Each vial contains:
Paclitaxel ………………….. 100 mg
Excipients q.s. to …………. a vial
Injection for infusion
Box of 1 vial
– 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.
Cool dry place, not exceeding 25°C, protected from light.
– 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.
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.
Please read carefully the leaflet before using.
