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CANPAXEL 100


Composition: 
Each vial contains:
        Paclitaxel ....................... 100 mg
        Excipients q.s. to ……....... a vial

Dosage form: Injection for infusion

Packaging: Box of 1 vial

Pharmacodynamics: 
- Paclitaxel, that is extracted from the bark of the Pacific Yew tree, Taxus brevifolia, is a mitotic inhibitor used in cancer chemotherapy. Paclitaxel promotes the assembly of microtubules from tubulin dimers and stabilizes microtubules by preventing depolymerization. This stability results in the inhibition of the normal dynamics reorganization of the microtubule network that is essential for vital interphase and mitotic cellular functions, also affect the mitochondria. In addition, paclitaxel induces abnormal arrays of microtubules during mitosis. 

Pharmacokinetics:
- Paclitaxel plasma concentrate is proportional to infusion dose and declined in a biphasic manner. Paclitaxel is 89% or more bound to plasma protein in vitro and the presence of cimetidine, ranitidine, dexamethason, or diphenhydramin do not affect protein binding of paclitaxel.
- Steady-state volume of distribution is reported to range from 5 to 6 liter/kg body weight (68-162 ml/m2), indicating extensive extravascular distribution, tissue binding, or both. The metabolism and distribution of paclitaxel has not been fully elucidated. Half-life is about 6-13 hours, only about 2 to 13% of a dose is reported to be excreted in urine, as unchanged drug, indicating extensive non-renal clearance. Paclitaxel is metabolized in the liver. Metabolites are excreted in the faeces via the bile, the primary metabolite being 6α-hydroxypaclitaxel.

Indications:
- CANPAXEL 100 is indicated for the treatment of metastatic ovarian cancer after failure or contradiction of anthracyclin, platinum therapy.
- CANPAXEL 100 is for treatment of metastatic breast cancer after failure or impossibility of anthracyclin therapy. 

Dosage and administration:
- Paclitaxel administered intravenously over 3 hours at a dose of 175 mg/m2, and repeated at least 3-week intervals. Patients should not receive retreatment until neutrophils recover to a level > 1500/mm3 and platelets recover to a level > 100 000/mm3.
- The dose should be reduced by 20% in subsequent courses in patients who experience severe neutropenia or peripheral neuropathy (below 0,5 x 109/lít) (500/mm3).

- CANPAXEL 100 should be administered under the supervision of a physician experienced in the use of cancer chemotherapeutic agents. Appropriate management of complications is possible only when adequate diagnostic and treatment facilities are readily available.

- Suitable dilution solutions include 0.9% Sodium Chloride Injection; 5% Dextrose Injection; 5% Dextrose and 0.9% Sodium Chloride Injection; or 5% Dextrose in Ringer’s Injection to a final concentration of 0.3 to 1.2 mg/mL (e.g. ~100 to 1000 ml). 
- The solutions are physically and chemically stable for up to 27 hours at ambient temperature (approximately 25°C) and room lighting conditions. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. 

- Dilution should be performed by trained staff in a designated area and must be sterile. It is necessary to wear adequate protective gloves. Precautions to avoid contact with the skin and mucous membranes should be adhered to. 
- Paclitaxel solutions should be prepared and stored in glass, polypropylene, or polyolefin containers. Non-PVC containing administration sets, such as those which are polyethylene-lined, should be used.

• Patients should receive pretreatment to prevent life threatening anaphylaxis 
Prednisolon: 30 - 40 mg (6 - 8 tablet 5 mg), taken 12 hours and 6 hours prior to the administration of paclitaxel, concomitantly H1-antagonists such as Clemastine: intravenous 2 mg prior administration of Paclitaxel 30 - 60minutes (can use other antihistamines), as well as cimetidine (300 mg) or ranitidine (50 mg): intravenous 30 - 60 minutes before paclitaxel infusion.

Contraindication:  Please read carefully the leaflet before using.

Storage: Cool dry place, not exceeding 25°C, protected from light.

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