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Crimectin plus is recommended for control (where the diagnosis has been confirmed) and the treatment of following parasitical infestations:
Gastrointestinal roundworms
Ostertagia ostertagi (adult, L4 and L3 stages, including larval stages), Ostertagia lyrata (adult and L4 stage), Haemonchus placei (adult, L4 and L3 stages, including inhibited larval stages), Mecistocirrus digitatus (adult), Trichostrongylus axei (adult and L4 stage), Trichostrongylus columbriformis (adult and L4 stage)
Cooperia spp. (adult, L4 and L3 stages), Cooperia oncophora (adult and L4 stage), Cooperia punctata (adult and L4 stage), Cooperia pectinata (adult and L4 stage), Nematodirus helvetianus (adult ), Nematodirus spathiger (adult), Strongyloides papillosus (adult), Bunostomum phlebotomum (adult, L4 and L3 stages), Toxocara vitulorum (adult, L4 and L3 stages), Oesophagostomum radiatum (adult, L4 and L3 stages), Trichuris spp. (adult)
Eye worms
Thelazia spp. (adult).
Lungworms
Dictyocaulus viviparus (adult, L4-stage, including inhibited larval stages).
Warbles
Hypoderma bovis, Hypoderma lineatum, Dermatobia hominis (all larval stages).
Myiasis
Chrysomya bezziana, Cochliomyia hominivorax.
Sucking lice
Linognathus vituli, Haematopinus eurysternus, Solenopotes capillatus,
Mites
Psoroptes ovis, Sarcoptes scabiei.
Ticks
Ornithodoros savignyi, Boophilus microplus, Boophilus decoloratus (resistant to organo-phosphorics compounds, synthetic pyrethroids and amides)
Liver fluke
Fasciola hepatica, Fasciola gigantica (adult and immature stages).
Crimectin Plus is useful for controlling parasitical infestations with:
Lice (chewing louse): Damalinia bovis.
Mites: Chorioptes bovis.
Crimectin Plus, administered in recommended doses of 1ml/50 kg body weight, controls re-infestation with:
Haemonchus placei, Trichostrongylus axei, Cooperia punctata, Cooperia oncophora and Cooperia surnabada acquired up to 14 days after first treatment; Ostertagia ostertagi and Oesophagostomum radiatum acquired up to 21 de days after first treatment and Dyctiocaulus viviparus acquired up to 28 days after first treatment. Crimectin Plus prevents larval invasion of Chrysomya bezziana. The treatment is effective against larva not older than 2 days. The mature larva resists 3 or more days after treatment. Crimectin Plus may be used as preventive treatment in planned procedures such as neutering, ear tagging, preventing invasion of Chrysomya bezziana during 14 days after treatment. To prevent the development of Chrysomya bezziana larva at navel level to new-born calves, Crimectin Plus should be administered not later than 24 hours after birth. Administer immediately Crimectin Plus after neutering procedure in male-calves. All animals injected with Crimectin Plus, at birth or after neutering, will be daily examined until complete healing of the wounds. If necessary, a topic insecticide may be used.
Ivermectin 10 mg/ml
Clorsulon 100 mg/ml
Do not administer intramuscularly or intravenously. Do not use in case of hypersensitivity to the active substances or to any of the excipients.
Transitory discomfort has been observed in some animals following subcutaneous administration. A low incidence of soft inflammatory reaction at the site of injection has been observed, which disappears without treatment.
The recommended dose is 1 ml/50 kg bodyweight (based on a dosage level of 200 mcg ivermectin plus 2 mg clorsulon per kg bodyweight).
The product should be given only by subcutaneous injection under the loose skin in front of, or behind the shoulder.
When the temperature of the product is below 5oC, difficulty in administration may be encountered due to increased viscosity. Warming the product and injection equipment to about 15oC will increase the ease with which the product can be injected. A sterile 16 caliber gauge (15-20mm) needle is recommended.
To ensure administration of a correct dose, bodyweight should be determined as accurately as possible; accuracy of the dosing device should be checked.
Treatment program in geographical regions with Hypoderma spp.
Ivermectin is effective against all larva stages of Hypoderma spp. In order to obtain the best results, the cattle should be treated as soon as possible after the end of the swarming of the warble flies. Not being ivermectin-related, if the Hypoderma larva are killed during migration in vital zones, severe reactions parasite-host may occur. For instance, if larvae of Hypoderma lineatum are killed in esophageal tissue, this may cause gastric dilatation or volvulus. If larvae of Hypoderma bovis are killed during migration through the spine, this may induce paralysis. Therefore, the treatments should be initiated before or after larva migration stages. Cattle treated with ivermectin, after fly season has ended (September), may be treated again during winter for internal parasites, mites or lice, destroying also Hypoderma larva.
Meat and offal: 66 days.
Milk: Not permitted for use in lactating animals producing milk for human consumption.
Do not store above 25°C. Do not refrigerate. Protect from frost. Store in the original container. Store in a dry place. Protect from direct sunlight.
Shelf-life of the veterinary medicinal product as packaged for sale: 2 years.
Shelf-life after first opening the immediate packaging: 28 days.
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. Resistance to macrocyclic lactones (which includes ivermectin) has been reported in Cooperia spp., in cattle within the EU and other parasites outside 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.
Special precautions for use in animals
Divide doses greater than 10 ml between two injection sites to reduce occasional discomfort or site reaction. Different injection sites should be used for other parenteral products administered concurrently. Administer the product only in target species as it is stated by package leaflet, section >>method and route(s) of administration<<. The product should be administered only by subcutaneous injection under the loose skin in front of or behind the shoulder, using any standard automatic device or a single-dose calibrated device. Use a dry, sterile needle.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Do not eat, drink or smoke whilst handling the product. Wash hands after use. Direct contact with the skin or eyes should be avoided. If this occurs, rinse with plenty of water. Take care to avoid self-injection: the product may cause local irritation and/or pain at the site of injection. In case of accidental self injection, seek medical advice and show the package leaflet or label to the doctor.
Use during pregnancy or lactation
At recommended doses, the product does not affect the reproduction. The product may be administered to beef cattle, during gestation or lactation, but the milk will not be given for human consumption.
Interaction with other medicinal products and other forms of interaction
Not known.
Overdose (symptoms, emergency procedures, antidotes), if necessary
The safety studies revealed a high safety margin. The administration of 25 ml Crimectin Plus per 50 kg bodyweight resulted in an injection site lesion (tissue necrosis, oedema, fibrosis and inflammation). No other drug-related adverse reactions could be determined.
Incompatibilities
In the absence of compatibilities studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
Vials of 50 ml, 100 ml, 250 ml and 500 ml.
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