Land: New Zealand
Språk: engelsk
Kilde: Medsafe (Medicines Safety Authority)
Evolocumab 140 mg/mL;
Amgen New Zealand Limited
140 mg
Solution for injection
Active: Evolocumab 140 mg/mL Excipient: Glacial acetic acid Polysorbate 80 Proline Sodium hydroxide Water for injection
Prescription
Repatha is indicated as an adjunct to diet and exercise in: Hypercholesterolaemia Repatha is indicated in adults with primary hypercholesterolaemia (including heterozygous familial hypercholesterolaemia and non-familial hypercholesterolaemia) to reduce low-density lipoprotein cholesterol (LDL-C): - in combination with a statin or statin with other lipid lowering therapies, or - alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant. Homozygous Familial Hypercholesterolaemia Repatha is indicated in adults and adolescents aged 12 years and over with homozygous familial hypercholesterolaemia in combination with other lipid-lowering therapies.
Package - Contents - Shelf Life: Syringe, glass, Type I pre-filled 1 mL - 1 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 30 days from date of manufacture stored at or below 25°C protect from light. no return to refrigeration allowed
2017-10-16
Repatha 1 REPATHA ® _Evolocumab (rch) - e” voe lok’ ue mab _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS CMI This leaflet answers some common questions about Repatha. It does not contain all the available information. It does not take the place of talking to your doctor, nurse or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you using Repatha against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR DOCTOR, PHARMACIST OR NURSE. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT REPATHA IS USED FOR Repatha is a medicine to lower increased levels of cholesterol. Repatha lowers levels of total cholesterol, "bad" cholesterol (LDL cholesterol), and fatty substances called triglycerides in the blood. In addition, Repatha raises levels of "good" cholesterol (HDL cholesterol). Evolocumab, the active ingredient of Repatha, works by helping the liver’s ability to remove bad cholesterol from the blood. Cholesterol is one of several fatty substances found in the bloodstream. Your total cholesterol is made up mainly of LDL and HDL. LDL cholesterol is often called "bad" cholesterol because it can build up in the walls of your arteries forming plaque. Eventually this plaque build- up can lead to a narrowing of the arteries. This narrowing can slow or block blood flow to vital organs such as the heart and brain. This blocking of blood flow can result in a heart attack or stroke and can cause other health problems. HDL cholesterol is often called "good" cholesterol because it helps keep the bad cholesterol from building up in the arteries and protects against heart disease. Triglycerides are another form of fat in your blood that may increase your risk for heart disease. Repatha is used in adults who cannot control their cholesterol levels by a cholesterol lowering diet. You should stay on your cholesterol lowering diet as directed by your doctor while taking this medicine. Repatha is used in addi Les hele dokumentet
NEW ZEALAND DATA SHEET Repatha – 27 June 2021 PAGE 1 OF 26 This medicine is not currently marketed in New Zealand 1. REPATHA ® (140 MG SOLUTION FOR INJECTION) Repatha 140 mg solution for injection pre-filled syringe Repatha 140 mg solution for injection pre-filled pen 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 1 mL single-use pre-filled syringe and pen contain 140 mg of evolocumab in 1 mL (140 mg/mL). Evolocumab is produced using recombinant DNA technology in Chinese hamster ovary (CHO) cells. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection. Repatha is a sterile, preservative-free solution, clear to opalescent; colourless to yellowish solution for injection, practically free from particles. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Repatha is indicated as an adjunct to diet and exercise in: Prevention of Cardiovascular Events Repatha is indicated to reduce the risk of cardiovascular events (myocardial infarction, stroke and coronary revascularisation) in adults with established cardiovascular disease in combination with an optimally dosed statin and/or other lipid-lowering therapies (see section 5.1 Pharmacodynamic properties, Clinical efficacy). Hypercholesterolaemia Repatha is indicated in adults with primary hypercholesterolaemia (including heterozygous familial hypercholesterolaemia and non-familial hypercholesterolaemia) to reduce low- density lipoprotein cholesterol (LDL-C): in combination with a statin or statin with other lipid lowering therapies, or alone or in combination with other lipid-lowering therapies in patients who are statin- intolerant. NEW ZEALAND DATA SHEET Repatha – 27 June 2021 PAGE 2 OF 26 Homozygous Familial Hypercholesterolaemia Repatha is indicated in adults and adolescents aged 12 years and over with homozygous familial hypercholesterolaemia in combination with other lipid-lowering therapies. 4.2 DOSE AND METHOD OF ADMINISTRATION Dose _Hypercholesterolaemia and Prevention of Cardiovascular Events _ The recomm Les hele dokumentet