it s not just dogs we re protecting

it’s not just dogs we’re protecting Dolpac® is a broad spectrum anthelmintic for dogs, containing pyrantel, oxantel, and praziquantel; three active ...
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it’s not just dogs we’re protecting

Dolpac® is a broad spectrum anthelmintic for dogs, containing pyrantel, oxantel, and praziquantel; three active ingredients, with specific activities against the most common roundworm and tapeworm species[1]. Dolpac® is available in three flavoured tablet strengths; Dolpac® for Small Dogs, Dolpac® for Medium Dogs and Dolpac® for Large Dogs. It’s not just dogs that Dolpac® protects, a regular worming programme also reduces the risk of zoonotic transmission of worms to humans too.

Get with the programme.... the Dolpac® programme •

3 active ingredients



Every 3 months*

Effective, broad spectrum, easy to use, affordable worming for dogs

* Young dogs over the age of 2 months may require more frequent worming

The programme it’s not just dogs we’re protecting.

Three active ingredients for high performance, broad spectrum action Dolpac® contains a combination of three active ingredients: pyrantel (as embonate), oxantel (as embonate), and praziquantel.

Pyrantel Pyrantel is extremely effective against Toxascaris leonina, Toxocara canis, Ancylostoma caninum and Uncinaria stenocephala[2]. An imidazothiazol derivative belonging to the tetrahydropyrimidine group of anthelmintics, pyrantel binds to the acetylcholine receptors in nematode muscle cell membranes. This irreversible binding depolarises the membranes and eventually paralyses the worms.

Oxantel Oxantel, is a meta-oxyphenyl derivative of pyrantel, with specific activity against whipworm (Trichuris vulpis)[3].

Praziquantel Praziquantel is active against tapeworm, (mature or immature stages of Taenia hydatigena, Taenia pisiformis, Taenia ovis, Taenia taeniaeformis, Dipylidium caninum)[4]. Praziquantel acts by inducing an influx of calcium ions across the parasite tegument which causes immediate muscular spasm. The tegument is disrupted making it more susceptible to attack by proteolytic enzymes. The prevalence of intestinal nematodes and cestodes determined in multicentre field trials, showed, where intestinal worms were present, 182/235 dogs (77%) had a single species worm infestation, 45/235 dogs (19%) were infected by two worm species and 8/235 (4%) by 3 worm species[1]. Individually, oxantel, pyrantel and praziquantel are effective against individual worm species. Dolpac® contains a combination of these actives providing an effective broad spectrum anthelmintic with specific activity against the most common worms found in dogs (including dogs with polyparasitism)[1]. Figure 1: The prevalence of individual worm species in infected dogs in a multicentre field trial[1] 60

Worms susceptible to:

pyrantel

oxantel

praziquantel

% of infested dogs

50 40 30 20 10 0 Toxocara canis

Trichuris vulpis

Uncinaria stenocephala

Dipylidium caninum

Ancylostoma caninum

Taenia hydatigena

Toxascaris leonina

The programme it’s not just dogs we’re protecting.

Proven, broad spectrum efficacy against specific nematodes and cestodes Clinical field studies carried out in accordance with internationally recognised guidelines† evaluated the efficacy of Dolpac® in the treatment of naturally acquired gastrointestinal nematode and/or cestode infestations in dogs[1]. Administered at 20mg/kg oxantel, 5mg/kg pyrantel & 5mg/kg praziquantel per kg bodyweight, Dolpac® showed excellent ability to reduce parasitic infestation.

% reduction in faecal egg counts*

Figure 2: Efficacy of Dolpac® in reducing nematodes in 235 dogs [1] 100 80 60 40

99.2%

20 0

Ancylostoma caninum

98.9%

99.4%

Toxocara canis

Toxocaris leonina

97.6% Trichuris vulpis

98.7% Uncinaria stenocephala

* Percentages as the geometric mean reduction in egg counts taken at days 3,7 and 14 compared to day 0 (pre-treatment)

Figure 3: Efficacy of Dolpac® in reducing cestodes [1] % reduction in dogs with faecal proglottids**

100 80 60 40 20 0

100%

99%

Taenia spp

Dipylidium caninum

**Percentages expressed as mean reduction in dogs positive for faecal proglottids when assessed at days 3,7 and 14 compared to day 0 †

VICH GL7 (efficacy of anthelmintics) and VICH GL19 (specific recommendations for canines).

The programme it’s not just dogs we’re protecting.

Safety and Tolerance of Dolpac® During tolerance studies, no adverse reactions were recorded when Dolpac® was administered at 5 times the recommended dose for 6 consecutive weeks[5].

