Λογότυπο www.galinos.gr Beta
 

Ιατροφαρμακευτική πληροφόρηση για τον επαγγελματία υγείας

Φάρμακα Δραστικές ουσίες Συμπληρώματα διατροφής Έλεγχος συγχορήγησης Νόσοι ICD-10
Κλαύδιος Γαληνός
Είσοδος χρηστών
Όνομα χρήστη
Συνθηματικό
Εικονίδιο Είσοδος χρήστη
Εικονίδιο Δωρεάν εγγραφή
Εικονίδιο Ανανέωση συνθηματικού

Ακολουθήστε μας Λογότυπο Facebook Λογότυπο Twitter

Αναζήτηση σε 63811 καταχωρήσεις
Εικονίδιο αναζήτησης

Βιβλιογραφική αναφορά

Προτάσεις

SPC, UK: Benlysta 120 mg and 400 mg powder for concentrate for solution for infusion (2012)

Εκδότης

Εκδότης GlaxoSmithKline UK
Διεύθυνση Stockley Park West, Uxbridge, Middlesex, UB11 1BT
Σφάλμα Για την προβολή της πλήρους καταχώρησης χρειάζεται να έχετε συνδρομή σε ισχύ (αγορά συνδρομής).
Ολοκληρώνοντας τη διαδικασία δωρεάν εγγραφής θα αποκτήσετε, χωρίς καμία δέσμευση εκ μέρους σας, συνδρομή διάρκειας 30 ημερών.

Περιεχόμενα

Name of the medicinal product

Benlysta® 120 mg powder for concentrate for solution for infusion. Benlysta® 400 mg powder for concentrate ...

Qualitative and quantitative composition

Each vial contains 120 mg of belimumab. After reconstitution, the solution contains 80 mg belimumab per ...

Pharmaceutical form

Powder for concentrate for solution for infusion. White to off-white powder.

Therapeutic indications

Benlysta is indicated as add-on therapy in adult patients with active, autoantibody-positive systemic ...

Posology and method of administration

Benlysta treatment should be initiated and supervised by a qualified physician experienced in the diagnosis ...

Contraindications

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

Special warnings and precautions for use

Benlysta has not been studied in the following patient groups, and is not recommended in: severe active ...

Interaction with other medicinal products and other forms of interaction

No interaction studies have been performed.

Fertility, pregnancy and lactation

Women of childbearing potential/Contraception in males and females Women of child-bearing potential must ...

Effects on ability to drive and use machines

No studies on the effects on the ability to drive and use machines have been performed. No detrimental ...

Undesirable effects

Summary of the safety profile The safety of Benlysta in patients with SLE has been evaluated in 3 placebo-controlled ...

Overdose

There is no clinical experience with overdose of Benlysta. Two doses up to 20 mg/kg administered 21 days ...

Pharmacodynamic properties

Pharmacotherapeutic group: Selective immunosuppressants ATC code: L04AA26 Mechanism of action Benlysta ...

Pharmacokinetic properties

The pharmacokinetic parameters quoted below are based on population parameter estimates for the 563 patients ...

Preclinical safety data

Nonclinical data reveal no special hazard for humans based on studies of repeated dose toxicity and toxicity ...

List of excipients

Citric acid monohydrate (E330) Sodium citrate (E331) Sucrose Polysorbate 80

Incompatibilities

Belimumab is not compatible with 5% glucose. This medicinal product must not be mixed with other medicinal ...

Ημερομηνία λήξης

Unopened vials: 4 years. Reconstituted solution After reconstitution with water for injections, the reconstituted ...

Special precautions for storage

Unopened vials: Store in a refrigerator (2°C 8°C). Do not freeze. Store in the original carton in order ...

Nature and contents of container

120 mg vial: Type 1 glass vials (5 ml), sealed with a latex-free, siliconised chlorobutyl rubber stopper ...

Special precautions for disposal and other handling

Preparation of the solution for infusion Reconstitution Reconstitution and dilution must be carried out ...

Marketing authorization holder

Glaxo Group Limited Glaxo Wellcome House Berkeley Avenue Greenford Middlesex UB6 0NN United Kingdom ...

Marketing authorization number(s)

Benlysta 120 mg Powder for concentrate for solution for infusion: EU/1/11/700/001 Benlysta 400 mg Powder ...

Date of first authorization / renewal of the authorization

Date of first authorisation: 13 July 2011

Date of revision of the text

24th October 2012
Απαγορεύεται η αναπαραγωγή και αναδιανομή. Το έργο επεξεργασίας των παραπάνω πληροφοριών αποτελεί πνευματική ιδιοκτησία της Ergobyte Πληροφορική Α.Ε. και προστατεύεται από τη νομοθεσία περί πνευματικών δικαιωμάτων.