Myocrisin

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Sodium aurothiomalate monohydrate 20mg;  

Available from:

sanofi-aventis new zealand limited

INN (International Name):

Sodium aurothiomalate monohydrate 20 mg

Dosage:

20 mg

Pharmaceutical form:

Solution for injection

Composition:

Active: Sodium aurothiomalate monohydrate 20mg   Excipient: Nitrogen Phenylmercuric nitrate Water for injection

Units in package:

Ampoule, 10x0.5ml, 5 mL

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Prime European Therapeuticals SpA - Euticals SpA

Product summary:

Package - Contents - Shelf Life: Ampoule, 0.5 ml glass - 10 dose units - 36 months from date of manufacture stored at or below 25°C protect from light

Authorization date:

1969-12-31

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

New Zealand Data Sheet
May 2018
Myocrisin - sodium aurothiomalate
myocrisin-ccsiv1-dsv5-31may18
Page 1
DATA SHEET
1
PRODUCT NAME
MYOCRISIN 10 mg solution for injection
MYOCRISIN 20 mg solution for injection
MYOCRISIN 50 mg solution for injection
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ampoule of MYOCRISIN solution for injection contains 10 mg (2%
w/v), 20 mg (4% w/v)
or 50 mg (10% w/v) of sodium aurothiomalate.
Excipient with known effect: phenylmercuric nitrate.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Solution for injection.
Clean bright, almost colourless solution.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
MYOCRISIN is indicated in the management of active progressive
rheumatoid arthritis, and
progressive juvenile chronic arthritis, especially if polyarticular or
seropositive.
4.2
DOSE AND METHOD OF ADMINISTRATION
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
administration of the drug (see section
4.4).
Do not use a darkened solution (more than pale yellow).
New Zealand Data Sheet
May 2018
Myocrisin - sodium aurothiomalate
myocrisin-ccsiv1-dsv5-31may18
Page 2
Some rheumatologists provide their patients with a ‘gold card‘ on
which is recorded the amount
of gold salt injected and results of laboratory tests, at the same
time issuing a pro forma for further
treatment to the general practitioner responsible for the management
of the patient. These are
valuable aids in the early detection, and so reduce the incidence of
toxic reactions.
DOSE
_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