Utrogestan

Страна: Новая Зеландия

Язык: английский

Источник: Medsafe (Medicines Safety Authority)

Активный ингредиент:

Progesterone 100mg;  ; Progesterone 100mg; Progesterone 100mg; Progesterone 100mg

Доступна с:

Pharmaco (NZ) Ltd

ИНН (Международная Имя):

Progesterone 100 mg

дозировка:

100 mg

Фармацевтическая форма:

Capsule

состав:

Active: Progesterone 100mg   Excipient: Arachis oil Gelatin Glycerol Soya oil Titanium dioxide Active: Progesterone 100mg Excipient: Gelatin Glycerol Purified water Soya oil Sunflower oil Titanium dioxide Active: Progesterone 100mg Excipient: Gelatin Glycerol Purified water Soya oil Sunflower oil Titanium dioxide Active: Progesterone 100mg Excipient: Gelatin Glycerol Purified water Soya oil Sunflower oil Titanium dioxide

Штук в упаковке:

Blister pack, 30 capsules

класс:

Prescription

Тип рецепта:

Prescription

Производитель:

Changzhou Jiaerke Pharmaceuticals Group Corp Ltd

Терапевтические показания :

Adjunctive use with an oestrogen in postmenopausal women with an intact uterus (for hormone replacement therapy [HRT]).

Обзор продуктов:

Package - Contents - Shelf Life: Blister pack, PVC/Aluminium or PVC/PVdC/Aluminium - 15 capsules - 36 months from date of manufacture stored at or below 30°C. Do not refrigerate. - Blister pack, PVC/Aluminium or PVC/PVdC/Aluminium - 30 capsules - 36 months from date of manufacture stored at or below 30°C. Do not refrigerate.

Дата Авторизация:

2008-08-20

тонкая брошюра

Utrogestan 100mg, soft capsule
1
UTROGESTAN
_Progesterone 100mg, soft capsule _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Utrogestan 100mg
soft capsules. 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 Utrogestan
100mg soft capsules against the
benefits it is expected to have for
you.
IF YOU HAVE ANY CONCERNS ABOUT
USING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST. KEEP THIS
LEAFLET WITH YOUR MEDICINE.
You may need to read it again.
WHAT UTROGESTAN
100MG SOFT CAPSULES
ARE USED FOR
This medicine is provided as a soft
capsule that contains the natural
female hormone, progesterone, for
oral use.
Utrogestan 100mg soft capsules
are for women for the treatment of:
as hormone replacement therapy
(HRT) in combination with
oestrogen in postmenopausal
women with an intact uterus
(womb)
Your doctor may have prescribed
Utrogestan 100mg soft capsules for
another purpose. Ask your doctor if
you have any questions about why
this medicine has been prescribed
for you.
Utrogestan 100mg soft capsules
are available only with a doctor’s
prescription.
This medicine is not addictive.
This medicine is not a
contraceptive.
BEFORE YOU USE
UTROGESTAN 100MG SOFT
CAPSULES
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE UTROGESTAN 100MG
SOFT CAPSULES IF YOU HAVE AN
ALLERGY TO:

ANY MEDICINE CONTAINING
PROGESTERONE

ANY OF THE INGREDIENTS LISTED
AT THE END OF THIS LEAFLET.
Symptoms of an allergic reaction
may include:

skin rash, itching or hives

swelling of the face, lips,
tongue or other parts of the
body

shortness of breath, wheezing
or difficulty breathing
DO NOT TAKE UTROGESTAN 100MG
SOFT CAPSULES IF YOU HAVE OR HAVE
HAD ANY OF THE FOLLOWING
CONDITIONS:

unusual vaginal bleeding that
has not been evaluated by
your doctor

severe liver problems

known or suspected cancer of
the breast or genital tract
�

Характеристики продукта

NEW ZEALAND DATA SHEET
UTROGESTAN 100mg caps UTROGEST005
Jan 2018
Page 1 of 9
UTROGESTAN 100MG CAPSULES
Progesterone
1 PRODUCT NAME
UTROGESTAN 100MG CAPSULES
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Soft, round, slightly yellow capsule containing a whitish oily
suspension of 100 mg progesterone
(micronised).
Excipient(s) with known effect: Soya lecithin
For full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Capsules, soft
4 CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
UTROGESTAN 100 mg capsule is indicated in adults, _via_ the oral
route, for:
_HORMONE REPLACEMENT THERAPY _
•
Adjunctive use with an oestrogen in postmenopausal women with an
intact uterus (for hormone
replacement therapy [HRT])
4.2
DOSE AND METHOD OF ADMINISTRATION
_DOSAGE _
The recommended dose is as follows, according to the indication:
_ _
_ORAL ROUTE _
•
_IN THE TREATMENT OF MENOPAUSE: _ oestrogen alone therapy is not
recommended on its own in
menopausal women with an intact uterus. The usual dose is 200 mg/day
at bedtime at least 12
to 14 days per month, i.e. on days 15 to 26 of each cycle or in the
last 2 weeks of each treatment
sequence of oestrogen therapyfollowed by approximately one week
without any replacement
therapy and during which withdrawal bleeding may occur.
Alternatively 100 mg can be given at bedtime, from days 1 to 25 of
each cycle, withdrawal
bleeding being less with this treatment schedule.
_METHOD OF ADMINISTRATION _
This product is intended only for oral use.
UTROGESTAN 100 mg should not be taken with food; it is preferable to
take the capsules in the
evening at bedtime.
NEW ZEALAND DATA SHEET
UTROGESTAN 100mg caps UTROGEST005
Jan 2018
Page 2 of 9
_ORAL ROUTE _
Each capsule of UTROGESTAN 100 mg must be swallowed with a little
water.
_ _
_PAEDIATRIC USE _
There is no relevant use of UTROGESTAN 100 mg in the paediatric
population in the indications listed
above.
_USE IN THE ELDERLY _
There is no relevant use of UTROGESTAN 100 mg in the elderly
population in the indications listed
above.
_ _
4.3
CONTRAIND