ESTALIS SEQUI 50/250 patches sachet composite pack

国家: 澳大利亚

语言: 英文

来源: Department of Health (Therapeutic Goods Administration)

有效成分:

norethisterone acetate, Quantity: 4.8 mg (Equivalent: estradiol hemihydrate, Qty 0.806 mg; Equivalent: norethisterone acetate, Qty 250 microgram/24 h); estradiol, Quantity: 0.512 mg (Equivalent: estradiol, Qty 50 microgram/24 h; Equivalent: estradiol hemihydrate, Qty 0.529 mg)

可用日期:

Sandoz Pty Ltd

药物剂型:

Drug delivery system, transdermal

组成:

Excipient Ingredients: oleic acid; povidone; dipropylene glycol; polytrimethylhydrosilylsiloxane; xylene; ammonia; toluene; 1,1,1-trimethyl-N-(trimethylsilyl)silanamine; dimeticonol; polyethylene terephthalate; polyvinylidene flouride; ethyl acetate; ethanol; acrylates/VA copolymer; ethylene/vinyl acetate copolymer

给药途径:

Transdermal

每包单位数:

4 patches Estalis oestradiol 50mcg/day (Week 1&2), 4 patches Estalis Sequi 50/250 (Week 3 & 4)

处方类型:

(S4) Prescription Only Medicine

疗效迹象:

For the short-term treatment of symptoms of oestrogen deficiency in menopausal women who have an intact uterus. Combination HRT should not be used in hysterectomised women because it is not needed in these women and it may increase the risk of breast cancer.

產品總結:

Visual Identification: An off-white translucent patch with a removable pre-cut liner: 16cm2 round patch.; Container Type: Sachet; Container Material: Al laminated with LDPE/paper; Container Life Time: 2 Years; Container Temperature: Store at 2 to 8 degrees Celsius

授权状态:

Registered

授权日期:

2020-10-17

资料单张

ESTALIS
® SEQUI
_estradiol / norethisterone acetate (NETA)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about the menopause (the
"change of life"), hormone
replacement therapy and Estalis
Sequi.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
The information in this leaflet was
last updated on the date listed on the
final page. More recent information
on the medicine may be available.
YOU SHOULD ENSURE THAT YOU SPEAK
TO YOUR PHARMACIST OR DOCTOR TO
OBTAIN THE MOST UP TO DATE
INFORMATION ON THE MEDICINE. YOU
CAN ALSO DOWNLOAD THE MOST UP TO
DATE LEAFLET FROM
WWW.NOVARTIS.COM.AU.
Those updates may contain important
information about the medicine and
its use of which you should be aware.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using this medicine
against the benefits they expect it
will provide.
IF YOU HAVE ANY CONCERNS ABOUT THIS
MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHEN YOU MUST NOT
USE ESTALIS SEQUI
DO NOT USE ESTALIS SEQUI OR OTHER
ESTROGENS, WITH OR WITHOUT A
PROGESTOGEN TO PREVENT HEART
ATTACKS, STROKE OR DEMENTIA.
A study called the Women's Health
Initiative indicated increased risk of
heart attack, stroke, breast cancer,
and blood clots in the legs or lungs in
women receiving treatment with a
product containing conjugated
estrogens 0.625 mg and the
progestogen medroxyprogesterone
acetate (MPA). The researchers
stopped the study after 5 years when
it was determined the risks were
greater than the benefits in this
group. The Women's Health
Initiative Memory Study indicated
increased risk of dementia in women
aged 65-79 years taking conjugated
estrogens and MPA. There are no
comparable data currently available
for other doses of conjugated
estrogens and MPA or other
combinations of estrogens and
progestogens. Therefore, you should
assume the risks will be similar for
other medic

产品特点

1
AUSTRALIAN PRODUCT INFORMATION
ESTALIS® SEQUI
Transdermal Matrix Patch combination pack
WARNING
Estrogens and progestogens should not be used for the prevention of
cardiovascular disease or
dementia.
The Women’s Health Initiative (WHI) study reported increased risks
of myocardial infarction, stroke,
invasive breast cancer, pulmonary emboli, and deep vein thrombosis in
postmenopausal women (50 to
79 years of age) during 5 years of treatment with conjugated estrogens
(0.625 mg) combined with
medroxyprogesterone acetate (2.5 mg) relative to placebo (See Section
5.1 PHARMACODYNAMIC
PROPERTIES Clinical Trials and Section 4.4 SPECIAL WARNINGS AND
PRECAUTIONS FOR
USE).
The WHI study reported increased risks of stroke and deep vein
thrombosis in postmenopausal
women (50 to 79 years of age) during 6.8 years of treatment with
conjugated estrogens (0.625 mg)
relative to placebo (See Section 5.1 PHARMACODYNAMIC PROPERTIES
Clinical Trials and
Section 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE).
The Women’s Health Initiative Memory Study (WHIMS), a substudy of
WHI, reported increased risk
of developing probable dementia in postmenopausal women 65 years of
age or older during 4 to 5.2
years of treatment with conjugated estrogens, with or without
medroxyprogesterone acetate, relative
to placebo. It is unknown whether this finding applies to younger
postmenopausal women (See
Section 5.1 PHARMACODYNAMIC PROPERTIES Clinical Trials and Section 4.4
SPECIAL
WARNINGS AND PRECAUTIONS FOR USE).
Other doses of conjugated estrogens and medroxyprogesterone acetate,
and other combinations and
dosage forms of estrogens and progestogens were not studied in the WHI
clinical trials and, in the
absence of comparable data, these risks should be assumed to be
similar. Because of these risks,
estrogens with or without progestogens should be prescribed at the
lowest effective doses and for the
shortest duration consistent with treatment goals and risks for the
individual woman.
1
NAME OF THE MEDICINE
Estalis Sequi Week 1 and 2 (estradiol)
Es