Valsts: Izraēla
Valoda: angļu
Klimata pārmaiņas: Ministry of Health
GUSELKUMAB
J-C HEALTH CARE LTD
L04AC16
SOLUTION FOR INJECTION
GUSELKUMAB 100 MG / 1 ML
S.C
Required
CILAG AG, SWITZERLAND
GUSELKUMAB
Plaque psoriasisTremfya is indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.Psoriatic arthritisTremfya, alone or in combination with methotrexate (MTX), is indicated for the treatment of active psoriatic arthritis in adult patients who have had an inadequate response or who have been intolerant to a prior disease-modifying antirheumatic drug (DMARD) therapy.
2023-04-30
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1 TREMFYA_PI_March 2022 1. NAME OF THE MEDICINAL PRODUCT Tremfya 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Tremfya 100 mg solution for injection in pre-filled syringe Each pre-filled syringe contains 100 mg of guselkumab in 1 mL solution. Tremfya 100 mg solution for injection in pre-filled pen Each pre-filled pen contains 100 mg of guselkumab in 1 mL solution Guselkumab is a fully human immunoglobulin G1 lamda (IgG1λ) monoclonal antibody (mAb) to the interleukin (IL)-23 protein, produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection (injection) The solution is clear and colourless to light yellow. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Plaque psoriasis Tremfya is indicated for the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Psoriatic arthritis Tremfya, alone or in combination with methotrexate (MTX), is indicated for the treatment of active psoriatic arthritis in adult patients who have had an inadequate response or who have been intolerant to a prior disease-modifying antirheumatic drug (DMARD) therapy (see section 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Tremfya is intended for use under the guidance and supervision of a physician experienced in the diagnosis and treatment of conditions for which Tremfya is indicated. Posology Plaque psoriasis The recommended dose of Tremfya is 100 mg by subcutaneous injection at weeks 0 and 4, followed by a maintenance dose every 8 weeks. Consideration should be given to discontinuing treatment in patients who have shown no response after 16 weeks of treatment. Psoriatic arthritis The recommended dose of Tremfya is 100 mg by subcutaneous injection at weeks 0 and 4, followed by a maintenance dose every 8 weeks. For patients at high risk for joint damage according to clinical 2 TREMFYA_PI_March 2022 judgement, a dose of 100 mg every 4 weeks may be considered (see sect Izlasiet visu dokumentu