Krajina: Austrália
Jazyk: angličtina
Zdroj: Department of Health (Therapeutic Goods Administration)
ravulizumab, Quantity: 100 mg/mL
Alexion Pharmaceuticals Australasia Pty Ltd
Injection, intravenous infusion
Excipient Ingredients: monobasic sodium phosphate; dibasic sodium phosphate; polysorbate 80; arginine; sucrose; water for injections
Intravenous Infusion
each (1 x vial)
(S4) Prescription Only Medicine
Ultomiris is indicated:,? for the treatment of patients with Paroxysmal Nocturnal Haemoglobinuria (PNH),? for the treatment of patients with Atypical Haemolytic Uraemic Syndrome (aHUS),? as an add-on to standard therapy for the treatment of adult patients with generalised myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody-positive.,? for the treatment of adult patients with Neuromyelitis Optica Spectrum Disorder (NMOSD) who are anti-aquaporin 4 (AQP4) antibody-positive.,Ultomiris is not intended for the acute treatment of a NMOSD relapse.
Visual Identification: Clear to slight translucent, clear to yellowish colour solution, practically free from particles; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 18 Months; Container Temperature: Store at 2 to 8 degrees Celsius
Registered
2021-03-23
ULTOMIRIS ® 2 2 1 0 0 5 _ C M I 1 0 0 M G / M L ( R E F : D 2 2 1 1 2 4 _ P I ) CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. ▼ This medicine is subject to additional monitoring due to approval of an extension of indications. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems. See the full CMI for further details. WARNING: Important safety information is provided in a boxed warning in the full CMI. Read before using this medicine. 1. WHY AM I USING ULTOMIRIS? Ultomiris contains the active ingredient ravulizumab rch. For more information, see Section 1. Why am I using Ultomiris? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE ULTOMIRIS? Ultomiris is a medicine that affects your body’s defence system and so can lower the ability of your immune system to fight infections. Using this medicine increases your risk of severe infection and sepsis (infection of the blood). You must be vaccinated against meningococcal infection and be aware of the signs and symptoms of a meningococcal infection. You must always carry a “Patient Safety Card” with you. TALK TO YOUR DOCTOR IF YOU HAVE AN INFECTION OR HAVE HAD AN ALLERGIC REACTION TO ANY OF THE INGREDIENTS LISTED AT THE END OF THE CMI. For more information, see Section 2. What should I know before I use Ultomiris? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Talk to your doctor if you have any other medical conditions or are taking any other medicines. The effect of using Ultomiris on other medicines has not been studied. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. HOW DO I USE ULTOMIRIS? • Ultomiris will be given to you directly into the vein (intravenously) by a doctor or nurse. The infusion will take approxi Prečítajte si celý dokument
1 221005_ULTOMIRIS 100mg/mL PI CCDS v8.0 This medicinal product is subject to additional monitoring in Australia due to approval of an extension of indications. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse events at www.tga.gov.au/reporting- problems. AUSTRALIAN PRODUCT INFORMATION – ULTOMIRIS ® (RAVULIZUMAB RCH) 100 MG/ML SOLUTION FOR INTRAVENOUS INFUSION WARNING: SERIOUS MENINGOCOCCAL INFECTIONS LIFE-THREATENING MENINGOCOCCAL INFECTIONS/SEPSIS HAVE OCCURRED IN PATIENTS TREATED WITH ULTOMIRIS. MENINGOCOCCAL INFECTION MAY BECOME RAPIDLY LIFE-THREATENING OR FATAL IF NOT RECOGNISED AND TREATED EARLY (SEE _SECTION 4.4 SPECIAL WARNINGS AND _ _PRECAUTIONS FOR USE_). • REFER TO THE MOST CURRENT EDITION OF THE AUSTRALIAN IMMUNISATION HANDBOOK FOR MENINGOCOCCAL VACCINATION GUIDELINES. • IMMUNISE PATIENTS WITH MENINGOCOCCAL VACCINES AT LEAST 2 WEEKS PRIOR TO ADMINISTERING THE FIRST DOSE OF ULTOMIRIS, UNLESS THE RISKS OF DELAYING ULTOMIRIS THERAPY OUTWEIGH THE RISK OF DEVELOPING A MENINGOCOCCAL INFECTION (SEE _SECTION 4.4 _ _SPECIAL WARNINGS AND PRECAUTIONS FOR USE_ FOR ADDITIONAL GUIDANCE ON THE MANAGEMENT OF THE RISK OF MENINGOCOCCAL INFECTION). • VACCINATION REDUCES, BUT DOES NOT ELIMINATE, THE RISK OF MENINGOCOCCAL INFECTIONS. MONITOR PATIENTS FOR EARLY SIGNS OF MENINGOCOCCAL INFECTIONS AND EVALUATE IMMEDIATELY IF INFECTION IS SUSPECTED. 1 NAME OF THE MEDICINE Ravulizumab _rch_ 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Ultomiris is a formulation of ravulizumab _rch_ which is a long acting humanised monoclonal IgG2/4K antibody produced in Chinese hamster ovary (CHO) cell culture by recombinant DNA technology. Ultomiris is supplied as a single use vial containing 100 mg/mL (300 mg in 3 mL or 1100 mg in 11 mL) of ravulizumab _rch_. _For the full list of excipients, see section 6.1 List of Excipients_. 3 PHARMACEUTICAL FORM Concentrated solution for intravenous infusion. Ultomiris 100 mg/mL is a translucent, clear to yellowish c Prečítajte si celý dokument