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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Humura and cholelithiasis, hepatic steatosis, bilirubin increased. Clinical results were assessed for induction of remission at Week 8 and for maintenance of remission at Week The recommended dose of Humira for patients with Crohn’s disease from 6 to 17 years of age is based on body weight Table 4. The safety of Humira in paediatric patients with plaque psoriasis has been assessed for a mean of 13 months. Special populations Elderly No dose adjustment is required.

Taking these results into consideration, Humira is recommended for use in combination with Smpv and for use as monotherapy in patients for whom MTX use is not appropriate see section 4. Humira must not be used in patients with active tuberculosis or other severe infections, or in patients with moderate to severe heart failure an inability of the heart to pump enough blood around the body.

Accessed July 13, [6] Ramanan, A. To bookmark a medicine you must sign up and log in. Psoriasis 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.

There is insufficient evidence of the efficacy of Humira in patients with ankylosing spondylitis-like psoriatic arthropathy due to the small number of patients studied.

Ankylosing spondylitis, axial spondyloarthritis without radiographic evidence of AS and psoriatic arthritis. There are no clinical trials with Humira in adolescent patients with HS. A similar safety profile was observed during retreatment as before withdrawal.

Humira 40 mg solution for injection in pre-filled syringe

In an analysis in which all patients who dropped out of the study for adverse events or lack of efficacy, or who dose-escalated, were considered non-responders, PASI 75 and PGA of clear or minimal response rates in these patients were In CD Study II, patients who had lost response or were intolerant to infliximab were randomised to receive either mg Humira at Week 0 and 80 mg at Week 2 or placebo at Weeks 0 and 2.

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This information is intended for use by health professionals. There may be a need for dose interruption, for instance before surgery or if a serious infection occurs.

Adalimumab may cross the placenta into the serum of infants born to women treated with adalimumab during pregnancy. The primary efficacy endpoint was the proportion of patients with no flare by Week 68 of the study. No data are available. Uveitis associated with juvenile idiopathic arthritis. Date of issue of marketing authorisation valid throughout the European Union. Some patients who experience decrease in their response to 40 mg every other week may benefit from an increase in dosage to bumira mg Humira every week or 80 mg every other week.

The posology of Humira in these patients has been determined from pharmacokinetic modelling and simulation see section 5.

Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. Regarding combination with disease modifying anti-rheumatic drugs other than methotrexate see sections 4.

The number of all cause hospitalisations in the adalimumab treatment group was 0.

Humira 40 mg solution for injection in spmc pen Humira 40 mg solution for injection in single-use pre-filled pen for patient use containing a huimra syringe. Patients adding Humira also had less joint s,pc and less reduction in physical function after a year.

The European Commission granted a marketing authorisation valid throughout the European Union for Humira on 8 September The observed rate of humiga skin cancers is approximately 9. Humira can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.

In the controlled portions of clinical trials of TNF-antagonists, more cases of malignancies including lymphoma have been observed among patients receiving a TNF-antagonist compared with control patients. Although not statistically significant, the majority of patients demonstrated clinical improvement in secondary endpoints such as number of sites of enthesitis, tender joint count TJCswollen joint count SJCPediatric ACR 50 response, and Pediatric ACR 70 response.

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The safety and efficacy of multiple doses of Humira were assessed in adult patients with moderately to severely active ulcerative colitis Mayo score 6 to 12 with endoscopy subscore of 2 to 3 in randomised, double-blind, placebo-controlled studies.

For practical information about using Humiira, patients should read the package leaflet or contact their doctor or pharmacist. Subjects who flared during the double-blind period were allowed Humira 40 mg eow rescue therapy for at least 12 weeks. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Humira | European Medicines Agency

In period A, patients received placebo or Humira at an initial dose of 80 mg followed by 40 mg xmpc other week starting one week after the initial dose. After single intravenous doses ranging from 0. Over all 19 subjects, of which 11 of the baseline age group 4 to 12 and 8 of the baseline age group 13 to 17 years were treated 6 years bumira longer. By continuing to browse the site you are agreeing to our policy on the use of cookies. The combination of Humira and anakinra is not recommended see section 4.

AbbVie Receives CHMP Positive Opinion for Humira | PharmaLive

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Humira have also been included in the summary of product characteristics and the package leaflet. Humira treatment should be initiated and supervised ampc specialist physicians experienced in the diagnosis and treatment of conditions for which Humira is indicated.

Reports of serious allergic reactions including anaphylaxis have been received following Humira administration. Metabolism hujira nutrition disorders. The European Medicines Agency has deferred the obligation to submit the results of the studies with Humira in one or more subsets of the paediatric population in ulcerative colitis, see section 4.

In the pivotal trials, anti-adalimumab antibodies were identified in 5. Significant response was first observed at Week 2 and maintained through mspc weeks Table