Company name: Novartis Animal Health UK Ltd
Address: Frimley Business Park
Frimley
Camberley
Surrey
GU16 7SR
Telephone: 01276 694402
Fax: 01276 694403
Levitape Oral Suspension for Sheep
Company name: Novartis Animal Health UK Ltd
Address: Frimley Business Park
Frimley
Camberley
Surrey
GU16 7SR
Telephone: 01276 694402
Fax: 01276 694403
A white aqueous suspension for oral administration containing 18.8 mg/ml praziquantel and 37.5 mg/ml levamisole hydrochloride.
Levitape is a broad spectrum anthelmintic for use in the treatment and control of nematode and tapeworm infections in sheep. It is highly effective against mature and developing immature forms of nematodes, including lungworms and against adult forms of tapeworm. Levitape should be used in cases of parasitic gastroenteritis and lungworm disease caused by those organisms sensitive to treatment with praziquantel and levamisole hydrochloride.
Stomach and Bowel Worms
Bunostomum spp. Chabertia spp, Cooperia spp, Haemonchus spp, Nematodirus spp, Oesophagostomum spp, Teladorsagia (Ostertagia) spp, Trichostrongylus spp.
Lungworms: Dictyocaulus spp.
Tapeworms: Moniezia spp.
Levitape should be administered as an oral drench using suitably calibrated drenching equipment. It should be well shaken before use.
To ensure administration of a correct dose, bodyweight should be determined as accurately as possible; accuracy of the dosing device should be checked.
Do not mix with other products.
The recommended dose rate is 1 ml per 5 kg bodyweight (7.5 mg/kg levamisole and 3.75 mg/kg praziquantel) according to the following recommendations:
Bodyweight (kg) | Dose (ml) |
Up to 10 | 2 |
10-15 | 3 |
16-20 | 4 |
21-25 | 5 |
26-30 | 6 |
Above 31 | Add 1 ml per 5 kg |
Contra-indications, warnings, etc
Intensive use or misuse of any anthelmintic can give rise to resistance.
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 levamisole has been reported in Teladorsagia, Cooperia and Trichostrongylus species in sheep in a number of countries including the EU. There are reports of resistance in Haemonchus in sheep outside 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.
Levitape can be given to debilitated stock (in the absence of intercurrent disease). Due regard must always be given to the physical condition of animals undergoing treatment, particularly those in advanced pregnancy and/or under stress from adverse weather conditions, poor nutrition, penning, handling etc.
Do not use in sheep that are severely stressed or in ill-health.
Animals must not be treated within a period of 14 days before or after treatment with organophosphorus compounds.
Veterinary advice should be sought:
1. on appropriate dosage programmes and stock management to achieve adequate parasite control and to reduce the likelihood of anthelmintic resistance developing:
2. if the product does not achieve the desired clinical effect, since other diseases, nutritional imbalances or anthelmintic resistance may be involved.
Do not exceed recommended dose rates. not achieve the desired clinical effect, since other diseases, nutritional imbalances or anthelmintic resistance may be involved.
Do not exceed recommended dose rates.
Hazard warnings
At normal levamisole dose levels, sheep rarely show side-effects. Any effect of over-dosage will be due to the levamisole component of the product and symptoms are therefore those of levamisole over-dosage. They are transient and include head-shaking, salivation, lachrymation, slight muscle tremors and mild excitability. There are no specific antidotes for levamisole poisoning.
Praziquantel has a wide margin of safety and symptoms of poisoning have not been described for sheep. The praziquantel component of Levitape poses no hazard to sheep at normal dose rates.
Levitape can be given to pregnant and lactating sheep, (provided the milk is not to be used for human consumption) and unweaned lambs, but observing withdrawal periods.
Do not administer at the same time as a product containing nicotine-like compounds.
Keep out of the reach and sight of children.
For animal treatment only.
Operator warnings
When using do not eat, drink or smoke.
Wash splashes from eyes and skin immediately. If irritation persists consult your doctor. Take off immediately any contaminated clothing. Wash hands and exposed skin before meals and after work.
Levamisole can cause idiosyncratic reactions and serious blood disorders in a very small number of people. If symptoms such as dizziness, nausea, vomiting or abdominal discomfort are experienced when using the product, or sore mouth and fever occur shortly afterwards, then medical advice should be sought immediately.
Protection of the Environment
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Withdrawal Periods
Meat - 28 days
Milk - milk from treated sheep must not be used for human consumption.
Store below 25˚C. Protect from direct sunlight and frost. Store in original container tightly closed. Shake container well before use.
Following the treatment of lungworm infections with Levitape, sheep may sometimes cough for 15-30 minutes after treatment whilst adult worms are expelled from the bronchi.
Chemical group of anthelmintic: 2-LV
Marketing authorisation holder (if different from distributor)
Merial Animal Health Ltd
PO Box 327
Sandringham House
Harlow Business Park
Harlow
Essex. CM19 5TG