UTROGESTAN 200 progesterone 200 mg soft vaginal capsule blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

progesterone, Quantity: 200 mg

Available from:

Besins Healthcare Australia Pty Ltd

INN (International Name):

progesterone

Pharmaceutical form:

Pessary, shell

Composition:

Excipient Ingredients: glycerol; lecithin; titanium dioxide; Gelatin; purified water; Sunflower Oil

Administration route:

Vaginal

Units in package:

7 capsules, 7 capsules starter pack, 84 capsules, 90 capsules, 15 capsules, 30 capsules, 21 capsules, 56 capsules, 45 capsules, 28 capsules, 14 capsules, 42 capsules

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Luteal phase support ? Luteal Support of Assisted Reproductive Technology (ART) cycles,Support during pregnancy ? Prevention of preterm birth in women with singleton pregnancy who have a short cervix (midtrimester sonographic cervix less than or equal to 25 mm) and/or a history of spontaneous preterm birth. ? Treatment of unexplained threatened miscarriage in women with bleeding in the current pregnancy and a history of at least three or more previous miscarriages. Use in women with less than three miscarriages may be warranted in those with reduced chances of future pregnancy such as those undergoing IVF treatment with limited viable egg and/or embryo availability or advanced fertility age. However, the benefit of treatment in clinical trials was limited to women with three or more miscarriages. (See Section 5 Pharmacological properties; Clinical trials; Threatened Unexplained Miscarriage)

Product summary:

Visual Identification: Slightly yellow ovoid soft capsule containing a whitish oily suspension; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2016-07-12

Patient Information leaflet

UTROGESTAN 200 CMI
1
UTROGESTAN 200®
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 UTROGESTAN ?
UTROGESTAN contains the active ingredient progesterone. UTROGESTAN is
used for women who need extra progesterone
while undergoing fertility treatment (e.g. ART); for the treatment of
unexplained threatened miscarriage; for the prevention of
preterm birth in women with a short cervix and or history of
spontaneous preterm birth.
For more information, see Section 1. Why am I using UTROGESTAN?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE UTROGESTAN?
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.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
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.
4.
HOW DO I USE UTROGESTAN?
•
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.
5.
WHAT SHOULD I KNOW WHILE USING UTROGESTAN?
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
•

Summary of Product characteristics

UTROGESTAN 200, soft capsule
PRODUCT INFORMATION
V13-0222
AUSTR R 232824
1/17
AUSTRALIAN PRODUCT INFORMATION
UTROGESTAN 200 (PROGESTERONE) SOFT CAPSULE
_(FOR VAGINAL USE) _
1.
NAME OF THE MEDICINE
Progesterone
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Utrogestan contains the active ingredient: Progesterone (micronised)
200 mg.
Excipient with known effect: Soyabean lecithin .
For the full list of excipients, see section 6.1 List of Excipients
3.
PHARMACEUTICAL FORM
Utrogestan 200 soft capsule is an ovoid, slightly yellow, soft
capsule, containing a whitish oily
suspension.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Utrogestan 200, soft capsules are indicated for:
_LUTEAL PHASE SUPPORT _
•
Luteal Support of Assisted Reproductive Technology (ART) cycles
_SUPPORT DURING PREGNANCY _
•
Prevention of preterm birth in women with singleton pregnancy who have
a short cervix
(midtrimester sonographic cervix ≤25 mm) and/or a history of
spontaneous preterm birth.
•
Treatment of unexplained threatened miscarriage in women with bleeding
in the current
pregnancy and a history of at least three or more previous
miscarriages.
Use in women with less than three miscarriages may be warranted in
those with reduced
chances of future pregnancy such as those undergoing IVF treatment
with limited viable egg
and/or embryo availability or advanced fertility age. However, the
benefit of treatment in
clinical trials was limited to women with three or more miscarriages.
(See Section 5
Pharmacological properties; Clinical trials; Threatened Unexplained
Miscarriage)
4.2
DOSE AND METHOD OF ADMINISTRATION
ADULTS
:
_LUTEAL PHASE SUPPORT (LPS)_
The recommended dosage is 600 mg/day, in three divided doses, from the
day of embryo transfer
until at least the 7
th
week of pregnancy and not later than the 12
th
week of pregnancy.
UTROGESTAN 200, soft capsule
PRODUCT INFORMATION
V13-0222
AUSTR R 232824
2/17
_PREVENTION OF PRETERM BIRTH (PTB)_
The usual dose is 200 mg/day, recommended at bedtime. Treatment can be
initiated during the
sec