NOAH Compendium

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Date: Wednesday, September 30, 2020 19:19

Release 2.47
Noromectin 0.08% w/v Drench Oral Solution
 
Species: Sheep
Therapeutic indication: Pharmaceuticals: Endoparasiticides: Anthelmintics for sheep
Active ingredient: Ivermectin
Product:Noromectin 0.08% w/v Drench Oral Solution
Product index: Noromectin Drench
Sheep - meat: 14 days
Withdrawal notes: Do not us in sheep producing milk for human consumption
Qualitative and quantitative composition
Active substance(s):
Ivermectin
0.08% w/v
Excipients:
Benzyl Alcohol
3.0% v/v
For a full list of excipients, see section Pharmaceutical Particulars
Pharmaceutical form
Oral solution.
A pale yellow clear liquid.
Clinical particulars
Target species
Sheep
Indications for use, specifying the target species
The treatment and control of gastrointestinal nematodes, and lungworms and nasal bots of sheep
Gastrointestinal worms (adult and immature):
Haemonchus contortus, Ostertagia circumcincta, Trichostrongylus spp, Cooperia spp, Nematodirus spp including N. battus, Strongyloides papillosus, Oesophagostomum spp, and adult Chabertia ovina.
Inhibited larval stages and benzimidazole resistant strains of H. contortus and Ostertagia circumcincta are also controlled.
Lungworms (adult and immature):
Dictyocaulus filaria
Nasal bot (all larval stages):
Oestrus ovis
Contra-indications
The product has been formulated specifically for use in sheep. It should not be used in other species, as adverse reactions, including fatalities in dogs, may occur.
The product is not for intravenous or intramuscular use.
Special Warnings for each target species
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 (an avermectin) has been reported in Teladorsagia in sheep and goats within the EU and it is common 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.
Special precautions for use
Special precautions for use in animals
None
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Do not smoke, drink or eat while handling the product.
Avoid contact with skin and eyes. In case of accidental eye or skin contact, wash the affected area with clean running water immediately. Seek medical attention if irritation persists.
Wash hands after use.
Adverse reactions (frequency and seriousness)
Some animals may cough slightly immediately after treatment. This is a temporary occurrence and is of no clinical consequence.
Use during pregnancy, lactation or lay
The product can be administered to ewes at any stage of pregnancy or lactation provided that the milk is not used for human consumption.
Interaction with other medicinal products and other forms of interaction
None known
Amounts to be administered and administration route
Ivermectin should be administered at a dosage rate of 200 μg per kg bodyweight (2.5 ml per 10 kg bodyweight). It should be administered orally. It is recommended that a suitably calibrated dosing gun is used to allow accurate dosing especially in young animals.
To ensure administration of a correct dose, body weight should be determined as accurately as possible; accuracy of the dosing device should be checked.
Do not mix with other products.
Overdose (symptoms, emergency procedures, antidotes), if necessary
No antidote has been identified, however symptomatic treatment may be beneficial.
Withdrawal period
Sheep may not be slaughtered for human consumption until 14 days after the last treatment.
Do not use in sheep producing milk for human consumption.
Pharmacological particulars
Pharmacotherapeutic group: Anthelmintic 3-AV
ATC Vet Code: QP54 AA 01
Pharmacodynamic properties
Ivermectin is a 22,23-dihydro derivative of an avermectin (which is a fermentation product produced by Streptomyces avermitilis) and consists of 2 homologues: B1a and B1b. It is a highly effective parasiticide with nematocidal, insecticidal and acaricidal activity documented in a wide range of domesticated animals.
Avermectins interact with glutamate-gated chloride ion channels, to increase membrane permeability to chloride ions, causing irreversible neuromuscular blockade in nematodes, followed by paralysis and death.
Pharmacokinetic properties
After administration orally to sheep at a dose of 200 µg/kg, the maximum plasma concentration of ivermectin was 5.99 µg/ml at 16.2 hours after administration and the elimination half-life was approximately 25 hours.
Pharmaceutical particulars
List of excipients
Benzyl Alcohol
Polysorbate 80
Dimethylacetamide
Disodium Phosphate Dihydrate
Sodium Acid Phosphate Dihydrate
Water Purified
Incompatibilities
None known
Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 5 Years.
Special precautions for storage
Do not store above 25°C.
Protect from direct sunlight.
Nature and composition of immediate packaging
Supplied in 1.0L, 2.5L, 5.0L volumes, presented in high density polyethylene Jerry Cans or high density polyethylene back-packs both closed with white polypropylene, screw-fit caps summounting board faced, aluminium foil induction seals.
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
EXTREMELY DANGEROUS TO FISH AND AQUATIC LIFE. Do not contaminate ponds, waterways or ditches with the product or used container. Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Marketing Authorisation Holder (if different from distributor)
Norbrook Laboratories Limited
Station Works
Newry
Co. Down
BT35 6JP
Northern Ireland
Marketing Authorisation Number
Vm 02000/4184
Significant changes
Date of the first authorisation or date of renewal
25th May 2000
Date of revision of the text
August 2010
Any other information
Nil.
Legal category
Legal category: POM-VPS
GTIN
GTIN description:Noromectin Drench for Sheep - 1L
GTIN:5023534004776
GTIN description:Noromectin Drench for Sheep - 2.5L
GTIN:5023534004783
GTIN description:Noromectin Drench for Sheep - 5L
GTIN:5023534004790