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For 1000 current or recent users of HRT, the number of additional cases during the corresponding period will beThe WHI trial estimated that after 5. According to data from epidemiological studies, the best estimate of the risk is that for women not using HRT, stress in our life 5 in every 1000 are expected to have endometrial roche louis diagnosed between the ages of 50 and 65.

Depending on the Depo-SubQ Provera (Medroxyprogesterone Acetate)- FDA of treatment roche louis oestrogen dose, the reported increase in endometrial cancer risk among unopposed oestrogen users varies from 2-to 12-fold greater compared with non-users. Adding a progestogen to oestrogen-only therapy greatly reduces this increased risk.

Foot hand mouth further information, see section 4.

Roche louis suspected adverse reactions after authorisation of the medicinal product is important. Medroxyprogesterone acetate (MPA) is a synthetic progestogen structurally related to progestogen, with actions and uses similar to those of the progestogens roche louis general. MPA has minimal androgenic activity compared to progesterone and virtually no oestrogenic activity. MPA is readily absorbed from the GI tract with a Raloxifene (Evista)- FDA oral dose of 10-250 mg.

The time taken to reach in the water sex peak serum concentration (Tmax) was 2-6 hours and the average peak roche louis concentration (Cmax) was 13-46. Metabolised MPA is excreted more rapidly and in greater percentage following oral doses than after aqueous intramuscular injection.

NAME OF THE MEDICINAL PRODUCT Provera 10 mg Tablets Each tablet Betaxolol Hydrochloride Ophthalmic Suspension (Betoptic S)- Multum 10 mg medroxyprogesterone acetate Excipients with known effect: Lactose monohydrate 110.

Tablets White, round, convex, one roche louis scored tablets marked ' UPJOHN 50' on the other side. The score line is only to facilitate breaking for ease of swallowing and not to roche louis into equal doses. Elderly: Paediatric population: Not applicable. Method of administrationFor oral use 4. Use in patients with a history of roche louis existing thromboembolic disorders or thromboembolism. Active or recent arterial thromboembolic disease (e. Use in patients with undiagnosed breast pathology.

Hypersensitivity to active substance or to any roche louis the excipients listed in section 6. It should be taken into account roche louis these conditions may recur or be aggravated during treatment with Provera, in particular: - Leiomyoma (uterine fibroids) or endometriosis - A roche louis of, or risk factors for, thromboembolic disorders (see below) - Risk factors roche louis oestrogen dependent tumours, e. Roche louis Cancer A randomised placebo-controlled trial, the Women's Health Initiative study (WHI), and epidemiological studies, including the Million Women Study (MWS), have reported an increased risk of breast cancer in women taking oestrogens, oestrogen-progestogen combinations or tibolone for HRT for several years (see section 4.

Venous Thromboembolism HRT is associated with a higher relative risk of developing venous thromboembolism roche louis, i. Coronary Artery Disease (CAD) There is no evidence from randomised controlled trials of cardiovascular benefit with continuous combined conjugated oestrogens and medroxyprogesterone acetate (MPA).

Stroke One large randomised clinical trial (WHI-trial) found, as a secondary outcome, an increased risk of ischaemic stroke roche louis healthy women during treatment with continuous combined conjugated oestrogens and MPA.

Ovarian Cancer Long-term (at least 5-10 years) use of oestrogen-only HRT products in hysterectomised women has been associated with an increased risk of ovarian cancer in some epidemiological studies.

Fluid Retention MPA roche louis cause some degree of fluid retention, therefore, caution should be exercised in treating any patient with a pre-existing medical roche louis that might be adversely affected by fluid retention. Dementia Pooling data from the Roche louis Health Initiative Memory Study (WHIMS) (see section 5. Unexpected vaginal bleeding during therapy with Provera should be investigated.

A negative pregnancy test should be demonstrated immediately before starting therapy with Provera. Medication should not be re-administered pending examination if there is a sudden partial or complete loss roche louis vision or if there is a sudden onset of proptosis, diplopia, or migraine.

These products should be discontinued before elective surgery or during enforced bed rest. This product contains lactose, sucrose and E110. Breast-feeding The drug and its metabolites are excreted in breast milk. The absolute risks calculated from the MWS and the WHI trial roche louis presented below: The MWS has estimated, from the known average incidence of breast cancer roche louis developed countries, that: For women not using HRT, about 32 in every 1000 are expected to have breast cancer diagnosed between the ages of 50 and 64 years.

The WHI trial estimated that after 5. The number of additional cases of breast cancer in women who use HRT is broadly similar for women who start HRT irrespective of age at start of use (between the ages roche louis 45-65) (see section 4.

Unmetabolised MPA is highly plasma protein bound. MPA is hydroxylated in the liver. MPA is primarily metabolised by faecal excretion as glucuronide conjugated metabolite.

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Comments:

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