
| - | - | - |
|---|---|---|
| Product Group | : | Antiparasitics |
| Pharmaceutical Form | : | Solution for Injection |
| Active Ingredient | : | Praziquantel |
| Target Animal | : | Dog, Cat |
| Package Form | : | In 20 ml Amber Colored Glass Flacons |
COMPOSITION
It is a colorless pink yellowish colored sterile, ready-to-use solution containing 56.8 mg Praziquantel per ml.
PHARMACOLOGICAL PROPERTIES
Praziquantel, the active ingredient of Guadreks Solution for Injection, is an isoquinoline derivative and a broad-spectrum anthelmintic. Its mechanism of action is not fully understood, but it increases calcium ion influx through the parasite’s plasma membrane. This leads to calcium depletion, resulting in muscular contraction, paralysis, detachment from the intestinal wall, and subsequent elimination. Some of the worms are excreted in feces as fragmented segments, while others are digested within the intestines.
Following parenteral administration, praziquantel is rapidly distributed, binding about 80% to plasma proteins. The elimination half-life is 2–3 hours. About 80% of the dose is excreted via urine within 24 hours, with the remainder eliminated through bile and renal tubules.
AREA OF USE / INDICATIONS
It is indicated for the treatment of adult and larval forms of the following tapeworms (cestodes) in cats and dogs:
Echinococcus granulosus Echinococcus multilocularis
Dipylidium caninum Dipyllobothrium erinacei
Taenia hydatigena Taenia ovis
Taenia psiformis Taenia taeniformis
J. pasqualei Mesocestoides corti
Multiceps multiceps
USAGE AND DOSAGE
Pharmacological dose: 5.68 mg/kg body weight
Practical dose: 1 ml / 10 kg body weight, administered subcutaneously or intramuscularly.
Dogs:
Puppies and up to 2.5 kg: 0.25 ml
2.5–5 kg: 0.25–0.5 ml
5–10 kg: 0.5–1.0 ml
10–20 kg: 1–2 ml
Maximum dose: 3 ml
Cats:
1 kg and young kittens: 0.1 ml
1–2 kg: 0.1–0.2 ml
2–3 kg: 0.2–0.3 ml
3–5 kg: 0.4–0.5 ml
Over 5 kg: 0.6 ml
Minimum and maximum praziquantel doses: 3.5–7.5 mg/kg.
Due to higher metabolic activity, small animals may require relatively higher doses. Dogs over 25 kg should preferably receive intramuscular administration. Subcutaneous administration may cause transient pain. If more than 3 ml is required, the dose should be divided and injected into two different sites. In cats, neither subcutaneous nor intramuscular administration causes pain. Aseptic precautions should be observed.
SPECIAL CLINICAL INFORMATION AND SPECIAL WARNINGS FOR TARGET SPECIES
In suspected echinococcosis, intramuscular administration is recommended.
Preventing re-infestation should be the primary objective. If fecal testing is not possible after treatment, a second administration is necessary.
In field or farm conditions, a second treatment is mandatory due to risk of flea-mediated reinfestation.
Tapeworm treatment should always be accompanied by acaricidal treatment of animals and their environment.
To prevent reinfestation, fecal examinations should be carried out and repeat treatments given at intervals: every 2–3 weeks for Dipylidium caninum, and every 9–10 weeks for Echinococcus granulosus.
ADVERSE EFFECTS
Praziquantel has a very wide safety margin; even at doses up to 20 times higher (100 mg/kg), no toxic effects have been reported in cats or dogs.
DRUG INTERACTIONS
Dexamethasone may reduce serum concentrations of praziquantel.
SYMPTOMS OF OVERDOSE, PRECAUTIONS AND ANTIDOTE
Since sensitivity may be observed in large dogs, subsequent injections should be administered intramuscularly. Although practical overdose is unlikely, clinical symptoms that may rarely occur due to overdose and sensitivity include:
In dogs: Loss of appetite, temporary diarrhea, coordination disorder, lethargy.
In cats: In addition to the above, salivation, vomiting, lethargy, depression, unsteady gait, and muscle tremors may be observed.
Treatment is initiated based on the clinical picture. (Symptomatic treatment).
CONTRAINDICATIONS
Not recommended in unweaned puppies and kittens, as cestode infestations are rare.
It is not necessary to use in kittens under 6 weeks old or puppies under 4 weeks old.
GENERAL WARNINGS
Consult a veterinarian before use and in case of unexpected reactions.
Keep out of reach of children.
PRECAUTIONS TO BE TAKEN BY THE ADMINISTRATOR AND WARNINGS FOR VETERINARY SURGEON
Avoid contact with the product. Wash hands thoroughly after use.
STORAGE CONDITIONS AND SHELF LIFE
Store at room temperature (15–25ºC). Protect from light. Shelf life is 3 years.
COMMERCIAL PRESENTATION FORM
20 ml amber vials in cardboard boxes.
PLACE AND CONDITIONS OF SALE
To be sold in pharmacies, veterinary clinics, polyclinics, and animal hospitals with a veterinary prescription (VPR).
APPROVAL DATE OF LEAFLET 25.11.2004
MARKETING AUTHORIZATION DATE AND NO 09.05.2002 – 011/1045
NAME AND ADDRESS OF MARKETING AUTHORIZATION HOLDER
VİLSAN Veteriner İlaçları Tic. ve San. A.Ş.
Balıkhisar Mah. Balıkhisar Köy İçi Küme Evleri No:765A Akyurt / Ankara – Türkiye
MANUFACTURER COMPANY
VİLSAN Veteriner İlaçları Tic. ve San. A.Ş.
Balıkhisar Mah. Balıkhisar Köy İçi Küme Evleri No:765A Akyurt / Ankara – Türkiye
Made in Turkiye