STIEVA-A 0.05% 0.5mg/g cream tube

Negara: Australia

Bahasa: Inggris

Sumber: Department of Health (Therapeutic Goods Administration)

Bahan aktif:

tretinoin, Quantity: 0.5 mg/g

Tersedia dari:

GlaxoSmithKline Australia Pty Ltd

INN (Nama Internasional):

Tretinoin

Bentuk farmasi:

Cream

Komposisi:

Excipient Ingredients: propylene glycol; purified water; PEG-40 stearate; white soft paraffin; propyl hydroxybenzoate; disodium edetate; stearyl alcohol; stearic acid; methyl hydroxybenzoate; butylated hydroxytoluene; isopropyl palmitate; butylated hydroxyanisole

Rute administrasi :

Topical

Unit dalam paket:

25g

Jenis Resep:

(S4) Prescription Only Medicine

Indikasi Terapi:

Indicated for use in the treatment of acne vulgaris, in particular forms where comedones, papules and pustules predominate.

Ringkasan produk:

Visual Identification: Smooth homogeneous white to light yellow cream. Free from contamination; Container Type: Tube; Container Material: Al; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius

Status otorisasi:

Registered

Tanggal Otorisasi:

1992-05-15

Selebaran informasi

STIEVA-A CREAM
_[Tretinoin 0.025% w/w, 0.05% w/w,0.1% w/w]_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET?
Please read this leaflet carefully
before you use STIEVA-A Cream.
This leaflet answers some common
questions about STIEVA-A. 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 has weighed
the expected benefits of you using
STIEVA-A Cream against the risks
this medicine could have for you.
IF YOU HAVE ANY CONCERNS ABOUT
USING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT IS STIEVA-A
CREAM USED FOR?
STIEVA-A Cream is used to treat
acne (spots).
STIEVA-A belongs to a group of
medicines called retinoids.
STIEVA-A Cream helps to:
•
Make your skin less oily
•
Loosen blackheads and
whiteheads so that they come out
more easily
•
Stop new blackheads, whiteheads
and spots from forming
•
Lowers the number of red,
inflamed acne spots.
STIEVA-A Cream is for use by
adults and adolescents with acne.
IT IS NOT FOR USE BY CHILDREN.
Your doctor may have prescribed
STIEVA-A Cream for another
reason.
STIEVA-A Cream is not addictive.
BEFORE YOU USE
STIEVA-A CREAM
_DO NOT USE IF:_
You must not use STIEVA-A Cream
if:
•
you are pregnant
•
you are planning a pregnancy
•
you have ever had an allergic
reaction to tretinoin or any of the
ingredients listed toward the end
of this leaflet. (See "Ingredients")
•
IF YOU OR ANY OF YOUR CLOSE
FAMILY HAVE HAD SKIN CANCER
•
IF YOU ARE BREAST-FEEDING
•
THE EXPIRY DATE (EXP) PRINTED
ON THE PACK HAS PASSED
•
THE PACKAGING IS TORN OR SHOWS
SIGNS OF TAMPERING
_TELL YOUR DOCTOR IF:_
You must tell your doctor if:
•
YOU ARE ALLERGIC TO FOODS, DYES,
PRESERVATIVES OR ANY OTHER
MEDICINES.
•
YOU ARE USING ANY OTHER
MEDICINES FOR ACNE.
You may need to use the two
products at different times of the
day (eg. one in the morning and
the other at bedtime).
•
YOU ARE TAKING ANY OTHER
M

Karakteristik produk

1
AUSTRALIAN PRODUCT INFORMATION
STIEVA-A (TRETINOIN) CREAM
1
NAME OF THE MEDICINE
Tretinoin
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
STIEVA-A Creams 0.025%, 0.05% and 0.1% contain the active ingredient
Tretinoin USP at
a concentration of 0.25 mg/g, 0.5 mg/g and 1.0 mg/g.
Excipients with known effect
Contains methyl hydroxybenzoate and propyl hydroxybenzoate
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Cream
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
STIEVA-A is indicated for use in the treatment of acne vulgaris, in
particular forms where
comedones, papules and pustules predominate. STIEVA-A is not generally
effective in most
cases of severe pustular or nodulocystic acne.
4.2
DOSE AND METHOD OF ADMINISTRATION
ADULTS AND ADOLESCENTS
STIEVA-A is for topical use only.
STIEVA-A should be applied once daily before retiring - to the whole
area under treatment.
The skin should be thoroughly cleansed and dried before application of
STIEVA-A.
Therapeutic effects may not be seen until 6-8 weeks after the start of
treatment. Treatment
should normally be continued for three months.
Patients being treated with STIEVA-A may continue to use cosmetics.
Patients should be advised that excessive application will not improve
efficacy, but may
increase the risk of skin irritation.
If undue irritation (redness, peeling or discomfort) occurs, patients
may use a non-
comedogenic moisturiser as needed and should reduce frequency of
application or
temporarily interrupt treatment. The normal frequency of application
should be resumed
once the irritation subsides. Treatment should be discontinued if the
irritation persists.
2
Formulation strength should be selected and adjusted according to the
patient’s tolerance.
4.3
CONTRAINDICATIONS
-
Pregnancy
-
Women planning a pregnancy
Patients with known hypersensitivity to any of the ingredients should
not use STIEVA-A.
Tretinoin preparations have been reported to cause severe irritation
of eczematous skin and
should only be used with the