PROVERA Tablet (2016)
Βιβλιογραφική αναφορά
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
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Περιεχόμενα
Name of the medicinal product
Provera 10 mg Tablets.
Qualitative and quantitative composition
Each tablet contains 10 mg medroxyprogesterone acetate. Excipients with known effect: Lactose monohydrate 110 mg, sucrose 2 mg. For the full list of excipients, see section 6.1.
Pharmaceutical form
Tablets.
Therapeutic indications
Progestogen. Indicated for dysfunctional (anovulatory) uterine bleeding, secondary amenorrhoea and for mild to moderate endometriosis.
Posology and method of administration
Posology Adults <u>Dysfunctional (anovulatory) uterine bleeding:</u> 2.5-10 mg daily for 5-10 days commencing on the assumed or calculated 16th-21st day of the cycle. Treatment should be given for two ...
Contraindications
Known, past or suspected breast cancer. Previous idiopathic or current venous thromboembolism (deep venous thrombosis, pulmonary embolism). Active or recent arterial thromboembolic disease (e.g. angina, ...
Special warnings and precautions for use
Medical Examination/Follow-Up Before initiating or reinstituting therapy, a complete personal and family medical history should be taken. Physical (including pelvic) examination should be guided by this ...
Interaction with other medicinal products and other forms of interaction
Aminoglutethimide administered concurrently with Provera may significantly depress the bioavailability of Provera. Interactions with other medicinal treatments (including oral anti-coagulants) have rarely ...
Pregnancy and lactation
Pregnancy Provera is not indicated during pregnancy. If pregnancy occurs during medication with Provera, treatment should be withdrawn immediately. The results of most epidemiological studies to date relevant ...
Effects on ability to drive and use machines
No adverse effect has been reported.
Undesirable effects
The table below provides a listing of adverse drug reactions with frequency based on all-causality data from Phase 3 clinical studies that evaluated efficacy and safety of DMPA in gynaecology. Those most ...
Overdose
In animals Provera has been shown to be capable of exerting an adreno-corticoid effect, but this has not been reported in the human, following usual dosages. The oral administration of Provera at a rate ...
Pharmacodynamic properties
Pharmacotherapeutic group: Progestogens – Pregnen (4) derivatives ATC code: G03DA02 Medroxyprogesterone acetate has actions and uses similar to those of progesterone. MPA has minimal androgenic activity ...
Pharmacokinetic properties
MPA is rapidly absorbed from the G-I tract with a single oral dose of 10-250 mg. The time taken to reach the peak serum concentration (Tmax) was 2-6 hours and the average peak serum concentration (Cmax) ...
Preclinical safety data
None stated.
List of excipients
Lactose Sucrose Maize starch Liquid Paraffin Talc Calcium Stearate Purified Water
Incompatibilities
Not applicable.
Shelf life
5 years.
Special precautions for storage
Glass bottles: None. Blister packs: Store below 25°C.
Nature and contents of container
HDPE tamper-evident bottles with LDPE push-fit tamper evident caps, containing 50 tablets. Aluminium foil/PVC blisters, containing 10, 20, 30, 50, 90 or 100 tablets. Not all pack sizes may be marketed. ...
Special precautions for disposal and other handling
None.
Marketing authorization holder
Pfizer Limited, Ramsgate Road, Sandwich, CT13 9NJ, UK
Marketing authorization number(s)
PL 00057/1033
Date of first authorization / renewal of the authorization
Date of first authorisation: 21 September 2010
Date of revision of the text
10/2016
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