Noromectin Drench 0.08% for Sheep
For the treatment and control of gastrointestinal nematodes, lungworms and nasal bots of sheep.
Noromectin Drench at the recommended dosage level of 200mg ivermectin per kg bodyweight effectively controls the
following parasites of sheep:
Gastrointestinal worms: Haemonchus contortus [Adult, L4 and Inhibited L4], Ostertagia (Teladorsagia) circumcincta [Adult, L4 and Inhibited L4], Trichostrongylus axei [Adult and L4], Trichostrongylus colubriformis [Adult and L4], Trichostrongylus
vitrinus [Adult and L4], Cooperia curticei [Adult and L4], Cooperia oncophora [Adult and L4], Nematodirus battus [Adult and L4], Nematodirus filicollis [Adult and L4], Nematodirus spathiger [Adult and L4], Strongyloides papillosus [Adult and L4],
Oesophagostomum columbianum [Adult and L4], Oesophagostomum venulosum[Adult and L4], and adult
Chabertia ovina Inhibited larval stages and benzimidazole resistant strains of H. Contortus and Ostertagia (Teladorsagia) circumcincta also controlled.
Lungworms (adult and immature): Dictyocaulus filaria
Nasal bot (all larval stages): Oestrus ovis
Ivermectin should be administered at a dose rate of 200mg per kg bodyweight. Noromectin Drench for sheep should be given orally at the recommended dose rate of 1ml per 4kg bodyweight. Estimate bodyweight accurately. Use appropriate
and properly calibrated dosing equipment.
The treated animals should be monitored according to good husbandry practices.
Noromectin Drench can be administered to ewes at any stage of pregnancy or lactation provided that the milk is not used for human consumption. Noromectin Drench will not affect the fertility of breeding ewes and rams and can be given to all ages of animals including young lambs.
Animals must not be slaughtered for human consumption during treatment.
Sheep may not be slaughtered for human consumption until 10 days after the last treatment. Do not use in lactating sheep
producing milk for human consumption. Do not use in nonlactating dairy sheep within 60 days of lambing.
Do not smoke or eat while handling the product.
Wash hands after use. Avoid contact with the eyes.
Any spillages of the product into eyes should be washed immediately.
The product has been formulated specifically for use in sheep. It should not be administered to other species as severe adverse reactions may occur.
Cases of intolerance with fatal outcome are reported in dogs, especially collies, Old English Sheepdogs and related breeds or
crosses, and also in turtles/tortoises.
Frequent and repeated use may lead to the development of resistance. It is important that the correct dose is given in order
to minimise the risk of resistance. To avoid under dosing, animals should be grouped according to their body weight
and dosed according to the heaviest animal in the group.
The veterinary medicinal product was tolerated up to 3 times the recommended dose.
Symptoms of overdosage include trembling, convulsions and coma. In case of overdose, symptomatic treatment should be
given.
The solution is stable and ready for use.
Noromectin Drench does not deteriorate when stored under
normal conditions.
Do not store above 25°C. Following opening of the container, use the product within 6 months.
EXTREMELY DANGEROUS TO AQUATIC LIFE. Do not contaminate surface waters or ditches with product or used
container. Unused product and waste material should be disposed of in accordance with national requirements.
Some animals may cough slightly immediately after treatment.
For Animal Treatment Only
Keep out of reach and sight of Children
A liquid for oral administration containing:
0.08% w/v Ivermectin
3% Benzyl Alcohol as preservative.
Summary of Product Characteristics
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Noromectin Drench 0.8 mg/ml Oral Solution for Sheep
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Substance
Ivermectin
Excipient(s)
0.8 mg/ml
Benzyl alcohol
30 mg/ml
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Oral Solution.
A pale yellow clear liquid
4 CLINICAL PARTICULARS
4.1 Target Species
Sheep
4.2 Indications for use, specifying the target species
The medicinal product is indicated for the treatment and control of gastrointestinal nematodes, lungworms, and nasal bots of sheep.
Gastro-intestinal worms
Haemonchus contortus [Adult, L4 and inhibited L4], Ostertagia (Teladorsagia) circumcincta [Adult, L4 and inhibited L4],
Trichostrongylus axei [Adult and L4], Trichostrongylus colubriformis [Adult and L4], Trichostrongylus vitrinus [Adult and
L4], Cooperia curticei [Adult and L4], Cooperia oncophora [Adult and L4], Nematodirus battus [Adult and L4],
Nematodirus filicollis [Adult and L4], Nematodirus spathiger [Adult and L4], Strongyloides papillosus [Adult and L4], Oesophagostomum columbianum [Adult and L4], Oesophagostomum venulosum [Adult and L4] and adult Chabertia ovina.
