BLINCYTO Powder for concentrate solution (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
BLINCYTO 38.5 micrograms powder for concentrate and solution for solution for infusion.
Qualitative and quantitative composition
One vial of powder contains 38.5 micrograms blinatumomab. Reconstitution with water for injections results in a final blinatumomab concentration of 12.5 micrograms/mL. Blinatumomab is produced in Chinese ...
Pharmaceutical form
Powder for concentrate and solution for solution for infusion. BLINCYTO powder (powder for concentrate): White to off-white powder. Solution (stabiliser): Colourless-to-slightly yellow, clear solution ...
Therapeutic indications
BLINCYTO is indicated as monotherapy for the treatment of adults with Philadelphia chromosome negative CD19 positive relapsed or refractory B-precursor acute lymphoblastic leukaemia (ALL). BLINCYTO is ...
Posology and method of administration
Treatment should be initiated under the direction of and supervised by physicians experienced in the treatment of haematological malignancies. For the treatment of Philadelphia chromosome negative relapsed ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Breast-feeding (see section 4.6).
Special warnings and precautions for use
Neurologic events Neurologic events including events with a fatal outcome have been observed. Grade 3 (CTCAE version 4.0) or higher (severe or life-threatening) neurologic events following initiation of ...
Interaction with other medicinal products and other forms of interaction
No formal drug interaction studies have been performed. Results from an in vitro test in human hepatocytes suggest that blinatumomab did not affect CYP450 enzyme activities. Initiation of BLINCYTO treatment ...
Fertility, pregnancy and lactation
Pregnancy Reproductive toxicity studies have not been conducted with blinatumomab. In an embryo-foetal developmental toxicity study conducted in mice, the murine surrogate molecule crossed the placenta ...
Effects on ability to drive and use machines
Blinatumomab has major influence on the ability to drive and use machines. Confusion and disorientation, coordination and balance disorders, risk of seizures and disturbances in consciousness can occur ...
Undesirable effects
Summary of the safety profile The adverse reactions described in this section were identified in clinical studies of patients with B-precursor ALL (N=843). The most serious adverse reactions that may occur ...
Overdose
Overdoses have been observed including one patient who received 133-fold the recommended therapeutic dose of BLINCYTO delivered over a short duration. Overdoses resulted in adverse reactions which were ...
Pharmacodynamic properties
Pharmacotherapeutic group: Antineoplastic agents, other Antineoplastic agents ATC code: L01XC19 Mechanism of action Blinatumomab is a bispecific T-cell engager antibody construct that binds specifically ...
Pharmacokinetic properties
The pharmacokinetics of blinatumomab appear linear over a dose range from 5 to 90 mcg/m²/day (approximately equivalent to 9-162 mcg/day) in adult patients. Following continuous intravenous infusion, the ...
Preclinical safety data
Repeat-dose toxicity studies conducted with blinatumomab and the murine surrogate revealed the expected pharmacologic effects (including release of cytokines, decreases in leukocyte counts, depletion of ...
List of excipients
Powder: Citric acid monohydrate (E330) Trehalose dihydrate Lysine hydrochloride Polysorbate 80 Sodium hydroxide (for pH-adjustment) Solution (stabiliser): Citric acid monohydrate (E330) Lysine hydrochloride ...
Incompatibilities
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Shelf life
Shelf life Unopened vials: 5 years. Reconstituted solution: Chemical and physical in-use stability has been demonstrated for 24 hours at 2°C-8°C or 4 hours at or below 27°C. From a microbiological point ...
Special precautions for storage
Store and transport refrigerated (2°C-8°C). Do not freeze. Store the vials in the original package in order to protect from light. For storage conditions after reconstitution and dilution of the medicinal ...
Nature and contents of container
Each BLINCYTO pack contains 1 vial of powder for concentrate for solution for infusion and 1 vial of solution (stabiliser): 38.5 micrograms blinatumomab powder in a vial (type I glass) with a stopper (elastomeric ...
Special precautions for disposal and other handling
Aseptic preparation Aseptic handling must be ensured when preparing the infusion. Preparation of BLINCYTO should be: performed under aseptic conditions by trained personnel in accordance with good practice ...
Marketing authorization holder
Amgen Europe B.V., Minervum 7061, 4817 ZK Breda, The Netherlands
Marketing authorization number(s)
EU/1/15/1047/001
Date of first authorization / renewal of the authorization
Date of first authorisation: 23 November 2015 Date of last renewal: 19 April 2018
Πηγαίο έγγραφο
Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:
