Šalis: Australija
kalba: anglų
Šaltinis: Department of Health (Therapeutic Goods Administration)
Dust allergens, Quantity: 0.97 mL/mL (Equivalent: Dust allergens, Qty 97 mg/mL); Dust allergens, Quantity: 0.01 mL/mL (Equivalent: Dust allergens, Qty 1 mg/mL); Feathers, Quantity: 0.003 mL/mL (Equivalent: Feathers, Qty 0.3 mg/mL)
Stallergenes Australia Pty Ltd
Extract, liquid
Excipient Ingredients: glycerol; sodium chloride; sodium bicarbonate; water for injections
Subcutaneous
1 mL, 5 mL, 30 mL, 50 mL, 10 mL
Medicine Registered
Not scheduled. Not considered by committee
Indicated use of allergenic extracts is for the diagnosis and treatment (hypo-sensitization therapy) of patients who experience allergic symptoms.
Visual Identification: Clear liquid yellow to brown hue; Container Type: Multiple containers
Registered
1991-11-01
DBL™ CARBOPLATIN INJECTION _carboplatin_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about DBL Carboplatin 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 taking carboplatin 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 WITH THE MEDICINE. You may need to read it again. WHAT DBL CARBOPLATIN INJECTION IS USED FOR This medicine is used to treat: • ovarian cancer • cancer of the testes • some types of lung cancer • cancer of the brain and/or spinal cord • cancer of the head and neck • neuroblastoma (a cancer of the nerves and adrenal glands) • a type of cancer called sarcoma. Carboplatin belongs to a group of medicines called antineoplastic or cytotoxic medicines. You may also hear of these being called chemotherapy medicines. This medicine is classified as a platinum- complex cytotoxic. It works by killing cancer cells and/ or stopping cancer cells from growing and multiplying. DBL Carboplatin Injection is often used in combination with other medicines to treat 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 reason. This medicine is not addictive. This medicine is available only with a doctor's prescription. BEFORE YOU TAKE ARE GIVEN DBL CARBOPLATIN INJECTION _WHEN YOU MUST NOT BE GIVEN_ _IT_ YOU SHOULD NOT BE GIVEN DBL CARBOPLATIN INJECTION IF YOU HAVE AN ALLERGY TO: • any medicine containing carboplatin • other platinum-containing compounds such as cisplatin or oxaliplatin • mannitol 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 • ras Perskaitykite visą dokumentą
Version: pfpcarpi11121 Superscedes: hhpcarpi10420 Page 1 of 13 AUSTRALIAN PRODUCT INFORMATION – DBL ™ CARBOPLATIN INJECTION (CARBOPLATIN) 1. NAME OF THE MEDICINE Carboplatin 2. QUALITATIVE AND QUANTITATIVE COMPOSITION DBL Carboplatin Injection is a sterile solution of carboplatin in Water for Injections and is presented in vials containing 5, 15, or 45 mL of 10 milligrams/mL carboplatin. Each mL of DBL Carboplatin Injection contains Carboplatin 10 mg. 3. PHARMACEUTICAL FORM Solution for injection. DBL Carboplatin Injection is a clear, colourless or slightly yellow solution free from particulates. The solution does not contain any preservatives. The pH of the injection ranges between 4.0 to 7.0. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Carboplatin is indicated in the treatment of: • advanced stage ovarian cancer of epithelial origin • small cell lung carcinoma • carcinoma of the head and neck • carcinoma of the testis • paediatric cerebral tumours • soft tissue sarcoma • neuroblastoma. 4.2 DOSE AND METHOD OF ADMINISTRATION DOSAGE ADULT: The recommended dose of carboplatin in previously untreated adults with normal renal function is 400 milligrams/m 2 given as a single intravenous infusion over 15 to 60 minutes. Therapy should not be repeated until four weeks after the previous carboplatin course. It is recommended that according to clinical circumstances the initial dosage may require reduction by 20 to 25% in patients with risk factors such as increasing age, previous myelosuppressive therapy and poor performance status. Version: pfpcarpi11121 Superscedes: hhpcarpi10420 Page 2 of 13 Dosage modification may be required when carboplatin is used in combination with other myelosuppressive drugs or radiation therapy, to minimise additive myelosuppressive effects. Determination of haematologic nadir by weekly blood counts during initial courses is recommended for future dosage adjustment and scheduling of carboplatin. DOSAGE ADJUSTMENT _RENAL IMPAIRMENT _ In patients with initial impaired r Perskaitykite visą dokumentą