Levacide Drench 3% Oral Solution 5L

Product Description

Various sizes
- View product for choices SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT   Levacide Drench 3% Oral Solution 2. QUALITATIVE & QUANTITATIVE COMPOSITION Active Substance: 3% w/v Levamisole Hydrochloride (equivalent to 2.5%w/v levamisole) Excipients: Methyl Hydroxybenzoate 0.15% w/v as antimicrobial preservative sodium metabisulphite 0.15% w/v & disodium edetate dihydrate 0.05% w/v as antioxidants & Tartrazine (E102) 0.011% w/v as colourant. For a full list of excipients see section 6.1 3. PHARMACEUTICAL FORM   Oral solution.  A clear yellow liquid. 4. CLINICAL PARTICULARS 4.1  Target species   Cattle & sheep 4.2  Indications for use specifying the target species  A broad spectrum anthelmintic for use in the treatment & control of nematode infections.  It should be used in cases of parasitic gastro-enteritis & lungworm disease caused by mature & developing immature forms of those organisms sensitive to treatment with Levamisole Hydrochloride.    Lungworms:    Dictyocaulus spp.   Gastrointestinal worms:  Haemonchus spp Ostertagia spp (except inhibited Ostertagia larvae in cattle).       Nematodirus spp       Trichostrongylus spp       Cooperia spp       Oesophagostomum spp       Chabertia spp       Bunostomum spp 4.3  Contraindications   Animals must not be treated within a period of 14 days before or after treatment with organophosphorus compounds.  4.4  Special Warnings for each target species Care should be taken to avoid the following practices because they increase the risk of development of resistance & could ultimately result in ineffective therapy: Too frequent & 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 & having a different mode of action should be used.  Resistance to levamisole has been reported in Teladorsagia Cooperia & Trichostrongylus species in sheep in a number of countries including the EU.  There are reports of resistance in Haemonchus in sheep outside the EU.  Resistance to levamisole has been reported in Teladorsagia species in cattle in developed countries such as New Zeal&.  Therefore the use of this product should be based on local (regional farm) epidemiological information about susceptibility of nematodes & recommendations on how to limit further selection for resistance to anthelmintics.    In cases of lungworm infections coughing may persist for a considerable time following successful treatment.  This is due to damage caused by the parasites. 4.5  Special precautions for use i)  Special precautions for use in animals   Care should be taken to estimate accurately the liveweight of animals to be treated.  After treatment animals should be moved to clean pasture in order to prevent re-infection.   Veterinary advice should be sought:  a)  On appropriate dosing programmes & stock management to achieve adequate parasite control & to reduce the likelihood of anthelmintic resistance developing. b)  If the product does not achieve the desired clinical effect since other diseases nutritional disturbances or anthelmintic resistance might be involved. ii) Special precautions to be taken by the person administering the veterinary medicinal product to animals   Do not eat drink or smoke when using this product.  Wash splashes from eyes & skin immediately.  If irritation persists seek medical advice.  Remove any contaminated clothing immediately.  Wash hands & exposed skin after handling this product & before meals. Levamisole can cause idiosyncratic reactions & serious blood disorders in a very small number of people.  If symptoms such as dizziness nausea vomiting or abdominal discomfort are experienced when using this exclusive product or sore mouth throat or fever occur shortly afterwards then medical advice should be sought immediately. 4.6  Adverse reactions (frequency & seriousness)   None. 4.7  Use during pregnancy lactation or lay   The product can be safely administered to pregnant or lactating animals.  However care should be taken when treating heavily pregnant animals & animals under stress from adverse weather conditions poor nutrition penning handling etc. 4.8  Interaction with other medicinal products & other forms of interaction   Levamisole activity is not affected by benzimidazole resistance.  4.9  Amounts to be administered & administration route   Administer as an oral drench using a dosing gun system at a rate of 7.5 mg Levamisole hydrochloride perkg bodyweight.  Cattle should be dosed at a rate of 2.5 ml of product per 10kg bodyweight & sheep at a rate of 0.5 ml per 2kg bodyweight. CATTLE  -  2.5 ml per 10kg bodyweight BODYWEIGHT DOSE 50kg (approx 1 cwt) 12.5 ml 100kg (approx 2 cwt) 25 ml 150kg (approx 3 cwt) 37.5 ml 200kg (approx 4 cwt) 50 ml 250kg (approx 5 cwt) 62.5 ml 300kg (approx 6 cwt) 75 ml (Cattle over 300kg a further 2.5 ml per additional 10 kg) SHEEP  -  0.5 ml per 2kg bodyweight BODYWEIGHT DOSE 10kg (approx 22 lb) 2.5 ml 20kg (approx 44 lb) 5 ml 30kg (approx 66 lb) 7.5 ml 40kg (approx 88 lb) 10 ml 50kg (approx 110 lb) 12.5 ml 60kg (approx 132 lb) 15 ml   (Sheep over 60kg a further 0.5 ml per additional 2 kg) 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 before administration except if premixing is done by a veterinary surgeon or a pharmacist. Overdose (symptoms emergency procedures antidotes) if necessary   Safe for use in cattle & sheep at the recommended dosages. However if recommended doses are exceeded animals may exhibit signs of impaired motor functions such as muscle tremors & increased salivation which are of a temporary nature. Withdrawal period   Cattle – Meat: 14 days   Sheep – Meat 21 days   Not for use in cattle & sheep producing milk for human consumption. 5. PHARMACOLOGICAL PROPERTIES Pharmacotherapeutic group:  Anthelmintic ATC Vet Code:  QP52AE01 5.1  Pharmacodynamic properties   Levamisole Hydrochloride is the levo isomer of dl 2 3 5 6-Tetrahydro-6-phenyl-imidazo (2 1-b) thiazole Hydrochloride. Levamisole was found to be active against adult & immature gastro-intestinal & pulmonary nematodes when administered to experimentally infected animals by the oral subcutaneous intramuscular or intraperitoneal routes.  It is thought to act by paralysing the susceptible parasites which are then expelled from the alimentary canal. 6. PHARMACEUTICAL PARTICULARS 6.1  List of excipients   Methyl Hydroxybenzoate Sodium Metabisulphite Disodium Edetate Dihydrate Tartrazine (E102) Sodium Citrate Dihydrate Citric Acid Anhydrous Water Purified 6.2  Incompatibilities   None known. Shelf life   Shelf life of the veterinary medicinal product as packaged for sale: 2 Years. Special precautions for storage   Do not store above 25ºC.   Protect from light. Nature & composition of immediate packaging   Available in 1 2.5 & 5 litre white opaque low density polyethylene flexi-packs with white screw fit polypropylene cap.  Also available in 10 litre white opaque high density polyethylene jerry cans with a white screw fit polypropylene cap.   Not all pack sizes may be marketed. Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products   Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.  7. MARKETING AUTHORISATION HOLDER   Norbrook Laboratories Limited   Station Works   Newry   Co. Down  BT35 6JP 8. MARKETING AUTHORISATION NUMBER (S)   Vm 02000/4054 9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION   Date of First Authorisation:  04 April 1984 10. DATE OF REVISION OF THE TEXT 09 July 2008 