资料单张
_Solaraze 3% Consumer Medicine Information _
SOLARAZE
3% GEL
_DICLOFENAC SODIUM _
_ _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about Solaraze.
It does not contain all 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 risk of you using
Solaraze
against the benefit it is expected to have for you.
IF YOU HAVE ANY CONCERNS
ABOUT USING THIS MEDICINE, TALK TO YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE. You may want to
read it again.
WHAT SOLARAZE IS USED FOR
The name of your medicine is Solaraze. It contains the active
ingredient diclofenac
sodium. Diclofenac sodium belongs to a group called
non-steroidal anti-inflammatory
drugs (NSAIDs).
Solaraze is used to manage the skin condition known
as actinic or solar keratosis.
BEFORE YOU USE SOLARAZE
_WHEN YOU MUST NOT USE IT _
DO NOT USE SOLARAZE IF:
• You are allergic to diclofenac sodium or any of the
inactive ingredients listed
at the end of this leaflet.
• You are allergic to Aspirin
or any other NSAID medicine. Symptoms of an
allergic reaction to these medicines may include: asthma, wheezing or
shortness of breath, swelling of the face, lips or tongue, hives, itching
or skin
rash, fainting.
• You are in the last trimester of pregnancy.
• The tamper seal is broken.
• The expiry date printed on the carton is passed.
IF YOU ARE NOT SURE WHETHER YOU SHOULD START USING
SOLARAZE, CONTACT YOUR
DOCTOR.
1
_Solaraze 3% Consumer Medicine Information _
_BEFORE YOU START TO USE IT _
TELL YOUR DOCTOR OR PHARMACIST IF:
•
You have any allergies to any other
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产品特点
SOLARAZE
3% GEL
(DICLOFENAC SODIUM)
NAME OF THE MEDICINE
Solaraze (diclofenac sodium) Gel 3% contains the active
ingredient, diclofenac sodium, in a
clear, transparent, colourless to slightly yellow gel base.
The chemical name for diclofenac sodium is: Sodium [o-(2,6-dichloranilino)phenyl]acetate
Molecular weight: 318.13
CAS number: CAS-15307-79-6
DESCRIPTION
Diclofenac sodium is a white to slightly yellow
crystalline powder. It is freely soluble in
methanol, soluble in ethanol, sparingly soluble in acetone, and
partially insoluble in ether.
_Active. _Diclofenac sodium
_Inactive. _Sodium hyaluronate, benzyl alcohol, polyethylene glycol monomethyl ether (350)
and purified water.
PHARMACOLOGY
Diclofenac is a non-steroidal anti-inflammatory drug. The
mechanism of action of diclofenac
in actinic keratoses is not known but may be related to the inhibition of the cycloxygenase
pathway leading to reduced prostaglandin E
2
(PGE
2
) synthesis. Efficacy of the treatment
has only been demonstrated in placebo-controlled studies. Comparative studies with topical
5-fluorouracil have
not been conducted. The long term beneficial effects of Solaraze has not
been proven.
PHARMACOKINETICS
Absorption:
When Solaraze is applied topically, diclofenac is absorbed into
the epidermis. In a study in
patients with compromised skin
(mainly atopic dermatitis and other dermatitic conditions) of
the hands, arms or face, approximately 10% of the applied dose (2 grams of 3% gel over
100 cm
2
) of diclofenac was absorbed systemically in both normal and
compromised
epidermis after seven days, with four times daily applications.
After topical application of 2 g Solaraze three
times daily for six days to the calf of the leg in
healthy subjects, diclofenac could be detected in
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