国家: 澳大利亚
语言: 英文
来源: Department of Health (Therapeutic Goods Administration)
inclisiran, Quantity: 284 mg
Novartis Pharmaceuticals Australia Pty Ltd
Injection, solution
Excipient Ingredients: sodium hydroxide; phosphoric acid; water for injections
Subcutaneous
1 unit pack contains 1 pre-filled syringe
(S4) Prescription Only Medicine
Leqvio is indicated as an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in adults with heterozygous familial hypercholesterolaemia, atherosclerotic cardiovascular disease, or at high risk of a cardiovascular event:,? in combination with a statin or statin with other lipid-lowering therapies in patients unable to reach LDL-C goals with the maximum tolerated dose of a statin or,,? alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant.
Visual Identification: Leqvio is supplied as a solution for injection. The solution is clear, colorless to pale yellow and essentially free of particulates.; Container Type: Syringe; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
2021-09-14
LEQVIO ® L e q v i o ® 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 LEQVIO? Leqvio contains the active ingredient inclisiran. Leqvio is used to lower LDL-cholesterol ('bad' cholesterol) in addition to a cholesterol-lowering diet and exercise if you are an adult with a high cholesterol level in your blood. For more information, see Section 1. Why am I using Leqvio in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE LEQVIO? Do not use if you have ever had an allergic reaction to Leqvio or any of the ingredients listed at the end of the CMI. 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 Leqvio? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Leqvio is not expected to interact with other medicines even though it has not been tested. For more information, see Section 3. What if I am taking other medicines? in the full CMI. 4. HOW IS LEQVIO GIVEN? • Leqvio is given as an injection under the skin in your abdomen, alternatively the upper arm or thigh. It will be given to you by a doctor or healthcare provider. • The recommended dose is one injection initially, again at 3 months, followed by every 6 months. More instructions can be found in Section 4. How is Leqvio given? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING LEQVIO? THINGS YOU SHOULD DO • Remind any doctor, dentist or pharmacist you visit that you are using Leqvio. THINGS YOU SHOULD NOT DO • Do not use this medicine if you are allergic to inclisiran, or any of the ingredients listed at the end of this leaflet. DRIVING OR USING MACHINES • Leqvio is not expected to affect your ability to drive or use machin 阅读完整的文件
1 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 - LEQVIO ® (INCLISIRAN) SOLUTION FOR INJECTION 1 NAME OF THE MEDICINE Inclisiran 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each pre-filled syringe contains 1.5 mL of solution containing 284 mg inclisiran (equivalent to 300 mg inclisiran sodium). For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Leqvio is supplied as a solution for injection. The solution is clear, colourless to pale yellow and essentially free of particulates. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS Leqvio is indicated as an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in adults with heterozygous familial hypercholesterolaemia, atherosclerotic cardiovascular disease, or at high risk of a cardiovascular event: • in combination with a statin or statin with other lipid‐lowering therapies in patients unable to reach LDL‐C goals with the maximum tolerated dose of a statin or, • alone or in combination with other lipid‐lowering therapies in patients who are statin‐ intolerant. 4.2 D OSE AND METHOD OF ADMINISTRATION DOSAGE The recommended dose of Leqvio is 284 mg administered as a single subcutaneous injection: initially, again at 3 months, followed by every 6 months. _Missed dose _ If a planned dose of Leqvio is missed by less than 3 months, Leqvio should be administered and dosing maintained according to the patient’s original schedule. ▼ 2 If a planned dose of Leqvio is missed by more than 3 months, a new dosing schedule should be started – Leqvio should be administered initially, again at 3 months, followed by every 6 months. _Treatment Transition from PCSK9 Inhibitor Monoclonal Antibody _ When transitioning from a PCSK9 monoclonal antibody to Leqvio, administ 阅读完整的文件