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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

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Βιβλιογραφική αναφορά

Προτάσεις

SPC, UK: Humira Pre-filled Pen, Pre-filled Syringe and Vial (2012)

Εκδότης

Εκδότης AbbVie Limited
Διεύθυνση Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead, SL6 4XE
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

Humira 40 mg solution for injection in pre-filled syringe. Humira 40 mg solution for injection in pre-filled ...

Qualitative and quantitative composition

Each 0.8 ml single dose pre-filled syringe contains 40 mg of adalimumab. Each 0.8 ml single dose pre-filled ...

Pharmaceutical form

Clear solution for injection in pre-filled syringe. Clear solution for injection in pre-filled pen. ...

Therapeutic indications

Rheumatoid arthritis Humira in combination with methotrexate, is indicated for: the treatment of moderate ...

Posology and method of administration

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

Contraindications

Hypersensitivity to the active substance or to any of the excipients. Active tuberculosis or other severe ...

Special warnings and precautions for use

Infections Patients taking TNF-antagonists are more susceptible to serious infections. Impaired lung ...

Interaction with other medicinal products and other forms of interaction

Humira has been studied in rheumatoid arthritis, polyarticular juvenile idiopathic arthritis and psoriatic ...

Pregnancy and lactation

Pregnancy For Humira, limited clinical data on exposed pregnancies are available In a developmental toxicity ...

Effects on ability to drive and use machines

Humira may have a minor influence on the ability to drive and use machines. Vertigo and visual impairment ...

Undesirable effects

Humira was studied in 7,615 patients in pivatol controlled and open label trials for up to 60 months ...

Overdose

No dose-limiting toxicity was observed during clinical trials. The highest dose level evaluated has been ...

Pharmacodynamic properties

Pharmacotherapeutic group: Selective immunosuppressive agents ATC code: L04AB04 Mechanism of action ...

Pharmacokinetic properties

After subcutaneous administration of a single 40 mg dose, absorption and distribution of adalimumab was ...

Preclinical safety data

Non-clinical data reveal no special hazard for humans based on studies of single dose toxicity, repeated ...

List of excipients

Mannitol Citric acid monohydrate Sodium citrate Sodium dihydrogen phosphate dihydrate Disodium phosphate ...

Incompatibilities

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

Shelf life

24 months.

Special precautions for storage

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

Nature and contents of container

Humira 40 mg solution for injection in single-use pre-filled syringe (type I glass) for patient use: ...

Special precautions for disposal and other handling

Humira 40 mg solution for injection does not contain preservatives. Any unused product or waste material ...

Marketing authorization holder

Abbott Laboratories Ltd Abbott House, Vanwall Business Park Vanwall Road Maidenhead Berkshire SL6 4XE ...

Marketing authorization number(s)

EU/1/03/256/001 EU/1/03/256/002 EU/1/03/256/003 EU/1/03/256/004 EU/1/03/256/005 EU/1/03/256/007 EU/1/03/256/008 ...

Date of first authorization / renewal of the authorization

Date of first authorisation: 8 September 2003 Date of latest renewal: 8 September 2008

Date of revision of the text

August 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.