HUMIRA SMPC PDF

Patients who develop a new infection while undergoing treatment with Humira should be monitored closely. Administration of Humira should be discontinued if a. HIGHLIGHTS OF PRESCRIBING INFORMATION. These highlights do not include all the information needed to use. HUMIRA safely and effectively. See full. HUMIRA safely and effectively. See full prescribing information for. HUMIRA. HUMIRA (adalimumab) injection, for subcutaneous use. Initial U.S. Approval:

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The primary endpoint was the time to treatment failure, defined according to multiple components of intraocular inflammation that was based on the Standardization of Uveitis Nomenclature SUN criteria.

The safety profile for patients with uveitis treated with Humira every other week was consistent with the known safety profile of Humira. In this multicenter, double-masked, randomized, placebo-controlled trial, researchers assessed the efficacy and safety of HUMIRA in children and adolescents two years of age or older who had active JIA-associated uveitis.

Initial dose of 40 mg, followed by 40 mg given every other week starting one week after the initial dose. Marketing authorisation number s 9.

Given orally, immunoglobulin G proteins undergo intestinal proteolysis and have poor bioavailability. In Study I, improvements in the physical and mental component summary scores of the SF were also significant compared to placebo.

Humira 40 mg solution for injection in pre-filled syringe Humira uhmira mg solution for injection in single-use pre-filled syringe type I glass with a plunger stopper bromobutyl rubber and a needle with a needle shield thermoplastic elastomer. Taking these results into consideration, Humira is recommended for use in combination with MTX and for use as monotherapy jumira patients for whom MTX use is not appropriate see section 4.

Patients who develop humirs new infection while undergoing treatment with Humira should be monitored closely and undergo a complete diagnostic evaluation. The observed rate of non-melanoma skin cancers is approximately 9.

Safety of the recommended adalimumab dose spc the adolescent HS population is based on cross-indication safety profile of adalimumab in both adults and paediatric patients at similar or more frequent doses see section 5. By continuing to browse the site you are agreeing to our policy on the use of cookies. Humira is administered every other week via subcutaneous injection.

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Humira | European Medicines Agency

The impact of long-term treatment with Humira on the development of autoimmune diseases is unknown. Back to top AbbVie Ltd contact details. In paediatric uveitis, there is no experience in the treatment with Humira without concomitant treatment with methotrexate. Women of child bearing potential Women of childbearing potential should consider the use of adequate contraception to prevent pregnancy hmuira continue its use for at least five months after the last Humira treatment.

Patients subsequently underwent a mandatory taper schedule, with complete corticosteroid discontinuation by Week Over all 19 subjects, of which 11 of the baseline age group 4 to 12 and 8 ssmpc the baseline age group 13 to 17 years were treated 6 years or longer. Humira is contraindicated in moderate to severe heart humiraa see section 4.

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Table 6 Undesirable Effects. Opportunistic infections, including invasive fungal infections have been observed in patients receiving Humira.

A risk for the development of malignancies in children and adolescents treated with TNF-antagonists cannot be excluded. The median time to treatment failure was With the current knowledge, a possible risk for the development of lymphomas, leukaemia, and other malignancies in patients treated with a TNF-antagonist cannot be excluded.

Extensive pharmaceutical business and marketing intelligence. The following list of adverse reactions is based on experience from clinical trials and on postmarketing experience and are displayed by system organ class and frequency in Table 6 below: Humira is indicated for the treatment of active moderate to severe hidradenitis suppurativa acne inversa in adults and adolescents from 12 years of age with an inadequate response to conventional systemic HS therapy see sections 5.

Skip to main content. There is no relevant use of Humira in children aged less than 4 years for this indication. Keep the pre-filled syringe or pre-filled pen in its outer carton in order to protect from light.

After 12 weeks of therapy, patients who had received Humira in Period A were re-randomised in Period B to 1 of 3 treatment groups Humira 40 mg every week, Humira 40 mg every other week, or placebo from Week 12 to Week The syringe inside the pen is made from type 1 glass with a plunger stopper bromobutyl rubber and a needle with a needle shield thermoplastic elastomer. These include rare reports of pancytopenia, aplastic anaemia, central and peripheral demyelinating events and reports of lupus, lupus-related conditions and Stevens-Johnson syndrome.

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Melanoma and Merkel cell carcinoma have also been reported in patients treated with TNF-antagonists including adalimumab see section 4. There are no data available comparing Humira and MTX beyond 16 weeks of therapy.

Rare reports of pancytopenia including aplastic anaemia have been reported with TNF-antagonists. Tabulated list of adverse reactions The following list of adverse reactions is based on experience from clinical trials and on postmarketing experience and are displayed by system organ class and frequency in Table 6 below: Reports included cases of pulmonary and extra-pulmonary i.

The recommended dose of Humira for adult patients is an initial dose of 80 mg administered subcutaneously, followed by 40 mg subcutaneously given every other week starting one week after the initial dose.

Abdominal pain, nausea and vomiting.

Humira 40 mg solution for injection in pre-filled syringe

PR Newswire mediasite prnewswire. No patients developed lupus nephritis or central nervous system symptoms.

In monotherapy, some patients who experience a decrease in their response to Humira 40 mg every other week may benefit from an increase in dosage to 40 mg adalimumab every week or 80 mg every other week. Among those, 48 patients showed no progression of structural damage defined by a change from baseline in the mTSS of 0. In patients who have been exposed to tuberculosis and patients who have travelled in areas of high risk of tuberculosis or endemic mycoses, such as histoplasmosis, coccidioidomycosis, or blastomycosis, hmira risk and benefits of treatment with Humira should be considered prior to initiating therapy see Other opportunistic infections.

Approximately half the cases were lymphomas.