País: Austràlia
Idioma: anglès
Font: Department of Health (Therapeutic Goods Administration)
medroxyprogesterone acetate, Quantity: 10 mg
Pfizer Australia Pty Ltd
Tablet, uncoated
Excipient Ingredients: sucrose; purified talc; liquid paraffin; calcium stearate; lactose monohydrate; maize starch
Oral
30 tablets, 15 tablets
(S4) Prescription Only Medicine
1.Carcinoma: Palliative treatment of recurrent and/or metastatic breast or renal cell cancer and of inoperable recurrent or metastatic endometrial carcinoma. 2.Endometriosis: For use in the treatment of visually proven (laparoscopy) endometriosis where the required end-point of treatment is pregnancy, or for the control of symptoms when surgery is contraindicated or has been unsuccessful. 3. Secondary amenorrhoea proven not due to pregnancy: In amenorrhoea associated with a poorly developed proliferative endometrium, conventional oestrogen therapy may be employed in conjunction with medroxyprogesterone acetate. 4. Abnormal uterine bleeding, in the absence of organic pathology. 5. Adjunct to oestrogen therapy: Combination hormone replacement therapy should only be used in non-hysterectomised women.
Visual Identification: White, circular (about 7.14mm diameter) tablets embossed "Upjohn 50" on one side and single scored on the other.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius
Registered
1993-10-14
RALOVERA ® _Medroxyprogesterone acetate_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about RALOVERA. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking RALOVERA against the benefits it is expected to have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT RALOVERA IS USED FOR RALOVERA is a progestogen that comes from progesterone, a natural sex hormone. RALOVERA works in a similar way to progesterone. RALOVERA is used to treat: • endometriosis - a condition in which tissue similar to the lining of the uterus (womb) grows outside the uterus, causing pain and bleeding. RALOVERA helps to stop the growth of this tissue • secondary amenorrhoea (a lack of menstrual periods not due to pregnancy). RALOVERA, with or without an estrogen, helps to re-establish a regular menstrual cycle • abnormal bleeding from the uterus, when the lining of the uterus breaks down during the menstrual cycle rather than at the end, resulting in vaginal spotting or bleeding. RALOVERA helps to re-establish a regular menstrual cycle • certain types of cancer including cancer of the breast, kidney and endometrium • RALOVERA, in combination with an estrogen containing medicine, is used to relieve symptoms of menopause in women with an intact uterus. This is called hormone replacement therapy (HRT). RALOVERA is used to protect the lining of the uterus while the estrogens relieve the symptoms of menopause. RALOVERA is not suitable as a HRT treatment in women who have undergone a hysterectomy. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY RALOVERA HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. This medicine is available only with a doctor's prescription. BEFORE YOU TAKE RALOVERA _ Llegiu el document complet
Version: pfpralvt10420 Supersedes: pfpralvt10317 Page 1 of 13 AUSTRALIAN PRODUCT INFORMATION – RALOVERA ® (MEDROXYPROGESTERONE ACETATE) TABLETS 1. NAME OF THE MEDICINE Medroxyprogesterone acetate 2. QUALITATIVE AND QUANTITATIVE COMPOSITION RALOVERA tablets contain 2.5 mg, 5 mg or 10 mg medroxyprogesterone acetate as the active ingredient. EXCIPIENT(S) WITH KNOWN EFFECT: Lactose monohydrate For the full list of excipients, see Section 6.1 List of excipients. 3. PHARMACEUTICAL FORM 2.5 mg tablets: orange, circular, scored on one side, marked U64 on the other side. 5 mg tablets: pale blue, circular, scored on one side and marked 286 on both sides of the score line, marked U on the other side. 10 mg tablets: white, circular, scored on one side, marked UPJOHN 50 on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS CARCINOMA Palliative treatment of recurrent and/or metastatic breast or renal cell cancer and of inoperable recurrent or metastatic endometrial carcinoma. ENDOMETRIOSIS For use in the treatment of visually proven (laparoscopy) endometriosis where the required end-point of treatment is pregnancy, or for the control of symptoms when surgery is contraindicated or has been unsuccessful. SECONDARY AMENORRHOEA PROVEN NOT DUE TO PREGNANCY In amenorrhoea associated with a poorly developed proliferative endometrium, conventional estrogen therapy may be employed in conjunction with medroxyprogesterone acetate. Version: pfpralvt10420 Supersedes: pfpralvt10317 Page 2 of 13 ABNORMAL UTERINE BLEEDING IN THE ABSENCE OF ORGANIC PATHOLOGY ADJUNCT TO ESTROGEN THERAPY Combination hormone replacement therapy (HRT) should only be used in non-hysterectomised women (see Section 4.4 Special warnings and precautions for use). 4.2 DOSE AND METHOD OF ADMINISTRATION DOSAGE _INOPERABLE, RECURRENT, METASTATIC, ENDOMETRIAL CARCINOMA _ 200 mg to 400 mg daily. _BREAST CARCINOMA _ 500 mg daily until progression of disease. _RENAL CELL CARCINOMA _ 200 mg to 400 mg daily. _ENDOMETRIOSIS _ Beginning the first day of the men Llegiu el document complet