Summary of the Product Characteristics

1. Name of veterinary medicinal product:

Chanimec 10mg/ml solution for injection (in Ireland)

Medimec 10mg/ml solution for injection (in Finland)

Animec 10mg/ml solution for injection (in Netherlands, UK, Austria, Greece)

2. Qualitative and quantitative composition:

Each ml contains:

Active substance:

Ivermectin 10 mg

Excipients:

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form:

Solution for injection

Clear colourless to slight yellow-coloured solution with no visible particulates.

4 CLINICAL PARTICULARS

4.1 Target Species

Cattle and Pigs.

4.2 Indications for use, specifying the target species

The product is indicated for the effective treatment and control of the following harmful parasites of cattle and pigs:

Cattle:

Gastro-intestinal roundworms (adult and fourth stage larvae):

Ostertagia spp. (including inhibited O.ostertagi)

Haemonchus placei

Trichostrongylus axei

Trichostrongylus colubriformis

Cooperia spp.

Oesophagostomum radiatum

Nematodirus helvetianus (adult)

N. spathiger (adult)

Lungworms (adult and fourth stage larvae):

Dictyocaulus viviparus.

Warbles:

Hypoderma bovis

H. lineatum.

Mange mites:

Psoroptes bovis

Sarcoptes scabiei var. bovis.

Sucking lice:

Linognathus vituli

Haematopinus eurysternus

Pigs:

Gastrointestinal roundworms: (adult and fourth stage larvae):

Ascaris suum

Hyostrongylus rubidus

Oesophagostomum spp.

Strongylides ransomi (adult and somatic larval stage)

Lungworms:

Metastrongylus spp. (adult)

Lice:

Haematopinus suis

Mange mites:

Sarcoptes scabiei var. suis

The use of the product in cattle should take into account geographical differences in the occurrence patterns of parasites.

4.3 Contraindications

Do not administer by the intravenous or intramuscular route.

Do not use in animals with known hypersensitivity to the active ingredient.

Do not use in dogs or cats (see also section 4.5)

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.

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 hasbeen reported in Ostertagia ostertagi in cattle. Therefore, the use of this product should be based on local (regional, farm) epidemiological information about susceptibility of this helminth species and recommendations on how to limit further selection for resistance to anthelmintics.

4.5 Special precautions for use

Special precautions for use in animals

Administer the product only subcutaneously because intramuscular administration causes persistent drug residues at the site of injection.

To avoid secondary reactions due to the death of Hypoderma larvae in the oesophagus or in the spine it is recommended to administer the product at the end of warble fly activity and before the larvae reach their resting sites. Consult your veterinarian on the correct timing of treatment.

This product has been formulated specifically for use in cattle and pigs. It should not be used in other species as severe adverse reactions may occur, including fatalities in dogs. In addition, care should be taken to avoid ingestion of spilled product or access to used containers by these other species.

Special precautions to be taken by the person administering the veterinary medicinal product to animals

Take care to avoid self administration: the product may cause local irritation and/or pain at the site of injection.

Do not smoke or eat while handling the product.

Wash hands after use.

4.6 Adverse reactions (frequency and seriousness)

Cattle

Transitory discomfort has been observed in some cattle following subcutaneous administration. A low incidence of soft tissue swelling at the injection site has been observed. These reactions have disappeared without treatment.

Pigs

Mild and transient pain reactions may be seen in some pigs following subcutaneous injection.

All these reactions disappeared without treatment.

4.7 Use during pregnancy, lactation or lay

The product can be administered to beef cows at any stage of pregnancy or lactation provided that the milk is not intended for human consumption. It can be used in breeding sows and boars and will not affect fertility. The product can be given to all ages of animals including young calves and piglets.

Please refer to section 4.11.

4.8 Interaction with other medicinal products and other forms of interaction

The product can be used concurrently without adverse effects with foot and mouth disease vaccine or clostridial vaccine, given at separate injection sites.

