Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
netupitant, palonosetron hydrochloride
Helsinn Birex Pharmaceuticals Ltd
A04AA
netupitant, palonosetron
Antiemetics and antinauseants,
Vomiting; Neoplasms; Nausea; Cancer
Akynzeo is indicated in adults for the:Prevention of acute and delayed nausea and vomiting associated with highly emetogenic cisplatin based cancer chemotherapy.Prevention of acute and delayed nausea and vomiting associated with moderately emetogenic cancer chemotherapy.
Revision: 16
Authorised
2015-05-27
70 B. PACKAGE LEAFLET 71 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT AKYNZEO 300 MG/0.5 MG HARD CAPSULES netupitant/palonosetron READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor, pharmacist or nurse. • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. • If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Akynzeo is and what it is used for 2. What you need to know before you take Akynzeo 3. How to take Akynzeo 4. Possible side effects 5. How to store Akynzeo 6. Contents of the pack and other information 1. WHAT AKYNZEO IS AND WHAT IT IS USED FOR WHAT AKYNZEO IS Akynzeo contains two medicines (‘active substances’) called: • netupitant • palonosetron. WHAT AKYNZEO IS USED FOR Akynzeo is used to help prevent adults with cancer feeling sick (nausea) or being sick (vomiting) while having cancer treatment called ‘chemotherapy’. HOW AKYNZEO WORKS Chemotherapy medicines can cause the body to release substances called serotonin and substance P. This stimulates the vomiting centre in the brain, making you feel or be sick. The medicines in Akynzeo attach to the receptors in the nervous system through which serotonin and substance P work: netupitant (an NK 1 receptor antagonist) blocks the receptors for substance P, and palonosetron (a 5- HT 3 receptor antagonist) blocks certain receptors for serotonin. By blocking the actions of substance P and serotonin in this way, the medicines help prevent the stimulation of the vomiting centre and the resulting sickness. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE AKYNZEO DO NOT TAKE AKYNZEO IF: • you are allergic to netupitant or palonosetron, or any of the oth Прочетете целия документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Akynzeo 300 mg/0.5 mg hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 300 mg of netupitant and palonosetron hydrochloride equivalent to 0.5 mg of palonosetron. Excipients with known effect Each hard capsule contains 7 mg of sorbitol (E420) and 20 mg of sucrose. It may also contain a trace of lecithin derived from soya. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Hard capsule Opaque gelatin capsule of size “0” (length 21.7 mm) with white body and caramel cap with “HE1” printed on the body. The hard capsule is filled with three tablets and one soft capsule. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Akynzeo is indicated in adults for the: - Prevention of acute and delayed nausea and vomiting associated with highly emetogenic cisplatin-based cancer chemotherapy. - Prevention of acute and delayed nausea and vomiting associated with moderately emetogenic cancer chemotherapy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _ _ One 300 mg/0.5 mg capsule should be administered approximately one hour prior to the start of each chemotherapy cycle. The recommended oral dexamethasone dose should be reduced by approximately 50 % when co- administered with netupitant/palonosetron capsules (see section 4.5 and clinical studies administration schedule in section 5.1). _Special populations _ _ _ _Elderly people_ No dosage adjustment is necessary for elderly patients. Caution should be exercised when using this medicinal product in patients over 75 years, due to the long half-life of the active substances and the limited experience in this population. _Renal impairment _ 3 Dosage adjustment is not considered necessary in patients with mild to severe renal impairment. Renal excretion for netupitant is negligible. Mild to moderate renal impairment does not significantly affect palonosetron pharmacokinetic parameters. Total systemic exposure to intravenous palonosetron i Прочетете целия документ