Utrogestan

Страна: Новая Зеландия

Язык: английский

Источник: Medsafe (Medicines Safety Authority)

Активный ингредиент:

Progesterone 200mg;  ; Progesterone 200mg; Progesterone 200mg

Доступна с:

Pharmaco (NZ) Ltd

ИНН (Международная Имя):

Progesterone 200 mg

дозировка:

200 mg

Фармацевтическая форма:

Capsule

состав:

Active: Progesterone 200mg   Excipient: Gelatin Glycerol Purified water Soya oil Sunflower oil Titanium dioxide Active: Progesterone 200mg Excipient: Gelatin Glycerol Purified water Soya oil Sunflower oil Titanium dioxide Active: Progesterone 200mg Excipient: Gelatin Glycerol Purified water Soya oil Sunflower oil Titanium dioxide

Тип рецепта:

Prescription

Производитель:

Changzhou Jiaerke Pharmaceuticals Group Corp Ltd

Терапевтические показания :

Oral Route: Hormone replacement therapy - Adjunctive use with an oestrogen in postmenopausal women with an intact uterus (for hormone replacement therapy [HRT]). Vaginal Route: Luteal phase support - Supplementation of the luteal phase during Assisted Reproductive Technology (ART) cycles.

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 - 42 capsules - 36 months from date of manufacture stored at or below 30°C. Do not refrigerate.

Дата Авторизация:

2015-02-16

тонкая брошюра

UTROGESTAN 200 CMI
1
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
1.
WHY AM I USING UTROGESTAN ?
2.
WHAT SHOULD I KNOW BEFORE I USE UTROGESTAN?
3.
WHAT IF I AM TAKING OTHER MEDICINES?
4.
HOW DO I USE UTROGESTAN?
5.
WHAT SHOULD I KNOW WHILE USING UTROGESTAN?
6.
ARE THERE ANY SIDE EFFECTS?
UTROGESTAN 200®
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
UTROGESTAN contains the active ingredient progesterone. UTROGESTAN is
used for women who need extra progesterone
while undergoing fertility treatment (e.g. ART).
For more information, see Section 1. Why am I using UTROGESTAN? in the
full CMI.
Do not use if you have ever had an allergic reaction to UTROGESTAN or
any of the ingredients listed at the end of the CMI. Do
not use if you are breast-feeding.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS OR ARE
TAKING ANY OTHER MEDICINES.
For more information, see Section 2. What should I know before I use
UTROGESTAN? in the full CMI.
Some medicines may interfere with UTROGESTAN 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.
•
UTROGESTAN should be used as instructed by your doctor at the
recommended dose and timeframes for each use.
UTROGESTAN is intended to be inserted into the vagina.
More instructions can be found in Section 4. How do I use UTROGESTAN?
in the full CMI.
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
UTROGESTAN.
•
Follow all direction given to you by your doctor carefully.
THINGS YOU
SHOULD NOT DO
•
Do not use if you have unusual vaginal bleeding that has not been
evaluated by your doctor,
•
Do not use if you have known missed abortions or ectopic pregnancy
•
Do not use if you have or are suspected of having cancer of the breast
or genital tract
•
Do not use if you have a blood clot or bleeding on the brain.
•
Do not use if your liver is not working well.
DRIVING OR USING
MACHIN

Характеристики продукта

NEW ZEALAND DATA SHEET
UTROGESTAN 200mg caps UTROGEST007
Aug 2023
Page 1 of 9
UTROGESTAN 200MG CAPSULES
Progesterone
1 PRODUCT NAME
UTROGESTAN 200MG CAPSULES
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Soft, ovoid, slightly yellow capsule containing a whitish oily
suspension of 200 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 200 mg capsule is indicated in adults, _via_ the oral or
vaginal route, for:
ORAL ROUTE
_HORMONE REPLACEMENT THERAPY _
•
Adjunctive use with an oestrogen in postmenopausal women with an
intact uterus (for hormone
replacement therapy [HRT])
VAGINAL ROUTE
_LUTEAL PHASE SUPPORT _
•
Supplementation of the luteal phase during Assisted Reproductive
Technology (ART) cycles
4.2
DOSE AND METHOD OF ADMINISTRATION
_DOSAGE _
The recommended dose is as follows, according to the indication and
the administration route:
_ _
_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 therapy followed 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.
NEW ZEALAND DATA SHEET
UTROGESTAN 200mg caps UTROGEST007
Aug 2023
Page 2 of 9
_VAGINAL ROUTE _
•
_IN THE LUTEAL PHASE SUPPORT DURING ASSISTED REPRODUCTIVE TECHNOLOGY
(ART_
)_: _
the recommended
dosage is 600 mg/day, in three divided doses, from the evening after
the day of oocyte retrieval
or latest the day of embryo transfer until at least the 7
th
week of pregnancy and not later than the
12
th
week of pregnancy.
_METHOD OF ADMINISTRATI