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: Kineret 100 mg solution for injection in a pre-filled syringe (2011)

Εκδότης

Εκδότης Swedish Orphan Biovitrum Ltd
Διεύθυνση 1 Fordham House Court, Fordham House Estate, Newmarket Road, Cambridgeshire, CB7 5LL
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

Kineret 100 mg solution for injection in a pre-filled syringe.

Qualitative and quantitative composition

Each pre-filled syringe contains 100 mg of anakinra* per 0.67 ml (150 mg/ml). * Human interleukin-1 receptor ...

Pharmaceutical form

Solution for injection (injection) in a pre-filled syringe. Clear, colourless-to-white solution for injection ...

Therapeutic indications

Kineret is indicated for the treatment of the signs and symptoms of rheumatoid arthritis in combination ...

Posology and method of administration

Kineret treatment should be initiated and supervised by specialist physicians experienced in the diagnosis ...

Contraindications

Hypersensitivity to the active substance, any of the excipients or to E. coli derived proteins. Kineret ...

Special warnings and precautions for use

Allergic reactions Allergic reactions, including anaphylactic reactions and angioedema have been reported ...

Interaction with other medicinal products and other forms of interaction

Interactions between Kineret and other medicinal products have not been investigated in formal studies. ...

Fertility, pregnancy and lactation

There are limited amount of data from the use of anakinra in pregnant women. However, reproductive studies ...

Effects on ability to drive and use machines

Not relevant.

Undesirable effects

In all placebo-controlled studies, the most frequently reported adverse reactionwith Kineret was injection ...

Overdose

No dose-limiting toxicities were observed during clinical trials in rheumatoid arthritis patients. In ...

Pharmacodynamic properties

Pharmacotherapeutic group: Immunosuppressants, Interleukin inhibitors ATC code: L04AC03 Anakinra neutralises ...

Pharmacokinetic properties

The absolute bioavailability of anakinra after a 70 mg SC bolus injection in healthy subjects (n = 11) ...

Preclinical safety data

Anakinra had no observed effect on the fertility, early development, embryo-foetal development, or peri- ...

List of excipients

Sodium citrate Sodium chloride Disodium edetate Polysorbate 80 Sodium hydroxide Water for injections ...

Incompatibilities

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

Shelf life

3 years.

Special precautions for storage

Store in a refrigerator (2°C – 8°C). Do not freeze. Store in the original container in order to protect ...

Nature and contents of container

0.67 ml of solution for injection in a pre-filled syringe (Type I glass) with a plunger stopper (bromobutyl ...

Special precautions for disposal and other handling

Kineret is a sterile unpreserved solution. For single use only. Do not shake. Allow the pre-filled syringe ...

Marketing authorization holder

Swedish Orphan Biovitrum AB (publ) SE-112 76 Stockholm Sweden

Marketing authorization number(s)

EU/1/02/203/001 – 1-pack EU/1/02/203/002 – 7-pack EU/1/02/203/003 – 28-pack

Date of first authorization / renewal of the authorization

Date of first authorisation: 8 March 2002 Date of latest renewal: 20 March 2007

Date of revision of the text

02/2011
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.