Maa: Israel
Kieli: englanti
Lähde: Ministry of Health
PROGESTERONE
FERRING PHARMACEUTICALS LTD
G03DA04
VAGINAL TABLETS
PROGESTERONE 100 MG
VAGINAL
Required
FERRING PHARMACEUTICALS A/S, DENMARK
PROGESTERONE
PROGESTERONE
Progesterone supplementation or replacement in cases such as treatment of infertile women and IVF.
2022-07-31
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS )PREPARATIONS( - 1986 This medicine is dispensed with a doctor’s prescription only ENDOMETRIN VAGINAL TABLETS ACTIVE INGREDIENT - Each tablet contains 100 mg progesterone Inactive ingredients and allergens: See section 6 ‘Additional information’. READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. This leaflet contains concise information about this medicine. If you have any further questions, ask your doctor or pharmacist. Endometrin has been prescribed for you. Do not pass it on to others. It may harm them, even if it seems to you that their medical condition is similar to yours. 1. WHAT IS THIS MEDICINE INTENDED FOR? Endometrin is provided as a supplement or replacement of the hormone progesterone in cases of infertility and during in-vitro fertilization )IVF( treatments. THERAPEUTIC GROUP: Progestogenic hormones. Endometrin is provided as a vaginal tablet that contains the natural female sex hormone progesterone. Progesterone acts on the lining of the womb and helps you to become and to stay pregnant when you are treated for infertility. 2. BEFORE USING THIS MEDICINE Endometrin can only be used in women who are undergoing infertility treatments. The treatment starts on the day of egg retrieval. Your doctor will tell you when to begin the treatment. DO NOT USE THIS MEDICINE IF: You are sensitive )allergic( to progesterone or to any of the other ingredients in this medicine )see section 6(. You have unusual vaginal bleeding that has not been evaluated by the doctor. You had a miscarriage and your doctor suspects some tissue is still in the uterus or pregnancy outside of the womb. You currently have or have had severe liver problems. You have known or suspected breast or genital tract cancer. You have or have had blood clots in the legs, lungs, eyes or elsewhere in the body. You have porphyria disorders )a group of inherited or acquired disorders of certain enzymes). SPECIAL WARNINGS ABOUT USING THIS MEDICINE TAKE SPECIAL Lue koko asiakirja
1 1. NAME OF THE MEDICINAL PRODUCT Endometrin 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 vaginal tablet contains 100 mg progesterone. Excipient with known effect: 1 vaginal tablet contains approximately 760 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Vaginal tablets, white to off-white flat and oval tablet with the inscriptions “FPI” on one side and “100” on the other side. The vaginal tablets are supplied with one polyethylene vaginal applicator. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Progesterone supplementation or replacement in cases such as treatment of infertile women and IVF 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults _ The dose of Endometrin is 100 mg administered vaginally three times daily starting at oocyte retrieval and continuing for up to 12 weeks total duration. _Paediatric population _ There is no relevant use of Endometrin in the paediatric population. _Elderly _ No clinical data have been collected in patients over age 65. _Use in special populations _ There is no experience with use of Endometrin in patients with impaired liver or renal function. Method of Administration Endometrin is to be placed directly into the vagina by the applicator provided. 4.3 CONTRAINDICATIONS Endometrin should not be used in individuals with any of the following conditions: • Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. • Undiagnosed vaginal bleeding • Known missed abortion or ectopic pregnancy • Severe hepatic dysfunction or disease 2 • Known or suspected breast or genital tract cancer • Active arterial or venous thromboembolism or severe thrombophlebitis, or a history of these events • Porphyria 4.4 SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE Endometrin should be discontinued if any of the following conditions are suspected: myocardial infarction, cerebrovascular disorders, arterial or venous thromboembolism (venous thromboembolism or pulmonary embolism), thr Lue koko asiakirja