Nchi: Australia
Lugha: Kiingereza
Chanzo: Department of Health (Therapeutic Goods Administration)
pegcetacoplan, Quantity: 1080 mg
Swedish Orphan Biovitrum Pty Ltd
Injection, solution
Excipient Ingredients: water for injections; sodium hydroxide; sodium acetate trihydrate; glacial acetic acid; sorbitol
Subcutaneous
1 vial, 8 vials
(S4) Prescription Only Medicine
EMPAVELI is indicated in the treatment of adult patients with paroxysmal nocturnal haemoglobinuria (PNH) who have an inadequate response to, or are intolerant of, a C5 inhibitor.
Visual Identification: Clear glass vial containing a clear, colourless to slightly yellowish solution. Practically free from visible particles.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
2022-02-03
EMPAVELI* 1 EMPAVELI ® 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 new or being used differently. Please report side effects. 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 EMPAVELI? EMPAVELI contains the active ingredient pegcetacoplan. EMPAVELI is used to treat adult patients with a disease called paroxysmal nocturnal haemoglobinuria (PNH) who do not respond well enough to, or cannot take, a C5 inhibitor. For more information, see Section 1. Why am I using EMPAVELI? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE EMPAVELI? Do not use if you have ever had an allergic reaction to EMPAVELI or any of the ingredients listed at the end of the CMI. TALK TO YOUR DOCTOR IF YOU HAVE A SERIOUS BACTERIAL INFECTION THAT IS NOT CONTROLLED. TALK TO YOUR DOCTOR ABOUT YOUR VACCINATION HISTORY. YOU MAY NEED TO RECEIVE SOME VACCINATIONS BEFORE YOU START TO USE EMPAVELI. TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING. For more information, see Section 2. What should I know before I use EMPAVELI? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements, as medicines can affect each other, causing side effects. For more information, see Section 3. What if I am taking other medicines? in the full CMI. 4. HOW DO I USE EMPAVELI? EMPAVELI is intended for subcutaneous administration using a syringe system infusion pump. This means a needle is placed under the skin and the drug is slowly infused. A doctor or nurse will show you how to self-administer EMPAVELI before you use it for the first time, if they determi Soma hati kamili
1 Empaveli PI 28Mar2022 This medicinal product is subject to additional monitoring in Australia. 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 - EMPAVELI ® (PEGCETACOPLAN), SOLUTION FOR INJECTION WARNING: SERIOUS INFECTIONS CAUSED BY ENCAPSULATED BACTERIA USE OF EMPAVELI MAY PREDISPOSE INDIVIDUALS TO SERIOUS INFECTIONS, ESPECIALLY THOSE CAUSED BY ENCAPSULATED BACTERIA, SUCH AS _STREPTOCOCCUS PNEUMONIAE_, _NEISSERIA _ _MENINGITIDIS_, AND _HAEMOPHILUS INFLUENZAE _TYPE B, WHICH MAY BECOME RAPIDLY LIFE-THREATENING OR FATAL IF NOT RECOGNISED AND TREATED EARLY [SEE _SECTION 4.4, SPECIAL _ _WARNINGS AND PRECAUTIONS FOR USE_]. • VACCINATE AND/OR REVACCINATE ACCORDING TO CURRENT NATIONAL VACCINATION GUIDELINES SUCH AS THE AUSTRALIAN IMMUNISATION HANDBOOK; VACCINES AGAINST ENCAPSULATED BACTERIA SUCH AS _STREPTOCOCCUS PNEUMONIAE_, _NEISSERIA MENINGITIDIS_, AND _HAEMOPHILUS INFLUENZAE _TYPE B, ARE RECOMMENDED. • VACCINATE PATIENTS AGAINST ENCAPSULATED BACTERIA AS RECOMMENDED AT LEAST 2 WEEKS PRIOR TO ADMINISTERING THE FIRST DOSE OF EMPAVELI UNLESS THE RISKS OF DELAYING THERAPY WITH EMPAVELI OUTWEIGH THE RISK OF DEVELOPING A SERIOUS INFECTION. PATIENTS WHO INITIATE EMPAVELI LESS THAN 2 WEEKS AFTER VACCINATION MUST RECEIVE TREATMENT WITH APPROPRIATE PROPHYLACTIC ANTIBIOTICS UNTIL 2 WEEKS AFTER VACCINATION. _SEE SECTION 4.4, SPECIAL WARNINGS AND PRECAUTIONS FOR USE_ FOR ADDITIONAL GUIDANCE ON THE MANAGEMENT OF THE RISK OF SERIOUS INFECTION. • VACCINATION REDUCES, BUT DOES NOT ELIMINATE, THE RISK OF SERIOUS INFECTIONS. MONITOR PATIENTS FOR EARLY SIGNS OF SERIOUS INFECTIONS AND EVALUATE IMMEDIATELY IF INFECTION IS SUSPECTED. 1 NAME OF THE MEDICINE Pegcetacoplan 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 20 mL vial contains 1080 mg pegcetacoplan in a pH 5.0, 10 mM acetate buffer. For the full list of excipients, see section 6.1. List of Excipients. 2 Empaveli P Soma hati kamili