ERIVEDGE Hard capsule (2019)
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
Erivedge 150 mg hard capsules.
Qualitative and quantitative composition
Each hard capsule contains 150 mg of vismodegib. Excipient with known effect: Each hard capsule contains 71.5 mg lactose monohydrate per capsule. For the full list of excipients, see section 6.1.
Pharmaceutical form
Hard capsule (capsule). Pink coloured opaque body marked 150 mg and a grey opaque cap marked VISMO with black ink. The size of the capsule is Size 1 (dimensions 19.0 6.6 mm).
Therapeutic indications
Erivedge is indicated for the treatment of adult patients with: symptomatic metastatic basal cell carcinoma locally advanced basal cell carcinoma inappropriate for surgery or radiotherapy (see section ...
Posology and method of administration
Erivedge should only be prescribed by or under the supervision of a specialist physician experienced in the management of the approved indication. Posology The recommended dose is one 150 mg capsule taken ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Women who are pregnant or breast-feeding (see sections 4.4 and 4.6). Women of childbearing potential who do not ...
Special warnings and precautions for use
Embryo-foetal death or severe birth defects Erivedge may cause embryo-foetal death or severe birth defects when administered to a pregnant woman (see section 4.6). Hedgehog pathway inhibitors, (see section ...
Interaction with other medicinal products and other forms of interaction
Effects of concomitant medicinal products on vismodegib Clinically significant PK interactions between vismodegib and pH elevating agents are not expected. Results from a clinical study demonstrated a ...
Fertility, pregnancy and lactation
Women of childbearing potential (WCBP) Due to the risk of embryo-foetal death or severe birth defects caused by vismodegib, women taking Erivedge must not be pregnant or become pregnant during treatment ...
Effects on ability to drive and use machines
Erivedge has no or negligible influence on the ability to drive and use machines.
Undesirable effects
Summary of the safety profile The most common adverse drug reactions (ADR) occurring in ≥30% of patients, were muscle spasms (74.6%), alopecia (65.9%), dysgeusia (58.7%), weight decreased (50.0%), fatigue ...
Overdose
Erivedge has been administered at doses 3.6 times higher than the recommended 150 mg daily dose. No increases in plasma vismodegib levels or toxicity were observed during these clinical trials.
Pharmacodynamic properties
Pharmacotherapeutic group: Antineoplastic agents, other antineoplastic agents ATC code: L01XX43 Mechanism of action Vismodegib is an orally available small-molecule inhibitor of the Hedgehog pathway. Hedgehog ...
Pharmacokinetic properties
Absorption Erivedge is a highly permeable compound with low aqueous solubility (BCS Class 2). The single dose mean (CV %) absolute bioavailability of Erivedge is 31.8 (14.5) %. Absorption is saturable ...
Preclinical safety data
The preclinical safety profile of Erivedge was assessed in mice, rats, and dogs. Repeat-dose toxicity In general, the tolerability of Erivedge in repeat-dose toxicity studies in rats and dogs was limited ...
List of excipients
Capsule contents: Microcrystalline cellulose Lactose monohydrate Sodium lauril sulfate Povidone (K29/32) Sodium starch glycolate (Type A) Talc Magnesium stearate Capsule shell: Iron oxide black (E172) ...
Incompatibilities
Not applicable.
Shelf life
Shelf life: 4 years.
Special precautions for storage
Do not store above 30°C. Keep the bottle tightly closed in order to protect from moisture.
Nature and contents of container
HDPE bottle with a child-resistant closure containing 28 hard capsules. Each pack contains one bottle. The bottle cap material is Polypropylene. The cap liner is aluminum foil-lined waxed pulp board. ...
Special precautions for disposal and other handling
Any unused medicinal product at the end of treatment must immediately be disposed of by the patient in accordance with local requirements (if applicable, e.g. by returning the capsules to the pharmacist ...
Marketing authorization holder
Roche Registration GmbH, Emil-Barell-Strasse 1, 79639, Grenzach-Wyhlen, Germany
Marketing authorization number(s)
EU/1/13/848/001
Date of first authorization / renewal of the authorization
Date of first authorisation: 12 July 2013 Date of latest renewal: 26 May 2016
Πηγαίο έγγραφο
Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:
