País: Nova Zelanda
Idioma: anglès
Font: Medsafe (Medicines Safety Authority)
Siltuximab 100mg; ;
Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics
Siltuximab 100 mg
100 mg
Powder for infusion concentrate
Active: Siltuximab 100mg Excipient: Histidine Polysorbate 80 Sucrose
Prescription
Janssen Sciences Ireland UC
SYLVANT is indicated for the treatment of adult patients with multicentric Castleman's disease (MCD) who are human immunodeficiency virus (HIV) negative and human herpesvirus-8 (HHV-8) negative.
Package - Contents - Shelf Life: Vial, glass, Type 1 - 1 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 2 hours reconstituted stored at or below 25°C. prior to dilution 6 hours diluted stored at or below 25°C
2014-08-08
SYLVANT ® AUGUST 2022 CMI 3 PIL-SYL-NZ-1210-04 SYLVANT ® Siltuximab CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some of the common questions about SYLVANT. It does not contain all of the available information. It does not take the place of talking to your doctor or pharmacist. IF YOU HAVE ANY CONCERNS ABOUT USING SYLVANT, ASK YOUR DOCTOR OR PHARMACIST. Your doctor and pharmacist have more information. Keep this information handy. You can refer to it later if you have any questions. Please also refer to Consumer Medicine Information documents of other medicines your doctor may have prescribed for use in combination with SYLVANT. WHAT SYLVANT IS USED FOR SYLVANT is a prescription medicine used to treat multicentric Castleman’s disease (MCD) in patients who do not have human immunodeficiency virus (HIV) and human herpesvirus-8 (HHV-8) infection. Multicentric Castleman’s disease causes non-cancerous growths (tumours) to develop in the lymph nodes in the body. This disease may also make you feel tired, sweat at night, have a tingling feeling, and a loss of appetite. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY IT HAS BEEN PRESCRIBED FOR YOU. HOW IT WORKS SYLVANT contains the active ingredient siltuximab. SYLVANT blocks the action of a specific protein called “interleukin-6”, which can cause inflammation. Blocking this protein helps to reduce the size of the affected lymph nodes and reduce the symptoms of the illness such as feeling tired. This should help you carry out your normal daily tasks. BEFORE YOU USE SYLVANT WHEN YOU MUST NOT USE IT DO NOT USE SYLVANT IF YOU KNOW YOU ARE ALLERGIC TO SILTUXIMAB OR ANY OF THE OTHER INGREDIENTS LISTED AT THE END OF THIS LEAFLET. Symptoms of an allergic reaction may include skin rash, itching or hives on the skin, shortness of breath, wheezing or difficulty breathing, swelling of the face, lips, tongue or other parts of the body. DO NOT USE IT AFTER THE EXPIRY DATE PRINTED ON THE PACK. DO NOT USE IT IF THE PACKAGING IS TORN OR SHOWS Llegiu el document complet
SYLVANT DATA SHEET – 18Dec2023 SPC-SYL-NZ-1209-05 Page 1 of 15 SYLVANT ® SILTUXIMAB NEW ZEALAND DATA SHEET 1. PRODUCT NAME SYLVANT 100 mg powder for infusion concentrate SYLVANT 400 mg powder for infusion concentrate 2. QUALITATIVE AND QUANTITATIVE COMPOSITION SYLVANT is a chimeric (human murine) immunoglobulin G1k (IgG1k) monoclonal antibody against human Interleukin-6 (IL-6) produced in a Chinese Hamster Ovary (CHO) cell line. SYLVANT 100 MG POWDER FOR INFUSION CONCENTRATE Each single use vial contains 100 mg siltuximab powder for concentrate for solution for infusion. After reconstitution the solution contains 20 mg siltuximab per mL. SYLVANT 400 MG POWDER FOR INFUSION CONCENTRATE Each single use vial contains 400 mg siltuximab powder for concentrate for solution for infusion. After reconstitution the solution contains 20 mg siltuximab per mL. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for infusion concentrate. The product is a freeze-dried white powder. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS SYLVANT is indicated for the treatment of adult patients with multicentric Castleman’s disease (MCD) who are human immunodeficiency virus (HIV) negative and human herpesvirus-8 (HHV- 8) negative. 4.2 DOSE AND METHOD OF ADMINISTRATION The recommended dose is 11 mg/kg siltuximab given over 1 hour as an intravenous infusion administered every 3 weeks until treatment failure. Intravenous infusion (IV) of SYLVANT should be administered by qualified healthcare professionals. Appropriate personnel and medicinal product should be available to treat anaphylaxis if it occurs. TREATMENT CRITERIA Haematology laboratory tests should be performed prior to each dose of SYLVANT therapy for the first 12 months and every 3 dosing cycles thereafter. The prescriber should consider delaying SYLVANT DATA SHEET – 18Dec2023 SPC-SYL-NZ-1209-05 Page 2 of 15 treatment if the treatment criteria outlined in Table 1 are not met, before administering SYLVANT. Dose reduction is not recommended. TA Llegiu el document complet