Myocrisin 20mg/0.5mL injection ampoule

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

sodium aurothiomalate

Available from:

Sanofi-Aventis Australia Pty Ltd

Class:

Medicine Registered

Authorization status:

Registered

Patient Information leaflet

MYOCRISIN
®
_Sodium aurothiomalate_
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Myocrisin.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you being given this
medicine against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
BEING GIVEN THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT MYOCRISIN IS
USED FOR
Myocrisin is a type of medicine used
to help treat rheumatoid arthritis and
Still's disease (a form of arthritis in
children).
Myocrisin helps to reduce the
inflammation which can occur with
arthritis.
Your doctor, however, may prescribe
Myocrisin for another purpose.
ASK YOUR DOCTOR OR PHARMACIST IF
YOU HAVE ANY QUESTIONS ABOUT WHY
IT HAS BEEN PRESCRIBED FOR YOU.
This medicine is only available with
a doctor's prescription.
BEFORE YOU ARE GIVEN IT
_WHEN YOU MUST NOT BE GIVEN_
_IT_
DO NOT RECEIVE MYOCRISIN IF YOU
HAVE:
•
LIVER DISEASE
•
KIDNEY DISEASE
•
DIABETES
•
BLOOD DISORDERS OR A HISTORY OF
BLOOD DISORDERS
•
ANY SERIOUS SKIN DISORDERS
•
ARE PREGNANT OR PLAN TO BECOME
PREGNANT
•
HISTORY OF SYSTEMIC LUPUS
ERYTHEMATOSUS, A DISEASE
AFFECTING THE SKIN, JOINTS AND
KIDNEYS
DO NOT RECEIVE MYOCRISIN IF YOU ARE
ALLERGIC TO IT OR ANY OF THE
INGREDIENTS LISTED AT THE END OF THIS
LEAFLET.
Some symptoms of an allergic
reaction include skin rash, itching,
shortness of breath or swelling of the
face, lips or tongue, which may cause
difficulty in swallowing or breathing.
DO NOT USE MYOCRISIN IF THE
SOLUTION HAS DARKENED IN COLOUR.
Any solution darker than a pale
yellow should not be used.
DO NOT RECEIVE IT IF YOU ARE
PREGNANT OR INTEND TO BECOME
PREGNANT.
It may affect your developing baby if
you are given it during pregnancy.
DO NOT RECEIVE IT IF YOU ARE
BREASTFEEDING OR PLANNING TO
BREASTFEED.
Myocri

Summary of Product characteristics

myocrisin-ccsiv1-piv5-06aug18
Page 1 of 8
AUSTRALIAN PRODUCT INFORMATION – MYOCRISIN (SODIUM
AUROTHIOMALATE) SOLUTION FOR INJECTION
1
NAME OF THE MEDICINE
Sodium aurothiomalate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ampoule of MYOCRISIN solution for injection contains 10mg, 20mg
or 50mg of
sodium aurothiomalate and phenylmercuric nitrate and water for
injections.
3
PHARMACEUTICAL FORM
Solution for injection
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Adjunctive treatment of rheumatoid arthritis that is not adequately
controlled by other anti-
inflammatory agents and conservative measures. In chronic, advanced
cases of rheumatoid
arthritis, gold therapy is less valuable.
Still's disease.
4.2
DOSE AND METHOD OF ADMINISTRATION
MYOCRISIN should be administered only by intramuscular injection.
Because of the possibility of an anaphylactic reaction, it is
recommended that patients be kept
under medical observation for a period of 30 minutes after the
administration of the drug.
Do not use a darkened solution (more than pale yellow).
_RHEUMATOID ARTHRITIS _
Dosage should be adjusted according to the response of the patient.
Recommended initial
dosage schedules: injection, at weekly intervals, of 1, 5 and 10mg to
test the patient's
tolerance, followed by a 50mg/week to a total of 1g, or twenty weekly
injections of 50mg to a
total of 1g. Whatever initial dosage regimen is adopted it is
essential to continue therapy on a
maintenance basis, usually at the rate of 50mg/month until a total of
about 3g has been given;
alternatively, the treatment is continued indefinitely or maintained
for at least two years after
remission has been achieved.
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Page 2 of 8
_STILL'S DISEASE _
Dosage is proportionate to the body weight of the patient. MYOCRISIN
is given at weekly
intervals, initiating treatment with the smallest doses and increasing
to the following maxima:
under 25kg bodyweight: 10mg; 25 to 50kg bodyweight: 20mg; over 50kg
bodyweight: 50mg.
Therapy should be continued for about six