Země: Austrálie
Jazyk: angličtina
Zdroj: Department of Health (Therapeutic Goods Administration)
progesterone, Quantity: 200 mg
Besins Healthcare Australia Pty Ltd
progesterone
Pessary, shell
Excipient Ingredients: glycerol; lecithin; titanium dioxide; Gelatin; purified water; Sunflower Oil
Vaginal
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
(S4) Prescription Only Medicine
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)
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
Licence status A
2016-07-12
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 • Přečtěte si celý dokument
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 Přečtěte si celý dokument