CRIMECTIN PLUS inj

COMPOSITION

Each mL of product contains Ivermectin 10 mg and Clorsulon 100 mg.

TARGET SPECIES

Cattle.

INDICATIONS

Crimectin PLUS is recommended for the prevention (in populations where the diagnosis has been confirmed) and treatment of the following infestations: Gastrointestinal nematodes produced by: Ostertagia ostertagi (adults, L4 and L3 including larval stages) Ostertagia lyrata (adults and L4) Haemonchus placei (adults, L4 and L3 including inhibited larval stages) Mecistocirrus digitatus (adults) Trichostrongylus axei (adults and L4) Trichostrongylus colubriformis (adults and L4) Cooperia spp (adults, L4 and L3) Cooperia oncophora (adults and L4) Cooperia punctata (adults and L4) Cooperia pectinata (adults and L4) Nematodirus helvetianus (adults) Nematodirus spathiger (adults) Strongyloides papillosus (adults) Bunostomum phlebotomum (adults, L4 and L3) Toxocara vitulorum (adults, L4 and L3) Oesophagostomum radiatum (adults, L4 and L3) Trichuris Spp. (adults); Ocular nematodoses produced by: Thelazia Spp. (adults); Lung nematodoses produced by: Dictyocaulus viviparus (adults, L4 including inhibited larval stages); Hypodermosis produced by: Hypoderma bovis; Hypoderma lineatum; Dermatobia hominis (all larval stages). Infestations with chewing louse (biting): Linognathus vituli; Haematopinus eurysternus; Solinopotes capillatus. Scabies produced by: Psoroptes ovis; Sarcoptes scabiei. Trematodoses produced by: Fasciola hepatica; Fasciola gigantica (adult and immature forms). Crimectin PLUS helps to control infestations with: Louse (mallophaga): Damalinia bovis, Mange mites: Chorioptes bovis; Crimectin PLUS administered at the recommended dose of 1 mL/50 kg body weight effectively controls reinfections with Haemonchus placei, Trichostrongylus axei, Cooperia punctata, Cooperia oncophora and Cooperia surnabada for 14 days after the first treatment; Ostertagia ostertagi and Oesophagostomum radiatum for 21 days after the first treatment and Dictyocaulus viviparus for 28 days after the first treatment. 

Crimectin PLUS prevents invasion of Crysomyia benzzania larvae. The treatment is effective against larvae aged maximum days; mature larvae resist three or more days after treatment. Crimectin PLUS can be used preventively in planned procedures such as castration, ear marking, preventing invasion of Crysomyia benzzania for 14 days after treatment. To prevent the development of Crysomyia benzzania larvae in the umbilicus in newborn calves, Crimectin PLUS is administered within 24 hours of calving. Following calf castration, Crimectin PLUS is administered immediately. 

All animals injected with Crimectin PLUS at birth or castration will be examined daily until complete wound healing. If necessary, apply an insecticide for external use.

CONTRAINDICATIONS

Do not administer intramuscularly or intravenously. Do not use in cases of hypersensitivity to the active substances or to any of the excipients.

ADVERSE REACTIONS

Following subcutaneous administration, some transient discomfort has been observed in some animals. Occasionally there may be a slight inflammatory reaction at the injection site, reaction remitted spontaneously.

DOSAGE FOR EACH SPECIES, METHOD AND ROUTE(S) OF ADMINISTRATION

The recommended dose for cattle is 1 mL/50 kg body weight, equivalent to 200 mcg ivermectin/kg body weight and 2 mg clorsulon/kg bw Administration will be only by subcutaneous injection under the skin in front of or behind the shoulder blade. 

In order to administer the correct dose, body weight should be determined as accurately as possible; the accuracy of the dosing equipment will be checked.

 Treatment program in Hypoderma spp areas: Ivermectin is highly effective against all stages of Hypoderma spp. Larvae (hypodermosis/gadfly). 

For best results, cattle should be treated immediately as soon as possible after the end of the fly season. 

