Country: Нови Зеланд
Језик: Енглески
Извор: Medsafe (Medicines Safety Authority)
Cisplatin 1 mg/mL
Novartis New Zealand Ltd
Cisplatin 1 mg/mL
1 mg/mL
Solution for injection
Active: Cisplatin 1 mg/mL Excipient: Hydrochloric acid Sodium chloride Water for injection
Vial, glass, Amber glass with butyl rubber stopper and crimp cap 10 mg in 10 mL vial, 10 mL
Prescription
Prescription
Heraeus Deutschland GmbH & Co. KG
Cisplatin Ebewe is indicated as palliative therapy to be employed as follows: Metastatic Non-seminomatous Germ Cell Carcinoma: In established combination therapy with other approved chemotherapeutic agents in patients with metastatic non-seminomatous germ cell tumours who have already received appropriate surgical and/or radiotherapeutic procedures. Metastatic Ovarian Tumours: Cisplatin Ebewe, as a single agent, is indicated as secondary therapy in patients with metastatic ovarian tumours refractory to standard chemotherapy who have not previously received Cisplatin Ebewe therapy. Advanced and Refractory Carcinoma of the Bladder: Cisplatin Ebewe, as a single agent, is indicated as secondary therapy in patients with advanced stage bladder cancer refractory to standard chemotherapy who have not previously received Cisplatin Ebewe therapy. Squamous Cell Carcinoma of the Head and Neck (Refractory to Standard Chemotherapy): Cisplatin Ebewe, as a single agent, is indicated as secondary therapy in patients with squamous cell carcinoma of the head and neck refractory to standard chemotherapy who have not previously received Cisplatin Ebewe therapy.
Package - Contents - Shelf Life: Vial, glass, Amber glass with butyl rubber stopper and crimp cap - 10 mL - 24 months unopened stored at or below 25°C protect from light. Do not refrigerate - Vial, glass, Amber glass with butyl rubber stopper and crimp cap - 50 mL - 24 months unopened stored at or below 25°C protect from light. Do not refrigerate - Vial, glass, Amber glass with butyl rubber stopper and crimp cap - 100 mL - 24 months unopened stored at or below 25°C protect from light. Do not refrigerate
2004-07-26
Cisplatin Ebewe Cisplatin Ebewe_CMI_v4_Feb 2016 Page 1 of 5 CISPLATIN EBEWE _Cisplatin (siss-PLAT-in) injection _ CONSUMER MEDICINE INFORMATION _ _ _ _ WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Cisplatin Ebewe. 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 being given Cisplatin Ebewe against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT BEING GIVEN THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET IN A SAFE PLACE._ _ You may need to read it again. WHAT CISPLATIN EBEWE IS USED FOR Cisplatin Ebewe belongs to a group of medicines known as antineoplastic or cytotoxic agents. You may also hear it referred to as a chemotherapy medicine. Cisplatin Ebewe is a platinum- containing medicine and is used as an anticancer drug to interfere with the growth of cancer cells and eventually destroy them. Cancer cells are like normal cells which have changed so that they grow out of control in the body. Since the growth of normal body cells may also be affected by Cisplatin Ebewe, other effects may also occur (see Side Effects). Cisplatin Ebewe may be used alone or with other anticancer therapies for the treatment of ovarian, testicular and head and neck cancers. Cisplatin Ebewe has been chosen as your therapy, as the benefits of treatment are expected to be greater than the unwanted or side effects. Ask your doctor if you have any questions about why this medicine has been prescribed for you. This medicine is available only with a doctor's prescription BEFORE YOU ARE GIVEN CISPLATIN EBEWE _WHEN YOU MUST NOT BE _ _GIVEN IT _ YOU SHOULD NOT BE GIVEN CISPLATIN EBEWE IF YOU HAVE AN ALLERGY TO CISPLATIN EBEWE, OTHER PLATINUM-CONTAINING COMPOUNDS OR ANY OF THE INGREDIENTS LISTED AT THE END OF THIS LEAFLET. Symptoms of an allergic reaction to Cisplatin Ebewe may include: shortness of breath, wheezing or diff Прочитајте комплетан документ
NEW ZEALAND DATA SHEET Page 1 of 12 1 PRODUCT NAME CISPLATIN EBEWE ® 1 mg/mL Solution for injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains cisplatin 1 mg/mL 10mg in 10mL, 50mg in 50mL and 100mg in 100mL Excipients with known effect: None For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection. Clear colourless sterile aqueous solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Cisplatin Ebewe is indicated as palliative therapy to be employed as follows: METASTATIC NON-SEMINOMATOUS GERM CELL CARCINOMA: In established combination therapy with other approved chemotherapeutic agents in patients with metastatic non-seminomatous germ cell tumours who have already received appropriate surgical and/or radiotherapeutic procedures. METASTATIC OVARIAN TUMOURS: Cisplatin Ebewe, as a single agent, is indicated as secondary therapy in patients with metastatic ovarian tumours refractory to standard chemotherapy who have not previously received Cisplatin Ebewe therapy. ADVANCED AND REFRACTORY CARCINOMA OF THE BLADDER: Cisplatin Ebewe, as a single agent, is indicated as secondary therapy in patients with advanced stage bladder cancer refractory to standard chemotherapy who have not previously received Cisplatin Ebewe therapy. SQUAMOUS CELL CARCINOMA OF THE HEAD AND NECK (REFRACTORY TO STANDARD CHEMOTHERAPY): Cisplatin Ebewe, as a single agent, is indicated as secondary therapy in patients with squamous cell carcinoma of the head and neck refractory to standard chemotherapy who have not previously received Cisplatin Ebewe therapy. NEW ZEALAND DATA SHEET Page 2 of 12 4.2 DOSE AND METHOD OF ADMINISTRATION NOTE: Needles or intravenous sets containing aluminium parts that may come in contact with Cisplatin Ebewe should not be used for preparation or administration. Aluminium reacts with Cisplatin Ebewe, causing precipitate formation and a loss of potency. The solution should be used intravenously only and should be administered by I.V. infusion only as recommended Прочитајте комплетан документ