CRIMECTIN inj

COMPOSITION

Each mL of product contains Ivermectin 10 mg.

TARGET SPECIES

Cattle, pigs, sheep and goats.

INDICATIONS

Crimectin Inj is effective both in the prevention (in the cases where the diagnosis has been confirmed) and treatment of infestations with the following ecto- and endoparasites:

Cattle - Gastrointestinal nematodes (mature and immature); pulmonary nematodes (mature and stage four); myiases (all three stages); lice; ticks.

Sheep and goats - Gastrointestinal nematodes (mature and stage four); pulmonary nematodes (mature and stage four); Dictyocaulus spp (mature and stage four); myiases (all larval stages); scabies (Sarcoptes, Psoroptes).

Pigs - Gastrointestinal nematodes (mature and stage four); pulmonary nematodes (mature); lice; ticks.

The use of the product in the target species should take into account the geographical differences related to the occurrence and development of the parasites.

CONTRAINDICATIONS

Do not administer intramuscularly or intravenously. Do not use in species other than those indicated, because side effects, even death, may occur in dogs.

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

ADVERSE REACTIONS

Occasionally there may be a slight inflammatory reaction at the injection site, reaction remitted spontaneously.

Destruction of migratory larvae of Hypoderma spp in the vital organs of the body can cause unwanted “host-parasite” reactions, which are not characteristic of ivermectin.

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

Subcutaneous administration. Crimectin Inj should only be administered by subcutaneous route!

Cattle, sheep, goats - 1 mL/50 kg live body weight, equivalent to 0.2 mg Ivermectin/kg live body weight.

Pigs - 1 mL/33 kg live body weight, equivalent to 0.3 mg Ivermectin/kg live body weight. For piglets, especially those weighing less than 16 kg, for which less than 0.5 mL is indicated, it is important to accurately dose the product. If animals are treated collectively and not individually, they should be grouped by body weight and dosed appropriately to avoid under/overdose.

WARNINGS/ADVICE ON CORRECT ADMINISTRATION

Administration of the product will be done under aseptic conditions.

WITHDRAWAL PERIOD(S)

Pigs (meat and offal) 28 days

Goats (meat and offal) 28 days

Sheep (meat and offal) 21 days

Cattle (meat and offal) 49 days

Do not use in animals producing milk for human consumption.

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

Keep out of reach of children. 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

Some precautions should be taken to avoid the following practices because they may increase the risk of developing resistance and, implicitly, lead to treatment inefficiency: too frequent and repeated use of antihelmintics from the same class over a prolonged period of time; underdosing, which may be due to an underestimation of body weight, misuse of the product or non-calibration of the dosing device (if any).

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.

SPECIAL PRECAUTIONS FOR USE IN ANIMALS

Do not administer intramuscularly or intravenously.

Ivermectin is highly effective against all stages of cattle myiasis. However, the right moment of treatment is very important. For best results, cattle should be treated immediately after the hot season. Occasionally, dead larvae of Hypoderma lineatum dead in the periesophageal tissue can cause salivation and swelling.

Similarly, Hypoderma bovis larvae dying in the spinal canal can cause neurological conditions (dizziness or even paralysis), therefore cattle should be treated either before or after the development of these larval stages.

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

Avoid direct contact with skin or eyes. In case of accidental contact, rinse with plenty of water.

Do not smoke or eat while handling the product.

At the time of administration, accidental self-injection shall be avoided; the product may cause local irritation and/or painful reactions at the injection site.

USE DURING PREGNANCY AND LACTATION 

Do not use in lactating animals if milk is for human consumption. Do not use 28 days before parturition in animals whose milk is intended for human consumption.

INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION

None known.

OVERDOSE (SYMPTOMS, EMERGENCY PROCEDURES, ANTIDOTES)

Ivermectin is not toxic even after a 30-fold higher dose than the recommended therapeutic dose. If toxic reactions due to overdose are suspected, symptomatic treatment is recommended.

The toxic symptoms caused by overdosage can be: tremors, seizures and ultimately coma.

INCOMPATIBILITIES

None known.

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 national requirements.

Medicines should not be disposed of via waste water or household waste.

Ask your vet for information on how to dispose of medicines no longer required.

These measures contribute to environmental protection.

PRESENTATION/PACKAGE

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