দেশ: নিউ জিলণ্ড
ভাষা: ইংরেজি
সূত্র: Medsafe (Medicines Safety Authority)
Methotrexate 20 mg/mL
Sandoz New Zealand Limited
Methotrexate 20 mg/mL
20 mg/mL
Injection with diluent
Active: Methotrexate 20 mg/mL Excipient: Sodium chloride Sodium hydroxide Water for injection
Syringe, glass, Clear type 1 glass with bromo-butyl plunger, 7.5mg, 0.375 mL
Prescription
Prescription
Fermion Oy
- Active rheumatoid arthritis in adult patients where treatment with disease modifying antirheumatic drugs (DMARDs) is indicated. - Polyarthritic forms of severe, active juvenile idiopathic arthritis (JIA) when the response to nonsteroidal anti-inflammatory drugs (NSAIDs) has been inadequate - Severe forms of psoriasis vulgaris, particularly of the plaque type, which cannot be sufficiently treated with conventional therapy such as phototherapy, PUVA, and retinoids, and severe psoriatic arthritis.
Package - Contents - Shelf Life: Syringe, glass, Clear type 1 glass with bromo-butyl plunger, 7.5mg - 0.375 mL - 24 months from date of manufacture stored at or below 25°C protect from light - Syringe, glass, Clear type 1 glass with bromo-butyl plunger, 10mg - 0.5 mL - 24 months from date of manufacture stored at or below 25°C protect from light - Syringe, glass, Clear type 1 glass with bromo-butyl plunger, 12.5 mg - 0.625 mL - 24 months from date of manufacture stored at or below 25°C protect from light - Syringe, glass, Clear type 1 glass with bromo-butyl plunger, 15mg - 0.75 mL - 24 months from date of manufacture stored at or below 25°C protect from light - Syringe, glass, Clear type 1 glass with bromo-butyl plunger, 17.5 mg - 0.875 mL - 24 months from date of manufacture stored at or below 25°C protect from light - Syringe, glass, Clear type 1 glass with bromo-butyl plunger, 20mg - 1 mL - 24 months from date of manufacture stored at or below 25°C protect from light - Syringe, glass, Clear type 1 glass with bromo-butyl plunger, 22.5 mg - 1.125 mL - 24 months from date of manufacture stored at or below 25°C protect from light - Syringe, glass, Clear type 1 glass with bromo-butyl plunger, 25mg - 1.25 mL - 24 months from date of manufacture stored at or below 25°C protect from light - Syringe, glass, Clear type 1 glass with bromo-butyl plunger, 27.5 mg - 1.375 mL - 24 months from date of manufacture stored at or below 25°C protect from light - Syringe, glass, Clear type 1 glass with bromo-butyl plunger, 30mg - 1.5 mL - 24 months from date of manufacture stored at or below 25°C protect from light - Syringe, glass, Clear type 1 glass with bromo-butyl plunger, 40mg - 2 mL - 24 months from date of manufacture stored at or below 25°C protect from light
2011-01-05
Methotrexate Sandoz® 1 METHOTREXATE SANDOZ® 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. WARNING: Important safety information is provided in a boxed warning in the full CMI. Read before using this medicine. 1. WHY AM I USING METHOTREXATE SANDOZ? Methotrexate Sandoz contains the active ingredient methotrexate (as disodium). Methotrexate Sandoz is used to treat inflammatory conditions, including severe psoriasis, and active rheumatoid arthritis. For more information, see Section 1. Why am I using Methotrexate Sandoz? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE METHOTREXATE SANDOZ? Do not use if you have ever had an allergic reaction to Methotrexate Sandoz 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 Methotrexate Sandoz? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with Methotrexate Sandoz 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 USE METHOTREXATE SANDOZ? • Methotrexate Sandoz is given as a ONCE WEEKLY injection under the skin (subcutaneous). • You may decide together with your doctor on a suitable weekday each week to receive your injection. More instructions can be found in Section 4. How do I use Methotrexate Sandoz? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING METHOTREXATE SANDOZ? THINGS YOU SHOULD DO • Remind any doctor, dentist or pharmacist you visit that you are using Methotrexate Sandoz. • Ensure you and your partner are using a reliable method of contraception during, and at least for six months after treatment with Methotrexate Sandoz. • Tell your doctor if you develop an infection or you noti সম্পূর্ণ নথি পড়ুন
230320-methotrexate sandoz-ds Page 1 of 22 NEW ZEALAND DATA SHEET METHOTREXATE SANDOZ (METHOTREXATE) WARNING Methotrexate must only be used by physicians experienced in anti-metabolite chemotherapy, or in the case of non-oncological conditions, by a specialist physician. Patients should be fully informed of the risk of fatal or severe toxic reactions involved with the administration of methotrexate and should be under constant supervision of the physician. 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 and only when the diagnosis has been established, by biopsy and/or after consultation. 1. Methotrexate may produce depression of the bone marrow, anaemia, aplastic anaemia, leucopenia, neutropenia, thrombocytopenia and bleeding. 2. At high or prolonged doses, methotrexate may be hepatotoxic. Liver atrophy, necrosis, cirrhosis, fatty changes and periportal fibrosis have been reported. Since changes may occur without previous signs of gastro-intestinal or haematological toxicity, it is imperative that hepatic function be determined prior to initiation of treatment and monitored regularly throughout therapy. Special caution is indicated in the presence of liver damage or impaired hepatic function. Concomitant use of other drugs with hepatotoxic potential and alcohol should be avoided. 3. Malignant lymphomas, which may regress following withdrawal of methotrexate, may occur in patients receiving low-dose methotrexate and, thus, may not require cytotoxic treatment. Discontinue methotrexate first and, if the lymphoma does not regress, appropriate treatment should be instituted. 4. Potentially fatal opportunistic infections, especially _Pneumocystis jirovecii _ pneumonia, may occur with methotrexate therapy. 5. USE IN PREGNANCY Category D. This category specifies drugs, which have caused an increased incidence of human foe সম্পূর্ণ নথি পড়ুন