Kraj: Australia
Język: angielski
Źródło: Department of Health (Therapeutic Goods Administration)
busulfan, Quantity: 60 mg
Arrotex Pharmaceuticals Pty Ltd
Busulfan
Injection, solution
Excipient Ingredients: dimethylacetamide; macrogol 400
Intravenous Infusion
8
(S4) Prescription Only Medicine
Busulfan injection is indicated for use in combination with cyclophosphamide, melphalan or fludarabine in conditioning prior to haematopoietic stem cell transplantation.
Visual Identification: A clear and colorless solution; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Licence status A
2014-10-09
BUSULFAN APOTEX INJECTION _Contains the active ingredient busulfan_ CONSUMER MEDICINE INFORMATION _FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055_ WHAT IS IN THIS LEAFLET This leaflet answers some common questions about this medicine. 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 this medicine 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 THIS MEDICINE IS USED FOR Busulfan APOTEX Injection is used in adults, new-born infants, children and adolescents as a treatment prior to transplantation of either bone marrow or blood stem cells. It is used in combination with other chemotherapeutic drugs, namely cyclophosphamide, melphalan or fludarabine. Busulfan APOTEX Injection contains the active ingredient busulfan and belongs to a group of medicines called alkylating agents. Busulfan destroys the original bone marrow before the transplant. There is no evidence that this medicine is addictive. Your doctor may have prescribed this medicine for another reason. 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 THIS MEDICINE _WHEN YOU MUST NOT BE GIVEN_ _IT_ DO NOT TAKE THIS MEDICINE IF YOU HAVE AN ALLERGY TO: busulfan or 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, throat or other parts of the body • rash, itching or hives on the skin • fainting or hay fever-like symptoms DO NOT TAKE THIS MEDICINE IF YOU ARE PREGNANT, THINK YOU MAY BE PREGNANT OR ARE BREASTFEEDING. Busulfan may affect your developing Przeczytaj cały dokument
1 AUSTRALIAN PRODUCT INFORMATION BUSULFAN APOTEX (BUSULFAN) INJECTION 1 NAME OF THE MEDICINE Busulfan 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 10 mL vial of busulfan injection contains 60 mg (6 mg/mL) of busulfan. For the full list of excipients see section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM Busulfan APOTEX Injection is supplied as a sterile solution in 10 mL single-use clear glass vials. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Busulfan injection is indicated for use in combination with cyclophosphamide, melphalan or fludarabine in conditioning prior to haematopoietic stem cell transplantation. 4.2 DOSE AND METHOD OF ADMINISTRATION IV busulfan administration should be supervised by a physician experienced in conditioning treatment prior to HSCT. It is intended for dilution with 0.9% sodium chloride solution for injection or 5% glucose solution for injection. DOSAGE In adult patients eligible for myeloablative HSCT the proposed dosage recommendation is 3.2 mg/kg body weight/day for four days, giving a total dose of 12.8 mg/kg. IN NEW-BORN INFANTS, CHILDREN AND ADOLESCENTS (0 TO 17 YEARS) ELIGIBLE FOR MYELOABLATIVE HSCT IT IS RECOMMENDED THAT DOSING IS BASED ON A PATIENT’S BODY WEIGHT AS FOLLOWS: ACTUAL BODY WEIGHT (KG) IV BUSULFAN DOSE (MG/KG/DAY) TOTAL IV BUSULFAN DOSE (MG/KG) < 9 4.0 16.0 9 to < 16 4.8 19.2 16 to 23 4.4 17.6 > 23 to 34 3.8 15.2 > 34 3.2 12.8 The IV busulfan daily dose may be given as a single three-hour infusion once daily (od) over 4 consecutive days for a total of 4 doses. Alternatively the daily dose may be divided and given as a two to three hour infusion every 12 hours (bd) for four days, giving a total of 8 doses, or every 6 hours (qid) for four days, giving a total of 16 doses. 2 In a non-myeloablative conditioning regimen (also known as a reduced-intensity conditioning regimen) a lower IV busulfan daily dose may be administered and/or the dose may be administered for less than four days, resulting in a lower total dose. In clinical trials IV busulfan total Przeczytaj cały dokument