CYCLOGEST progesterone 400 mg pessary strip pack

국가: 오스트레일리아

언어: 영어

출처: Department of Health (Therapeutic Goods Administration)

유효 성분:

progesterone, Quantity: 400 mg

제공처:

Gedeon Richter Australia Pty Ltd

약제 형태:

Pessary

구성:

Excipient Ingredients: Hard fat

관리 경로:

Vaginal

패키지 단위:

15

처방전 유형:

(S4) Prescription Only Medicine

치료 징후:

CYCLOGEST is indicated for luteal phase support as part of an Assisted Reproductive Technology (ART) treatment for women.

제품 요약:

Visual Identification: Off-white, approximately 10 mm x 30 mm, torpedo shaped pessary; Container Type: Strip Pack; Container Material: PVC/PE; Container Life Time: 48 Months; Container Temperature: Store below 25 degrees Celsius

승인 상태:

Registered

승인 날짜:

2022-02-11

환자 정보 전단

Cyclogest CMI- v1-A11022
1
CYCLOGEST
®
PROGESTERONE 400 MG PESSARY
________________________________________________________________________________________________________
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.
________________________________________________________________________________________________________
▼
This medicine is new or being used differently. Please report side
effects. See the full CMI for further details.
1. WHY AM I USING CYCLOGEST?
Cyclogest contains the active ingredient progesterone. Cyclogest is
for women who need extra progesterone while undergoing
treatment in an Assisted Reproductive Technology (ART) programme.
For more information, see Section 1 Why am I using Cyclogest? in the
full CMI.
2. WHAT SHOULD I KNOW BEFORE I USE CYCLOGEST?
Do not use if you have ever had an allergic reaction to Cyclogest 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 ARE BREASTFEEDING.
For more information, see Section 2 What should I know before I use
Cyclogest? in the full CMI.
3. WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Cyclogest 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 CYCLOGEST?
•
A 400 mg pessary is administered vaginally twice a day.
More instructions can be found in Section 4 How do I use Cyclogest? in
the full CMI
5. WHAT SHOULD I KNOW WHILE USING CYCLOGEST?
THINGS YOU SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
Cyclogest
•
Tell your doctor if you have any undiagnosed vaginal bleeding or have
had a missed
abortion or ectopic pregnancy
•
Tell your doctor if you have or have had any blood clots
•
Tell your doctor if you have or have had severe liver pr

제품 특성 요약

cyclogest_v1_A110222
1 of 11
AUSTRALIAN PRODUCT INFORMATION
CYCLOGEST
® (PROGESTERONE) PESSARIES
1.
NAME OF THE MEDICINE
PROGESTERONE
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each CYCLOGEST pessary contains 400 mg progesterone
For the full list of excipients, see section
6.1 LIST OF EXCIPIENTS
.
3.
PHARMACEUTICAL FORM
Pessary
Off-white, approximately 10 mm x 30 mm, torpedo shaped pessary.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_CYCLOGEST is indicated for luteal phase support as part of an
Assisted Reproductive Technology _
_(ART) treatment for women_
.
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSAGE
One 400 mg pessary administered vaginally twice a day (BID) starting
at oocyte retrieval. If
pregnancy has been confirmed, the administration of progesterone
should be continued for 38 days
from the start of therapy
or up until 12 weeks of pregnancy according to need at the judgement
of the
treating physician.
METHOD OF ADMINISTRATION
For vaginal insertion.
Patient Instructions:
The pessary should be removed from its wrapper and inserted deep into
the vagina, by pushing the pessary
upwards and backwards while either in a squatting position or lying
down. If a recommended twice daily dose
is being administered then a preferable time of dosing is in the
morning and at night before retiring.
Missed dose:
A missed dose should be administered as soon as remembered, unless the
missed dose is noticed at the day of
the next dose. In the latter case the missed dose should be omitted
and the
regular dosing regimen continued.
cyclogest_v1_A110222
2 of 11
4.3
CONTRAINDICATIONS
-
Hypersensitivity to the active substance or to any of the excipients
listed in Section
6.1 LIST
OF EXCIPIENTS.
-
Undiagnosed vaginal bleeding
-
Known or suspected progesterone sensitive malignant tumours
-
Porphyria
-
Known missed abortion or ectopic pregnancy
-
Active arterial or venous thromboembolism or severe thrombophlebitis,
or a history of these
events
-
Severe hepatic dysfunction or disease
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR US