Country: Awstralja
Lingwa: Ingliż
Sors: Department of Health (Therapeutic Goods Administration)
progesterone, Quantity: 400 mg
Gedeon Richter Australia Pty Ltd
Pessary
Excipient Ingredients: Hard fat
Vaginal
15
(S4) Prescription Only Medicine
CYCLOGEST is indicated for luteal phase support as part of an Assisted Reproductive Technology (ART) treatment for women.
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
Registered
2022-02-11
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 Aqra d-dokument sħiħ
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 Aqra d-dokument sħiħ