Noromectin 1.0% w/v Multi Injection Solution for Injection
Solution for injection containing:
Ivermectin 10mg in 1ml
For the treatment and control of internal and external parasites of beef and non-lactating dairy cattle, sheep and pigs.
One low-volume dose of Noromectin Multi Injection controls internal and external parasites that impair the health and productivity.
Noromectin Multi Injection is a ready-to-use, sterile, nonaqueous solution of ivermectin. Ivermectin is derived from the avermectins, a family of highly active, broad-spectrum antiparasitic agents which are isolated from fermentation of the soil organism Streptomyces avermitilis.
Noromectin Multi Injection is a 1.0% w/v sterile solution of ivermectin. At the rate of 1ml per 50kg bodyweight by subcutaneous injection, this formulation will deliver the recommended dosage level of 200 ?g ivermectin per kg bodyweight to cattle and/or sheep. At the rate of 1ml per 33kg bodyweight by subcutaneous injection, this formulation will deliver the recommended dosage level of 300 ?g ivermectin per kg bodyweight to pigs.
Noromectin Multi Injection is indicated for the treatment and control of the following species of gastrointestinal roundworms, lungworms, eyeworms, warbles, mites and sucking lice.
Gastrointestinal roundworms (adult and fourth stage larvae): Ostertagia ostertagi (including inhibited larval stages), Ostertagia lyrata, Haemonchus placei, Trichostrongylus axei, Trichostrongylus colubriformis, Cooperia oncophora, Cooperia punctata, Cooperia pectinata, Bunostomum phlebotomum, Oesophagostomum radiatum, Strongyloides papillosus (adult), Nematodirus helvetianus (adult), Nematodirus spathiger (adult), and Trichuris spp (adult).
Lungworms (adult and fourth stage larvae): Dictyocaulus viviparus.
Eyeworms (adult): Thelazia spp
Warbles: Hypoderma bovis and Hypoderma lineatum.
Mange Mites: Psoroptes bovis, Sarcoptes scabiei var bovis.
Sucking Lice: Linognathus vituli, Haematopinus eurysternus, and Solenopotes capillatus.
Noromectin Multi Injection may also be used as an aid in the control of the biting louse Damalinia bovis and the mange mite Chorioptes bovis, but complete elimination may not occur.
Noromectin Multi Injection is indicated for the effective treatment and control of the following harmful species of gastrointestinal roundworms, lungworms, nasal bots and psoroptic mange (sheep scab):
Gastrointestinal roundworms (adults and fourth stage larvae): Ostertagia circumcincta, O. trifurcata, Haemonchus contortus, Trichostrongylus axei (adults), Trichostrongylus colubriformis, Trichostrongylus vitrinus (adults), Cooperia curticei, Oesophagostomum venulosum, Oesophagostomum columbianum, Nematodirus filicollis, Chabertia ovina, Trichuris ovis (adults).
Inhibited larval stages and benzimidazole resistant strains of Haemonchus contortus and Ostertagia circumcincta are also controlled.
Lungworms: Dictyocaulus filaria (adults and fourth stage larvae), Protostrongylus rufescens (adults).
Mange Mites: Psoroptes ovis.
Nasal Bot: Oestrus ovis (all larval stages).
Noromectin Multi Injection is indicated for the treatment and control of the harmful species of gastrointestinal roundworms, lungworms, lice and mange mites of pigs.
Gastrointestinal worms: Ascaris suum (adults and fourth stage larvae), Hyostrongylus rubidus (adults and fourth stage larvae), Oesophagostomum spp (adults and fourth stage larvae) Strongyloides ransomi (adults and somatic larval stages).
Lungworms: Metastrongylus spp (adults).
Lice: Haematopinus suis.
Mange mites: Sarcoptes scabiei var suis.
Noromectin Multi Injection may also be used as an aid in the control of adult whipworm (Trichuris suis).
Persistent activity: When cattle have to graze on pasture contaminated with infective larvae of cattle nematodes, treatment with Noromectin Multi Injection at the recommended dose rate controls re-infection with Haemonchus placei, Cooperia spp and Trichostrongylus axei acquired up to 14 days after treatment, Ostertagia ostertagi andOesophagostomum radiatum acquired up to 21 days after treatment and Dictyocaulus viviparus acquired up to 28 days after treatment.
To obtain optimal benefit from the persistent activity of Noromectin Multi Injection, it is recommended that calves which are set-stocked in their first grazing season should be treated 3, 8 and 13 weeks after the day of turn-out. This can protect the animals from parasitic gastro-enteritis and lungworm disease throughout the grazing season, provided they are set-stocked, all the calves are included in the program, and that no untreated cattle are added to the pasture.
Treated calves should always be monitored according to good husbandry practices.
