EVISTA Film-coated tablet (2022)
Βιβλιογραφική αναφορά
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Περιεχόμενα
Name of the medicinal product
Evista 60 mg film coated tablets.
Qualitative and quantitative composition
Each film coated tablet contains 60 mg raloxifene hydrochloride, equivalent to 56 mg raloxifene free base. Excipient with known effect: Each tablet contains lactose (149.40 mg). For the full list of excipients, ...
Pharmaceutical form
Film coated tablet. Elliptically shaped, white tablets.
Therapeutic indications
Evista is indicated for the treatment and prevention of osteoporosis in postmenopausal women. A significant reduction in the incidence of vertebral, but not hip fractures has been demonstrated. When determining ...
Posology and method of administration
Posology The recommended dose is one tablet daily by oral administration, which may be taken at any time of the day without regard to meals. Due to the nature of this disease process, Evista is intended ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Must not be used in women with child bearing potential (see section 4.6). Active or past history of venous thromboembolic ...
Special warnings and precautions for use
Raloxifene is associated with an increased risk for venous thromboembolic events that is similar to the reported risk associated with current use of hormone replacement therapy. The risk-benefit balance ...
Interaction with other medicinal products and other forms of interaction
Concurrent administration of either calcium carbonate or aluminium and magnesium-hydroxide containing antacids do not affect the systemic exposure of raloxifene. Co-administration of raloxifene and warfarin ...
Pregnancy and lactation
Pregnancy Evista is only for use in postmenopausal women. Evista must not be taken by women of child bearing potential. Raloxifene may cause foetal harm when administered to a pregnant woman. If this medicinal ...
Effects on ability to drive and use machines
Raloxifene has no or negligible influence on the ability to drive and use machines.
Undesirable effects
a. Summary of the safety profile The clinically most important adverse reactions reported in postmenopausal women treated with Evista were venous thromboembolic events (see section 4.4), which occurred ...
Overdose
In some clinical trials, daily doses were given up to 600 mg for 8 weeks and 120 mg, for 3 years. No cases of raloxifene overdose were reported during clinical trials. In adults, symptoms of leg cramps ...
Pharmacodynamic properties
Pharmacotherapeutic group: Selective Oestrogen Receptor Modulator ATC code: G03XC01 Mechanism of action and Pharmacodynamic effect As a selective oestrogen receptor modulator (SERM), raloxifene has selective ...
Pharmacokinetic properties
Absorption Raloxifene is absorbed rapidly after oral administration. Approximately 60% of an oral dose is absorbed. Presystemic glucuronidation is extensive. Absolute bioavailability of raloxifene is 2%. ...
Preclinical safety data
In a 2-year carcinogenicity study in rats, an increase in ovarian tumors of granulosa/theca cell origin was observed in high-dose females (279 mg/kg/day). Systemic exposure (AUC) of raloxifene in this ...
List of excipients
<u>Tablet core:</u> Povidone Polysorbate 80 Anhydrous lactose Lactose monohydrate Crospovidone Magnesium stearate <u>Tablet coating:</u> Titanium dioxide (E171) Polysorbate 80 Hypromellose Macrogol 400 ...
Incompatibilities
Not applicable.
Shelf life
3 years.
Special precautions for storage
Store in the original package. Do not freeze.
Nature and contents of container
vista tablets are packed either in PVC/PVDC blisters or in high density polyethylene bottles. Blister boxes contain 14, 28, or 84 tablets. Bottles contain 100 tablets. Not all pack sizes may be marketed ...
Special precautions for disposal and other handling
No special requirements.
Marketing authorization holder
SUBSTIPHARM, 24 rue Erlanger, 75016 Paris, France
Marketing authorization number(s)
EU/1/98/073/001 EU/1/98/073/002 EU/1/98/073/003 EU/1/98/073/004
Date of first authorization / renewal of the authorization
Date of first authorisation: 5 August 1998 Date of latest renewal: 8 August 2008
Πηγαίο έγγραφο
Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:
