Guadreks

-	-	-
Product Group	:	Antiparasitics
Pharmaceutical Form	:	Oral Tablet
Active Ingredient	:	Praziquantel
Target Animal	:	Sheep, Horse, Dog, Cat
Package Form	:	5 blisters containing 10 tablets

Composition - Pharmacological Properties
Indications – Usage
Undesirable Effects – Warnings

COMPOSITION

It contains 250 mg praziquantel per tablet.

PHARMACOLOGICAL PROPERTIES
Praziquantel, contained in Guadreks Oral Tablet, is an isoquinoleine compound and is a fluxidal active ingredient has a broad-spectrum effective against tapeworms, anti-cestodal and some butterflies. It prevents entry into the cell by disturbing the permeability of the membrane in tapeworm and destroys the parasite's energy source. The anthelmintic effect is based on the principle of damaging the parasite's covering (tegument). This effect cause absorption of praziquantel through the tegument, disrupting cell membrane tension, thereby inhibiting calcium permeability in parasires. As a result, severe contractions occur throughout all segments within a short period. As a result, the hooks that cause to attach the parasite to the digestive tract are released, and the parasite's connection to the digestive tract is severed. Praziquantel also affects the larvae of tapeworms. Praziquantel is rapidly and completely absorbed from the digestive tract, reached peak plasma concentration within 2 hours. It binds to plasma proteins at a rate of 80% and rapidly distributes throughout the body. Elimination half-life is 2-3 hours. It is rapidly metabolized in the kidneys and liver, with the majority of the administered drug (80%) excreted within the first 24 hours and nearly all of it within 48 hours via urine and bile.

AREA OF USE/INDICATIONS

It is used for the treatment and control of tapeworm (cestode) and certain fluke (trematode) infestations in sheep, horses, dogs, and cats. It is used to eliminate the symptoms of disease caused by the parasite Coenurus cerebralis in sheep.

Parasite species effectively treated by Guadreks according to animal species:

Sheep:

Tapeworm: Moniezia spp., (especially M. expansa, M. benedeni), Stilesia spp. (especially S. globipunctata), Avitellina spp., Coenurus cerebralis, Cysticercus tenuicollis, Thysanezia spp., (especially T. giardi).

Fluke: Dicrocoelium dendriticum, Schistosoma spp., Orientobilharzia spp..

Horse:

Tapeworm: Anaplocephala spp., P. aranoplocephala mamillana

Dog and Cat:

Tapeworm: Dipylidium caninum, Taenia spp. (especially T. pisiformis, T. hydatigena, T. ovis, T. serialis, T. taeniaformis), Ecinococcus spp. (especially E. granulosus, E. multilocularis), Mesocestoides spp, Diphylobotrium spp., Spirometra spp., (especially S. erinacei), Joyeuxiella spp. (especially J. pasqualei), Diphylobotrium latum, Multiceps multiceps.

Fluke: Paragonimus spp., (özellikle P. kellikotti), Opistorchis spp

USAGE AND DOSAGE
Pharmacological Dose: 5-10 mg/kg bw in sheep, 7,5-15 mg/kg bw in cat and dog, 1 mg/kg bw in horse are administered orally.

Practical Dose:

Lamb (less than 25 kg)	½ tablet
Lamb (more than 25 kg)	1 tablet
Sheep	1 – 1½ tablets
Ram (more than 60 kg)	2 tablets
Foal	½ - 1 tablet
Horse	1 – 2 tablets
Dog (less than 15 kg)	½ tablet
Dog (15-25 kg)	1 tablet
Dog (less than 40 kg)	2 tablets
Cat	½ tablet

For the treatment of certain parasitic diseases, dosages and application periods may be determined by the veterinarian.

SPECIAL CLINICAL INFORMATION AND SPECIAL WARNINGS FOR TARGET SPECIES

· For the treatment of Oriental bilharziasis, 30 mg/kg should be administered.

· For less sensitive tapeworm species such as Diphylobotrium spp. and Spirometra spp. in dogs, cats, and other carnivores, twice the specified dose should be administered daily without interruption for 2 days. For liver, lung, and duodenal trematodes (Paragonimus spp., Opistorchis spp.), the tapeworm doses specified above should be administered at three times the daily dose for 2-3 days without interruption.

· It forms cysts in the brain by the eggs of Taenia multiceps which lives in the intestines of dogs and wild carnivores with the intermediate form of this tapeworm, Coenurus cerebralis, develops in sheep grazing on pastures contaminated. Within a few days following the first signs of illness appear 2-8 months later, the animal will definitely die. In cases of Coenurus cerebralis (delibaş disease) and against peritoneal cysticercos (Cysticercus tenuicollis), when administered at a dose of 50-100 mg/kg b.w. for 2-5 consecutive days, it reduces the symptoms of the disease in cases caused by chronic Coenurus cerebralis.

· Considering the living conditions of dogs and cats and the maturation of tapeworms in the host body and egg laying (pre-parent period), treatment should be repeated every 4 weeks in hunting and herding dogs, every 6 weeks in areas where E. granulosus, T. ovis, and T. hydatigena are prevalent, and every 2-3 weeks in areas with D. caninum infestation, every 2-3 weeks, every 3 months for domestic dogs, and every 4-6 months for domestic cats.

Use during pregnancy: It can be used in pregnant animals safely.

ADVERSE EFFECTS

· Praziquantel has an extremely high therapeutic index and does not cause any toxicity even at doses 20 times higher (100 mg/kg.ca).

· Vomiting and diarrhea may occur very rarely in dogs sensitive to praziquantel.

DRUG INTERACTIONS

When used concurrently with dexamethasone, the plasma concentration of praziquantel is reduced by half.

SYMPTOMS OF OVERDOSE, PRECAUTIONS AND ANTIDOTE

It is generally well tolerated at recommended doses. No significant side effects were observed in 3-5 times the application. In case of overdose, depression and anorexia may occur.

WITHDRAWAL PERIODS

‘0’ day for meat and milk.

CONTRAINDICATIONS

Do not use in puppy younger than 4 weeks old.

GENERAL WARNINGS

Consult a veterinarian before use and if any unexpected reactions occur.

Keep out of reach of children and away from foodstuffs.

SYMPTOMS OF OVERDOSE, PRECAUTIONS AND ANTIDOTE

Praziquantel has a high safety index, so the risk of overdose is low. In the rare event of excessive high-dose administration, mild poisoning symptoms such as tremors and convulsions may be observed. In case of poisoning, symptomatic treatment should be administered. There is no specific antidote.

PRECAUTIONS TO BE TAKEN BY THE ADMINISTRATOR AND WARNINGS FOR VETERINARY SURGEON

· Avoid contact with skin and eyes. In case of contact, wash your skin, hands, and eyes thoroughly with water.

· Wash your hands thoroughly after applying the drug. Dispose of empty packaging in the trash.

STORAGE CONDITIONS AND SHELF LIFE

It should be stored in the original packaging, protected from light, below 25°C, without refrigeration or freezing. Shelf life is 3 years.

PLACE OF SALE AND CONDITIONS

Sold by veterinary prescription in pharmacies and veterinary clinics (VHP).

COMMERCIAL PRESENTATION FORM

5 x 10 tablets with boxes.

APPROVAL DATE OF LEAFET: 27.07.2005

MARKETING AUTHORIZATION DATE AND NO: 27.07.2005 – 014/0088

NAME AND ADDRESS OF MARKETING AUTHORIZATION HOLDER