DIANE-35 ED tablet blister pack

国家: 澳大利亚

语言: 英文

来源: Department of Health (Therapeutic Goods Administration)

有效成分:

cyproterone acetate, Quantity: 2 mg; ethinylestradiol, Quantity: 35 microgram

可用日期:

Bayer Australia Ltd

药物剂型:

Tablet, sugar coated

组成:

Excipient Ingredients: povidone; calcium carbonate; maize starch; sucrose; lactose monohydrate; macrogol 6000; purified talc; magnesium stearate; glycol montanate

给药途径:

Oral

每包单位数:

1 x 28 tablets (1 x 21 beige, 1 x 7 white), 3 x 28 tablets (3 x 21 beige, 3 x 7 white)

处方类型:

(S4) Prescription Only Medicine

疗效迹象:

Diane-35 ED is indicated for: The treatment of signs of androgenisation in women, such as severe acne (involving inflammation or nodularity or risk of scarring) where prolonged oral antibiotics or local treatment alone has not been successful, or idiopathic hirsutism of mild to moderate degree. Diane-35 will also provide effective oral contraception in this patient group. It should not be used in combination with other hormonal contraceptives (see CONTRAINDICATIONS).,If the hirsutism has only recently appeared or has lately intensified to a considerable extent the cause (androgen-producing tumour or an adrenal-enzyme defect) must be clarified by differential diagnosis.

產品總結:

Visual Identification: White, round tablets.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

授权状态:

Registered

授权日期:

1992-07-22

资料单张

DIANE®-35 ED CMI VX1.0
1
RESTRICTED
DIANE® -35 ED
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING DIANE®-35 ED?
DIANE®-35 ED contains the active ingredient cyproterone acetate and
ethinylestradiol.
DIANE®-35 ED is used for treatment of signs of androgenization in
women.
For more information, see Section 1. Why am I using DIANE®-35 ED?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE DIANE®-35 ED?
Do not use if you have ever had an allergic reaction to Diane or any
of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any
other medicines, or are pregnant or plan to become
pregnant or if breastfeeding.
For more information, see Section 2. What should I know before I use
DIANE®-35 ED?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with DIANE®-35 ED and affect how it
works.
A list of these medicines is in Section 3. What if I am taking other
medicines?
in the full CMI.
4.
HOW DO I USE DIANE®-35 ED?
Take one tablet daily at about the same time every day. TAKE YOUR
FIRST TABLET FROM THE RED AREA ON THE BLISTER PACK
CORRESPONDING TO THE DAY OF THE WEEK. FOLLOW THE DIRECTION OF THE
ARROWS ON THE BLISTER PACK UNTIL ALL THE TABLETS HAVE BEEN
TAKEN. FOLLOW THE INSTRUCTIONS PROVIDED AND USE DIANE®-35 ED UNTIL
YOUR DOCTOR TELLS YOU TO STOP
More instructions can be found in Section 4. How do I use DIANE®-35
ED?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING DIANE®-35 ED?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit and if you are
going to have surgery, tell the
surgeon or anesthetist beforehand that you are using DIANE®-35 ED
•
IF YOU ARE ABOUT TO HAVE ANY BLOOD TESTS, TELL YOUR DOCTOR THAT YOU
ARE TAKING THIS MEDICINE.
•
STOP TAKING DIANE-35 ED AND SEE YOUR DOCTOR IMMEDIATELY OR GO TO THE
EMERGENCY DEPARTMENT AT
YOUR NEAREST HOSPI

产品特点

210122 Diane-35 ED PI
1
Australian Product Information
DIANE
®
-35 ED (CYPROTERONE ACETATE / ETHINYLESTRADIOL) TABLETS
1
NAME OF THE MEDICINE
Cyproterone acetate and ethinylestradiol
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
DIANE-35
ED
contains
the
synthetic
progestogen,
cyproterone
acetate
and
the
synthetic
estrogen, ethinylestradiol.
Each beige active tablet contains cyproterone acetate 2 mg and
ethinylestradiol 35 µg.
EXCIPIENTS WITH KNOWN EFFECT:
Lactose monohydrate.
_For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS _
3
PHARMACEUTICAL FORM
Tablet, sugar coated
DIANE-35 ED tablets are available in blister packs of 28 tablets. Each
blister contains 21 round
beige active tablets followed by 7 round white placebo tablets.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
DIANE 35 ED is indicated for:
•
The
treatment
of
signs
of
androgenisation
in
women,
such
as
severe
acne
(involving
inflammation or nodularity or risk of scarring) where prolonged oral
antibiotics or local treatment
alone has not been successful, or idiopathic hirsutism of mild to
moderate degree.
•
DIANE-35 ED will also provide effective oral contraception in this
patient group. It should
not be used in combination with other hormonal contraceptives (see
SECTION 4.3
CONTRAINDICATIONS).
If the hirsutism has only recently appeared or has lately intensified
to a considerable extent the
cause
(androgen-producing
tumour
or
an
adrenal-enzyme
defect)
must
be
clarified
by
differential diagnosis.
4.2
D
OSE AND METHOD OF ADMINISTRATION
Combined oral contraceptives, when taken correctly have a failure rate
of approximately 1% per
year.
210122 Diane-35 ED PI
2
DIANE-35 ED is to be taken regularly in order to achieve therapeutic
efficacy and the required
contraceptive protection. Previously used hormonal contraception
should be discontinued. The
dose regimen of DIANE-35 ED is similar to the usual regimen of most of
the COCs. Thus, the
same administration rules must be considered. The irregular intake of
DIANE-35 ED can lead to
int