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Novartis Fasinex Fluke Treatment

  • 5% for Sheep » 2.2 litre bottle £82.90
  • 5% for Sheep » 5 litre bottle £155.57
  • 24% for Cattle » 0.8 litre Bottle £97.19
  • 24% for Cattle » 2.2 litre Bottle £206.52
  • 24% for Cattle » 5 litre Bottle £397.60

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£82.90 to £397.60

Description

For the treatment of acute, subacute and chronic infection due to triclabendazole susceptible. Fasciola hepatica. Highly effective against all stages of F.hepatica from 2-week-old early immature forms to adult fluke. POM-VPS.

Fasinex 240 24% Oral Suspension for cattle

Presentation

A cream coloured aqueous suspension containing 24% w/v triclabendazole.

Uses

For the treatment of acute, subacute and chronic infection due to triclabendazole susceptible Fasciola hepatica. Fasinex 240 is highly effective against all stages of F. hepatica from 2-week-old early immature forms to adult fluke. If infected animals are treated before disease has developed, fasciolosis can be prevented.

Dosage and administration

Recommended dosage is 5 ml per 100 kg bodyweight, equivalent to 12mg triclabendazole per kg of body weight. Fasinex 240 is administered orally after thorough shaking of the suspension. Most types of drenching guns are suitable. Clean drenching equipment before and after use. Fasinex 240 can safely be given to young, pregnant or stressed cattle, not producing milk or intended to produce milk for human consumption.

To ensure administration of a correct dose, bodyweight should be determined as accurately as possible; accuracy of the dosing device should be checked. If animals are to be treated collectively rather than individually they should be grouped according to their bodyweight and dosed accordingly, in order to avoid under- or over-dosing.

Body Weight (kg)

Volume to Administer (ml)

Up to 50 kg

2.5

>50-70

3.5

>70-100

5

>100-150

7.5

>150-200

10

>200-300

15

>300-400

20

>400-500

25

For each additional 100kg body weight add 5ml to dose.

Fasinex 240 is given once. The administration may be repeated several weeks or months after the first treatment depending on the epidemiological situation. In case of acute fasciolosis, treat immediately, then repeat in approximately 4-6 weeks, and consult a veterinary surgeon for advice.

In wintering - Where cattle are inwintered, a single dose of Fasinex 240 should be given 2 weeks after housing.

Treatment of sub-acute and acute outbreaks - Affected cattle, usually young animals, should be treated immediately after diagnosis is reached. Veterinary advice should be sought for subsequent dosing intervals.

Contra-indications, warnings, etc

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 triclabendazole has been reported in Fasciola hepatica in cattle in a number of countries including ones in the EU. Therefore the use of this product should be based on local epidemiological information about susceptibility of F.hepatica and recommendations on how to limit further selection for resistance to anthelmintics. Dosing programmes should be discussed with your Veterinary Advisor.

Fasinex 240 is neither embryotoxic nor teratogenic.

Operator warnings: Do not eat, drink or smoke whilst handling this product. Wash hands and exposed skin before meals and after work. In case of accidental spillage onto skin or in eyes, wash immediately with water. Take off any contaminated clothes.

Withdrawal periods

Meat and offal: 52 days

Milk for human consumption may only be taken from 48 hours after calving. Not intended for use within 48 days of calving. Should a cow calve earlier than 48 days after the last treatment, milk for human consumption may only be taken from 50 days after the last treatment.

Pharmaceutical precautions

Store in tightly closed original container.

Shelf-life after first opening the immediate packaging 12 months.

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements. The product may adversely affect aquatic organisms. Do not contaminate ponds, waterways or ditches with the product or empty containers.

Legal category

POM-VPS

Packaging Quantities

0.8 litre, 2.2 litre and 5 litre packs.

Further information

Triclabendazole inhibits cellular transport mechanisms and binds to a different tubulin receptor, possibly the tubulozole receptor, than do other benzimidazoles, which bind to the colchicine receptor. Triclabendazole also inhibits protein synthesis. Triclabendazole is readily absorbed and oxidised to its sulfoxide and sulfone. Triclabendazole sulfoxide reaches peak concentrations approximately 1 day after administration of FASINEX and the sulfone reaches peak concentrations approximately 3 days after administration. Both metabolites bind strongly to plasma protein, particularly albumin. Metabolites are excreted via the bile, primarily as conjugates. More than 90% of the total dose of FASINEX is excreted in the faeces, about 5% in the urine and 1% in milk. Elimination is virtually complete by 10 days after administration.

