Maa: Australia
Kieli: englanti
Lähde: Department of Health (Therapeutic Goods Administration)
methotrexate, Quantity: 2.5 mg
Pfizer Australia Pty Ltd
Tablet, uncoated
Excipient Ingredients: magnesium stearate; maize starch; lactose monohydrate; polysorbate 80; microcrystalline cellulose; pregelatinised maize starch
Oral
30
Medicine Registered
(S4) Prescription Only Medicine
ANTINEOPLASTIC CHEMOTHERAPY: Treatment of breast cancer, gestational choriocarcinoma, and in patients with chorioadenoma destruens and hydatidiform mole. Palliation of acute and subacute lymphocytic leukaemia. Greatest effect has been observed in palliation of acute lymphoblastic (stem cell) leukaemias. In combination with corticosteroids, methotrexate may be used for induction of remission. The drug is now most commonly used for the maintenance of induced remissions. Methoblastin is also effective in the treatment of the advanced stages (III and IV, Peters Staging System) of lymphosarcoma, particularly in children and in advanced cases of mycosis fungoides. PSORIASIS CHEMOTHERAPY: (See WARNINGS box and Precautions). Because of the high risk attending to its use, Methoblastin is only indicated in the symptomatic control of severe, recalcitrant, disabling psoriasis which is not adequately responsive to other forms of therapy, but only when the diagnosis has been established, as by biopsy and/or after dermatolo
Visual Identification: Yellow, round, biconvex, uncoated tablets engraved M 2.5 on one side and blank on the other.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure
Registered
1991-09-23
METHOBLASTIN ® M E T H O B L A S T I N ® CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about taking this medicine, speak to your doctor or pharmacist. WARNING: Important safety information is provided in a boxed warning in the full CMI. Read before taking this medicine. 1. WHY AM I TAKING METHOBLASTIN? Methoblastin contains the active ingredient methotrexate. Methoblastin is used to treat certain types of cancers, severe psoriasis or rheumatoid arthrtis when the condition does not improve with other medicines. For more information, see Section 1. Why am I taking Methoblastin? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I TAKE METHOBLASTIN? Do not take if you have ever had an allergic reaction to Methoblastin 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 take Methoblastin? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with Methoblastin and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. HOW DO I TAKE METHOBLASTIN? The dose of medicine given to you will depend on the condition being treated, your medical condition, your age, your size and how well your kidneys and liver are working. More instructions can be found in Section 4. How do I take Methoblastin? in the full CMI. 5. WHAT SHOULD I KNOW WHILE TAKING METHOBLASTIN? THINGS YOU SHOULD DO • Remind any doctor, dentist or pharmacist you visit that you are taking Methoblastin. • You and your partner must use a reliable method of contraception (birth control pills or condom) while taking Methoblastin and for at least 6 months after you stop treatment. • Discuss with your doctor how much water or fluids you should have as not enough fluid intake can increase th Lue koko asiakirja
Version: pfpmetht10422 Supersedes: pfpmetht10821 Page 1 of 29 AUSTRALIAN PRODUCT INFORMATION – METHOBLASTIN ® (METHOTREXATE) WARNINGS Methotrexate must be used only by physicians experienced in antimetabolite chemotherapy, or in the case of non-oncological conditions, by a specialist physician. Because of the possibility of fatal or severe toxic reactions, the patient should be fully informed by the physician of the risks involved and should be under his constant supervision. Deaths have been reported with the use of methotrexate. In the treatment of psoriasis and rheumatoid arthritis, methotrexate should be restricted to severe, recalcitrant, disabling disease which is not adequately responsive to other forms of therapy, but only when the diagnosis has been established by biopsy and/or after appropriate consultation. POTENTIAL OF FATAL TOXICITY FROM DOSING ERRORS Both the physician and the pharmacist should emphasise to the patient the importance of the weekly dosing regimen: mistaken daily use may cause serious and sometimes life-threatening or fatal toxicity (see Section 4.2 and 4.4, 4.9). For the same reason great care should be taken with dispensing to ensure the correct tablet strength of Methoblastin is given to the patient. Methoblastin is available as 2.5 mg and 10 mg tablets. ORGAN SYSTEM TOXICITY _GASTROINTESTINAL _ Diarrhoea and ulcerative stomatitis are frequent toxic effects and require interruption of therapy; otherwise, haemorrhage enteritis and death from intestinal perforation may occur. Gastrointestinal toxicity has been reported with concomitant administration of methotrexate (usually in high doses) along with nonsteroidal anti-inflammatory agents (NSAIDs). _HAEMATOLOGICAL _ Methotrexate may produce marked depression of bone marrow, anaemia, aplastic anaemia, leucopenia, neutropenia, thrombocytopenia and bleeding. Unexpectedly severe (sometimes fatal) marrow suppression and aplastic anaemia have been reported with concomitant administration of methotrexate (usually in high doses) along with Lue koko asiakirja