Šalis: Australija
kalba: anglų
Šaltinis: Department of Health (Therapeutic Goods Administration)
cisplatin, Quantity: 1 mg/mL
Accord Healthcare Pty Ltd
Injection, concentrated
Excipient Ingredients: water for injections; sodium chloride; hydrochloric acid; sodium hydroxide
Intravenous
1
(S4) Prescription Only Medicine
Cisplatin Accord may be used as a monotherapy or in combination with other chemotherapeutic agents in the treatment of:,? Metastatic non-seminomatous 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 in an amber glass vial; Container Type: Vial; Container Material: Glass Type I Coloured; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius
Registered
2018-07-09
Cisplatin Accord - version 4 1 CISPLATIN ACCORD CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. 1. WHY AM I USING CISPLATIN ACCORD? Cisplatin Accord contains the active ingredient cisplatin. Cisplatin Accord is used for the treatment of ovarian cancer, cancer of the testes, cancer of the bladder, cancer of the head and neck. For more information, see Section 1. Why am I using Cisplatin Accord? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE CISPLATIN ACCORD? Do not use if you have ever had an allergic reaction to an any medicine containing cisplatin, carboplatin, other platinum- containing compounds, or any of the ingredients listed at the end of the CMI. TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING. For more information, see Section 2. What should I know before I use Cisplatin Accord? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with Cisplatin Accord and affect how it works. See Section 3. What if I am taking other medicines? in the full CMI. 4. HOW DO I USE CISPLATIN ACCORD? Cisplatin Accord is an injection and will be given to you by your doctor or nurse. More instructions can be found in Section 4. How do I use Cisplatin Accord? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING CISPLATIN ACCORD? THINGS YOU SHOULD DO • Be sure to keep all your doctor's appointments. • You will have blood and other tests from time to time to check on your progress and detect any unwanted side effects. • Tell all the doctors, dentists, and pharmacists who are treating you that you are being given Cisplatin Accord. • If you are about to be started on any new medicine, tell your doctor or pharmacist that you are being given Cisplatin Accord. • If you plan to have surgery that needs a general anaesthetic, tell your doctor or dentist that you are be Perskaitykite visą dokumentą
1 AUSTRALIAN PRODUCT INFORMATION CISPLATIN ACCORD CONCENTRATED INJECTION 1 NAME OF THE MEDICINE Cisplatin 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 mL contains 1 mg cisplatin. 1 vial of 10 mL concentrated injection for infusion contains 10 mg cisplatin. 1 vial of 25 mL concentrated injection for infusion contains 25 mg cisplatin. 1 vial of 50 mL concentrated injection for infusion contains 50 mg cisplatin. 1 vial of 100 mL concentrated injection for infusion contains 100 mg cisplatin. Cisplatin is a yellow to orange crystalline powder. It is slightly soluble in water, sparingly soluble in dimethylformamide and practically insoluble in ethanol (96 precent). For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS . 3 PHARMACEUTICAL FORM Cisplatin Accord is a clear, colourless to pale yellow sterile, isotonic, preservative free concentrated injection for infusion. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS Cisplatin Accord may be used as a monotherapy or in combination with other chemotherapeutic agents in the treatment of: • Metastatic non-seminomatous germ cell carcinoma • Advanced stage, refractory ovarian carcinoma • Advanced stage, refractory bladder carcinoma • Refractory squamous cell carcinoma of the head and neck 4.2 D OSE AND METHOD OF ADMINISTRATION Cisplatin Accord contains no antimicrobial agent. The product is for single use in one patient only. Discard any residue. ADULTS AND CHILDREN: MONOTHERAPY 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; • _treatment of ovarian cancer: _ cyclophosphamide, doxorubicin, hexamethylmelamine, fluorouracil; • _treatment of head and neck ca Perskaitykite visą dokumentą