Land: Australië
Taal: Engels
Bron: Department of Health (Therapeutic Goods Administration)
cisplatin, Quantity: 1 mg/mL
Pfizer Australia Pty Ltd
Injection, solution
Excipient Ingredients: sodium chloride; mannitol; water for injections
Intravenous
1x50mg/50mL(E), 1x50mg/50mL
Not scheduled. Not considered by committee, (S4) Prescription Only Medicine
Cisplatin Injection is indicated for the palliative treatment of metastatic non-seminomatous germ cell carcinoma, advanced-stage refractory ovarian carcinoma, advanced-stage refractory bladder carcinoma and refractory squamous cell carcinoma of the head and neck. It may be used as a single agent or in combination with other chemotherapeutic agents. It may be employed, in appropriate circumstances, in addition to other modalities, eg radiotherapy or surgery.
Visual Identification: Clear, colourless to pale yellow solution, free from visible particulates; Container Type: Vial; Container Material: Glass Type I Coloured; Container Life Time: 2 Years; Container Temperature: Store between 15-25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
1994-01-31
DBL™ CISPLATIN INJECTION _cisplatin_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about DBL Cisplatin Injection. 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 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 DBL CISPLATIN INJECTION IS USED FOR DBL Cisplatin Injection belongs to a group of medicines known as antineoplastic or cytotoxic agents. You may also hear it referred to as a chemotherapy medicine. This medicine is used to treat: • testicular cancer • ovarian cancer • bladder cancer • cancer of the head and neck DBL Cisplatin Injection 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, other effects may also occur (see Side Effects). DBL Cisplatin Injection may be used alone or with other anticancer therapies. DBL Cisplatin Injection 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. Your doctor may have prescribed it for another reason. This medicine is available only with a doctor’s prescription. BEFORE YOU ARE GIVEN DBL CISPLATIN INJECTION _WHEN YOU MUST NOT BE GIVEN_ _IT_ DO NOT USE DBL CISPLATIN INJECTION IF YOU HAVE AN ALLERGY TO: • any medicine containing cisplatin • any other platinum-containing compounds • any of the ingredients listed at the end of this leaflet. Some of the symptoms of an alle Lees het volledige document
Version pfpcisdi11021 Supersedes: hhpcispi10420 Page 1 of 12 AUSTRALIAN PRODUCT INFORMATION – DBL ™ CISPLATIN INJECTION (CISPLATIN) 1. NAME OF THE MEDICINE Cisplatin 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each mL of DBL Cisplatin Injection contains 1 mg cisplatin. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection. DBL Cisplatin Injection is a clear, colourless to pale yellow sterile solution of cisplatin 1 mg/mL, mannitol 1 mg/mL and sodium chloride 9 mg/mL in water for injections. The solution does not contain any preservative. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS DBL Cisplatin Injection is indicated for the palliative treatment of metastatic non-seminomatous germ cell carcinoma, advanced-stage refractory ovarian carcinoma, advanced-stage refractory bladder carcinoma and refractory squamous cell carcinoma of the head and neck. It may be used as a single agent or in combination with other chemotherapeutic agents. It may be employed, in appropriate circumstances, in addition to other modalities, e.g., radiotherapy or surgery. 4.2 DOSE AND METHOD OF ADMINISTRATION DOSAGE The usual dose in adults and children when used as single agent therapy is 50-100 mg/m 2 as a single IV infusion every 3-4 weeks, or 15-20 mg/m 2 as a daily IV infusion for 5 days every 3-4 weeks. DOSAGE ADJUSTMENT _HEPATIC IMPAIRMENT_ _ _ Human studies show a high uptake of cisplatin in the liver. An elevated serum glutamic oxaloacetic transaminase (SGOT) has been reported in some cases and the adult dosage should be used with caution. Version pfpcisdi11021 Supersedes: hhpcispi10420 Page 2 of 12 _RENAL IMPAIRMENT _ Cisplatin displays high tissue uptake in the kidneys, exhibits dose related and cumulative nephrotoxicity, and is excreted mainly in the urine. In addition, the plasma elimination half-life of cisplatin is prolonged in renal failure. Caution should be exercised in patients with pre-existing renal dysfunction. Cisplatin is contraindicated in patients with serum creatin Lees het volledige document