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 Περιεχόμενα  Φάρμακα Α - Ζ  Συγχορήγηση

HUMIRA 40mg/0.8ml Solution for injection (2018)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Humira 40 mg/0.8 ml solution for injection.

Qualitative and quantitative composition

Each 0.8 ml single dose vial contains 40 mg of adalimumab. Adalimumab is a recombinant human monoclonal antibody produced in Chinese Hamster Ovary cells. For the full list of excipients, see section 6.1. ...

Pharmaceutical form

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

Therapeutic indications

Juvenile idiopathic arthritis Polyarticular juvenile idiopathic arthritis Humira in combination with methotrexate is indicated for the treatment of active polyarticular juvenile idiopathic arthritis, in ...

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 Following the administration of 24 mg/m² (up to a maximum of 40 mg) subcutaneously every other week to patients with polyarticular juvenile idiopathic arthritis (JIA) who were ...

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 vial in the outer carton in order to protect from light.

Nature and contents of container

Humira 40 mg solution for injection in single-use vial (type I glass), fitted with rubber stoppers, aluminium crimps and flip-off seals. 1 Pack of 2 boxes each containing: 1 vial (0.8 ml sterile solution), ...

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)

EU/1/03/256/001

Date of first authorization / renewal of the authorization

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

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