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:

Author: Dora Vudolabar
Country: Montserrat
Language: English (Spanish)
Genre: Education
Published (Last): 19 February 2009
Pages: 340
PDF File Size: 20.18 Mb
ePub File Size: 13.94 Mb
ISBN: 441-5-90812-628-1
Downloads: 1213
Price: Free* [*Free Regsitration Required]
Uploader: Dojas

Efficacy of adalimumab for the treatment of adolescent patients with HS is predicted based on the demonstrated efficacy and exposure-response relationship in adult HS patients and the likelihood that the disease course, pathophysiology, and drug effects are substantially similar to that of adults at the same exposure levels. Humira is a medicine that acts on the immune system and is used to treat the following conditions: Systemic infections including sepsis, candidiasis and influenzaintestinal infections including gastroenteritis viralskin and soft tissue infections including paronychia, cellulitis, impetigo, necrotising fasciitis and herpes zosterear infections, oral infections including herpes simplex, oral herpes and tooth infectionsreproductive tract infections including vulvovaginal mycotic infectionurinary tract infections including pyelonephritisfungal infections, joint infections.

There is no apparent correlation between the presence of anti-adalimumab antibodies and the occurrence of adverse events. Clinical response CR was maintained in and patients, respectively.

You are therefore advised to be selective about which sections or pages you wish to print. The smoc levels of free adalimumab not bound to anti-adalimumab antibodies, AAA were observed to be lower in patients with measurable AAA.

AbbVie Receives CHMP Positive Opinion for Humira | PharmaLive

Available data suggest that clinical response is usually achieved within weeks of treatment. Melanoma and Merkel cell carcinoma have also been reported in patients treated with TNF-antagonists including adalimumab see section 4. Humira has not been studied in patients with enthesitis-related arthritis aged less than 6 years. Qualitative and quantitative composition 3. Humira may have a minor influence on the ability to drive and humora machines.

  HELSINKI BILDIRGESI PDF

Humira | European Medicines Agency

Last updated March 31, After Week 2, patients in both adalimumab arms received 40 mg eow. Thus additional caution should be exercised in considering Humira treatment of these patients see section 4. There is a known association between intermediate uveitis and central demyelinating disorders. After subcutaneous administration of a single 40 mg dose, absorption and distribution of adalimumab was slow, humita peak serum concentrations being reached about 5 days after administration. In patients with enthesitis-related arthritis, anti-adalimumab antibodies were identified in Infections Patients taking TNF-antagonists are more susceptible to serious infections.

Humira 40 mg solution for injection in pre-filled syringe

Surgery There is limited safety experience of surgical procedures in patients treated with Humira. In order to improve traceability of biological medicinal products, the nameand the batch number of the administered product should be clearly recorded.

Some of those had a fatal outcome. At Week 16, more patients randomised to Humira 0. Consequently, these infants may be at increased risk for infection.

Veterinary regulatory Overview Research and development Marketing authorisation Post-authorisation. Paediatric population In general, the adverse events in paediatric patients were similar in frequency and type to those seen in adult patients.

There is limited safety experience in patients undergoing arthroplasty while receiving Humira. After adjustment for weight differences, gender and age appeared to have a minimal effect on adalimumab clearance. smpx

Psoriasis Humira is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy. Table 6 Undesirable Effects. The recommended Humira dose is 80 mg at Week 0 followed by 40 mg every other week starting at Week 1 via subcutaneous injection. RA studies III and V had an additional primary endpoint at 52 weeks of retardation of disease progression as detected by X-ray results.

  DIE LUSTIGE WITWE LIBRETTO PDF

In controlled hunira open label adult and paediatric studies with Humira, serious infections including fatal infections, which occurred rarely have been reported, which include reports of tuberculosis including miliary and extra-pulmonary locations and invasive humirz infections e. Not all presentations or pack sizes may be marketed. In Study UV I statistically significant differences in favour of adalimumab versus placebo were observed for each component of treatment failure.

Uveitis Humira is indicated for the treatment of non-infectious intermediate, humra 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. Patients taking TNF-antagonists are more susceptible to serious infections. Humira is indicated for the treatment humora moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy.

Improvement in health-related quality of life and physical function was maintained during the open-label extension through Week smpx A total of stable responders participated in a withdrawal and retreatment evaluation in an open-label extension study. Rare postmarketing cases of hepatosplenic T-cell lymphoma have been identified in patients treated with adalimumab.

Elimination Population pharmacokinetic analyses with data from over 1, RA patients revealed a trend toward higher apparent clearance of adalimumab with increasing body smpcc.

Posted in: Science