SUMMARY OF PRODUCT CHARACTERISTICS

1. Name of the veterinary medicinal product

Noreprinec 5 mg/ml Pour-On Solution for Beef and Dairy Cattle (UK)

Robonex 5mg/ml Pour-On Solution for Beef and Dairy Cattle (BE, FR, IE)

2. Qualitative and quantitative composition

1ml of solution contains:

Active Substance:

Eprinomectin 5mg

Excipients:

Butylated Hydroxytoluene (E321) 0.1mg

For a full list of excipients, see section 6.1

3. Pharmaceutical form

Pour-on solution

A Clear to Very Light Yellow Solution.

4. Clinical Particulars

4.1 Target species

Beef and dairy cattle

4.2 Indications for use, specifying the target species

Indicated for the treatment and prevention of the following parasites

Gastrointestinal Roundworms (adults and fourth stage larvae):

Ostertagia spp., Ostertagia lyrata (adult),Ostertagia ostertagi (including inhibited O. ostertagi), Cooperia spp.(including inhibited Cooperia spp),Cooperia oncophora, Cooperia pectinata, Cooperia punctata, Cooperia surnabada, Haemonchus placei, Trichostrongylus spp.,Trichostrongylus axei, Trichostrongylus colubriformis, Bunostomum phlebotomum, Nematodirus helvetianus, Oesophagostomum spp. (adult),Oesophagostomum radiatum, Trichurisspp (adult).

Lungworms (adults and fourth stage larvae):

Dictyocaulus viviparus

Warbles (parasitic stages):

Hypoderma bovis, H. lineatum

Mange Mites:

Chorioptes bovis, Sarcoptes scabieivarbovis

Lice:

Damalinia bovis (biting lice),Linognathus vituli (sucking lice),Haematopinus eurysternus (sucking lice),Solenopotes capillatus (sucking lice).

Horn Flies:

Haematobia irritans.

Prolonged Activity

Applied as recommended, the product prevents reinfections with:

Parasite* Prolonged Activity

Dictyocaulus viviparus up to 28 days

Ostertagiaspp up to 28 days

Oesophagostomum radiatum up to 28 days

Cooperiaspp up to 21 days

Trichostrongylusspp up to 21 days

Haemonchus placei up to 14 days

Nematodirus helvetianus up to 14 days

*The following parasite species are included within each of the relevant genera: Ostertagia ostertagi, O. lyrata, Cooperia oncophora, C. punctata, C. surnabada, Trichostronglus axei, T. colubroformis.

4.3 Contraindications

This product is formulated only for topical application to beef and dairy cattle, including lactating dairy cattle. Do not use in other animal species. Do not administer orally or by injection.

Do not use in animals with known hypersensitivity to the active ingredient or any of the excipients.

4.4 Special Warnings for each target species

The details provided in section 4.10 apply.

If there is a risk for re-infestation, the advice of a veterinarian should be sought regarding the need for and frequency of repeat administration.

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 bodyweight, 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.

To date no resistance to eprinomectin (a macrocyclic lactone) has been reported within the EU. However resistance to other macrocyclic lactones has been reported in parasite species in cattle within the EU. Therefore, 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.

While mite and louse numbers decline rapidly following treatment, due to the feeding habits of the parasites, in some cases several weeks may be required for complete eradication.

For effective use, the product should not be applied to areas of the backline covered with mud or manure.

4.5 Special precautions for use

Not to be used in other species; avermectins can cause fatalities in dogs.

The product should be applied only to healthy skin.

This product may be irritating to human skin and eyes and may cause hypersensitivity.

Avoid skin and eye contact with the product during treatment and when handling recently treated animals.

Users should wear rubber gloves, boots and a waterproof coat when applying the product.

Should clothing become contaminated, remove as soon as possible and launder before re-use.

If accidental skin contact occurs, wash the affected area immediately with soap and water.

If accidental eye exposure occurs, flush eyes immediately with water.

This product may be toxic after accidental ingestion.

Avoid accidental ingestion of the product by hand to mouth contact.

Do not smoke, eat or drink while handling the product.

In the event of ingestion, wash out mouth with water and seek medical advice.

Wash hands after use.

This product is flammable. Keep away from sources of ignition.

Inhalation of the product may cause irritation.

Use only in well ventilated areas or outdoors.

Eprinomectin is very toxic to dung fauna and aquatic organisms and may accumulate in sediments.

The risk to aquatic ecosystems and dung fauna can be reduced by avoiding too frequent and repeated use of eprinomectin (and products of the same anthelmintic class) in cattle.

