Riik: Austraalia
keel: inglise
Allikas: Department of Health (Therapeutic Goods Administration)
chlorambucil, Quantity: 2 mg
Aspen Pharmacare Australia Pty Ltd
Tablet, film coated
Excipient Ingredients: lactose; microcrystalline cellulose; stearic acid; colloidal anhydrous silica; titanium dioxide; hypromellose; iron oxide yellow; iron oxide red; macrogol 400
Oral
50 tablets, 25 tablets
(S4) Prescription Only Medicine
Treatment of Hodgkin's disease, certain forms of non-Hodgkin's lymphoma, chronic lymphocytic leukaemia, Waldenstrom's macroglobulinaemia, advanced ovarian adenocarcinoma. Leukeran has a significant effect in a proportion of patients with breast cancer
Visual Identification: Brown, film-coated, round, biconvex tablets, engraved 'GX EG3' on one side and 'L' on the other.; Container Type: Bottle; Container Material: Glass Type III Coloured; Container Life Time: 3 Years; Container Temperature: Store at 2 to 8 degrees Celsius
Licence status A
2000-12-12
LEUKERAN ® _chlorambucil 2 mg tablets_ CONSUMER MEDICINE INFORMATION (CMI) WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Leukeran. It does not contain all the available information. It does not take the place of talking to your doctor. All medicines have risks and benefits. Your doctor has weighed the risks of you taking Leukeran 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 LEUKERAN IS USED FOR Leukeran contains chlorambucil as the active ingredient. Leukeran belongs to a group of medicines called cytotoxics and is used to treat some types of cancer and certain blood disorders. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY LEUKERAN HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. This medicine is only available with a doctor's prescription. There is no evidence that it is addictive. BEFORE YOU TAKE IT _WHEN YOU MUST NOT TAKE IT_ DO NOT TAKE LEUKERAN IF YOU HAVE EVER HAD AN ALLERGIC REACTION TO: • chlorambucil • any of the tablet ingredients listed at the end of this leaflet. Symptoms of an allergic reaction may include shortness of breath, wheezing or difficulty in breathing; swelling of the face, lips, tongue or any other parts of the body; rash, itching or hives on the skin. DO NOT TAKE LEUKERAN IF YOU ARE PLANNING TO BECOME PREGNANT OR LIKELY TO FATHER A CHILD. Leukeran may harm the eggs and sperm so reliable contraceptive methods must be taken to avoid pregnancy whilst you or your partner is taking this medicine. DO NOT TAKE LEUKERAN IF YOU ARE PREGNANT OR BREAST FEEDING UNLESS YOU AND YOUR DOCTOR HAVE DISCUSSED THE RISKS AND BENEFITS INVOLVED. DO NOT TAKE LEUKERAN AFTER THE EXPIRY DATE (EXP) PRINTED ON THE BOTTLE LABEL. DO NOT TAKE IT IF THE BOTTLE SHOWS SIGNS OF HAVING BEEN TAMPERED WITH. IF YOU ARE NOT SURE WHETHER YOU SHOULD BE TAKING LEUKERAN, TALK TO YOUR DOCTOR. _BEFO Lugege kogu dokumenti
LEUKERAN_Product Information (PI) Page 1 of 9 AUSTRALIAN PRODUCT INFORMATION (PI) CHLORAMBUCIL (LEUKERAN) TABLETS 1. NAME OF THE MEDICINE LEUKERAN chlorambucil 2mg tablet 2. QUALITATIVE AND QUANITATIVE COMPOSITION LEUKERAN tablets contain 2 mg chlorambucil Chlorambucil is a white or off-white crystalline or granular powder. It is practically insoluble in water, freely soluble in acetone and in alcohol. 3. PHARMACEUTICAL FORM Tablets, film-coated 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATION Treatment of Hodgkin's disease, certain forms of non-Hodgkin's lymphoma, chronic lymphocytic leukaemia, Waldenstrom's macroglobulinaemia, advanced ovarian adenocarcinoma. LEUKERAN has a significant effect in a proportion of patients with breast cancer. 4.2 DOSE AND METHOD OF ADMINISTRATION THE LITERATURE SHOULD BE CONSULTED FOR FULL DETAILS OF THE TREATMENT SCHEDULES USED. LEUKERAN IS AN ACTIVE CYTOTOXIC AGENT FOR USE ONLY UNDER THE DIRECTION OF PHYSICIANS EXPERIENCED IN THE ADMINISTRATION OF SUCH AGENTS. LEUKERAN is administered orally and should be taken daily on an empty stomach (at least one hour before meal or three hours after meal). HODGKIN'S DISEASE: Used as a single agent a typical dosage is 0.2 mg/kg/day for four to eight weeks. LEUKERAN is usually included in combination therapy and a number of regimens have been used. LEUKERAN may also be used as an alternative to nitrogen mustard with a reduction in toxicity but similar therapeutic results. NON-HODGKIN'S LYMPHOMA: Used as a single agent the usual dosage is 0.1 to 0.2 mg/kg/day for four to eight weeks initially; maintenance therapy is then given either by a reduced daily dosage or intermittent courses of treatment. LEUKERAN is useful in the management of patients with advanced diffuse lymphocytic lymphoma and those who have relapsed after radiotherapy. LEUKERAN_Product Information (PI) Page 2 of 9 There is no significant difference in the overall response rate obtained with chlorambucil as a single agent and combination chemotherapy in patients with advanced n Lugege kogu dokumenti