Inhibited larval stages and benzimidazole resistant strains of H contortus and Ostertagia (Teladorsagia) circumcincta are also controlled.
Lungworms (adult and immature):
Dictyocaulus filaria
Nasal bot (all larval stages): Oestrus ovis
4.3 Contraindications
Do not use in animals in which milk is intended for human consumption.
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 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.
4.5 Special precautions for use
Special precautions for use in animals
The product has been formulated specifically for sheep. It should not be administered to other species as severe adverse reactions may occur. Cases of intolerance with fatal outcome are reported in dogs, especially Collies, old English Sheepdogs and related breeds or crosses, and also in turtles/tortoises.
Special precautions to be taken by the person administering the veterinary medicinal product to animals Do not smoke or eat while handling the product.
Wash hands after use.
During administration avoid contact with the eyes. Any spillage of the product into the eyes should be washed immediately.
4.6 Adverse reactions (frequency and seriousness)
Some animals may cough slightly immediately after treatment.
4.7 Use during pregnancy, lactation or lay
The medicinal product can be administered to ewes at any stage of pregnancy or lactation provided that the milk is not used for human consumption.
Do not use in lactating sheep producing milk for human consumption.
4.8 Interaction with other medicinal products and other forms of interaction
None known.
4.9 Amounts to be administered and administration route
Ivermectin should be administered at a dose rate of 200 micrograms per kg bodyweight. The medicinal product should be given orally at the recommended dose rate of 1 ml per 4 kg bodyweight. The treated animals should be monitored according to good husbandry practices.
To ensure administration of a correct dose, body weight 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 overdosing.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
The veterinary medicinal product was tolerated up to 3 times the recommended dose. Symptoms of overdose include trembling, convulsions and coma. In case of overdose, symptomatic treatment should be given.
4.11 Withdrawal Period(s)
Meat and offal: 10 days.
Milk: Not permitted for use in lactating sheep producing milk for human consumption. Do not use in non-lactating dairy sheep within 60 days of lambing.
5 PHARMACOLOGICAL or IMMUNOLOGICAL PROPERTIES
Pharmacotherapeutic group: Endectocide ATC vet code: QP54AA01
5.1 Pharmacodynamic properties
Ivermectin in 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 parasiticide with nematocidal, insecticidal and acaricidal activity documented in a wide range of domesticated animals.
Ivermectin is a macrocyclic lactone derivative and acts by inhibiting nerve impulses. It binds selectively and with high affinity to glutamate-gated chloride ion channels which occur in invertebrate nerve and muscle cells. This leads to an increase in the permeability of the cell membrane to chloride ions with hyperpolarization of the nerve or muscle cell, resulting in paralysis and death of the relevant parasites. Compounds of this class may also interact with other ligand-gated chloride channels, such as those gated by the neurotransmitter gamma-aminobutyric acid (GABA). The margin of safety for compounds of this class is attributable to the fact that mammals do not have glutamate-gated chloride channels. The macrocyclic lactones have a low affinity for other mammalian ligand-gated chloride channels and they do not readily cross the blood-brain barrier.
5.2 Pharmacokinetic particulars
Peak levels of ivermectin are observed around 16 hours following oral administration of the medicinal product.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
N,N-dimethylacetamide Polysorbate 80
Benzyl Alcohol
Disodium hydrogen (orthophosphate dihydrate) Sodium dihydrogen (orthophosphate dihydrate) Purified water
6.2 Incompatibilities
None known
6.3 Shelf-life
Shelf life of the veterinary medicinal product as packaged for sale: 5years
Shelf life after first opening the immediate packaging: 6 months
6.4 Special precautions for storage
Do not store above 25°C.
6.5 Nature and composition of immediate packaging
The veterianry medicinal product will be supplied in 1.0 L, 2.5 L and 5.0 L and 2 x 5.0 L high density polyethylene Jerry can containers complete with polypropylene caps and 1.0 L, 2.5 L, 5.0 L and 2 x 5.0 L high density polyethylene Backpack containers complete with polypropylene plastic screw caps.
Not all pack sizes may be marketed.
6.6 Special precautions for the disposal of unused veterinary medicinal products or waste materials
EXTREMELY DANGEROUS TO AQUATIC LIFE. Do not contaminate surface waters or ditches with product or used containers. Any unused product or waste material should be disposed of in accordance with national requirements.
7 MARKETING AUTHORISATION HOLDER
Norbrook Laboratories Limited
Station Works
Camlough Road
Newry
Co Down BT35 6JP
8 MARKETING AUTHORISATION NUMBER(S)
VPA 10999/078/001
9 DATE OF THE FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 14th June 2000
Date of last renewal: 20th September 2006
10 DATE OF REVISION OF THE TEXT
September 2015
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