And it’s not only dogs that Dolpac® protects Humans can also become infected by some of the same worm species that affect dogs. Outdoor play and their attraction to pets put children at a higher risk than adults. Humans can become infected with ascarids (Toxocara spp.) through ingestion of infective eggs found in the environment. When a human ingests infective eggs, the eggs hatch and release larvae that can migrate anywhere in the body, a condition known as visceral larval migrans. The signs and symptoms seen in humans are determined by the tissues or organs damaged during larval migration. Organs commonly affected are the eye, brain, liver, and lung, where infections can cause permanent visual, neurological, or other tissue damage. Similarly hookworm larvae can cause zoonotic disease in humans, most commonly they can cause a condition known as cutaneous larval migrans. Larvae penetrate exposed skin and migrate beneath the surface causing a narrow, red intensely itchy rash. Hookworms have also been shown to penetrate to deeper tissues causing symptoms of visceral larval migrans, or to migrate to the intestines causing eosinophilic enteritis.

Risk of zoonotic infection in humans Children’s play habits and their attraction to pets put them at higher risk for infection than adults.

Risk of transmission Low to zero Frequency of animal-child contact

Frequency of worming

Medium

High

No contact

Occasional contact

Frequent contact

(protection of animal health only)

(garden and playgrounds) protection of animal health and prevention of zoonosis

(family and neighbours) protection of animal health and prevention of zoonosis

4 x per year

minimum 4 x per year

4-12 x per year

The programme it’s not just dogs we’re protecting.

An easy to use alternative Dolpac comes with a number of features to make life easier: •

Flavoured, divisible tablets



Dispensing envelopes in every pack



Dosing wall chart



3 tablet sizes to cover all weight ranges



Client worming guide



Informative website: www.dolpac.co.uk

The Dolpac® Programme in veterinary practice We hope by adopting Dolpac® within your practice that you will be able to increase the number of your clients worming their pets at the correct frequency. With a wormer at an affordable price you should be able to help your clients, their pets, their children and your practice. Get them onto a regular worming programme, the Dolpac® Programme. Every 2 weeks

Getting with the programme The Dolpac® Programme in veterinary practice - suggested worming regime

Puppies 2-3 months

*

Puppies over 6 months

Every 4 weeks

Every 3 months

Puppies 3-6 months

More frequent worming may be appropriate after assessing the likelihood of the dog to reacquire infection together with the risk of zoonotic transmission to man.

* *

Adult dogs

Dolpac® Tablets for Small Dogs

Dolpac® Tablets for Medium Dogs

Dolpac® Tablets for Large Dogs

One tablet per 2kg bodyweight in a single intake, by oral route.

One tablet per 10kg bodyweight in a single intake, by oral route.

One tablet per 25kg bodyweight in a single intake, by oral route.

Weight of Dog

1kg

Number of Tablets

1/2

Weight of Dog

3.1kg - 5kg

Number of Tablets

1/2

Weight of Dog

10.1kg - 12.5kg

Number of Tablets

1/2

1.1kg - 2kg

1

5.1kg - 10kg

1

12.6kg - 25kg

1

2.1kg - 4kg

2

10.1kg - 20kg

2

25.1kg - 50kg

2

50.1kg - 75kg

3

Dolpac® summary of key points • Broad spectrum of action [2-4] • Highly effective [1] • Well tolerated [5] • Good safety profile [5] • Easy to give flavoured tablets • Good range of support materials

SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT: Dolpac Tablets for Small Dogs. Dolpac Tablets for Medium Dogs. Dolpac Tablets for Large Dogs. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION: Active substances: Dolpac Tablets for Small Dogs: Oxantel 40.06mg equivalent to 111.8mg of oxantel embonate, Pyrantel 9.99mg equivalent to 28.8mg of pyrantel embonate, Praziquantel 10.00mg, Excipient to one divisible tablet 190mg. Dolpac Tablets for Medium Dogs: Oxantel 200.28mg equivalent to 559mg of oxantel embonate, Pyrantel 49.94mg equivalent to 144mg of pyrantel embonate, Praziquantel 50.00mg, Excipient to one divisible tablet 950mg. Dolpac Tablets for Large Dogs: Oxantel 500.70mg equivalent to 1397.5mg of oxantel embonate, Pyrantel 124.85mg equivalent to 360mg of pyrantel embonate, Praziquantel 125.00mg, Excipient to one divisible tablet 2375mg. Excipients: For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM: Tablet, pale yellow to yellow, elongated, divisible tablet. 4. CLINICAL PARTICULARS: 4.1 Target species: Dogs. 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: Nematodes: Toxocara canis, Toxascaris leonina, Ancylostoma caninum, Uncinaria stenocephala, Trichuris vulpis. Cestodes: Dipylidium caninum, Taenia spp. 4.3 Contraindications: 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 Dolpac for Small Dogs one tablet per 2kg bodyweight in a single intake, by oral route. Dolpac for Medium Dogs one tablet per 10kg bodyweight in a single intake, by oral route. Dolpac for Large Dogs one tablet per 25kg 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: Dolpac Tablets for Small Dogs The recommended dose rate is 20 mg oxantel / 5mg pyrantel /5mg praziquantel per kg bodyweight. ie one tablet per 2kg bodyweight in a single intake, by oral route. Dolpac Tablets for Medium Dogs

