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Docetaxel — Description, Dosage, Side Effects | PillsCard
Rx
Docetaxel
160 mg/8 ml, Koncentrat do sporządzania roztworu do infuzji
INN: Docetaxelum
Available in:
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Form
Koncentrat do sporządzania roztworu do infuzji
Dosage
160 mg/8 ml
Route
dożylna
Storage
16.2 Storage Store between 2°C and 25°C (36°F and 77°F). Retain in the original package to protect from light. Freezing does not adversely affect the product. After first use and following multiple needle entries and product withdrawals, Docetaxel Injection multiple-dose vials are stable for up to 28 days when stored between 2°C and 8°C (36°F and 46°F) and protected from light.
User Reviews
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About This Product
Manufacturer
Sanofi Winthrop Industrie (Niemcy)
Composition
Docetaxelum
ATC Code
L01CD02
Source
URPL
11 DESCRIPTION Docetaxel is an antineoplastic agent belonging to the taxoid family. It is prepared by semisynthesis beginning with a precursor extracted from the renewable needle biomass of yew plants. The chemical name for docetaxel is (2R,3S)-N-carboxy-3-phenylisoserine,N-tert-butyl ester, 13-ester with 5β-20-epoxy-1,2α,4,7β,10β,13α-hexahydroxytax-11-en-9-one 4-acetate 2-benzoate trihydrate. Docetaxel has the following structural formula: Docetaxel is a white or almost white crystalline powder with an molecular formula of C 43 H 53 NO 14 •3H 2 O, and a molecular weight of 861.9. It is freely soluble in acetone, soluble in methanol and practically insoluble in water. One-vial Docetaxel Injection, USP Docetaxel injection, USP is a sterile, non-pyrogenic, pale yellow to brownish-yellow solution at 20 mg/mL concentration. Each mL contains docetaxel trihydrate equivalent to 20 mg docetaxel anhydrous, 540 mg polysorbate 80, 0.5 mg citric acid anhydrous and 395 mg ethyl alcohol dehydrated. Docetaxel injection, USP is available in single use vials containing 20 mg (1 mL), 80 mg (4 mL) or 160 mg (8 mL) docetaxel anhydrous. Docetaxel injection, USP requires NO prior dilution with a diluent and is ready to add to the infusion solution. Image
⚠️ Warnings
Docetaxel is an antineoplastic agent and, as with other potentially toxic compounds, caution should be exercised when handling it and preparing Docetaxel solutions. The use of gloves is recommended.
If Docetaxel concentrate or infusion solution should come into contact with skin, wash immediately and thoroughly with soap and water. If Docetaxel concentrate or infusion solution should come into contact with mucous membranes, wash immediately and thoroughly with water.
Preparation for the intravenous administration
Preparation of the infusion solution
DO NOT use other docetaxel medicinal products consisting of 2 vials (concentrate and solvent) with this medicinal product (Docetaxel 20 mg/ml concentrate for solution for infusion, which contains only 1 vial).
Docetaxel 20 mg/ml concentrate for solution for infusion requires NO prior dilution with a solvent and is ready to add to the infusion solution.
Each vial is of single use and should be used immediately.
If the vials are stored under refrigeration, allow the required number of boxes of Docetaxel concentrate for solution for infusion to stand below 25°C for 5 minutes before use.
More than one vial of Docetaxel concentrate for solution for infusion may be necessary to obtain the required dose for the patient. Aseptically withdraw the required amount of Docetaxel concentrate for solution for infusion using a calibrated syringe fitted with a 21G needle.
In Docetaxel 20 mg /ml vial the concentration of docetaxel is 20 mg/ml.
The required volume of Docetaxel concentrate for solution for infusion must be injected into a 250 ml infusion bag or bottle containing either glucose solution 50 mg/ml (5%) or sodium chloride 9 mg/ml (0.9%) solution for infusion.
If a dose greater than 190 mg of docetaxel is required, use a larger volume of the infusion vehicle so that a concentration of 0.74 mg/ml docetaxel is not exceeded.
Mix the infusion bag or bottle manually using a rocking motion.
The infusion bag solution should be used within 8 hours below 25°C including the one hour infusion to the patient.
As with all parenteral products, Docetaxel infusion solution should be visually inspected prior to use, solutions containing a precipitate should be discarded.
Any unused product or waste material should be disposed of in accordance with local requirements.