The risk to aquatic ecosystems will be further reduced by keeping treated cattle away from water bodies for two to four weeksafter treatment.

4.6 Adverse reactions (frequency and seriousness)

No undesirable effects have been identified when the product is used at the recommended dose rate.

4.7 Use during pregnancy, lactation or lay

May be used in dairy cattle during all stages of lactation.

Studies have demonstrated a wide safety margin. Studies conducted at three times the recommended use level of 0.5 mg eprinomectin/kg b.w. had no adverse effect on breeding performance of cows or bulls.

4.8 Interaction with other medicinal products and other forms of interaction

None known.

4.9 Amounts to be administered and administration route

Administer only by topical application at the dose rate of 1 ml per 10 kg of body weight, corresponding to the recommended dose rate of 0.5 mg eprinomectin per kg b.w. The product should be applied topically by pouring along the backline in a narrow strip extending from the withers to the tailhead.

Rainfall at anytime before or after treatment will not affect the efficacy of the product.

To ensure administration of a correct dose, bodyweight should be determined as accurately as possible; accuracy of the dosing device (dosing cup or dosing gun delivery system) should be checked.

For best results use as part of a program to control both internal and external parasites of cattle based on the epidemiology of these parasites.

In adult cattle, after administration of 5 times the recommended dose (2.5 mg eprinomectin/kg body weight), mild hair loss was observed. No other signs of toxicity were seen.

No antidote has been identified.

Meat & offal: 10 days

Milk: zero hours.

5. pharmacological properties

Pharmacotherapeutic group: Avermectins.

ATC Vet Code: QP54AA04

Mode of action

Eprinomectin is a member of the macrocyclic lactone class of endectocides. Compounds of the class bind selectively and with high affinity to glutamate-gated chloride ion channels which occur in invertebrate nerve or 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 parasite.

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 properties

The bioavailability of topically applied eprinomectin in cattle is about 30% with most absorption occurring by about 10 days after treatment. Eprinomectin is not extensively metabolized in cattle following topical administration. In all biological matrices, the B1a component of eprinomectin is the single most abundant residue.

Eprinomectin consists of the components B_1a(90%) and B_1b(10%) which differ by a methylene unit and is not extensively metabolized in cattle. Metabolites amount to approximately 10% of the total residues in plasma, milk, edible tissues and faeces.

The metabolism profile is nearly identical, qualitatively and quantitatively, in the above biological matrices and does not change significantly with time after administration of eprinomectin. The percent contribution of B_1aand B_1bto the overall metabolite profile remains constant. The ratio of the two drug components in the biological matrices is identical to that in the formulation demonstrating that the two eprinomectin components are metabolized with nearly equal rate constants. Since the metabolism and the tissue distribution of the two components are quite similar, the pharmacokinetics of the two components would be also similar.

Eprinomectin is strongly linked to plasma proteins (99%). Faeces is the major route of elimination.

5.3 Environmental properties

Like other macrocyclic lactones, eprinomectin has the potential to adversely affect non-target organisms. Following treatment, excretion of potentially toxic levels of eprinomectin may take place over a period of several weeks. Faeces containing eprinomectin excreted onto pasture by treated animals may reduce the abundance of dung feeding organisms which may impact on the dung degradation.

Eprinomectin is very toxic to aquatic organisms and may accumulate in sediments

6. Pharmaceutical particulars

6.1 List of excipients

Butylated Hydroxytoluene (E321)

Cetearyl Ethylhexanoate and Isopropyl Myristate

Propylene Glycol Dicaprylocaprate

Denatonium Benzoate

Isopropyl Alcohol

6.2 Incompatibilities

No major incompatibility has been identified.

Shelf-life of the veterinary medicinal product as packaged for sale: 2 years.

Shelf-life after first opening the immediate packaging: 3 months

Do not store above 30°C.

Keep container in the outer carton.

Protect from light.

Translucent 250 mL and 1L HDPE containers with integral squeeze measure pour system and white HDPE caps.

White 1L, 2.5L and 5L HDPE backpacks and white polypropylene screw caps.

Not all packs sizes may be marketed.

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

Extremely dangerous to fish and aquatic life. Do not contaminate ponds, waterways or ditches with the product or empty container.

7. MARKETING AUTHORISATION HOLDER

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry

Co. Down

BT35 6JP

Northern Ireland

8. MARKETING AUTHORISATION NUMBER

Vm:02000/4341

9. DATE OF FIRST AUTHORISATION

Date:20 March 2013

10. DATE OF REVISION OF THE TEXT

Date:October 2013

Approved:25/10/2013