Weight of Dog 1kg

Number of Tablets 1/2

1.1kg - 2kg

1

2.1kg - 4kg

2

Weight of Dog

Number of Tablets

The recommended dose rate is 20 mg oxantel / 5mg pyrantel /5mg praziquantel per kg bodyweight. ie one tablet per 10kg bodyweight in a single intake, by oral route.

3.1kg - 5kg

Dolpac Tablets for Large Dogs

Weight of Dog

Number of Tablets

10.1kg - 12.5kg

1/2

The recommended dose rate is 20 mg oxantel / 5mg pyrantel /5mg praziquantel per kg bodyweight. ie one tablet per 25kg bodyweight in a single intake, by oral route.

The tablet can be divided into equal 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): Not applicable. 5. PHARMACOLOGICAL PROPERTIES: Provisional ATC vet Code: QP52A ; Anthelmintics. 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 (ascarids, 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: 6.1 List of excipients: Dextrates, Povidone K30, Sodium lauryl sulphate, Bacon flavour, Crospovidone, Sodium stearyl fumarate. 6.2 Incompatibilities: None. 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. 6.5 Nature and composition of immediate packaging: Polyamide-aluminium-PVC/aluminium blister strip of: Small Tablets: Cardboard box with 6 strips of 10 tablets. Medium and Large Tablets: Cardbox with 20 strips of 3 tablets. 6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products: Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements. 7. MARKETING AUTHORISATION HOLDER: Vétoquinol UK Limited, Vétoquinol House, Great Slade, Buckingham Industrial Park, Buckingham, MK18 1PA. 8. MARKETING AUTHORISATION NUMBER(S): UK: Dolpac tablets for small dogs Vm 08007/4119, Dolpac tablets for medium dogs Vm 08007/4120, Dolpac tablets for large dogs Vm 08007/4121. Ireland: Dolpac tablets for small dogs VPA 10966/032/001, Dolpac tablets for medium dogs VPA 10966/032/002, Dolpac tablets for large dogs VPA 10966/032/003. 9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION: UK: 14.01.08, Ireland 25.1.08. 10. DATE OF REVISION OF THE TEXT: January 2008. LEGAL CATEGORY: UK: POM-V. IRELAND: POM.

1/2

5.1kg - 10kg

1

10.1kg - 20kg

2

12.6kg - 25kg

1

25.1kg - 50kg

2

50.1kg - 75kg

3

References: 1. Grandemange, E., Claerebout, E., Genchi, C., and Franc, M., (2007). Field evaluation of the efficacy and the safety of a combination of oxantel/pyrantel/praziquantel in the treatment of naturally acquired gastrointestinal nematode and/or cestode infestations in dogs in Europe. Vet. Parasitol. 145:94-99. 2. Cadiergues, M.C., and Franc, M., (1994). Pyrantel in pets – a review. Rev. Med. Vet 145:449-453. 3. Martin, R.J., Clark, C.L., Trailovic, S.M., Robertson, A.P., (2004). Oxantel is an N-type (methyridine and nicotine) agonist not an L-type (levamisole and pyrantel) agonist: classification of cholinergic anthelmintics in Ascaris. Int. J. Parasitol 34: 1083-1090. 4. Day, T. A., Bennett, J. L., Pax, R. A., (1992). Praziquantel- the enigmatic antiparasitic. Parasitol. Today 8 (10): 342-344 5. Trial reference number Vetoquinol study 9302 T4F1.

This brochure has been printed on recycled paper

Vetoquinol UK Limited, Vetoquinol House, Great Slade, Buckingham Industrial Park, Buckingham, MK18 1PA. TEL: 01280 814500 FAX: 01280 825460 EMAIL: [email protected] website: www.vetoquinol.co.uk

Vetoquinol Ireland Limited, Vetoquinol House, Great Slade, Buckingham Industrial Park, Buckingham, MK18 1PA. TEL: 1800 406117 FAX: 1800 406116 EMAIL: [email protected] website: www.vetoquinol.co.uk 2023