HUMIRA SMPC PDF

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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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Of patients who were randomised to Humira 40 mg every other week, patients continued on Humira 40 mg every other week for 5 years. In order to improve traceability of biological medicinal products, the nameand the batch number of the administered product should be clearly recorded.

Humira can only be obtained by prescription. For detailed information on the use of Humira in all conditions, including when it can be spmc in children, see the summary of product characteristics. Doses of 20 or 40 mg of Humira were given by subcutaneous injection every other week with placebo on alternative weeks or every week for 26 weeks; placebo was given every week for the same duration.

Humira is a medicine that acts on the immune system and is used to treat the following conditions: The mean trough concentrations were maintained in patients who himira to receive adalimumab treatment eow for 52 weeks. During 52 weeks of studies UC-I and UC-II, lower rates of all-cause hospitalisations and UC-related hospitalisations were observed for the adalimumab-treated arm compared to the placebo arm.

Patients on Humira may receive concurrent vaccinations, except for live vaccines.

AbbVie Receives CHMP Positive Opinion for Humira | PharmaLive

Adverse events of the haematologic system, including medically significant cytopenia e. Humira is indicated for the treatment of paediatric chronic non-infectious anterior uveitis in patients from 2 years of age who have had an inadequate response to or are intolerant to conventional therapy, or in whom conventional therapy is inappropriate.

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In himira exploratory clinical huimra evaluating the use of another TNF-antagonist, infliximab, in patients with moderate to severe chronic obstructive pulmonary disease COPD humirw, more malignancies, mostly in the lung or head and neck, were reported in infliximab-treated patients compared with control patients. Rare reports of pancytopenia including aplastic anaemia have been reported with TNF-antagonists.

After single intravenous doses ranging from 0. Melanoma and Merkel cell carcinoma have also been reported in patients treated with TNF-antagonists including adalimumab see section 4.

Humira | European Medicines Agency

For further information, see the package leaflet. Methotrexate should be continued during treatment with Humira. Mannitol Polysorbate 80 Water for injections. Doses of 20, 40 or 80 mg of Humira or placebo were given every other week for 24 weeks. Uveitis is an inflammation of the uvea, which includes the iris, choroid, and the ciliary body in the eye.

The safety of Humira in paediatric patients with plaque psoriasis has been assessed for a mean of 13 months. Glucocorticoids, salicylates, nonsteroidal anti-inflammatory drugs, or analgesics can be continued during treatment with Humira. Humira 40 humiira Weekly.

A marketing authorization decision is anticipated by September. These trials included rheumatoid arthritis patients with short term and long standing disease, juvenile idiopathic arthritis polyarticular juvenile uumira arthritis and enthesitis-related arthritis as well as axial spondyloarthritis ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of ASpsoriatic arthritis, Crohn’s disease, ulcerative colitis, psoriasis, hidradenitis suppurativa and uveitis patients.

Humira has not been studied in patients aged less than 2 years. Most Recent Most Recent. Cases of worsening congestive heart failure have also been reported in patients receiving Humira. Radiographic changes were assessed in the psoriatic arthritis studies.

Maintenance of remission and response rates are presented in Table Humira is given as an injection under the skin, usually every 2 weeks. If a patient develops symptoms suggestive of a lupus-like syndrome following treatment with Humira and is positive for antibodies against double-stranded DNA, further treatment with Humira should not be given see section 4. 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: In the open label period of the study, PASI 75 and PGA clear or minimal responses were maintained for up to an additional 52 weeks with no new safety findings.

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The primary efficacy endpoint was the proportion of patients with no flare by Week 68 of the study. The most common side effects with Humira seen in more than 1 patient in 10 are infections including in the nose, throat and sinusesinjection site reactions redness, itching, bleeding, pain or swellingheadache and muscle and bone pain. The predicted exposures indicate that in the absence of methotrexate, a loading dose may lead to an initial increase in systemic exposure.

Improvement in health-related quality of life and physical function was maintained during the wmpc extension through Week Pregnancy A large number approximately of prospectively collected pregnancies exposed to adalimumab resulting in live birth with known outcomes, including more than exposed during the first trimester, does not indicate an increase in the rate of malformation in the newborn.

The safety and efficacy of Humira in children aged years have not yet been established.

Humira 40 mg solution for injection in pre-filled syringe

The benefits and risks of continued 40 mg weekly or 80 mg every other week therapy should be carefully reconsidered in a patient with an inadequate response after the increase in dosage see section 5. The proportion of patients who discontinued treatment due to adverse events during the double-blind, controlled portion of pivotal studies was 5. Treatment with Humira may result in the formation of autoimmune antibodies.