Land: Australië
Taal: Engels
Bron: Department of Health (Therapeutic Goods Administration)
evolocumab, Quantity: 420 mg
Amgen Australia Pty Ltd
Injection, solution
Excipient Ingredients: proline; glacial acetic acid; polysorbate 80; sodium hydroxide; water for injections
Subcutaneous
1
(S4) Prescription Only Medicine
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 CLINICAL TRIALS).,Primary 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.
Visual Identification: Clear to opalescent, colourless to yellowish solution; Container Type: Cartridge; Container Material: Other composite material; Container Life Time: 2 Years; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
2020-12-03
REPATHA ® A U R e p a t h a ® C M I v 8 . 1 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. 1. WHY AM I USING REPATHA? Repatha contains the active ingredient evolocumab. Repatha is used to treat high cholesterol. Repatha is also used to treat high cholesterol in adults and people 12 years and older who have high cholesterol because of a condition that runs in their family. Repatha can be used with other cholesterol lowering medicines in adults with heart disease to reduce the risk of heart attack, stroke, and certain heart procedures to restore blood flow to the heart. For more information, see Section 1. Why am I using Repatha? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE REPATHA? Do not use if you have ever had an allergic reaction to evolocumab 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 Repatha? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with Repatha 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 REPATHA? • Repatha is injected under the skin (subcutaneous) • Repatha can be self-administered by injection under the skin after training from your doctor or nurse. More instructions can be found in Section 4. How do I use Repatha? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING REPATHA? THINGS YOU SHOULD DO • Remind any doctor, dentist, pharmacist or nurse you visit that you are using Repatha. • Keep all of your doctor's appointments so that your progress can be monitored. THINGS YOU SHOULD NOT DO • Do not stop using this medicine or lower your dose without checking with your doctor. • Do not give your medi Lees het volledige document
REPATHA (EVOLOCUMAB) SOLUTION FOR INJECTION PAGE 1 OF 31 AUSTRALIAN PRODUCT INFORMATION – REPATHA (EVOLOCUMAB) SOLUTION FOR INJECTION 1. NAME OF THE MEDICINE Evolocumab 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Repatha is a sterile, preservative-free solution for injection containing 140 mg/mL evolocumab in a pre-filled syringe or pre-filled pen or a 420 mg/3.5 mL solution delivering 120 mg/mL evolocumab in a pre-filled cartridge co-packaged with an automated mini- doser (AMD). For the full list of excipients, see section 6.1 List of excipients. 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 trials). Primary 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. REPATHA (EVOLOCUMAB) SOLUTION FOR INJECTION PAGE 2 OF 31 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 Dosage (dose and interval) _Primary Hypercholesterolaemia and Preventi Lees het volledige document