Land: Australië
Taal: Engels
Bron: Department of Health (Therapeutic Goods Administration)
icatibant acetate, Quantity: 31.38 mg (Equivalent: icatibant, Qty 30 mg)
Generic Health Pty Ltd
Injection, solution
Excipient Ingredients: water for injections; sodium hydroxide; glacial acetic acid; sodium chloride
Subcutaneous
1 syringe with 1 x 25 G Luer lock needle
(S4) Prescription Only Medicine
Icatibant Lupin is indicated for symptomatic treatment of acute attacks of hereditary angioedema (HAE) in adults, adolescents and children aged 2 years and older with C1-esterase-inhibitor deficiency.
Visual Identification: Clear, colourless solution.; Container Type: Syringe; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius
Registered
2022-06-22
Icatibant Lupin v1.0 1 ICATIBANT LUPIN 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. 1. WHY AM I USING ICATIBANT LUPIN? Icatibant Lupin contains the active ingredient Icatibant acetate. Icatibant Lupin is used for treating the symptoms of an acute attack of hereditary angioedema (HAE) in adults, adolescents and children aged 2 years and older. For more information, see Section 1. Why am I using Icatibant Lupin? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE ICATIBANT LUPIN? Do not use if you have ever had an allergic reaction to icatibant acetate or any of the ingredients listed at the end of the CMI. DO NOT GIVE ICATIBANT LUPIN TO A CHILD UNDER 2 YEARS OF AGE OR WEIGHING LESS THAN 12 KG. 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 Icatibant Lupin? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with Icatibant Lupin and affect how it works. 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 ICATIBANT LUPIN? • Your doctor will determine the exact dose of Icatibant Lupin and will tell you how often it should be used. • The recommended dose of Icatibant Lupin for adults is one subcutaneous (under the skin) injection of 30 mg. More instructions can be found in Section 4. How do I use Icatibant Lupin? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING ICATIBANT LUPIN? THINGS YOU SHOULD DO • Remind any doctor, dentist, or pharmacist you visit that you are using Icatibant Lupin or if you are about to be started on any new medicine. • Tell your doctor immediately, if you notice that your symptoms o Lees het volledige document
▼ 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 – ICATIBANT LUPIN (ICATIBANT ACETATE) SOLUTION FOR INJECTION 1 NAME OF THE MEDICINE Icatibant acetate 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each pre-filled syringe of 3 mL contains icatibant acetate equivalent to 30 mg icatibant. Each mL of the solution contains 10 mg of icatibant. For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM Solution for injection. Icatibant Lupin is supplied as a sterile solution for injection in single use pre-filled syringes. The solution should be clear and colourless and free from visible particles. The pH of the injection is approximately 5.5. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Icatibant Lupin is indicated for symptomatic treatment of acute attacks of hereditary angioedema (HAE) in adults, adolescents and children aged 2 years and older with C1-esterase-inhibitor deficiency. _ _ 4.2 DOSE AND METHOD OF ADMINISTRATION DOSAGE Adults The recommended dose of Icatibant Lupin for adults is one subcutaneous injection of 30 mg. In the majority of cases a single injection of Icatibant Lupin is sufficient to treat an attack. In case of insufficient relief or recurrence of symptoms, a second injection of Icatibant Lupin can be administered after 6 hours. If the second injection produces insufficient relief or a recurrence of symptoms is observed, a third injection of Icatibant Lupin can be administered after a further 6 hours. No more than 3 injections of Icatibant Lupin should be administered in a 24-hour period. Icatibant Lupin v1.0 Page 2 of 15 (icatibant acetate) solution for injection In clinical trials, not more than 8 injections of Icatibant Lupin per month have been administered. Adolescents and Children (aged 2 to 17 years) The recommended dose o Lees het volledige document