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 ivermectin has been reported in Teladorsagia in sheep and goats (also is common in Haemonchus in sheep in various parts of the world other than the EU). It has been reported in Cooperia oncophora in cattle, in Teladorsagia in cattle in New Zealand and Haemonchus in cattle in other parts of the world. 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.
Dosage & Administration
Noromectin Multi Injection should be given only by subcutaneous injection at the recommended dosage level of 200 ?g ivermectin per kilogram bodyweight. Each ml contains 10mg of ivermectin sufficient to treat 50kg of bodyweight. Use the following dosage schedule.
Noromectin Multi Injection should be given only by subcutaneous injection at the recommended dosage level of 200 ?g Ivermectin per kilogram bodyweight (0.5ml per 25kg bodyweight). Each ml contains 10mg ivermectin to treat 50kg bodyweight.
Noromectin Multi Injection is to be given subcutaneously only. Inject once under the loose skin in the neck. For the treatment and control of sheep scab (Psoroptes ovis) two injections with a seven day interval are required to treat clinical signs of scab and eliminate living mites. Use of a 17 gauge x ½ inch (15-20 mm) needle is suggested. Replace with a fresh sterile needle after every 10-12 animals. Injection of wet or dirty animals is not recommended.
Noromectin Multi Injection should be given only by subcutaneous injection in the neck at the recommended dosage level of 300 ?g ivermectin per kilogram bodyweight (1ml per 33kg bodyweight).
Use the following dosage schedule. In young pigs, especially those weighing under 16kg for which less than 0.5ml of Noromectin is indicated, dosing accuracy is important. The use of a syringe that can accurately deliver 0.1ml is recommended. For piglets weighing less than 16kg the product should be given at 0.1ml per 3kg.
Cattle must not be slaughtered for human consumption until 49 days after the last treatment. Do not use in cattle producing milk for human consumption. Do not use in nonlactating dairy cows including pregnant heifers within 60 days of calving.
Pigs must not be slaughtered for human consumption until 28 days after the last treatment.
Sheep must not be slaughtered for human consumption until 42 days after the last treatment. Do not use in lactating ewes producing milk for human consumption.
Contraindictions, Warnings etc
Treatment of psoroptic mange (sheep scab) with one injection is not recommended, because although a clinical improvement may be seen, elimination of all mites may not occur.
Sheep scab (Psoroptes ovis) is an extremely contagious external parasite of sheep. Following treatment of infected sheep, great care must be taken to avoid re-infestation, as mites may be viable for up to 15 days off the sheep. It is important to ensure all sheep which have been in contact between treated infected and non-treated non-infected flocks must be avoided until at least 7 days after the last treatment.
This product is for subcutaneous administration only and should not be given via other routes.
Noromectin Multi Injection is a low volume product for cattle, sheep and pigs: it should not be used in other species as adverse reactions, such as fatalities in dogs, may occur.
Transitory discomfort has been observed in some cattle following subcutaneous administration. Tissue swellings at the injection site have been observed. These reactions resolve without treatment. Further information is available upon request. Immediately following injection activity suggesting pain, sometimes intense but usually transient has been observed in some sheep.
Do not eat, drink or smoke while handling the product. Direct contact of the product with the skin should be kept to a minimum. Wash hands after use.
Take care to avoid self-injection: the product may cause irritation and/or pain at the site of injection.
When the container is broached (opened) for the first time, using the in-use shelf-life which is specified on this package insert, the date on which any product remaining in the container should be discarded should be worked out. This discard date should be written in the space provided on the label.
EXTREMELY DANGEROUS TO FISH AND AQUATIC LIFE.
Do not contaminate ponds, waterways or ditches with product or used container.
Dispose of any unused product and empty containers in accordance with guidance from your local waste regulation authority.
This product does not contain any antimicrobial preservative.
Swab septum before removing each dose
Use a dry sterile needle and syringe
When using the 250ml, 500ml and 1 litre pack sizes, use only automatic syringe equipment. To refill the syringe use of a draw-off needle is recommended to avoid excess broaching of the stopper.
Protect from light. Do not store above 25ºC.
Following withdrawal of the first dose, use the product within 28 days.
Discard unused material. Avoid introduction of contamination.
Cattle Overdose: Single doses of 4.0 mg/kg ivermectin (20 times the recommended dosage) administered subcutaneously, results in ataxia and depression. No antidote has been identified. Symptomatic treatment may be beneficial.
Sheep Overdose: Dose levels of up to 4mg/kg given subcutaneously can result in ataxia and depression. Symptomatic treatment may be beneficial.
Pig Overdose: Ivermectin has a recognised wide safety margin and is known to be safe in all ages of swine. It has no adverse effects on fertility in sows or breeding performance of boars.
Clinical signs of ivermectin toxicity in swine include tremors, bilateral mydriasis and recumbency with some biochemical abnormalities including a transient depression of serum iron. Such changes were only observed when ivermectin was administered subcutaneously at a dose of 30 mg/kg (100 times the normal therapeutic dose).
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