg bodyweight daily for 5 days (= 7.5 mg fenbendazole/kg bodyweight daily for 5 days).
Single dose treatment
For the treatment and control of encysted mucosal stages of small strongyles administer 3 ml of the product per 10 kg bodyweight (= 30 mg fenbendazole / kg bodyweight). For the treatment and control of migrating and tissue stages of large strongyles administer 6 ml of the product per 10 kg bodyweight (= 60 mg fenbendazole / kg bodyweight). For the treatment of diarrhoea cause by Strongyloides westeri in two to three week old sucking foals administer 5 ml of the product per 10kg bodyweight (= 50mg fenbendazole / kg bodyweight). Do not mix with other products.

Contra-indications, warnings, etc

Do not use in horses and other equines intended for human consumption. Fenbendazole as a medicated liquid feed should not be used in the treatment of clinical infestations in cattle and sheep. When administered in liquid feed by divided dosage, Florazole 10% Suspension may not be effective against Strongyloides and Trichuris spp. in cattle and Strongyloides, Dictyocaulus and Bunostomum spp. in sheep. 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 another pharmacological class and having a different mode of action should be used. Resistance to benzimidazoles (which include fenbendazole) has been reported in Teladorsagia, Haemonchus, Cooperia and Trichostrongylus species in small ruminants in a number of countries, including the EU. 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.
Resistance to fenbendazole has been reported in cyathostomes in horses. 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.
When incorporating this product into liquid feed, after thoroughly shaking the suspension, measure the required volume of the suspension and add it to approximately 10% of the liquid feed. Thoroughly mix this material and then add the remaining liquid feed and once again mix to produce a homogenous dispersion. Mix the medicated feed thoroughly prior to administration for example by rolling the drum or barrel. Assess bodyweight as accurately as possible before calculating the dosage. Intensive use or misuse of anthelmintic can give rise to resistance. To reduce this risk, dosing programmes should be discussed with your veterinary surgeon. Fenbendazole belongs to the benzimidazole (1 BZ) class of anthelmintics. Do not mix with other products.
Withdrawal periods
Animals must not be slaughtered for human consumption during treatment. Cattle may be slaughtered for human consumption only after 12 days from last treatment. Sheep may be slaughtered for human consumption only after 15 days from last treatment. Milk for human consumption must not be taken during treatment. Milk for human consumption may be taken from cows only after 5 days from last treatment. Milk for human consumption may be taken from sheep only after 7 days from last treatment. Not to be used in horses intended for human consumption. Treated horses may never be slaughtered for human consumption. The horse must have been declared as not intended for human consumption under national horse passport legislation.
Operator warnings
Direct contact with the skin should be kept to a minimum. Wear suitable protective clothing including impermeable rubber gloves. Wash hands after use. For animal treatment only. Keep out of reach and sight of children.
Pharmaceutical precautions
Do not store above 25°C. Protect from frost. Do not freeze. Shake container before use. Keep container in outer carton. Disposal warnings: Dispose of any unused product and empty containers in accordance with guidance from your local waste regulation authority. DANGEROUS to aquatic life. Do not contaminate ponds, waterways or ditches with the product or used container.

Packaging Quantities

1, 2, 5 and 10 litre containers.

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