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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During treatment with Humira, other concomitant therapies e. First medicine recommended for approval skpc hidradenitis suppurativa. Changes since initial authorisation of medicine List item. The safety and efficacy of Humira were assessed in two randomized, double-blind placebo controlled studies in patients with non-radiographic axial spondyloarthritis nr-axSpA.

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 huira is inappropriate. After doses of 0. Mood alterations including depressionanxiety, insomnia.

Patients smppc with Humira should be given the Patient Reminder Card. Humira has been studied in rheumatoid arthritis, polyarticular juvenile idiopathic arthritis and psoriatic arthritis patients taking Humira as monotherapy and those taking concomitant methotrexate. Any unused medicinal product or waste material should be disposed of in accordance with local requirements. Clinical results were assessed for induction of remission at Week 8 and for maintenance of remission at Week Of ampc remaining patients, evaluable patients reached 78 weeks of open-label adalimumab treatment.

Product details Name Humira. Reproductive system and breast disorders. If latent tuberculosis is suspected, a physician with expertise in the treatment of tuberculosis should be consulted. Humira hummira indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine 6-MP or azathioprine AZAor who are intolerant to or have medical contraindications for such therapies.

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The second received 20 mg of Humira every week for 52 weeks. The long half-life of adalimumab should be taken into consideration if a surgical procedure is planned. Humira 40 mg solution for injection in single-use pre-filled pen for patient use containing a pre-filled syringe.

Clinical remission and clinical response defined as reduction in PCDAI score of at least 15 points from Baseline rates are presented in Table Humira is a medicine that acts on the immune system and is used to treat the following conditions:. Patients who had been randomised to placebo in Period A were assigned to receive Humira 40 mg every week in Period B. The predicted exposures indicate that in the absence of methotrexate, a loading dose may lead to an initial increase in systemic exposure.

There is limited safety experience of surgical procedures in patients treated with Humira.

Muscle spasms including blood creatine phosphokinase increased. Adalimumab should only be used during pregnancy if clearly needed.

No dose recommendations can be made. If adequate response is achieved with 40 mg every week or 80 mg every other week, the dosage may subsequently be ssmpc to 40 mg every other week. In a developmental toxicity study conducted in monkeys, there was no indication of maternal toxicity, embryotoxicity or teratogenicity. A risk for the development of malignancies in patients treated with TNF-antagonists cannot huimra excluded. Find out more here. This rare type of T-cell lymphoma has a very aggressive disease course and is usually fatal.

Humira 40 mg solution for injection in pre-filled syringe

Antibiotics may be continued during treatment with Humira if necessary. Approximately twice the proportion of patients in the placebo humiea in the first 12 weeks of Studies HS-I and HS-II, compared with those in the Humira group experienced worsening of abscesses The patients improved following discontinuation of therapy.

PR Newswire mediasite prnewswire. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme:.

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Humira is indicated smpv the treatment of active enthesitis-related arthritis in patients, 6 years of age and older, who have had an inadequate response to, or who are intolerant of, conventional therapy see section 5.

Formation of anti-adalimumab antibodies is associated with dmpc clearance and reduced efficacy of adalimumab. Therefore, caution should be exercised when using any TNF-antagonist in COPD patients, as well as in patients with increased risk for malignancy due to heavy smoking.

The results for the 40 mg every other week dose are summarised in Table 7.

AbbVie Receives CHMP Positive Opinion for Humira | PharmaLive

Over all 19 subjects, of which 11 of the baseline age group 4 to 12 and 8 of smpd baseline age group hunira to 17 years were treated 6 years or longer. The reported rates for non-melanoma skin cancers and lymphomas are approximately 0. In the larger AS study I with patients, results showed statistically significant improvement of the signs and symptoms of ankylosing spondylitis in patients treated with Humira compared to placebo.

Humira is administered every other week via subcutaneous injection.

Revised SPC: Humira (adalimumab) Pre-filled Pen, Pre-filled Syringe and Vial –

Multiple sclerosis, demyelinating disorders e. Uveitis Humira is indicated for the treatment of non-infectious intermediate, posterior and panuveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid-sparing, or in whom corticosteroid treatment is inappropriate.

There were no distinct differences between adalimumab-treated and untreated women for the secondary endpoints spontaneous abortions, minor birth defects, preterm delivery, birth size and serious or opportunistic infections and hmuira stillbirths or malignancies were reported.

These packs will include information on the safety of the medicine and an alert card to be given to patients.