FLAMAZINE silver sulfadiazine 1.0% w/w cream tube

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

silver sulfadiazine, Quantity: 10 mg/g

Available from:

Smith & Nephew Pty Ltd

INN (International Name):

Silver sulfadiazine

Pharmaceutical form:

Cream

Composition:

Excipient Ingredients: polysorbate 60; polysorbate 80; cetyl alcohol; propylene glycol; liquid paraffin; purified water; glyceryl monostearate

Administration route:

Topical

Units in package:

50 g, 20 g, 80 g

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

FLAMAZINE cream is indicated for the prevention of infection in severe burns. Other types of wounds, such as pressure sores and leg ulcers, may also benefit from the application of FLAMAZINE cream.

Product summary:

Visual Identification: White to off-white cream; Container Type: Tube; Container Material: LDPE; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2010-06-11

Patient Information leaflet

FLAMAZINE Cream
1
FLAMAZINE™ Cream
_ _
_silver sulfadiazine _
_ _
Consumer Medicine Information
What is in this leaflet ?
This leaflet answers some
common questions about
FLAMAZINE. It does not
contain all of the available
information.
It does not take the place of
talking to your doctor (or
pharmacist).
All medicines have risks and
benefits. Your doctor _or _
_pharmacist _has weighed the
risks of you using FLAMAZINE
against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS
ABOUT THIS MEDICINE, ASK
YOUR DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE. You may need to
read it again.
What FLAMAZINE is
used for
FLAMAZINE is a topical
antibacterial cream with an
active ingredient which
belongs to the group of
antibiotic medicines called
sulfonamides.
FLAMAZINE is used to
prevent infection in severe
burns. Other types of
wounds, such as pressure
sores and leg ulcers, may
also benefit from the
application of FLAMAZINE
cream.
• It is soothing when applied
and has proven activity
against a broad range of
organisms including both
Gram-positive and Gram-
negative bacteria and some
viruses and fungi.
Your doctor may have
prescribed FLAMAZINE for
another reason.
ASK YOUR DOCTOR IF YOU HAVE
ANY QUESTIONS ABOUT WHY
FLAMAZINE HAS BEEN
PRESCRIBED FOR YOU.
This medicine is available
only with a doctor’s
prescription (except for
Pharmacy-Only 50g tube in
NZ).
Before you use
FLAMAZINE
_ _
_WHEN YOU MUST NOT USE IT_
DO NOT USE FLAMAZINE IF:
YOU HAVE AN ALLERGY TO:
• FLAMAZINE or any
medicine within the
Sulfonamide group or any of
the ingredients in FLAMAZINE
listed at the end of this
leaflet.
ASK YOUR DOCTOR _OR _
_PHARMACIST _IF YOU ARE NOT
SURE.
DO NOT GIVE FLAMAZINE to
premature infants or
newborn infants in the first
months of life. Sulfonamides
may cause a life-threatening
condition known as
“_kernicterus_” (jaundice of
the brain) in babies during
the first months of life by
interfering with normal
metabolism.
_ _
_Tampering and expiry date _
_warnings: _
DO NOT USE FLAMAZINE IF THE

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION – FLAMAZINE
◊ (SILVER SULFADIAZINE
1.0% W/W) CREAM
1
NAME OF THE MEDICINE
Silver sulfadiazine
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
COMPOSITION: _Active ingredient_. Silver sulfadiazine 1.0% w/w.
_Excipients. _Polysorbate 60 Ph. Eur,
Polysorbate 80 Ph. Eur, Glyceryl Monostearate Ph. Eur, Cetyl Alcohol
Ph. Eur, Liquid Paraffin Ph. Eur,
Propylene Glycol Ph. Eur and Purified Water Ph. Eur.
DESCRIPTION: A sterile white hydrophilic cream containing silver
sulfadiazine 1%. The cream is a
semisolid oil-in-water emulsion. The silver sulfadiazine is in a fine
micronised form.
3
PHARMACEUTICAL FORM
Cream. White to off-white.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
FLAMAZINE cream is indicated for the prevention of infection in severe
burns. Other types of
wounds, such as pressure sores and leg ulcers, may also benefit from
the application of FLAMAZINE
cream.
4.2
D
OSE AND METHOD OF ADMINISTRATION
METHOD OF ADMINISTRATION:
To be applied topically.
BURNS: The burn wound should be cleaned and FLAMAZINE cream applied
over all the affected areas
to a depth of 3-5 mm.
This application is best achieved with a sterile gloved hand and/or
sterile spatula.
Where necessary, the cream should be re-applied to any area from which
it has been removed by
patient activity.
In burns, FLAMAZINE cream should be re-applied at least every 24
hours, or more frequently if the
volume of exudate is large.
HAND BURNS: FLAMAZINE cream can be applied to the burn and the whole
hand enclosed in a clear
plastic bag or glove which is then closed at the wrist. The patient
should be encouraged to move the
hand and fingers. The dressing should be changed when an excessive
amount of exudate has
accumulated in the bag.
2
LEG ULCERS/PRESSURE SORES: The cavity of the ulcer should be filled
with FLAMAZINE cream to a depth
of at least 3-5mm. As FLAMAZINE cream can cause maceration of normal
skin on prolonged contact,
care should be taken to prevent spread onto non-ulcerated areas.
Application of FLAMAZINE cream