Country: Малезија
Језик: Енглески
Извор: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
GUSELKUMAB
JOHNSON & JOHNSON SDN. BHD.
GUSELKUMAB
1 Units
Cilag AG
TREMFYA ® SOLUTION FOR INJECTION TREMFYA ® ONE-PRESS ® SOLUTION FOR INJECTION Guselkumab (100mg/ml) _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ WHAT IS IN THIS LEAFLET 1. What TREMFYA is used for 2. How TREMFYA works 3. Before you use TREMFYA 4. How to use TREMFYA 5. While you are using it 6. Side effects 7. Storage and Disposal of TREMFYA 8. Instructions for Use 9. Product description 10. Manufacturer and Product Registration Holder 11. Date of revision WHAT TREMFYA IS USED FOR PLAQUE PSORIASIS: TREMFYA is used to treat adults with moderate to severe “plaque psoriasis”, an inflammatory condition affecting the skin and nails. TREMFYA can improve skin clearance and nail appearance and reduce symptoms of psoriasis, such as scaling, shedding, flaking, itching, pain and burning. TREMFYA may improve your health related quality of life. PALMOPLANTAR PUSTULOSIS: TREMFYA is used to treat adults with palmoplantar pustulosis, an inflammatory condition causing redness and pustules affecting the palms of the hands and/or soles of the feet. PSORIATIC ARTHRITIS: TREMFYA is used to treat adults with active psoriatic arthritis, an inflammatory disease of the joints, usually accompanied by psoriasis. If you have active psoriatic arthritis you will be given TREMFYA alone or in combination with a conventional Disease Modifying Anti- Rheumatic Drug (DMARD) such as methotrexate. HOW TREMFYA WORKS TREMFYA contains the active substance guselkumab which is a type of protein called a monoclonal antibody. This medicine works by neutralizing the activity of a protein called IL-23, which is present at increased levels in people with psoriasis. BEFORE YOU USE TREMFYA - _When you must not use it _ TREMFYA may lower your ability to fight infections and may increase your risk of infections. Do not use TREMFYA if you have any symptoms of infection unless you are instructed to by your healthcare provider. _Children and adolescents _ TREMFYA is not recommended for children and adolescents under 18 years of age because it has not been Прочитајте комплетан документ
PRODUCT NAME TREMFYA ® (guselkumab) TREMFYA ® One-Press ® (guselkumab) DOSAGE FORMS AND STRENGTHS Guselkumab is a fully human immunoglobulin G1 lambda (IgG1λ) monoclonal antibody (mAb) that binds selectively to the extracellular human interleukin 23 (IL-23) protein with high specificity and affinity. Guselkumab is produced in a mammalian cell line using recombinant DNA technology. TREMFYA is available as a solution for injection in the following presentations: PRE-FILLED SYRINGE Each 100 mg Prefilled syringe contains 100 mg of guselkumab per 1 mL PRE-FILLED PEN Each 100 mg Prefilled pen contains 100 mg of guselkumab per 1 mL For excipients, see _List of Excipients_ (Pharmaceutical Information). CLINICAL INFORMATION 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. PALMOPLANTAR PUSTULOSIS TREMFYA is indicated for the treatment of moderate to severe palmoplantar pustulosis (PPP) in adult patients who do not adequately respond to conventional therapy. DOSAGE AND ADMINISTRATION DOSAGE – ADULTS (18 YEARS AND OLDER) TREMFYA is administered by subcutaneous injection. _ _ _PLAQUE PSORIASIS _ The recommended dose of TREMFYA is 100 mg to be given as subcutaneous injection at week 0, week 4 and every 8 weeks thereafter. Consideration should be given to discontinuing treatment in patients who have shown no response after 16 weeks of treatment. _PSORIATIC ARTHRITIS _ The recommended dose 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 judgement, a dose of 100 mg every 4 weeks (q4w) may be considered. Прочитајте комплетан документ