Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
USTEKINUMAB
JOHNSON & JOHNSON SDN BHD
USTEKINUMAB
1Pieces Pieces
CILAG AG
1 _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ STELARA ® SOLUTION FOR INJECTION IN PREFILLED SYRINGE Ustekinumab (45mg/0.5ml, 90mg/1ml) WHAT IS IN THIS LEAFLET 1. What Stelara ® is used for 2. How Stelara ® works 3. Before you use Stelara ® 4. How to use Stelara ® 5. While you are using it 6. Side effects 7. Storage and Disposal of Stelara ® 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT STELARA ® IS USED FOR Stelara is a prescription medicine that is approved for the treatment of: • Adults with moderate to severe plaque psoriasis that is chronic (doesn’t go away) • Adults with active psoriatic arthritis, an inflammatory disease of the joints that is usually accompanied by psoriasis • Adults with moderately to severely active Crohn’s disease or ulcerative colitis HOW STELARA ® WORKS Stelara blocks the action of two proteins in your body called interleukin 12 (IL-12) and interleukin 23 (IL-23). IL-12 and IL- 23 are made by your body's immune system. In people with psoriasis, psoriatic arthritis or Crohn’s disease, IL-12 and IL- 23 can cause their immune system to attack normal healthy parts of their body. Stelara can block the IL-12 and IL-23 from causing the immune system to attack the skin, nails, joints or the digestive tract. BEFORE YOU USE STELARA ® _-_ _ _ _When you must not use it_ You should not receive Stelara if you have: • had an allergic reaction to Stelara, or any of the other ingredients in Stelara. See the end of this labeling for a complete list of ingredients in Stelara. _-_ _ _ _Before you start to use it _ Your doctor will assess your health before each treatment. Tell your doctor about all of your medical conditions before each treatment, including if you: • ever had an allergic reaction to Stelara. Ask your doctor if you are not sure. • have any kind of infection, even if it is very minor • have an infection that won't go away or a history of infection that keeps coming back. • have had TB (tuberculosis), or Baca dokumen lengkap
1 PRODUCT NAME STELARA ® Solution for Injection in Pre-filled Syringe STELARA ® 130mg/26mL Concentrate for Solution for Infusion STELARA ® Solution for Injection in Single-use Vial DOSAGE FORMS AND STRENGTHS Ustekinumab is a fully human IgG1κ monoclonal antibody with an approximate molecular weight of 148600 daltons. Ustekinumab is produced by a recombinant cell line cultured by continuous perfusion and is purified by a series of steps that includes measures to inactivate and remove viruses. STELARA is available in the following presentations: _SOLUTION FOR INJECTION FOR SUBCUTANEOUS ADMINISTRATION _ _Pre-filled Syringe _ • 45 mg / 0.5 mL • 90 mg / 1.0 mL _SINGLE-USE VIAL_ • 45 mg / 0.5 mL _CONCENTRATE FOR SOLUTION FOR INTRAVENOUS INFUSION (only for intravenous induction dose for the _ _treatment of Crohn’s disease and ulcerative colitis) _ _Single-use Vial _ • 130 mg / 26 mL For excipients, see _List of Excipients._ CLINICAL PARTICULARS THERAPEUTIC INDICATIONS PLAQUE PSORIASIS _(VIA SUBCUTANEOUS ADMINISTRATION ONLY) _ STELARA is indicated for the treatment of moderate to severe plaque psoriasis in adults who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate (MTX) or PUVA (psoralen and ultraviolet A) (see _Pharmacodynamic Properties_ ). PEDIATRIC PLAQUE PSORIASIS _(VIA SUBCUTANEOUS ADMINISTRATION ONLY WITH SINGLE-USE VIAL)_ 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 _Pharmacodynamic Properties_ ). PSORIATIC ARTHRITIS (PSA) _(VIA SUBCUTANEOUS ADMINISTRATION ONLY) _ 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 (se Baca dokumen lengkap