ACTIVE SUBSTANCES

Albendazole 50 mg

Levamisole 30 mg

Excipients:

Lactose, starch, aerosil, talc, avicel, magnesium stearate

Directions

The product is indicated for the treatment of helminth infestations, namely cestodes and nematodes, regardless of location, in dogs and cats, as follows:

• nematodes in dogs: Toxocara canis, Ancylostoma caninum,
• nematodes in dogs and cats: Toxocaris leonina, Uncinaria stenocephala, Capillaria spp.,
• cestodes in dogs: Echinococcus spp,
• cestodes in dogs and cats: Taenia spp., Mesocestoides spp.

CONTRAINDICATIONS

Do not use in case of severe liver or kidney disease.

Do not use in case of hypersensitivity to the active substances or to any of the excipients.

ADVERSE REACTIONS

They are not known under conditions where the recommended doses are respected.

TARGET SPECIES

Dogs and cats.

DOSAGE, METHOD AND ROUTE OF ADMINISTRATION

The product is administered orally at a dose of 1 tablet/5 kg of live weight, daily, for 2 consecutive days.

RECOMMENDATIONS ON CORRECT ADMINISTRATION

To ensure the correct dose is administered, the body weight of the animals should be determined as accurately as possible.

The veterinary medicinal product PARACAN tablets are administered individually.

WAITING TIME

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SPECIAL STORAGE PRECAUTIONS

Keep out of reach of children.

Store below 25ºC, in the original packaging.

Do not use after the expiry date stated on the label.

SPECIAL WARNINGS

Special warnings for each target species

The following practices should be avoided, as they increase the risk of developing resistance and ultimately lead to treatment ineffectiveness:

• frequent and repeated use of antiparasitics from the same class, over a long period of time,
• underdosing which may result from underestimation of the animals' body weight.

Special precautions for use in animals

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

In case of accidental ingestion of the product or allergy caused by its contact with the skin, seek medical advice immediately and show the product leaflet or the label. People with known hypersensitivity to one of the components of the product should avoid contact with it.

Use during pregnancy and lactation

The product is not indicated during pregnancy because albendazole is associated with teratogenic and embryotoxic effects.

Interactions with other medicinal products or other forms of interaction

Avoid concomitant use with products containing organophosphorus insecticides. These products should be administered 14 days before or after treatment with PARACAN tablets.

Overdose (symptoms, emergency procedures, antidotes)

In case of overdose, side effects may occur, manifested by: restlessness, nervousness, sialorrhea, these phenomena disappear without treatment, after 2-3 hours. In case of acute poisoning, symptomatic therapy and general measures to support the animal should be initiated.

incompatibility

In the absence of compatibility studies, this veterinary medicinal product should not be administered concomitantly with other veterinary medicinal products.

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

To protect the environment, medicines should not be disposed of via wastewater or household waste, but should be disposed of in accordance with local requirements. Any unused veterinary medicinal product or waste materials derived from the use of such products should be disposed of in accordance with local requirements.

PHARMACODYNAMIC PROPERTIES

Albendazole is a benzimidazole carbamate, which acts as a broad-spectrum anthelmintic, active against nematodes and cestodes. It is active against: nematodes in dogs (Toxocara canis, Ancylostoma caninum), nematodes in dogs and cats (Toxocaris leonina, Uncinaria stenocephala, Capillaria spp.) and cestodes in dogs (Echinococcus spp.), cestodes in dogs and cats (Taenia spp., Mesocestoides spp.). Parasite intoxication is attributed to the blocking of enzymatic systems involved in glucose uptake. In dogs and cats, albendazole is used in the treatment of nematodoses and cestodes.

Levamisole is a highly soluble imidazole anthelmintic that acts through a cholinergic effect on parasites, causing a depolarization block and a spastic paralysis that sets in quickly at the ganglia level (parasympathetic and sympathetic). In 1971, it was discovered that levamisole has an important immunostimulating effect by activating T lymphocytes (differentiation and maturation of T lymphocytes) and macrophages (restores the phagocytic activity of macrophages and granulocytes), respectively stimulating cellular immunity.

PHARMACOKINETICS

Albendazole is poorly absorbed (45% in the gastrointestinal tract) and is metabolized in the liver to an active sulfonamide metabolite. It reaches a maximum plasma concentration of 0.0375 µg/ml after a 50 mg oral dose and has a half-life of 8 hours. The active metabolites of albendazole, albendazole sulfoxide and albendazole sulfone, reach peak plasma concentrations 20 hours after administration. Approximately 47% of the oral dose is recovered as metabolites in the urine.

Levamisole is rapidly and completely absorbed from the gastrointestinal tract after oral administration, reaching a maximum level after about one hour and is eliminated within 24 hours in a proportion of over 90%. It is extensively metabolized, one of the main metabolites has immunostimulatory properties. The half-life is about 4 hours for levamisole and 16 hours for its metabolites.

PRESENTATION METHOD

High density polyethylene bottles of 20 tablets or PVC/Al blisters of 10 tablets.

AUTHORIZATION

120301/15.11.2012

Currently, product safety information is not available.

Currently, manufacturer information is not available.

Currently, information about the person responsible is not available.

Size: Small, Medium, Large

Age: Junior, Adult, Senior

Presentation type: Box

Brand Name: Romvac

Quantity: 20 Tablets