Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Sodium aurothiomalate
Sanofi
M01CB01
Sodium aurothiomalate
20mg/1ml
Solution for injection
Intramuscular
No Controlled Drug Status
Valid as a prescribable product
BNF: 10010300; GTIN: 5000283651635
_I_ IS THIS LEAFLET HARD TO SEE OR READ? PHONE 0845 372 7101 FOR HELP READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor, pharmacist or nurse. • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. • If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See Section 4. WHAT IS IN THIS LEAFLET: 1. What Myocrisin is and what it is used for 2. What you need to know before you have Myocrisin 3. How Myocrisin is given 4. Possible side effects 5. How to store Myocrisin 6. Further information 1. WHAT MYOCRISIN IS AND WHAT IT IS USED FOR The name of your medicine is Myocrisin® 20mg/ml & 100mg/ml Solution for Injection (called Myocrisin in this leaflet). Myocrisin contains a medicine called sodium aurothiomalate. This belongs to a group of medicines called antiarthritics. It works by a number of different ways to reduce the pain and swelling in arthritic joints. Myocrisin can be used to treat arthritis in adults and children when: • You have had arthritis for a long time • Your arthritis is gradually getting worse • Your arthritis affects lots of joints in your body 2. WHAT YOU NEED TO KNOW BEFORE YOU HAVE MYOCRISIN DO NOT HAVE MYOCRISIN AND TELL YOUR DOCTOR IF: X You are allergic (hypersensitive) to sodium aurothiomalate or any of the other ingredients of Myocrisin (listed in Section 6 below). Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue. X You are pregnant, might become pregnant or think you may become pregnant (see ‘Pregnancy and breast-feeding’ below) X You have liver or kidney problems X You have ever had a blood problem X You have ever had a problem where your Read the complete document
OBJECT 1 MYOCRISIN INJECTION 2% Summary of Product Characteristics Updated 20-Dec-2013 | SANOFI 1. Name of the medicinal product Myocrisin 20mg/ml Solution for Injection 2. Qualitative and quantitative composition Each 0.5ml of solution for injection contains 10mg of Sodium aurothiomalate (20mg/ml). For a full list of excipients, see section 6.1. 3. Pharmaceutical form Injection 4. Clinical particulars 4.1 Therapeutic indications Myocrisin is used in the management of active progressive rheumatoid arthritis and progressive juvenile chronic arthritis especially if polyarticular or seropositive. 4.2 Posology and method of administration Do not use a darkened solution (more than pale yellow). Myocrisin should be administered only by deep intramuscular injection followed by gentle massage of the area. The patient should remain under medical observation for a period of 30 minutes after drug administration. ADULTS An initial test dose of 10 mg should be given in the first week followed by weekly doses of 50 mg until signs of remission occur. At this point 50 mg doses should be given at two week intervals until full remission occurs. With full remission the interval between injections should be increased progressively to three, four and then, after 18 months to 2 years, to six weeks. If after reaching a total dose of 1 g (excluding the test dose), no major improvement has occurred and the patient has not shown any signs of gold toxcicity, six 100 mg injections may be administered at weekly intervals. If no sign of remission occurs after this time other forms of treatment are to be considered. ELDERLY There are no specific dosage recommendations. Elderly patients should be monitored with extra caution CHILDREN: Progressive juvenile chronic arthritis: Weekly doses of 1 mg/kg should be given but not exceeding a maximum weekly dose of 50 mg. Depending on urgency, this dose may be preceded by a smaller test dose such as 1/10 or 1/5 of the full dose for 2-3 weeks. Continue weekly doses until signs of remission appear then inc Read the complete document