البلد: إسرائيل
اللغة: الإنجليزية
المصدر: Ministry of Health
USTEKINUMAB
J-C HEALTH CARE LTD
L04AC05
SOLUTION FOR INJECTION
USTEKINUMAB 45 MG / 0.5 ML
S.C
Required
CILAG AG, SWITZERLAND
USTEKINUMAB
* Pque Poriasis STELARA is indicated for the treatment of moderate to severe plaque psoriasis in adult patients (18 years or older) who have failed to, or have contraindication to or who are intolerant to other systemic therapies including ciclosporin, methotrexate or psoralen plus U.V (PUVA).* Psoriatic ArthritisStelara, alone or in combination with MTX, is indicated for the treatment of active psoriatic arthritis in adult patients when the response to previous non-biological disease-modifying anti-rheumatic drug (DMARD) therapy has been inadequatePediatric plaque psoriasis:STELARA is indicated for the treatment of moderate to severe plaque psoriasis in adolescent patients from the age of 12 years and older, who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies.* Crohn’s Disease:STELARA is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a TNFα antagonist or have medical contraindications to such therapies.
2014-12-31
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986 The medicine is dispensed with a doctor’s prescription only STELARA ® 45 mg Vial, Solution for Injection STELARA ® Pre-filled Syringe, 45 mg, Solution for Injection STELARA ® Pre-filled Syringe, 90 mg, Solution for Injection Active ingredient and its quantity: Each vial contains: ustekinumab 45 mg/0.5 ml Each 0.5 ml pre-filled syringe contains: ustekinumab 45 mg Each 1 ml pre-filled syringe contains: ustekinumab 90 mg Inactive and allergenic ingredients in the preparation – see section 6 “Further Information”. Read the leaflet carefully in its entirety before using the medicine. This leaflet contains concise information about the medicine. If you have further questions, refer to the doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them even if it seems to you that their medical condition is similar. 1. WHAT IS THE MEDICINE INTENDED FOR? Plaque psoriasis Stelara is indicated for the treatment of moderate to severe plaque psoriasis in adult patients (18 years or older) who have failed to, have a contraindication to, or who are intolerant to other systemic therapies including ciclosporin, methotrexate or Psoralen plus U.V (PUVA). Plaque psoriasis in children Stelara is indicated for the treatment of moderate to severe plaque psoriasis in children and adolescent patients from the age of 6 years and older, who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies. Psoriatic arthritis ( PsA) Stelara, alone or in combination with methotrexate, is indicated for the treatment of active psoriatic arthritis in adult patients, when the response to previous non-biological disease modifying anti rheumatic drug (DMARD) therapy has been inadequate. Crohn’s disease Stelara is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response with, lost resp اقرأ الوثيقة كاملة
Stelata PFS_PVP_SPC_07_2023 1. NAME OF THE MEDICINAL PRODUCT STELARA 45 mg Vial STELARA pre-filled syringe 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each single-use vial contains 45 mg ustekinumab in 0.5 mL Each single-use 45 mg pre-filled syringe contains 45 mg ustekinumab in 0.5 mL Each single-use 90 mg pre-filled syringe contains 90 mg ustekinumab in 1.0 mL Ustekinumab is a fully human IgG1κ monoclonal antibody to interleukin (IL)-12/23 produced in a murine myeloma cell line using recombinant DNA technology. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection in vial. Solution for injection in pre-filled syringe (injection). The solution is clear to slightly opalescent, colourless to light yellow. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Plaque psoriasis STELARA is indicated for the treatment of moderate to severe plaque psoriasis in adult patients (18 years or older) who have failed to, have a contraindication to, or who are intolerant to other systemic therapies including ciclosporin, methotrexate or Psoralen plus U.V (PUVA) (see section 5.1). Paediatric plaque psoriasis STELARA is indicated for the treatment of moderate to severe plaque psoriasis in children and adolescent patients from the age of 6 years and older, who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies (see section 5.1). Psoriatic arthritis (PsA) STELARA, alone or in combination with MTX, is indicated for the treatment of active psoriatic arthritis in adult patients when the response to previous non-biological disease-modifying anti-rheumatic drug (DMARD) therapy has been inadequate (see section 5.1). Crohn’s Disease STELARA is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a TNFα antagonist or have medical contraindications to such therapies. Ulcerative colitis STELARA is اقرأ الوثيقة كاملة