HUMIRA 40mg/0.4ml Solution for injection in pre-filled syringe / pen (2018)
Βιβλιογραφική αναφορά
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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 0.4 ml single dose pre-filled syringe contains 40 mg of adalimumab. Humira 40 mg solution for injection in pre-filled syringe with automatic ...
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 Polysorbate 80 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/1/03/256/012 EU/1/03/256/013 EU/1/03/256/014 EU/1/03/256/015 Humira 40 mg solution for injection in pre-filled syringe with automatic needle ...
Date of first authorization / renewal of the authorization
Date of first authorisation: 08 September 2003 Date of latest renewal: 08 September 2008
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