Krajina: Austrália
Jazyk: angličtina
Zdroj: Department of Health (Therapeutic Goods Administration)
cisplatin, Quantity: 50 mg
Pfizer Australia Pty Ltd
Injection, solution
Excipient Ingredients: water for injections; hydrochloric acid; sodium chloride; sodium hydroxide; mannitol
Intravenous
50mL x 1
(S4) Prescription Only Medicine
Cisplatin injection may be used singularly or in combination with other chemotherapeutic agents in the treatment of: - metastatic nonseminomatous germ cell carcinoma; advanced stage, refractory ovarian carcinoma; advanced stage, refractory bladder carcinoma; refractory squamous cell carcinoma of the head and neck
Visual Identification: A clear, colourless to pale yellow solution, free of visible particulate matter.; Container Type: Vial; Container Material: PP; Container Life Time: 2 Years; Container Temperature: Store between 15-25 degrees Celsius
Registered
1994-06-23
CISPLATIN INJECTION _cisplatin_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about 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 using Cisplatin Injection 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 CISPLATIN INJECTION IS USED FOR Cisplatin belongs to a group of anticancer medicines known as the platinum complexes. Cisplatin works by preventing the growth of cancer cells and eventually destroying them. It is used for cancer of the ovary, testis, bladder and also head and neck cancer. 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 purpose. This medicine is available only with a doctor's prescription. BEFORE YOU ARE GIVEN CISPLATIN INJECTION _WHEN YOU MUST NOT BE GIVEN_ _IT_ DO NOT USE CISPLATIN INJECTION IF YOU HAVE AN ALLERGY TO: • any medicine containing cisplatin, carboplatin or other medicines containing platinum • any of the ingredients listed at the end of this leaflet 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 CISPLATIN INJECTION SHOULD NOT BE GIVEN IF: • you have kidney disease or poor kidney function • you have a low blood count • you have hearing problems. DO NOT USE THIS MEDICINE IF YOU ARE PREGNANT OR PLANNING TO BECOME PREGNANT. It may affect your developing baby. FEMALES: TELL YOUR DOCTOR OR PHARMACIST IF YOU ARE PREGNANT OR INTEND TO BECOME PREGNANT. Birth control should be used during treatment with Cisplatin and for at least 26 weeks after you stop Prečítajte si celý dokument
Version: pfpcispi10420 Supersedes: pfpcispi10919 Page 1 of 12 AUSTRALIAN PRODUCT INFORMATION – CISPLATIN INJECTION (CISPLATIN) 1. NAME OF THE MEDICINE Cisplatin 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Cisplatin Injection is a sterile, isotonic, preservative free solution containing cisplatin 1 mg/mL. For the full list of excipients, see Section 6.1 List of excipients. 3. PHARMACEUTICAL FORM Solution for injection. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Cisplatin Injection may be used singularly or in combination with other chemotherapeutic agents in the treatment of: • Metastatic nonseminomatous germ cell carcinoma • Advanced stage, refractory ovarian carcinoma • Advanced stage, refractory bladder carcinoma • Refractory squamous cell carcinoma of the head and neck. 4.2 DOSE AND METHOD OF ADMINISTRATION ADULT AND CHILDREN SINGLE AGENT THERAPY Typical doses and schedules are: 50-100 mg/m 2 as a single IV infusion every 3-4 weeks over 6-8 hours; or slow IV infusion of 15-20 mg/m 2 /day for 5 days, every 3-4 weeks. Dosage should be reduced in patients with depressed bone marrow function. COMBINATION THERAPY Cisplatin is commonly used in combination therapy with the following cytotoxic agents: • _treatment of testicular cancer: _ vinblastine, bleomycin, actinomycin D; Version: pfpcispi10420 Supersedes: pfpcispi10919 Page 2 of 12 • _treatment of ovarian cancer: _ cyclophosphamide, doxorubicin, hexamethylmelamine, 5- fluorouracil; • _treatment of head and neck cancer:_ bleomycin, methotrexate. SUBSEQUENT TREATMENT WITH CISPLATIN A repeat course of cisplatin should not be given until: • the serum creatinine is below 140 micromol/L and/or the plasma urea is below 9 mmol/L and • circulating blood elements are at an acceptable level (platelets at least 100,000/mm 3 , WBC at least 4000/mm 3 ). A base line audiogram should be taken and the patient monitored periodically for auditory deterioration (see Section 4.4 Special warnings and precautions for use). IMPAIRED HEPATIC FUNCTION Human st Prečítajte si celý dokument