SUMMARY OF PRODUCT CHARACTERISTICS

1. Name of the veterinary medicinal product

Paramectin 0.5% w/v Pour-On Solution

2. Qualitative and quantitative composition

Active Substance:

Ivermectin 0.5% w/v

Excipients:

Patent Blue V (E131) 0.0005%w/v

For a full list of excipients, see section 6.1

3. Pharmaceutical form

Pour-on solution.

A clear blue liquid.

4. Clinical Particulars

4.1 Target species

Beef and non-lactating dairy cattle

4.2 Indications for use, specifying the target species

Paramectin Pour-On is indicated for the effective treatment and control of the following gastrointestinal roundworms, lungworms, eyeworms, warbles, chorioptic and sarcoptic mange and sucking and biting lice in beef and non-lactating dairy cattle.

Gastrointestinal roundworms (adults and fourth stage larvae):

Ostertagia ostertagi (including inhibited O ostertagi), Haemonchus placei, Trichostrongylus axei, Trichostrongylus colubriformis, Cooperia spp, Oesophagostomum radiatum, Strongyloides papillosus (adult), Trichuris spp (adult).

Lungworms (adult and fourth stage larvae):

Dictyocaulus viviparus.

Eyeworms (adult):

Thelazia spp

Warbles (parasitic stages):

Hypoderma bovis, Hypoderma lineatum.

Lice:

Linognathus vituli, Haematopinus eurysternus, Solenopotes capillatus, Damalinia bovis.

Mange mites:

Chorioptes bovis, Sarcoptes scabiei var bovis.

Paramectin Pour-On given at the recommended dose of 500 micrograms ivermectin per kg bodyweight controls infections with Trichostrongylus axei and Cooperia spp acquired up to 14 days after treatment, Ostertagia ostertagi and Oesophagostomum radiatum acquired up to 21 days after treatment and Dictyocaulus viviparis acquired up to 28 days after treatment.

It also controls horn flies (Haematobia irritans) for up to 35 days after treatment.

4.3 Contraindications

Do not treat cattle when their hair or hide is wet. Do not treat cattle if rain is expected, as rain within 2 hours of treatment may reduce efficacy Do not apply to areas of skin which have mange, scabs or other lesions or to areas contaminated with mud or manure.

Paramectin Pour-on has been formulated for specific use in cattle. It should not be applied or administered to other species, as severe reactions, including fatalities in dogs, may occur.

4.4 Special Warnings for each target species

None.

4.5 Special precautions for use

For external use only.

i) Special precautions for use in animals

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. It has been reported in Cooperia oncophora in cattle within the EU, in Teladorsagia in cattle in developed countries such as New Zealand and Haemonchus in cattle 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.

Highly flammable - keep away from heat, sparks, open flame or other sources of ignition.

Paramectin Pour-On may be irritating to human skin and eyes and the user should be careful not to apply it to himself or other persons. Operators should wear nitrile rubber gloves and boots with a waterproof coat when applying the product. Protective clothing should be washed after use. If accidental skin contact occurs, wash the affected area immediately with soap and water. If accidental eye exposure occurs, flush the eyes immediately with water and get medical attention.

Do not smoke or eat while handling the product. Wash hands after use. Use only in well ventilated areas or outdoors.

Undesirable effects are not expected when the product is used at the recommended dose rate.

4.7 Use during pregnancy, lactation or lay

Paramectin Pour-On can be administered to beef cows at any stage of pregnancy or lactation provided that the milk is not intended for human consumption.

4.8 Interaction with other medicinal products and other forms of interaction

None.

The formulation should be applied along the midline of the back in a narrow strip between the withers and the tailhead.

To ensure administration of a correct dose, body weight should be determined as accurately as possible; accuracy of the dosing device should be checked.

250 ml bottle and 1 litre pack

(Squeeze dispensing bottle/twin-neck container/single neck container)

• Remove the cap (twin-neck container/single neck container) or attach the dispensing cup to the product bottle (squeeze-measure container) and hold the container in an upright position.

• Gently squeeze the container until the product is level with the desired dose volume increment.

• Dispense the product by tipping the container forward until inverted.

2.5 litre and 5 litre pack

(Collapsible Back Pack)

• Remove the shipping cap from the backpack container and replace with the vent cap provided.

• Attach the hose from the automatic dosing equipment to the outlet from the vent cap.

No signs of toxicity are likely up to 5 mg/kg (10 times the recommended dose rate). There is no known antidote.

Cattle (meat): 28 days. Do not use in cows producing milk for human consumption. Do not use in non-lactating dairy cows including pregnant heifers within 60 days of calving.

5. pharmacological properties

Pharmacotherapeutic group: Anthelmintic

ATC Vet Code: QP54AA01

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 parasiticide with nematocidal, insecticidal and acaricidal activity documented in a wide range of domesticated animals.

Avermectins act to stimulate GABA mediated chloride ion conductance, causing irreversible neuromuscular blockade in nematodes, followed by paralysis and death.

6. Pharmaceutical particulars

6.1 List of excipients

Patent Blue V (E131)

Isopropyl Alcohol

Triethanolamine

Crodamol Cap

None known.

Shelf life of the veterinary medicinal product as packaged for sale: 1 year.

Do not store above 30°C.

Protect from light.

Store in a tightly closed original container.

Carton containing 250 ml or 1.0 litre natural high density polyethylene twin neck bottle with integral graduated dispensing chamber with polypropylene screw cap with woodpulp faced aluminium wad seal.

Carton containing 250 ml or 1.0 litre natural high density polyethylene single neck bottle with integral graduated dispensing chamber with polypropylene screw cap with woodpulp faced aluminium wad seal.

Carton containing 250 ml or 1.0 litre natural high density polyethylene squeeze bottle with integral graduated dispensing chamber with polypropylene screw cap with woodpulp faced aluminium wad seal.

Carton containing 2.5 or 5 litres white low density polyethylene backpack with polypropylene screw cap with woodpulp faced aluminium wad seal.

Not all pack 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 used container.

7. MARKETING AUTHORISATION HOLDER

Norbrook Laboratories Limited

Station Works

Newry

Co. Down, BT35 6JP

Northern Ireland

8. MARKETING AUTHORISATION NUMBER(S)

Vm: 02000/4197

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 12^th March 2001

10. DATE OF REVISION OF THE TEXT

December 2008