Krajina: Austrália
Jazyk: angličtina
Zdroj: Department of Health (Therapeutic Goods Administration)
methotrexate, Quantity: 10 mg
Link Medical Products Pty Ltd T/A Link Pharmaceuticals
Methotrexate
Injection, solution
Excipient Ingredients: sodium chloride; sodium hydroxide; water for injections
Subcutaneous
1 pre-filled syringe, 24 pre-filled syringes, 12 pre-filled syringes, 4 pre-filled syringes, 6 pre-filled syringes
(S4) Prescription Only Medicine
Psoriasis Therapy (see WARNING box): TREXJECT may be of value in the symptomatic control of severe, recalcitrant, disabling psoriasis in adults which is not adequately responsive to other forms of treatment. However, due to the high risk associated with its use, methotrexate should be used after the diagnosis has been definitely established, as by biopsy and/or after dermatologic consultation.,Rheumatoid Arthritis Therapy (see WARNING box): Management of severe, recalcitrant, active rheumatoid arthritis in adults not responding to, or intolerant of, an adequate trial of NSAIDs and one or more disease modifying drugs. Aspirin, NSAIDs and/or low dose steroids may be continued, although the possibility of increased toxicity with concomitant use of NSAIDs including salicylate has not been fully explored. Steroids may be reduced gradually in patients who respond to methotrexate. Combined use of methotrexate with gold or penicillamine, has not been studied and may increase the incidence of adverse effects. Rest and physiotherapy as indicated should be continued.
Visual Identification: Yellow-brown, clear solution, free from turbidity, practically free from visible particles; Container Type: Syringe; Container Material: Glass Type I Clear; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Licence status A
2015-08-25
TREXJECT® 1 TREXJECT® 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 TREXJECT? TREXJECT contains the active ingredient methotrexate (as sodium). TREXJECT is used to treat inflammatory conditions, including severe psoriasis, and severe rheumatoid arthritis. For more information, see Section 1. Why am I using TREXJECT? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE TREXJECT? Do not use if you have ever had an allergic reaction to TREXJECT 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 TREXJECT? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with TREXJECT 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 TREXJECT • TREXJECT 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 TREXJECT? in the full CMI 5. WHAT SHOULD I KNOW WHILE USING TREXJECT? THINGS YOU SHOULD DO • Remind any doctor, dentist or pharmacist you visit that you are using TREXJECT • Ensure you and your partner are using a reliable method of contraception during, and at least for six months after treatment with TREXJECT • Tell your doctor if you develop an infection or you notice new or changed spots on your skin • Discuss with your doctor, your water and fluid intake. Dehydration can increase the risk of side effects • Tell your doctor if you are schedu Prečítajte si celý dokument
TREXJECT, METHOTREXATE (AS SODIUM) INJECTION VERSION: 8.0 Page 1 of 24 AUSTRALIAN PRODUCT INFORMATION – TREXJECT (METHOTREXATE (AS SODIUM)) SOLUTION FOR INJECTION WARNING Methotrexate must only be prescribed by physicians experienced in anti-metabolic therapy and the treatment of severe rheumatoid arthritis or psoriasis. 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. Methotrexate may produce depression of the bone marrow, anaemia, aplastic anaemia, leukopenia, neutropenia, thrombocytopenia and bleeding. 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. Potentially fatal opportunistic infections, especially Pneumocystis jirovecii pneumonia, may occur with methotrexate therapy. Use in pregnancy Category D. This category specifies drugs, which have caused an increased incidence of human foetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Methotrexate has caused foetal death and/or congenital anomalies. It should not be used in pregnant women or in those who might become pregnant. Methotrexate is contraindicated in the treatment Prečítajte si celý dokument