Κλαύδιος Γαληνός
Δωρεάν εγγραφή Αποκτήσετε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr για έναν μήνα
Γαληνός Office Χρησιμοποιήστε δωρεάν το νέο cloud πρόγραμμα διαχείρισης κάθε σύγχρονου ιατρείου
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
Γαληνός Mobile Κατεβάστε τη δωρεάν εφαρμογή και απολαύστε τις υπηρεσίες του Galinos.gr σε κινητό ή tablet
Γνωρίζατε οτι... Μοιραζόμαστε μαζί σας γεγονότα της πορείας του Galinos.gr από το 2011 μέχρι σήμερα

FASENRA Solution for injection (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

Fasenra 30 mg solution for injection in pre-filled syringe. Fasenra 30 mg solution for injection in pre-filled pen.

Qualitative and quantitative composition

Pre-filled syringe: Each pre-filled syringe contains 30 mg benralizumab* in 1 mL. Pre-filled pen: Each pre-filled pen contains 30 mg benralizumab* in 1 mL. * Benralizumab is a humanised monoclonal antibody ...

Pharmaceutical form

Solution for injection in pre-filled syringe (injection). Solution for injection in pre-filled pen (injection) (Fasenra Pen). Clear to opalescent, colourless to yellow solution and may contain translucent ...

Therapeutic indications

Fasenra is indicated as an add-on maintenance treatment in adult patients with severe eosinophilic asthma inadequately controlled despite high-dose inhaled corticosteroids plus long-acting β-agonists (see ...

Posology and method of administration

Fasenra treatment should be initiated by a physician experienced in the diagnosis and treatment of severe asthma. After proper training in the subcutaneous injection technique and education about signs ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

Special warnings and precautions for use

Fasenra should not be used to treat acute asthma exacerbations. Patients should be instructed to seek medical advice if their asthma remains uncontrolled or worsens after initiation of treatment. Abrupt ...

Interaction with other medicinal products and other forms of interaction

In a randomized, double-blind parallel-group study of 103 patients aged between 12 and 21 years with severe asthma, the humoral antibody responses induced by seasonal influenza virus vaccination do not ...

Pregnancy and lactation

Pregnancy There is a limited amount of data (less than 300 pregnancy outcomes) from the use of benralizumab in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect ...

Effects on ability to drive and use machines

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

Undesirable effects

Summary of the safety profile The most commonly reported adverse reactions during treatment are headache (8%) and pharyngitis (3%). Anaphylactic reactions have been reported. Tabulated list of adverse ...

Overdose

Doses of up to 200 mg were administered subcutaneously in clinical trials to patients with eosinophilic asthma without evidence of dose-related toxicities. There is no specific treatment for an overdose ...

Pharmacodynamic properties

Pharmacotherapeutic group: Drugs for obstructive airway diseases, other systemic drugs for obstructive airway diseases ATC code: R03DX10 Mechanism of action Benralizumab is an anti-eosinophil, humanised ...

Pharmacokinetic properties

The pharmacokinetics of benralizumab were dose-proportional in patients with asthma following subcutaneous administration over a dose range of 2 to 200 mg. Absorption Following subcutaneous administration ...

Preclinical safety data

As benralizumab is a monoclonal antibody, no genotoxicity or carcinogenicity studies have been conducted. Animal toxicology and/or pharmacology Non-clinical data reveal no special hazards for humans based ...

List of excipients

Histidine Histidine hydrochloride monohydrate Trehalose dihydrate Polysorbate 20 Water for injections

Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

Shelf life

Shelf life: 3 years.

Special precautions for storage

Store in a refrigerator (2°C to 8°C). Fasenra may be kept at room temperature up to 25°C for a maximum of 14 days. After removal from the refrigerator, Fasenra must be used within 14 days or discarded. ...

Nature and contents of container

Pre-filled syringe: One mL solution in a single-use pre-filled syringe made from type I glass with a staked 29-gauge 1⁄2-inch (12.7 mm) stainless steel needle, rigid needle shield, and Fluorotec-coated ...

Special precautions for disposal and other handling

Fasenra solution for injection is supplied in a sterile single-use pre-filled syringe or pre-filled pen for individual use. Do not shake. Do not freeze. Prior to administration, warm Fasenra by leaving ...

Marketing authorization holder

AstraZeneca AB, SE-151 85 Södertälje, Sweden

Marketing authorization number(s)

EU/1/17/1252/001 1 pre-filled syringe EU/1/17/1252/002 1 pre-filled pen

Date of first authorization / renewal of the authorization

Date of first authorisation: 8 January 2018

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.