Myocrisin 50mg/0.5ml solution for injection ampoules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Sodium aurothiomalate

Available from:

Sanofi

ATC code:

M01CB01

INN (International Name):

Sodium aurothiomalate

Dosage:

100mg/1ml

Pharmaceutical form:

Solution for injection

Administration route:

Intramuscular

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 10010300; GTIN: 5000283651659

Patient Information leaflet

_I_
IS THIS LEAFLET HARD TO
SEE OR READ?
PHONE [phone]
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

Summary of Product characteristics

OBJECT 1
MYOCRISIN 100MG/ML SOLUTION FOR INJECTION
Summary of Product Characteristics Updated 19-Dec-2013 | SANOFI
1. Name of the medicinal product
Myocrisin 100mg/ml Solution for Injection
2. Qualitative and quantitative composition
Each 0.5ml of solution for injection contains 50mg of Sodium
aurothiomalate (100mg/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 toxicity, 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 remi