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
Πρόγραμμα συνδρομητών 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
®
 Περιεχόμενα  Φάρμακα Α - Ζ  Συγχορήγηση

HUMIRA 40mg/0.8ml Solution for injection in pre-filled syringe / pen (2018)

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

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

Qualitative and quantitative composition

Humira 40 mg solution for injection in pre-filled syringe: Each 0.8 ml single dose pre-filled syringe contains 40 mg of adalimumab. Humira 40 mg solution for injection in pre-filled pen: Each 0.8 ml single ...

Pharmaceutical form

Solution for injection. (injection) Clear, colourless solution.

Therapeutic indications

Rheumatoid arthritis Humira in combination with methotrexate, is indicated for: the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease-modifying ...

Posology and method of administration

Humira treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of conditions for which Humira is indicated. Ophthalmologists are advised to consult ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Active tuberculosis or other severe infections such as sepsis, and opportunistic infections (see section 4.4). ...

Special warnings and precautions for use

Traceability In order to improve traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. Infections Patients taking TNF-antagonists ...

Interaction with other medicinal products and other forms of interaction

Humira has been studied in rheumatoid arthritis, polyarticular juvenile idiopathic arthritis and psoriatic arthritis patients taking Humira as monotherapy and those taking concomitant methotrexate. Antibody ...

Fertility, pregnancy and lactation

Women of child bearing potential Women of childbearing potential should consider the use of adequate contraception to prevent pregnancy and continue its use for at least five months after the last Humira ...

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 may occur following administration of Humira (see section 4.8).

Undesirable effects

Summary of the safety profile Humira was studied in 9,506 patients in pivotal controlled and open label trials for up to 60 months or more. These trials included rheumatoid arthritis patients with short ...

Overdose

No dose-limiting toxicity was observed during clinical trials. The highest dose level evaluated has been multiple intravenous doses of 10 mg/kg, which is approximately 15 times the recommended dose.

Pharmacodynamic properties

Pharmacotherapeutic group: Immunosuppressants, Tumour Necrosis Factor alpha (TNF-α) inhibitors ATC code: L04AB04 Mechanism of action Adalimumab binds specifically to TNF and neutralises the biological ...

Pharmacokinetic properties

Absorption and distribution After subcutaneous administration of a single 40 mg dose, absorption and distribution of adalimumab was slow, with peak serum concentrations being reached about 5 days after ...

Preclinical safety data

Non-clinical data reveal no special hazard for humans based on studies of single dose toxicity, repeated dose toxicity, and genotoxicity. An embryo-foetal developmental toxicity/perinatal developmental ...

List of excipients

Mannitol Citric acid monohydrate Sodium citrate Sodium dihydrogen phosphate dihydrate Disodium phosphate dihydrate Sodium chloride Polysorbate 80 Sodium hydroxide 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: 2 years.

Special precautions for storage

Store in a refrigerator (2°C–8°C). Do not freeze. Keep the pre-filled syringe or pre-filled pen in its outer carton in order to protect from light. A single Humira pre-filled syringe or pre-filled pen ...

Nature and contents of container

Humira 40 mg solution for injection in pre-filled syringe: Humira 40 mg solution for injection in single-use pre-filled syringe (type I glass) with a plunger stopper (bromobutyl rubber) and a needle with ...

Special precautions for disposal and other handling

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Marketing authorization holder

AbbVie Deutschland GmbH & Co. KG, Knollstrasse, 67061, Ludwigshafen, Germany

Marketing authorization number(s)

Humira 40 mg solution for injection in pre-filled syringe: EU/1/03/256/002 EU/1/03/256/003 EU/1/03/256/004 EU/1/03/256/005 Humira 40 mg solution for injection in pre-filled syringe with needle guard: ...

Date of first authorization / renewal of the authorization

Date of first authorisation: 08 September 2003 Date of latest renewal: 08 September 2008

Πηγαίο έγγραφο

Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση: