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Ιατροφαρμακευτική πληροφόρηση για τον επαγγελματία υγείας

Φάρμακα Δραστικές ουσίες Συμπληρώματα διατροφής Έλεγχος συγχορήγησης Νόσοι ICD-10
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Βιβλιογραφική αναφορά

Προτάσεις

SPC, UK: Cimzia 200 mg solution for injection (2012)

Εκδότης

Εκδότης UCB Pharma Limited
Διεύθυνση 208 Bath Road, Slough, Berkshire, SL1 3WE
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

Cimzia 200 mg solution for injection.

Qualitative and quantitative composition

Each pre-filled syringe contains 200 mg certolizumab pegol in one ml. Certolizumab pegol is a recombinant, ...

Pharmaceutical form

Solution for injection in pre-filled syringe. Clear to opalescent, colourless to yellow solution. The ...

Therapeutic indications

Cimzia, in combination with methotrexate (MTX), is indicated for the treatment of moderate to severe, ...

Posology and method of administration

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

Contraindications

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

Special warnings and precautions for use

Infections Patients must be monitored closely for signs and symptoms of infections including tuberculosis ...

Interaction with other medicinal products and other forms of interaction

Concomitant treatment with methotrexate, corticosteroids, nonsteroidal anti-inflammatory drugs (NSAIDs) ...

Fertility, pregnancy and lactation

Women of childbearing potential Women of childbearing potential should use adequate contraception to ...

Effects on ability to drive and use machines

Cimzia may have a minor influence on the ability to drive and use machines. Dizziness (including vertigo, ...

Undesirable effects

Cimzia was studied in 2,367 patients with rheumatoid arthritis in controlled and open label trials for ...

Overdose

No dose-limiting toxicity was observed during clinical trials. Multiple doses of up to 800 mg subcutaneously ...

Pharmacodynamic properties

Pharmacotherapeutic group: Tumour necrosis factor alpha (TNFα) inhibitors ATC code: L04AB05 Mechanism ...

Pharmacokinetic properties

Certolizumab pegol plasma concentrations were broadly dose-proportional. Pharmacokinetics observed in ...

Preclinical safety data

The pivotal non-clinical safety studies were conducted in the cynomolgus monkey. In rats and monkeys, ...

List of excipients

Sodium acetate Sodium chloride Water for injections

Incompatibilities

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

Shelf life

18 months.

Special precautions for storage

Store in a refrigerator (2°C – 8°C). Do not freeze. Keep the pre-filled syringe in the outer carton in ...

Nature and contents of container

One ml pre-filled syringe (type I glass) with a plunger stopper (bromobutyl rubber), containing 200 mg ...

Special precautions for disposal and other handling

This medicinal product is for single use only. Any unused product or waste material should be disposed ...

Marketing authorization holder

UCB Pharma SA Allée de la Recherche 60 B-1070 Bruxelles Belgium

Marketing authorization number(s)

EU/1/09/544/001-002

Date of first authorization / renewal of the authorization

Date of first authorisation: 01 October 2009

Date of revision of the text

06/2012
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.