País: Austrália
Língua: inglês
Origem: Department of Health (Therapeutic Goods Administration)
paclitaxel, Quantity: 30 mg
Fresenius Kabi Australia Pty Ltd
Paclitaxel
Injection, concentrated
Excipient Ingredients: PEG-35 castor oil; citric acid; ethanol
Intravenous
1 x 5 mL vial, 5 x 5 mL vials
(S4) Prescription Only Medicine
Primary treatment of ovarian cancer in combination with a platinum agent. Treatment of metastatic carcinoma of the ovary after failure of standard therapy. Treatment of metastatic carcinoma of the breast after failure of standard therapy. Adjuvant treatment of node-positive breast cancer administered sequentially to doxorubicin and cyclophosphamide. Treatment of metastatic cancer of the breast, in combination with trastuzumab (Herceptin), in patients who have tumours that over-express HER-2 and who have not received previous chemotherapy for their metastatic disease. In combination with gemcitabine (Gemzar), the treatment of patients with unresectable, locally recurrent or metastatic breast cancer who have relapsed following adjuvant/neoadjuvant chemotherapy. Prior chemotherapy should have included an anthracycline unless clinically contraindicated. Treatment of non-small cell lung cancer (NSCLC).
Visual Identification: Clear, slightly yellowish solution, free from visible particles; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius
Registered
2010-06-24
CMI for Paclitaxel Kabi October 2016 Filename: PacCMI-20161007_clean 1 PACLITAXEL KABI Paclitaxel (pak-li-TAX-el) CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Paclitaxel Kabi. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking Paclitaxel Kabi against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET. You may need to read it again. WHAT PACLITAXEL KABI IS USED FOR This medicine is used to treat: ovarian cancer breast cancer non-small cell lung cancer (NSCLC). This medicine belongs to a group of medicines called antineoplastic or cytotoxic medicines. You may also hear of these being called chemotherapy medicines. It works by killing cancer cells and stopping cancer cells from growing and multiplying. Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed it for another reason. This medicine is not addictive. This medicine is available only with a doctor's prescription. There is not enough information to recommend the use of this medicine for children. BEFORE YOU ARE GIVEN PACLITAXEL KABI _WHEN YOU MUST NOT BE _ _GIVEN IT_ _ _ You must not be given Paclitaxel Kabi if you have an allergy to: any medicine containing paclitaxel any of the ingredients listed at the end of this leaflet any medicines containing PEG 35 castor oil, such as cyclosporin injection or teniposide injection Some of the symptoms of an allergic reaction may include shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue or other parts of the body; rash, itching or hives on the skin. You must not be given this medicine if you have a very low white blood cell (WBC) count. Tell your doctor if you have an infection or Leia o documento completo
Filename: PacPI-20161007_clean Page 1 of 14 PRODUCT INFORMATION PACLITAXEL KABI NAME OF THE MEDICINE Paclitaxel is an anticancer agent from the taxane class of medicines. Paclitaxel is described chemically as 5β,20-Epoxy-1,7β-dihydroxy-9-oxotax-11-ene- 2α,4,10β,13α-tetrayl-4,10-diacetate-2-benzoate-13-[(2_R_,3_S_)-3-(benzoylamino)-2- hydroxy-3-phenylpropanoate] or (2_S_, 5_R_, 7_S_, 10_R_, 13_S_)-10,20-bis(acetoxy)-2- benzoyloxy-1,7-dihydroxy-9-oxo-5,20-epoxytax-11-en-13-yl(3_S_)-3-benzoylamino-3- phenyl-D-lactate. The structural formula is represented as follows: Empirical formula: C 47 H 51 NO 14 Molecular weight: 853.9 CAS Number: 33069-62-4 DESCRIPTION Paclitaxel is a white to off-white crystalline powder that is highly lipophilic, insoluble in water and melts at around 216–217°C. Paclitaxel Kabi is a sterile solution containing 6 mg/mL paclitaxel, 530 mg/mL PEG- 35 castor oil and 393 mg/mL ethanol. It is a clear to slightly yellowish solution free of visible particles. It is supplied as a non-aqueous solution intended for dilution with 0.9% Sodium Chloride Injection or 5% Glucose Injection prior to intravenous infusion. Paclitaxel Kabi must be diluted prior to intravenous infusion. PHARMACOLOGY Pharmacological Actions Paclitaxel is an antimicrotubule antineoplastic agent. It promotes microtubule assembly by enhancing the polymerisation of tubulin, the protein subunit of spindle microtubules, even in the absence of the mediators normally required for microtubule assembly (e.g. guanosine triphosphate), thereby inducing the formation of stable, nonfunctional microtubules. While the precise mechanism of action is not completely known, paclitaxel disrupts the dynamic equilibrium within the microtubule system and blocks cells in the late G2 phase and M phase of the cell cycle, inhibiting cell replication and impairing function of nervous tissue. Filename: PacPI-20161007_clean Page 2 of 14 Pharmacokinetics After paclitaxel is administered intravenously, its plasma concentration declines biphasically. The fi Leia o documento completo