Κλαύδιος Γαληνός
Δωρεάν εγγραφή Αποκτήσετε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr για έναν μήνα
Έλεγχος συγχορήγησης Ελέγξτε την αγωγή σας για αντενδείξεις και αλληλεπιδράσεις μεταξύ των φαρμάκων
Μητρότητα και φάρμακα Ενημερωθείτε για την ασφάλεια χορήγησης ενός φαρμάκου κατά τη διάρκεια της εγκυμοσύνης ή του θηλασμού
Συνδρομές Μάθετε περισσότερα για τα οφέλη και τις επιπλέον παροχές των συνδρομητικών προγραμμάτων
Ενδείξεις και αγωγές Βρείτε θεραπευτικές ενδείξεις και αγωγές για νόσους, συμπτώματα και ιατρικές πράξεις
Γνωρίζατε ότι... Μοιραζόμαστε μαζί σας γεγονότα της πορείας του Galinos.gr από το 2011 μέχρι σήμερα

ODOMZO Hard capsule (2019)

Αναφορές

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

Περιεχόμενα

Name of the medicinal product

Odomzo 200 mg hard capsules.

Qualitative and quantitative composition

Each hard capsule contains 200 mg sonidegib (as phosphate). Excipient with known effect: Each hard capsule contains 38.6 mg lactose monohydrate. For the full list of excipients, see section 6.1.

Pharmaceutical form

Hard capsule (capsule). Opaque pink hard capsule containing white to almost white powder with granules, with NVR imprinted in black ink on the cap and SONIDEGIB 200MG imprinted in black ink on the body. ...

Therapeutic indications

Odomzo is indicated for the treatment of adult patients with locally advanced basal cell carcinoma (BCC) who are not amenable to curative surgery or radiation therapy.

Posology and method of administration

Odomzo 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 200 mg sonidegib taken ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Pregnancy and breast-feeding (see sections 4.4 and 4.6). Women of childbearing potential who do not comply with ...

Special warnings and precautions for use

Muscle-related adverse events In the phase II pivotal study, muscle spasms, myalgia, myopathy and cases of CK elevations were observed. The majority of patients treated with Odomzo 200 mg daily who had ...

Interaction with other medicinal products and other forms of interaction

Sonidegib undergoes metabolism primarily by CYP3A4, and concomitant administration of strong inhibitors or inducers of CYP3A4 can increase or decrease sonidegib concentrations significantly. Agents that ...

Fertility, pregnancy and lactation

Women of childbearing potential Due to the risk of embryofoetal death or severe birth defects caused by sonidegib, women taking Odomzo must not be pregnant or become pregnant during treatment and for 20 ...

Effects on ability to drive and use machines

Odomzo has no or negligible influence on the ability to drive and use machines.

Undesirable effects

Summary of the safety profile The phase II pivotal study evaluated the safety of Odomzo in a total of 229 adult patients with locally advanced or metastatic BCC. Patients were treated with Odomzo 200 mg ...

Overdose

In dose escalation studies, Odomzo was administered at doses up to 3000 mg orally once daily. Patients should be monitored closely for adverse events and given appropriate supportive measures in all cases ...

Pharmacodynamic properties

Pharmacotherapeutic group: Antineoplastic agents, other antineoplastic agents ATC code: L01XX48 Mechanism of action Sonidegib is an orally bioavailable inhibitor of the Hh signalling pathway. It binds ...

Pharmacokinetic properties

Absorption Following the administration of a single dose of Odomzo (100 mg to 3000 mg) without food in patients with cancer, the median time-to-peak concentration (T<sub>max</sub>) was 2 to 4 hours. Sonidegib ...

Preclinical safety data

Sonidegib was evaluated in rats and dogs. General toxicology The majority of adverse effects of sonidegib can be attributed to its pharmacological mechanism of action on developmental pathways and effects ...

List of excipients

Capsule content: Crospovidone (Type A) Lactose monohydrate Magnesium stearate Poloxamer (188) Silica, colloidal anhydrous Sodium lauryl sulfate Capsule shell: Gelatin Iron oxide red (E172) Titanium dioxide ...

Incompatibilities

Not applicable.

Shelf life

5 years.

Special precautions for storage

Do not store above 30°C. Store in the original package in order to protect from moisture.

Nature and contents of container

10 1 hard capsule in PCTFE/PVC/Alu perforated unit-dose blisters. Each pack contains either 10 or 30 hard capsules. Not all pack sizes may be marketed.

Special precautions for disposal and other handling

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Marketing authorization holder

Sun Pharmaceutical Industries Europe B.V., Polarisavenue 87, 2132JH Hoofddorp, Netherlands

Marketing authorization number(s)

EU/1/15/1030/001 EU/1/15/1030/002

Date of first authorization / renewal of the authorization

14 August 2015

Πηγαίο έγγραφο

Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:

Μπορείτε να υποστηρίξετε τον Γαληνό στην αποστολή του να παρέχει δωρεάν έγκυρη πληροφόρηση για κάθε φάρμακο απενεργοποιώντας το Ad Blocker για αυτόν τον ιστότοπο.