IMNOVID 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
Imnovid 1 mg hard capsules. Imnovid 2 mg hard capsules. Imnovid 3 mg hard capsules. Imnovid 4 mg hard capsules.
Qualitative and quantitative composition
Imnovid 1 mg hard capsules: Each hard capsule contains 1 mg of pomalidomide. Imnovid 2 mg hard capsules: Each hard capsule contains 2 mg of pomalidomide. Imnovid 3 mg hard capsules: Each hard capsule contains ...
Pharmaceutical form
Hard capsule. Imnovid 1 mg hard capsules: Dark blue opaque cap and yellow opaque body, imprinted POML in white ink and 1 mg in black ink, size 4 gelatin hard capsule. Imnovid 2 mg hard capsules: Dark blue ...
Therapeutic indications
Imnovid in combination with bortezomib and dexamethasone is indicated in the treatment of adult patients with multiple myeloma who have received at least one prior treatment regimen including lenalidomide. ...
Posology and method of administration
Treatment must be initiated and monitored under the supervision of physicians experienced in the management of multiple myeloma. Dosing is continued or modified based upon clinical and laboratory findings ...
Contraindications
Pregnancy. Women of childbearing potential, unless all the conditions of the pregnancy prevention programme are met (see sections 4.4 and 4.6). Male patients unable to follow or comply with the required ...
Special warnings and precautions for use
Teratogenicity Pomalidomide must not be taken during pregnancy, since a teratogenic effect is expected. Pomalidomide is structurally related to thalidomide. Thalidomide is a known human teratogen that ...
Interaction with other medicinal products and other forms of interaction
Effect of pomalidomide on other medicinal products Pomalidomide is not anticipated to cause clinically relevant pharmacokinetic drug-drug interactions due to P450 isoenzyme inhibition or induction or transporter ...
Pregnancy and lactation
Women of childbearing potential / Contraception in males and females Women of childbearing potential should use effective method of contraception. If pregnancy occurs in a woman treated with pomalidomide, ...
Effects on ability to drive and use machines
Pomalidomide has minor or moderate influence on the ability to drive and use machines. Fatigue, depressed level of consciousness, confusion, and dizziness have been reported with the use of pomalidomide. ...
Undesirable effects
Summary of the safety profile Pomalidomide in combination with bortezomib and dexamethasone The most commonly reported blood and lymphatic system disorders were neutropenia (46.8%), thrombocytopenia (36.7%) ...
Overdose
Pomalidomide doses as high as 50 mg as a single dose in healthy volunteers, and 10 mg as once-daily multiple doses in multiple myeloma patients have been studied without reported serious adverse reactions ...
Pharmacodynamic properties
Pharmacotherapeutic group: Immunosuppressants, Other immunosuppressants ATC code: L04AX06 Mechanism of action Pomalidomide has direct anti-myeloma tumoricidal activity, immunomodulatory activities and ...
Pharmacokinetic properties
Absorption Pomalidomide is absorbed with a maximum plasma concentration (C<sub>max</sub>) occurring between 2 and 3 hours and is at least 73% absorbed following administration of single oral dose. The ...
Preclinical safety data
Repeat-dose toxicology studies In rats, chronic administration of pomalidomide at doses of 50, 250, and 1000 mg/kg/day for 6 months was well tolerated. No adverse findings were noted up to 1000 mg/kg/day ...
List of excipients
Capsule contents: Mannitol (E421) Starch, pregelatinised Sodium stearyl fumarate Capsule shell: Imnovid 1 mg hard capsules: Gelatin Titanium dioxide (E171) Indigotine (E132) Yellow iron oxide (E172) White ...
Incompatibilities
Not applicable.
Shelf life
4 years.
Special precautions for storage
This medicinal product does not require any special storage conditions.
Nature and contents of container
The capsules are packaged in Polyvinyl chloride (PVC)/ polychlorotrifluoroethylene (PCTFE) blisters with push through aluminium foil. Pack size of 14 or 21 capsules. Not all pack size may be marketed. ...
Special precautions for disposal and other handling
Capsules should not be opened or crushed. If powder from pomalidomide makes contact with the skin, the skin should be washed immediately and thoroughly with soap and water. If pomalidomide makes contact ...
Marketing authorization holder
Celgene Europe B.V., Winthontlaan 6 N, 3526 KV, Utrecht, Netherlands
Marketing authorization number(s)
Imnovid 1 mg hard capsules: EU/1/13/850/001 EU/1/13/850/005 Imnovid 2 mg hard capsules: EU/1/13/850/002 EU/1/13/850/006 Imnovid 3 mg hard capsules: EU/1/13/850/003 EU/1/13/850/007 Imnovid 4 mg hard capsules: ...
Date of first authorization / renewal of the authorization
Date of first authorisation: 05 August 2013 Date of latest renewal: 11 July 2018
Πηγαίο έγγραφο
Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:
