Negara: Uni Eropa
Bahasa: Inggris
Sumber: EMA (European Medicines Agency)
L-arginine hydrochloride, L-lysine hydrochloride
Advanced Accelerator Applications
V03AF11
arginine, lysine
Detoxifying agents for antineoplastic treatment
Radiation Injuries
LysaKare is indicated for reduction of renal radiation exposure during Peptide-Receptor Radionuclide Therapy (PRRT) with lutetium (177Lu) oxodotreotide in adults.
Revision: 4
Authorised
2019-07-25
17 B. PACKAGE LEAFLET 18 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT LYSAKARE 25 G/25 G SOLUTION FOR INFUSION L-arginine hydrochloride/L-lysine hydrochloride READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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. - If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What LysaKare is and what it is used for 2. What you need to know before you take LysaKare 3. How to take LysaKare 4. Possible side effects 5. How to store LysaKare 6. Contents of the pack and other information 1. WHAT LYSAKARE IS AND WHAT IT IS USED FOR WHAT LYSAKARE IS LysaKare contains the active substances arginine and lysine, two different amino acids. It belongs to a group of medicines which are used to reduce the side effects of anti-cancer medicine. WHAT LYSAKARE IS USED FOR LysaKare is used in adult patients to protect kidneys from unnecessary radiation during treatment with Lutathera (lutetium ( 177 Lu) oxodotreotide), a radioactive medicine used to treat certain tumours. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LYSAKARE Follow all of your doctor’s instructions carefully. As you will receive another treatment, Lutathera, with LysaKare, READ THE LUTATHERA LEAFLET CAREFULLY AS WELL AS THIS LEAFLET. If you have any further questions on the use of this medicine, ask your doctor, nurse or pharmacist. YOU SHOULD NOT BE GIVEN LYSAKARE - if you are allergic to arginine and lysine or any of the other ingredients of this medicine (listed in section 6). - If you have high blood levels of potassium (hyperkalaemia). WARNINGS AND PRECAUTIONS Talk to your doctor before taking LysaKare if your kidneys, heart or liver are severely impaired or if you have a history of high blood levels of potassium (hyperkalaemia). Because feeling sick (nausea) and vomiting are commonly seen with Baca dokumen lengkapnya
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT LysaKare 25 g/25 g solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One 1,000 mL bag contains 25 g of L-arginine hydrochloride and 25 g of L-lysine hydrochloride. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for infusion (infusion). Clear, colourless solution, free from visible particles pH: 5.1 – 6.1 Osmolarity: 420 – 480 mOsm/L 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS LysaKare is indicated for reduction of renal radiation exposure during peptide-receptor radionuclide therapy (PRRT) with lutetium ( 177 Lu) oxodotreotide in adults. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION LysaKare is indicated for administration with PRRT with lutetium ( 177 Lu) oxodotreotide therefore, it should only be administered by a health care provider experienced in the use of PRRT. Posology _Adults _ The recommended treatment regimen in adults consists of infusion of full bag of LysaKare concomitantly with lutetium ( 177 Lu) oxodotreotide infusion, even when patients require PRRT dose reduction. Pre-treatment with an anti-emetic 30 minutes prior to start of LysaKare infusion is recommended to reduce the incidence of nausea and vomiting. _Special populations _ _Renal impairment _ Due to the potential for clinical complications related to volume overload and an increase of potassium in blood associated with the use of LysaKare, this product should not be administered in patients with creatinine clearance <30 mL/min. Care should be taken with LysaKare use in patients with creatinine clearance between 30 and 50 mL/min. Treatment with lutetium ( 177 Lu) oxodotreotide is not recommended for patients with renal function between 30 and 50 mL/min therefore, the benefit risk for these patients will always need to be weighed carefully, which should include consideration of an increased risk for transient hyperkalaemia in these patients (see section 4.4). 3 _Paediatric population _ The safety and effic Baca dokumen lengkapnya