Dolpac 25 for dogs between 20 an 75 kg 1 tablet
Treatment of dogs harbouring mixed parasitic infestations (nematode and cestode)
Dolpac Tablets for Large Dogs
2. QUALITATIVE AND QUANTITATIVE COMPOSITION OF Dolpac
Each tablet contains :
Oxantel 500.70 mg (equivalent to 1397.5 mg of oxantel embonate)
Pyrantel 124.85 mg (equivalent to 360 mg of pyrantel embonate)
Praziquantel 125.00 mg
Excipient to one 2375 mg divisible tablet
For a full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM OF Dolpac
Pale yellow to yellow oblong tablet with breaking line.
4. CLINICAL PARTICULARS OF Dolpac
4.1 Target species
4.2 Indications for use, specifying the target species
For curative treatment of dogs harbouring mixed parasitic infestations with the following adult stages of nematode and cestode species:
See section 4.8
4.4 Special warnings for each target species
Parasite resistance to any particular class of anthelmintic may develop following frequent, repeated use of an anthelmintic of that class
Fleas serve as intermediate hosts for one of the common tapeworms – Dipylidium caninum. Tapeworm infestation may reoccur unless control of intermediate hosts (fleas) is undertaken.
4.5 Special precautions for use
i) Special precautions for use in animals
Roundworm and Hookworm infection:
In some animals, Ancylostoma caninum and Toxocara canis may not be totally eradicated by the treatment, resulting in a continued risk of egg shedding into the environment. Follow-up examinations of the faeces are advisable and according to the results of these examinations, treatment with a nematodicidal product may be carried out if necessary.
The product is not recommended for use in pups 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 responsible veterinarian.
Do not use in animals with known hypersensitivity to any of the components of the product.
ii) Special precautions to be taken by the person administering the veterinary medicinal product to animals
Some constituents of this product may cause allergic reactions or skin irritation.
Avoid contact with the skin.
People with known hypersensitivity to any of the ingredients should avoid contact with this product.
Wash hands after use.
In case of accidental ingestion, seek medical advice and show the package leaflet to the physician.
4.6 Adverse reactions (frequency and seriousness)
Vomiting and diarrhoea may be observed following the treatment.
Despite not being observed in studies performed with the product, anorexia can occur as it is a common adverse effect of products containing praziquantel.
4.7 Use during pregnancy, lactation or lay
The safety of the veterinary medicinal product has not been established during pregnancy and lactation. The use is not recommended during pregnancy and lactation.
4.8 Interaction with other medicinal products and other forms of interaction
Do not use simultaneously with levamisole, piperazine or choline esterase inhibitors
4.9 Amounts to be administered and administration route
The recommended dose rate is 20 mg oxantel / 5 mg pyrantel / 5 mg praziquantel per kg bodyweight, ie one tablet per 25 kg bodyweight in a single intake, by oral route.
Administer the required number of tablets, according to bodyweight, orally, in a single administration. Preferably, dogs should be fasted prior to treatment. Food may be given one hour or more after treatment.
Weight of dog: Number of tablets
From 10.1 to 12.5 kg: ½
From 12.6 to 25 kg: 1
From 25.1 to 50 kg: 2
From 50.1 to 75 kg: 3
The tablet can be divided into halves.
Dogs kept together or in kennels should be treated at the same time.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
Administration of the product to healthy dogs at 5 times the recommended dosage for 6 consecutive weeks had no adverse consequences.
4.11 Withdrawal period(s)
5. PHARMACOLOGICAL PROPERTIES OF Dolpac
Pharmacotherapeutic group: Praziquantel, combinations
ATCvet Code: QP52AA51
5.1 Pharmacodynamic properties
The product contains three active ingredients, pyrantel embonate, oxantel embonate and praziquantel. The spectrum of activity of the product is wide, directed towards gastro-intestinal roundworms (ascaris, whipworm and hookworms) and tapeworms.
Pyrantel has a paralysing effect on roundworm muscles, by activating acetylcholine receptors. Its activity is more particularly directed against Toxocara canis, Toxascaris leonina, Uncinaria stenocephala and Ancylostoma caninum. Its activity against Trichuris vulpis is negligible.
Oxantel is an m-oxyphenolic derivate of pyrantel, that has been developed for its activity against whipworms.
Praziquantel leads to muscular contractions, paralysis and altered parasite tegument integrity. It is active against adults and larval stages of dog tapeworms, Echinococcus, Taenia and Dipylidium.
5.2 Pharmacokinetic particulars
After oral administration, the absorption of oxantel embonate is negligible. Pyrantel is quickly absorbed but in small quantities (Tmax = 1.38 h, Cmax = 0.048 µg/ml) and is very quickly eliminated. Praziquantel is quickly absorbed (Tmax = 1.28 h, Cmax = 0.4 µg/ml) and eliminated (elimination half-life 1.5 h).
6. PHARMACEUTICAL PARTICULARS OF Dolpac
6.1 List of excipients
Sodium lauryl sulphate
Sodium stearyl fumarate
6.3 Shelf life
Shelf-life of the veterinary medicinal product as packaged for sale: three years
Discard any unused half tablet
6.4. Special precautions for storage
This veterinary medicinal product does not require any special storage conditions.