国: 南アフリカ
言語: 英語
ソース: South African Health Products Regulatory Authority (SAHPRA)
Pharmacare Limited û Woodmead
See ingredients
CREAM
EACH 1 g CREAM CONTAINS OESTRIOL 1 mg
Registered
1989-05-12
_ _ _ZA_SYNACRM_1406_01 _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ Page 1 of 13 _ 1.3.2 PATIENT INFORMATION LEAFLET READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU SYNAPAUSE VAGINAL CREAM is available without a doctor’s prescription, for you to treat a mild illness. Nevertheless you still need to use SYNAPAUSE VAGINAL CREAM carefully to get the best results from it. Keep this leaflet. You may need to read it again. Do not share SYNAPAUSE VAGINAL CREAM with any other person. Ask your pharmacist if you need more information or advice. You must see a doctor if your symptoms worsen or do not improve. SCHEDULING STATUS S2 PROPRIETARY NAME AND DOSAGE FORM SYNAPAUSE VAGINAL CREAM WHAT SYNAPAUSE VAGINAL CREAM CONTAINS Each gram of SYNAPAUSE VAGINAL CREAM contains: _Active ingredient:_ Estriol 1 mg. _Inactive ingredients:_ Cetyl alcohol, cetyl palmitate, chlorhexidine dihydrochloride, glycerol, lactic acid, octyldodecanol, polysorbate 60, sodium hydroxide, sorbitan stearate, stearyl alcohol _Preservative:_ Chlorhexidine hydrochloride 0,01 % _m/m _ Contains sugar:_ _Glycerol (sugar alcohol) Contains alcohol_: _Glycerol, cetyl alcohol_, _stearyl alcohol _ _ _ZA_SYNACRM_1406_01 _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ Page 2 of 13 _ WHAT SYNAPAUSE VAGINAL CREAM IS USED FOR SYNAPAUSE VAGINAL CREAM is used to restore the mucosal layer of the vaginal wall. BEFORE YOU APPLY SYNAPAUSE VAGINAL CREAM SYNAPAUSE VAGINAL CREAM MAY NOT BE SUITABLE for you if the answer is YES to any of the following questions: Are you pregnant or do you think you may be pregnant? Are you breastfeeding your baby? Do you have a tumour (e.g. a breast tumour or a tumour in your womb)? Have you recently had unexpected vaginal bleeding? Have you ever had an allergic reaction to one of the ingredients of SYNAPAUSE VAGINAL CREAM? Have you had abnormal growth of the lining of your womb (endometrial hyperplasia)? Have you or have you had a blood circulation disorder such as blood clots (in the veins 完全なドキュメントを読む
_ _ _ZA_SYNACRM_1406_01 _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ Page 1 of 13 _ 1.3.1.1 PROFESSIONAL INFORMATION FOR MEDICINES FOR HUMAN USE SCHEDULING STATUS S2 PROPRIETARY NAME AND DOSAGE FORM SYNAPAUSE VAGINAL CREAM COMPOSITION Each gram of SYNAPAUSE VAGINAL CREAM contains 1 mg estriol. _Excipients:_ Cetyl alcohol, cetyl palmitate, chlorhexidine dihydrochloride, glycerol, lactic acid, octyldodecanol, polysorbate 60, sodium hydroxide, sorbitan stearate, stearyl alcohol. _Preservative:_ Chlorhexidine hydrochloride 0,01 % _m/m _ Contains sugar:_ _Glycerol (sugar alcohol) Contains alcohol_: _Glycerol, cetyl alcohol_, _stearyl alcohol PHARMACOLOGICAL CLASSIFICATION A.18.6 Vaginal preparations PHARMACOLOGICAL ACTION Estriol is a natural short acting female hormone. During the vaginal use of estriol, systemic absorption of estriol occurs. INDICATIONS Hormone replacement therapy (HRT) for the treatment of atrophy of the lower urogenital tract related to oestrogen deficiency associated with the natural or surgical menopause. Pre- and postoperative therapy in postmenopausal or ovariectomised women _ _ _ZA_SYNACRM_1406_01 _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ Page 2 of 13 _ undergoing vaginal surgery. CONTRAINDICATIONS Known hypersensitivity to the active substances or to any of the inactive ingredients Known, past or suspected breast cancer Known or suspected oestrogen-dependent malignant tumours (e.g. endometrial cancer) Undiagnosed vaginal bleeding Untreated endometrial hyperplasia Previous idiopathic or current venous thromboembolism (deep venous thrombosis, pulmonary embolism, or a risk factor thereof e.g. known thrombophilic disease in a patient) Known thrombophilic disorders/diseases (e.g. Protein C, protein S or antithrombin deficiency) (see WARNINGS AND SPECIAL PRECAUTIONS) Pregnancy and lactation Active or recent arterial thromboembolic disease (e.g. angina, myocardial infarction) Acute liver disease or a history of liver disease as long as liver function tests failed to return 完全なドキュメントを読む