4.9 Amounts to be administered and administration route

Each ml contains 10mg of ivermectin sufficient to treat 50 kg of bodyweight of cattle, and 33 kg of bodyweight of pigs. Replace with a fresh sterile needle after every 10 to 12 animals. Massage the injection site after administration of the product. Injection of wet or dirty animals is not recommended.

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 over- dosing.

Cattle:

The product should be given only by subcutaneous injection at the recommended dosage level of 200 mcg ivermectin per kg bodyweight under the loose skin in front of, or behind, the shoulder in cattle. This is equivalent to 1ml per 50 kg bodyweight.

The volume administered per injection site should not exceed 10 ml.

Pigs:

In pigs, the recommended dosage level is 300 mcg ivermectin per kg bodyweight. This is equivalent to 1ml per 33 kg bodyweight. The recommended route of administration is by subcutaneous injection into the neck.

Young Pigs:

In young pigs, especially those below 16 kg for which less that 0.5 ml of the product is indicated, dosing accurately is important. The use of a syringe that can accurately deliver as little as 0.1 ml is recommended.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

In the case of overdose a symptomatic treatment should be given.

Cattle

Single doses of 4.0mg ivermectin per kg (20 x the use level) given subcutaneously resulted in ataxia and depression.

Pigs

A dose of 30mg ivermectin per kg (100 x the recommended dose of 0.3mg per kg) injected subcutaneously to pigs caused lethargy, ataxia, bilateral mydriasis, intermittent tremors, laboured breathing and lateral recumbency.

4.11 Withdrawal Period(s)

Cattle

Meat and offal: 49 days.

Do not use in lactating cows producing milk for human consumption. Do not use in cattle producing milk for human consumption or in dairy cows within 60 days prior to calving.

Pigs

Meat and offal: 28 days.

5 PHARMACOLOGICAL or IMMUNOLOGICAL PROPERTIES

ATCvet code: QP54AA01.

Pharmacotherapeutic Group: Endectocides

5.1 Pharmacodynamic properties

Mechanism of action

Ivermectin is a member of the macrocyclic lactone class of endectocides which have a unique mode of action. Compounds of this class bind 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 parasite. Compounds of this class may also interact with other ligandgated 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

Maximum plasma concentration

Cattle

At a dose level of 0.2mg ivermectin per kg a maximum plasma concentration of 35-50 ng/ml is reached in ± 2 days and the halflife in plasma is of 2.8 days.

It is also established that ivermectin is carried mainly in the plasma (80%). This distribution between plasma and blood cells remains relatively constant.

Pig

During trials carried out at a dose level of 0.3mg ivermectin per kg bodyweight, peak plasma concentrations were reached in 3 (±0.5) days and the drug persisted in plasma for up to 28 days.

Excretion: length of time and route

Cattle

Only about 1-2% is excreted in the urine the remainder is excreted in the faeces, approximately 60% of which is excreted as unaltered drug. The remainder is excreted as metabolites or degradation products.

Pigs

Biliary excretion is also the major route of ivermectin excretion in pigs.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Glycerol

Glycerol Formal

6.2 Incompatibilities

In the absence of incompatibility studies this veterinary medicinal product must not be mixed with other veterinary medicinal products.

6.3 Shelf-life

Shelf life of the veterinary medicinal product as packaged for sale: 3 years

Shelf life after first opening the immediate packaging: 28 days.

6.4 Special precautions for storage

This veterinary medicinal product does not require any special storage precautions.

6.5 Nature and composition of immediate packaging

Multidose polyethylene bottles of 50ml, 250ml and 500ml sealed with bromobutyl seals and aluminium overseals.

Not all pack sizes may be marketed.

6.6 Special precautions for the disposal of unused veterinary medicinal products or waste materials

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

The product should not enter water courses as this may be dangerous to fish and other aquatic organisms.

7 MARKETING AUTHORISATION HOLDER

Chanelle Animal Health Ltd.

7 Rodney Street,

Liverpool, L1 9HZ,

United Kingdom.

8 MARKETING AUTHORISATION NUMBER

Vm 11990/4023

9 DATE OF RENEWAL OF THE AUTHORISATION

21 September 2010

10 DATE OF REVISION OF THE TEXT

February 2011