Dolpac 10 for dogs (Canada)

Company: Vetoquinol

Oxantel/Pyrantel/Praziquantel tablets

Broad Spectrum Anthelmintic

Bacon Flavoured

Active Ingredients

VETERINARY USE ONLY

INDICATIONS: Dolpac is indicated for the treatment of parasitic infections caused by ascarids (Toxocara canis and Toxascaris leonina), hookworms (Ancylostoma caninum and Uncinaria stenocephala), whipworms (Trichuris vulpis), and tapeworms (Dipylidium caninum, Taenia pisiformis, T. hydatigena, T. ovis and adult and immature stages of Echinococcus spp.) in dogs and puppies two months of age or greater, with a body weight between 1 and 75 kg.

PHARMACOLOGY: Dolpac contains three active ingredients: Pyrantel Pamoate, Oxantel Pamoate and Praziquantel.

Pyrantel paralyses nematodes muscles by activating their acetylcholine receptors. It is active against Toxocara canis, Toxascaris leonina, Ancylostoma caninum and Uncinaria stenocephala. Oxantel is an m-oxyphenol analogue of pyrantel and it was developed for its activity against whipworms (Trichuris spp.). Praziquantel causes contractions, paralysis and tegumental lesions in tapeworms. It is effective against both adult and larval stages of canine cestodes.

After oral administration, Oxantel Pamoate absorption is negligible. Pyrantel is quickly absorbed from the gastrointestinal tract but no more than 15% is absorbed (T_max = 1.38 h, C_max = 0.048 mcg/mL) and its elimination is very fast (urinary excretion). Praziquantel is quickly absorbed (T_max = 1.28 h, C_max = 0.4 mcg/mL), metabolized in the liver and excreted in the bile, at which point its cestocidal activity is exhibited.

Dolpac 10 for dogs Dosage And Administration

The recommended dose of 20 mg Oxantel (base) / 5 mg Pyrantel (base) / 5 mg Praziquantel per kg body weight is provided by a single oral treatment.

Dolpac 2: one tablet per 2 kg body weight

Dolpac 10: one tablet per 10 kg body weight

Dolpac 25: one tablet per 25 kg body weight

A combination of two of the three strengths of Dolpac may be used to obtain a more precise dosage based on the body weight of each animal. Administer preferably on an empty stomach.

It is recommended to perform laboratory fecal examinations prior to instituting and during a parasite control program adapted to the needs of a specific patient.

It is generally recognised that puppies should be treated against nematodes more frequently than adults.

In some animals, Ancylostoma caninum and Toxocara canis may not be totally eliminated by the treatment, resulting in a continued risk of egg shedding into the environment. Follow-up fecal examinations are advisable and according to the results of these examinations, treatment with a nematodicidal product may be carried out if necessary.

Fleas serve as an intermediate hosts for one of the common tapeworms - Dipylidium caninum. Tapeworm infestation may reoccur unless control of the intermediate host (fleas) is undertaken.

CAUTIONS: This product is not recommended for use in puppies younger than two months old or weighing less than 1 kg.

In debilitated or heavily infested animals, the product should be used only according to a benefit/risk assessment by the treating veterinarian.

The safety of this product has not been tested in breeding dogs, in pregnant bitches and in lactating bitches.

Parasite resistance to any particular class of anthelmintic may develop following frequent, repeated use of an anthelmintic of that class.

Contraindications

Do not use in animals with known hypersensitivity to any of the components of this product.

Do not use simultaneously with levamisole, piperazine or choline esterase inhibitors.

Adverse Reactions

Vomiting and diarrhea may be observed following the treatment. Ataxia and muscle tremors have occasionally been reported. Despite not being observed in studies performed with this product, anorexia can occur as it is a common adverse effect of products containing Praziquantel.

Warnings

Keep out of reach of children.

Some constituents of this product may cause allergic reactions or skin irritation. Avoid contact with the skin. Wash hands after use.

SAFETY AND EFFICACY STUDIES: The safety of Dolpac was assessed in 24 beagle dogs following weekly oral administration for 6 consecutive weeks. The animals received a placebo, the therapeutic dose, three times the therapeutic dose or five times the therapeutic dose. Under the conditions of this study, there were no treatment-related effects on any parameters evaluated.

Two controlled, international, multicentre, blind and randomised trials were performed in Europe to assess the efficacy and also the safety of Dolpac in dogs when compared to Drontal^®P (Praziquantel/Pyrantel pamoate/Febantel tablets). In the first trial, 214 dogs received one dose of either Dolpac (n=161) or the control product, Drontal^®P (n=53). The second trial included 227 dogs receiving at least one dose of either Dolpac (n=168) or the control product, Drontal^®P (n=59). Both trials showed that the efficacy of Dolpac was greater than 90% elimination for each parasite studied and these results were comparable to those obtained with the control product. The incidence of adverse reactions was very low.

PRESENTATION: Dolpac tablets are scored and are bacon flavoured.

Dolpac 2: 6 blisters of 10 tablets, Dolpac 10: 5 blisters of 6 tablets and 10 blisters of 6 tablets and Dolpac 25: 10 blisters of 3 tablets and 20 blisters of 3 tablets.

STORAGE CONDITIONS: Store between 15°C and 25°C.

Vetoquinol N.-A. Inc., 2000, ch. Georges, Lavaltrie, QC, Canada J5T 3S5

456993 0718 C

CPN: 1234321.7