Without being related to ivermectin, the destruction of the hypoderma larva while it is in vital areas of the body can cause unwanted host-parasite reactions. Thus, if the Hypoderma lineatum larvae is killed in the oesophageal tissue, it can create gastric dilatation volvulus or paralysis if Hypoderma bovis is in the spinal canal. Therefore, treatments must be administered before or after these stages of larval migration. Cattle treated with ivermectin after the end of the fly season (in September) can be treated again with ivermectin in winter for internal parasites, mange or louse, thus destroying the possible larvae responsible for hypodermosis.

WARNINGS/ADVICE ON CORRECT ADMINISTRATION 

When the temperature of the product is less than 5 °C, administration may be difficult due to the product viscosity. Injection can be facilitated by warming the product and injection equipment to approx. 15 °C. Doses larger than 10 mL will be administered in two injections at two different sites to reduce transitive discomfort or side effects at the injection site. For other parenteral products, other injection sites will be used. 

Use sterile equipment. It is recommended to use a 16”-gauge needle, 15 or 20 mm long.

WITHDRAWAL PERIOD(S)

Meat and offal: 66 days. 

Milk: Use in animals producing milk for human consumption is not authorised.

SHELF LIFE

Shelf life of the veterinary medicinal product as packaged for sale: 2 years. Shelf-life after first opening the immediate packaging: 28 days.

SPECIAL PRECAUTIONS FOR STORAGE

Do not store above 25°C. Do not refrigerate or freeze. Store in the original package. Store in a dry place. Keep away from direct light.

SPECIAL PRECAUTIONS FOR EACH TARGET SPECIES

It is advisable to avoid the following practices because they increase the risk of developing parasite resistance and can make therapy ineffective: too frequent and repeated use of antihelmintics in the same class for too long; underdosing because of underestimation of body weight, incorrect product administration, dosage equipment decalibration, if used. 

All suspicious cases of anthelmintic resistance should be further investigated using appropriate tests (e.g., faecal egg count testing). Where tests clearly suggest resistance to a particular anthelmintic, another one shall be used, from a pharmacological class with a different mode of action. Resistance to macrocyclic lactones (including avermectin, ivermectin) was reported in Cooperia spp. in cattle within the EU and other parasite species outside the EU. This is why the use of this product should be based on local epidemiological information on nematode susceptibility and recommendations on how to limit the evolution of resistance to antihelmintics.

SPECIAL PRECAUTIONS FOR USE IN ANIMALS

Doses larger than 10 mL will be given in two injections at two different sites to reduce transient discomfort or side effects at the injection site. 

For other parenteral products, other injection sites will be used.

 Administer only to the species indicated in the package leaflet as mentioned in the dosing and administration section. The product should only be administered by subcutaneous injection, using any kind of equipment for the target species, either standard automated or single-dose calibrated, under the skin in front of or behind the shoulder blades, using a sterile needle.

SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE PRODUCT:

Do not smoke or eat while handling the product. Wash hands after using the product. Avoid contact with eyes or skin. If this happens, immediately rinse the affected area with water. In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.

USE DURING PREGNANCY AND LACTATION

No adverse effects on reproduction were observed at the recommended dose. 

Crimectin PLUS can be administered to cows (beef cattle) throughout their pregnancy or lactation period provided the milk is not intended for human consumption.

INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION

None known.

OVERDOSE (SYMPTOMS, EMERGENCY PROCEDURES, ANTIDOTES)

Studies have shown a high safety margin. The administration of 25 mL of Crimectin Plus/50 kg body weight can lead to injection site injuries (necrotic tissue, swelling, fibrosis and inflammation). 

No other side effects were determined.

INCOMPATIBILITIES

In the absence of compatibility studies, this medicinal product shall not be mixed with other veterinary medicinal products.

SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE MATERIALS, IF ANY

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

PRESENTATION/PACKAGE

50 mL, 100 mL, 250 mL and 500 mL polypropylene vials sealed with bromobutyl rubber stopper and aluminium cap.