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ENGLISH NAME: Paclitaxel Injection
SPECIFICATIONS: (1) 5 ml : 30 mg; (2) 10 ml : 60 mg; (3) 16.7 ml : 100 mg
LICENSE NUMBER: (1) 5 ml : 30 mg  H20057404;
(2) 10 ml : 60 mg  H20073210; (3) 16.7 ml : 100 mg  H20073211
PRODUCT PACKAGING: Glass Ampule; 50 vials/box 
FORMULATION: Injection
STORAGE CONDITION: Shading, Closed, Preservation of the Shade
SHELF LIFE: 18 Months
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Description: Paclitaxel Injection is a clear colorless to slightly yellow viscous solution. It is supplied as a nonaqueous solution intended for dilution with a suitable parenteral fluid prior to intravenous infusion. Paclitaxel is a natural product with antitumor activity. Paclitaxel is obtained via a semi-synthetic process from Taxus baccata. The chemical name for Paclitaxel is 5β,20-Epoxy-1,2α,4,7β,10β,13α-hexahydroxytax-11-en-9-one 4,10-diacetate 2-benzoate 13-ester with (2R,3S)-N-benzoyl-3-phenylisoserine. Paclitaxel is a white to off-white crystalline powder. It is highly lipophilic, insoluble in water, and melts at around 216 to 217°C. Paclitaxel Injection is used to treat various types of cancer. It is a cancer chemotherapy drug that works by slowing or stopping cancer cell growth.



Pharmacological effects: Paclitaxel is a novel antimicrotubule agent that promotes the assembly of microtubules from tubulin dimers and stabilizes microtubules by preventing depolymerization. This stability results in the inhibition of the normal dynamic reorganization of the microtubule network that is essential for vital interphase and mitotic cellular functions. In addition, Paclitaxel induces abnormal arrays or “bundles” of microtubules throughout the cell cycle and multiple asters of microtubules during mitosis.

Pharmacokinetics: Following intravenous administration of Paclitaxel Injection, Paclitaxel plasma concentrations declined in a biphasic manner. The initial rapid decline represents distribution to the peripheral compartment and elimination of the drug. The later phase is due, in part, to a relatively slow efflux of Paclitaxel from the peripheral compartment. Pharmacokinetic parameters of Paclitaxel following 3- and 24-hour infusions of Paclitaxel at dose levels of 135 and 175 mg/m2.

Indications: Paclitaxel is used to treat various types of cancer. It is a cancer chemotherapy drug that works by slowing or stopping cancer cell growth.

Precautions: Before using paclitaxel, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood disorders (e.g., low white blood cell count), decreased bone marrow function, current infections, heart problems (e.g., fast/slow/irregular heartbeat), high or low blood pressure, liver disease. This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages. Do not have immunizations/vaccinations without the consent of your doctor, and avoid contact with people who have recently received polio vaccine by mouth or flu vaccine inhaled through the nose. Since this medication can increase your risk of developing serious infections, wash your hands well to prevent the spread of infections. Avoid contact with people who have illnesses that may spread to others (e.g., flu, chickenpox). Caution is advised when using this drug in children because it contains alcohol. Children may be more sensitive to the side effects of alcohol, especially drowsiness and confusion. Caution is advised when using this drug in the elderly because they may be more sensitive to its side effects, especially the decrease in bone marrow function and numbness/tingling/burning of the hands/feet. Men using this medication should not plan to father a child while receiving treatment. This medication may affect sperm production in men and increase the risk of harm to the unborn baby.  If your partner becomes pregnant while you are using this medication, tell your doctor immediately. This medication is not recommended for use during pregnancy.

Adverse reaction: Nausea, vomiting, diarrhea, mouth sores, muscle/joint pain, numbness/tingling/burning of the hands/feet, flushing, dizziness, or drowsiness may occur. 
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