Država: Izrael
Jezik: angleščina
Source: Ministry of Health
GOLIMUMAB
J-C HEALTH CARE LTD
L04AB06
SOLUTION FOR INJECTION
GOLIMUMAB 50 MG / 0.5 ML
S.C
Required
CILAG AG, SWITZERLAND
GOLIMUMAB
GOLIMUMAB
Rheumatoid Arthritis :Simponi, in combination with methotrexate, is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis when the response to disease-modifying anti-rheumatic drug (DMARD) therapy including MTX has been inadequate.Juvenile idiopathic arthritis: Polyarticular juvenile idiopathic arthritis (pJIA)Simponi in combination with MTX is indicated for the treatment of polyarticular juvenile idiopathic arthritis in children with a body weight of at least 40 kg, who have responded inadequately to previous therapy with MTX.Simponi 100 mg is not recommended in children aged less than 18.Psoriatic Arthritis :Simponi, alone or in combination with methotrexate, is indicated for the treatment of adult patients with active and progressive psoriatic arthritis when the response to previous disease-modifying anti-rheumatic drug (DMARD) therapy has been inadequate.Ankylosing Spondylitis :Simponi is indicated for the treatment of adult patients with severe active ankylosing spondylitis who have responded inadequately to conventional therapy.Non-radiographic axial spondyloarthritis (nr-Axial SpA):Simponi is indicated for the treatment of adults with severe, active non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) evidence, who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs (NSAIDS).Ulcerative colitis (UC) :Simponi is 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 (AZA), or who are intolerant to or have medical contraindications for such therapies.
2017-01-31
JC Simponi Solution for inj (Pen/Syringe) Safety Information Card (Word) A4 10 9 11 / 1 Heb+Eng 04.10.21 Keren 2 Heb+Eng+Arabic 01.11.21 Haneen Client SIM SOL SIC SH270921 )הספדהל אל( תואירבה דרשמ רתאל תדעוימה word תסריג סיטרכ עדימ לפוטמל רישכתל ינופמיס ה סיטרכ עדימ תוחיטב עדימ ליכמ לפוטמל י ( ינופמיסב לופיטה ךלהמבו ינפל ריכהל ךילעש בושח Simponi .) .ךב לופיטב ברועמה אפור לכל הז סיטרכ גצה 1 . םימוהיז התא רשאכ לפוטמ התא ,ינופמיסב ףושח רתוי םימוהיזל םירומח תויהל םילולעו רתוי ריהמ בצקב חתפתהל םילולע םימוהיז . םימוהיז ,ףסונב .רתוי םימיוסמ .בוש עיפוהל םילולע רבעב םהב תיקלש _ _ _1.1_ _ _ _ :ינופמיסב לופיטה ינפל_ _ _ • םא ךלש אפורל רפסל שי התא הקול ב םא ינופמיסב לופיט לבקל ןיא .םוהיז התא לבוס מ ( תפחש TB םוהיז לכ וא ) רומח .רחא • תקידב רובעל ךילע רקס עגמב תייה םא וא תפחשב רבעב תילח םא ךלש אפורל רפסתש דואמ בושח .תפחשל תו/תקידב ךיראתו גוס תא ןלהל דעתל ךלש אפורהמ שקב אנא .רבעב תפחשב הלחש והשימ םע בורק רקסה :תפחשל תו/הנורחאה _________ הקידבה __ ___ ______ ______ ___ הקידבה ______ __ ________ ____________ ___ ךיראת ______ _ __ ___ ____________ ______ ךיראת _____ __ __________ _________ __ האצות ____________ _ __ __________ ______ האצות __ ___ ____________ _________ • התא םא ךלש אפורל רפס סיטיטפה ףיגנ לש אשנ B התאש דשוח וא הז ףיגנ לש אשנ . _1.2_ _ _ _ ךלהמב_ _ :וירחאלו ינופמיסב לופיטה_ _ _ • םא יאופר לופיט תלבקל דימ תונפל שי םיעיפ Preberite celoten dokument
Page 1 of 29 SIMPONI_SPC_ 05_2023_SUB 1. NAME OF THE MEDICINAL PRODUCT Simponi, solution for injection, in Auto-Injector pen or pre-filled Syringe 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One 0.5 ml Auto-Injector pen/ pre-filled syringe contains 50 mg of golimumab*. One 1.0 ml Auto-Injector pen / pre-filled syringe contains 100 mg of golimumab*. * Human IgG1κ monoclonal antibody produced by a murine hybridoma cell line with recombinant DNA technology. Excipient with known effect: Each Auto-Injector pen / pre-filled syringe contains 20.5 mg sorbitol per 50 mg dose. Each Auto-Injector pen / pre-filled syringe contains 41.0 mg sorbitol per 100 mg dose. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection in Auto-Injector pen (injection), SmartJect, /pre-filled syringe (injection) The solution is clear to slightly opalescent, colourless to light yellow. Patient reminder card The marketing of Simponi is subject to risk management plan (RMP) including a "patient reminder card". The Patient reminder card" emphasizes important safety information that the patient should be aware of before and during treatment. Please explain to the patient the need to review the card before starting treatment. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Rheumatoid Arthritis : Simponi, in combination with methotrexate, is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis when the response to disease-modifying anti- rheumatic drug (DMARD) therapy including MTX has been inadequate. Juvenile idiopathic arthritis _Polyarticular juvenile idiopathic arthritis (pJIA) _ Simponi in combination with MTX is indicated for the treatment of polyarticular juvenile idiopathic arthritis in children with a body weight of at least 40 kg, who have responded inadequately to previous therapy with MTX. Simponi 100 mg is not recommended in children aged less than 18. Psoriatic Arthritis : Simponi, alone or in combination with methotrexate, is indicated for the Preberite celoten dokument