Oratane

Country: New Zealand

Bahasa: Inggeris

Sumber: Medsafe (Medicines Safety Authority)

Bahan aktif:

Isotretinoin 20mg;  ;  

Boleh didapati daripada:

Douglas Pharmaceuticals Limited

INN (Nama Antarabangsa):

Isotretinoin 20 mg

Dos:

20 mg

Borang farmaseutikal:

Soft gelatin capsule

Komposisi:

Active: Isotretinoin 20mg     Excipient: Butylated hydroxyanisole Disodium edetate dihydrate dl-Alpha tocopherol Gelatin Glycerol Hydrogenated vegetable oil Indigo carmine Ponceau 4R Purified water Sorbitol Soya oil Titanium dioxide Yellow beeswax

Unit dalam pakej:

Blister pack, PVC/PVDC/alumin,starter pack,, 15 capsules

Kelas:

Prescription

Jenis preskripsi:

Prescription

Dikeluarkan oleh:

Chongqing Huapont Shengchem Pharmaceutical Co Ltd

Tanda-tanda terapeutik:

Severe forms of nodulo-cystic acne which are resistant to therapy, particularly cystic acne and acne conglobata, especially when the lesions involve the trunk. ORATANE should only be prescribed by physicians who are experienced in the use of systemic retinoids, preferably dermatologists, and understand the risk of teratogenicity if ORATANE is used during pregnancy.

Ringkasan produk:

Package - Contents - Shelf Life: Blister pack, PVC/PVDC/alumin,starter pack, - 15 capsules - 36 months from date of manufacture stored at or below 30°C - Blister pack, PVC/PVDC/alumin., - 60 capsules - 36 months from date of manufacture stored at or below 30°C - Blister pack, PVC/PVDC/alumin., - 90 capsules - 36 months from date of manufacture stored at or below 30°C - Blister pack, PVC/PVDC/alumin., - 120 capsules - 36 months from date of manufacture stored at or below 30°C - Blister pack, PVC/PVDC/alumin., - 180 capsules - 36 months from date of manufacture stored at or below 30°C

Tarikh kebenaran:

1998-01-12

Risalah maklumat

CONSUMER MEDICINE INFORMATION
Page 1 of 6
ORATANE*
_Isotretinoin _
5 mg, 10 mg, 20 mg, 30 mg and 40 mg Capsules
WHAT IS IN THIS LEAFLET
PLEASE READ THIS LEAFLET CAREFULLY BEFORE YOU START
TAKING ORATANE.
This
leaflet
answers
some
common
questions
about ORATANE. 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 taking ORATANE
against the benefits they expect it will have for
you.
IF
YOU
HAVE
ANY
CONCERNS
ABOUT
TAKING
THIS
MEDICINE, ASK YOUR DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE. YOU MAY
NEED TO READ IT AGAIN.
WHAT ORATANE IS USED FOR
The
active
ingredient
in
ORATANE
capsules
is
isotretinoin, a substance very similar to vitamin A.
ORATANE belongs to a group of medicines called
retinoids.
ORATANE capsules are used to treat acne. Of the
many acne medicines, ORATANE is used for more
severe cases.
ORATANE
capsules
work
by
cutting
down
the
amount of oily substances (sebum) made by your
glands in your skin. ORATANE capsules will also
help to reduce the bacteria, inflammation and
open clogged pores.
Your doctor may have prescribed ORATANE for
another reason.
ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT
WHY ORATANE HAS BEEN PRESCRIBED FOR YOU.
This medicine is available only with a doctor's
prescription.
ORATANE capsules are not addictive.
BEFORE YOU TAKE ORATANE
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE ORATANE IF YOU ARE PREGNANT OR FOR
AT LEAST ONE MONTH BEFORE YOU INTEND TO BECOME
PREGNANT.
If
you
fall
pregnant
while
taking
ORATANE capsules, there is an extremely high risk
of having a baby that is severely deformed.
PREGNANCY TESTING SHOULD BE PERFORMED BEFORE,
DURING (EVERY MONTH IS STRONGLY RECOMMENDED)
AND FOR A MONTH AFTER TREATMENT HAS FINISHED.
YOU
MUST
USE
EFFECTIVE
CONTRACEPTION
(BIRTH
CONTROL) FOR ONE MONTH BEFORE, DURING AND AT LEAST
ONE MONTH AFTER TREATMENT WITH ORATANE.
It is recommended that two complementary forms
of
contraception
inclu

Ciri produk

1 | P a g e
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
ORATANE* 5 mg soft gelatin capsule
ORATANE* 10 mg soft gelatin capsule
ORATANE* 20 mg soft gelatin capsule
ORATANE* 30 mg soft gelatin capsule
ORATANE* 40 mg soft gelatin capsule
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ORATANE 5 mg soft gelatin capsule contains 5 mg of isotretinoin.
Each ORATANE 10 mg soft gelatin capsule contains 10 mg of
isotretinoin.
Each ORATANE 20 mg soft gelatin capsule contains 20 mg of
isotretinoin.
Each ORATANE 30 mg soft gelatin capsule contains 30 mg of
isotretinoin.
Each ORATANE 40 mg soft gelatin capsule contains 40 mg of
isotretinoin.
EXCIPIENT(S) WITH KNOWN EFFECT
ORATANE soft gelatin capsules contain soyabean products. Sulfur
dioxide is present as a residue
in gelatin.
For the full list of excipients, _see Section 6.1._
3.
PHARMACEUTICAL FORM
ORATANE 5 mg capsules: Soft gelatin oval opaque white capsules,
approximately 8 mm in length
and 5 mm in diameter.
ORATANE 10 mg capsules: Soft gelatin oval opaque violet capsules,
approximately 10 mm in
length and 7 mm in diameter.
ORATANE 20 mg capsules: Soft gelatin oval opaque maroon capsules,
approximately 13 mm in
length and 8 mm in diameter.
ORATANE 30 mg capsules: Soft gelatin oval opaque pink capsules,
approximately 12 mm length
and 8 mm in diameter.
ORATANE 40 mg capsules: Soft gelatin oval opaque light orange
capsules, approximately 13 mm
length and 8 mm in diameter.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Severe forms of nodulo-cystic acne which are resistant to therapy,
particularly cystic acne and
acne conglobata, especially when the lesions involve the trunk.
2 | P a g e
ORATANE should only be prescribed by physicians who are experienced in
the use of systemic
retinoids, preferably dermatologists, and understand the risk of
teratogenicity if ORATANE is
used during pregnancy.
4.2.
DOSE AND METHOD OF ADMINISTRATION
DOSE
The therapeutic response to isotretinoin and some of the adverse
effects are dose-related and
vary between patients. This necessitates adapt