Plerion 5 / Plerion 10 Data Sheet

Presentation
Plerion 5 chewable tablets are brown, slightly speckled and oblong in shape.
Each chewable tablet (Plerion 5) contains:
25 mg pyrantel (as embonate)
100 mg oxantel (as embonate)
25 mg praziquantel.

Plerion 10 chewable tablets are brown, slightly speckled and round in shape.
Each chewable tablet (Plerion 10) contains:
50 mg pyrantel (as embonate)
200 mg oxantel (as embonate)
50 mg praziquantel.
 
Uses
For the treatment of dogs harbouring mixed parasitic infestations with the following adult stages of nematode and cestode species:

Ascarids: Toxocara canis, Toxascaris leonina.
Hookworms: Uncinaria stenocephala, Ancylostoma caninum.
Whipworms: Trichuris vulpis.
Tapeworms: Dipylidium caninum, Mesocestoides spp., Taenia ovis, Taenia pisiformis, Taenia hydatigena,Taenia multiceps, Echinococcus spp.
 
Dosage and administration
Single oral administration.
The recommended dose rate is 5 mg pyrantel + 20 mg oxantel + 5 mg praziquantel per kg bodyweight, i.e. 1 Plerion 5 tablet per 5 kg b.w., or 1 Plerion 10 tablet per 10 kg b.w.
The chewable tablets contain a flavour and are taken voluntarily by most dogs. The tablets can be given directly to the dog or with food.
To ensure a correct dosage, body weight should be determined as accurately as possible.
Echinococcosis represents a hazard for humans. As Echinococcosis is a notifiable disease to the World Organisation for Animal Health (OIE), specific guidelines on the treatment and follow-up, and on the safeguard of persons, need to be obtained from the relevant competent authority.
The administration should follow the dosage scheme proposed in the table below:
 

Body weight
of
dogs

Quantity of
Plerion 5
tablets

Quantity of
Plerion 10
tablets

2.5 - 5kg1
6 - 10 kg2 OR1
11 - 15 kg3
16 - 20 kg2
21 - 30 kg3
31 - 40 kg4
41 - 50 kg5
51 - 60 kg6
61 - 70 kg7

Contra-indications, warnings, etc.
Do not use in dogs younger than 2 months of age.
Plerion 5 tablets: Do not use in dogs weighing less than 2.5 kg.
Plerion 10 tablets: Do not use in dogs weighing less than 5 kg.
Do not use in animals with known hypersensitivity to any of the components of the product.
On rare occasions vomiting and diarrhoea may be observed following the treatment.
Although not observed in studies performed with this product, anorexia may occur as it is a common adverse effect of products containing praziquantel.
Parasite resistance to any particular class of anthelmintic may develop following frequent, repeated use of an anthelmintic of that class.
When D.caninum infection is present, concomitant treatment against intermediate hosts, such as fleas and lice, should be considered to prevent re-infection.
Dogs kept together or in kennels should be treated at the same time.

Roundworm and Hookworm infections:

In some animals, Ancylostoma caninum and Toxocara canis may not be totally eradicated by the treatment, resulting in a continued risk of shedding of eggs into the environment. Follow-up examinations of the faeces are advisable and, based on the results of these examinations, treatment with a nematodicidal product should be carried out, if necessary.
In debilitated or heavily infested animals, the product should be used only according to a benefit/risk assessment by the responsible veterinarian.
The safety of the product has not been established in bitches during pregnancy and lactation.
Laboratory studies in rats and rabbits have not produced any evidence of teratogenic, foetotoxic or maternotoxic effects. Use only according to the benefit/risk assessment by the responsible veterinary surgeon.
Do not use simultaneously with levamisole, piperazine or choline esterase inhibitors.
In safety studies overdoses of 3 times the highest recommended dose of 10 mg pyrantel, 40 mg oxantel and 10 mg praziquantel per kg bodyweight or overdoses of the highest recommended dose given for 3 consecutive days led to sporadic vomiting or soft faeces. These clinical signs resolved without further treatment.

Operator warnings:
Do not eat or drink while handling the product.
Wash your hands thoroughly with water and soap immediately after use of the product.
This veterinary medicinal product may cause irritation to the eyes; any contact with the eyes should be avoided while using the product. If accidental eye contact occurs, flush eyes immediately with plenty of water.
In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.

Withdrawal period:
Not applicable.
For animal treatment only.
Keep out of reach and sight of children.

Pharmaceutical precautions
This veterinary medicinal product does not require any special temperature storage conditions.
Store in the original container in order to protect from light.
Dispose of any unused product and empty containers in accordance with guidance from your local waste regulation authority.

Legal category
NFA-VPS

Packaging Quantities
PVC/PVDC/aluminium heat sealed peelable blisters.
Cartons containing:
2 tablets (1 blister with 2 tablets),
20 tablets (10 blisters with 2 tablets),
160 tablets (20 blisters with 8 tablets) and
200 tablets (25 blisters with 8 tablets).
Not all pack sizes may be marketed.

Further information
Nil

Marketing authorisation number
Plerion 5 chewable tables: Vm 01708/4543
Plerion 10 chewable tables: Vm 01708/4544