Страна: Австралия
Език: английски
Източник: Department of Health (Therapeutic Goods Administration)
medroxyprogesterone acetate, Quantity: 10 mg
Pfizer Australia Pty Ltd
Tablet, uncoated
Excipient Ingredients: lactose monohydrate; calcium stearate; liquid paraffin; sucrose; purified talc; maize starch
Oral
15 tablets, 30 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
1993-01-07
PROVERA ® _Medroxyprogesterone acetate_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about PROVERA. 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 PROVERA 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 PROVERA IS USED FOR PROVERA is a progestogen that comes from progesterone, a natural sex hormone. PROVERA works in a similar way to progesterone. PROVERA 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. PROVERA helps to stop the growth of this tissue • secondary amenorrhoea (a lack of menstrual periods not due to pregnancy). PROVERA, 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. PROVERA helps to re-establish a regular menstrual cycle • certain types of cancer including cancer of the breast, kidney and endometrium • PROVERA, 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). PROVERA is used to protect the lining of the uterus while the estrogens relieve the symptoms of menopause. PROVERA is not suitable as a HRT treatment in women who have undergone a hysterectomy. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY PROVERA 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 PROVERA _WHEN YOU MUST Прочетете целия документ
Version: pfpprovt10420 Supersedes: pfpprovt10317 Page 1 of 14 AUSTRALIAN PRODUCT INFORMATION – PROVERA ® (MEDROXYPROGESTERONE ACETATE) TABLETS 1. NAME OF THE MEDICINE Medroxyprogesterone acetate 2. QUALITATIVE AND QUANTITATIVE COMPOSITION PROVERA tablets contain 2.5 mg, 5 mg, 10 mg, 100 mg, 200 mg, 250 mg or 500 mg medroxyprogesterone acetate as the active ingredient. EXCIPIENT(S) WITH KNOWN EFFECT: Lactose monohydrate (2.5, 5 and 10 mg tablets) Sodium benzoate (100, 200, 250 and 500 mg tablets) 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. 100 mg tablets: white, scored, marked U467. 200 mg tablets: white, scored, marked U320. 250 mg tablets: white, scored, marked U403. 500 mg tablets: white, capsule-shaped, marked UPJOHN 717 on one side only. 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. Version: pfpprovt10420 Supersedes: pfpprovt10317 Page 2 of 14 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. ABNORMAL UTERINE BLEEDING IN THE ABSENCE OF ORGANIC PATHOLOGY ADJUNCT TO ESTROGEN THERAPY Combination hormone replacement therapy should only be used in non-hysterectomised women (see Section 4.4 Special warnings and prec Прочетете целия документ