Marketing authorisation number

Vm 12501/4164.

GTIN (Global Trade Item No)

Fasinex 240 0.8L

05037694022129

Fasinex 240 2.2L

05037694022136

Fasinex 240 5L

05037694022143

Fasinex 5% w/v Oral Suspension

Presentation

A white to cream coloured suspension containing 5% w/v triclabendazole.

Uses

For the treatment and control of liver fluke infections in sheep caused by all stages of triclabendazole susceptible Fasciola hepatica from 2 day old immature to adult fluke.

Dosage and administration

Fasinex 5% is given as an oral drench and is suitable for use through most types of drenching guns. To ensure administration of a correct dose, accuracy of the dosing device should be checked.

Recommended dose rate is 1 ml Fasinex 5% per 5 kg bodyweight, equivalent to 10 mg triclabendazole / kg bodyweight. Assess bodyweight accurately before calculating the dosage. If animals are to be treated collectively rather than individually, they should be grouped according to their bodyweight and dosed accordingly, in order to avoid under- or overdosing.

Examples:

Up to 10 kg – 2 ml

10-15 kg – 3 ml

16-20 kg – 4 ml

21-30 kg – 6 ml

31-40 kg – 8 ml

41-50 kg – 10 ml

51-60 kg – 12 ml

For each additional 5 kg add 1 ml to dose.

DOSING PROGRAMME

Advice from a veterinary surgeon or prescriber should be sought to build a dosing programme specific for each individual farm. Affected sheep should be treated immediately after diagnosis is reached with subsequent dosing intervals being sought from a veterinary surgeon or presciber.

Contra-indications, warnings, etc

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 triclabendazole has been reported in liver fluke (Fasciola hepatica) in cattle and sheep in a number of countries, including ones in the EU. Therefore, the use of this product should be based on local epidemiological information about susceptibility of F. hepatica and recommendations on how to limit further selection for resistance to anthelmintics. To reduce the risk of parasite resistance, dosing programmes should be discussed with a veterinary surgeon. Fasinex 5% contains the anthelmintic triclabendazole and losses associated with resistant strains of fluke in sheep treated with triclabendazole can be significant. If signs of fasciolosis continue after treatment with Fasinex 5%, DO NOT REPEAT THE DOSE and do not dose with other products containing triclabendazole. Seek veterinary advice. If resistance is suspected or confirmed, you should change active ingredient on veterinary advice.

Parasite resistance to a particular class of anthelmintic may develop following frequent repeated use or misuse of an anthelmintic of that class. To reduce this risk, dosing programmes should be discussed with your veterinary surgeon or presciber. Efficacy of this product against liver fluke is reduced if triclabendazole resistant strains are present. If lack of efficacy is suspected seek veterinary advice.

Indicated for use in pregnant ewes.

For animal treatment only. Keep out of sight and reach of children.

Operator warnings: When using, do not eat, drink or smoke. Wash splashes from eyes and skin immediately. Take off immediately any contaminated clothing. Wash hands and exposed skin before meals and after work.

Withdrawal Periods

Meat - Animals must not be slaughtered for human consumption during treatment. Sheep may be slaughtered for human consumption only after 56 days from last treatment.

Milk – Not authorised for use in ewes producing milk for human consumption including during the dry period. Do not use within 1 year prior to the first lambing in ewes intended to produce milk for human consumption.

Pharmaceutical precautions

Protect from light.

Protect from freezing.

Do not store above 25°C.

Store in tightly closed original container.

Do not contaminate ponds, waterways or ditches with the product or used container. Any unused veterinary medicinal products should be disposed of in accordance with local requirements.

Legal category

POM-VPS

Packaging Quantities

0.8 litre, 2.2 litre and 5 litre packs.

Further information

Triclabendazole is a flukicide. The majority of the oral dose in rats, sheep, goats and rabbits is eliminated in faeces after 6-10 days as unchanged drug or products of biliary excretion. Urinary excretion is minimal. Sulphone, sulphoxide, ketone and 4-hydroxy triclabendazole derivatives are the main metabolites identified in plasma.

Marketing authorisation number

Vm 12501/4018.

GTIN (Global Trade Item No)

Fasinex 5% 2.2L

05037694000196

Fasinex 5% 5L

05037694000219

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