Valsts: Izraēla
Valoda: angļu
Klimata pārmaiņas: Ministry of Health
FOSCARBIDOPA; FOSLEVODOPA
ABBVIE BIOPHARMACEUTICALS LTD, ISRAEL
SOLUTION FOR INFUSION
FOSLEVODOPA 240 MG / 1 ML; FOSCARBIDOPA 12 MG / 1 ML
S.C
Required
ABBVIE INC., USA
Treatment of advanced levodopa-responsive Parkinson’s disease with severe motor fluctuations and hyperkinesia or dyskinesia when available combinations of Parkinson medicinal products have not given satisfactory results.
2023-06-18
PRODUDOPA ® (FOSLEVODOPA/FOSCARBIDOPA) FOR ADVANCED PARKINSON’S DISEASE THIS PATIENT GUIDE CONTAINS IMPORTANT SAFETY INFORMATION YOU SHOULD BE AWARE OF. PLEASE KEEP THIS GUIDE AVAILABLE WHEN YOU ARE PREPARING TO USE THIS MEDICINE. - 2 - WHY SHOULD I READ THIS PATIENT GUIDE? PRODUODOPA ® is a medicine to treat the symptoms of advanced Parkinson’s disease. It is used when other medicines no longer work as well as they did to treat the symptoms of the disease. You or your caregiver will deliver this medicine under your skin through a small plastic tube (cannula) in the area around the belly button. This area is your infusion site. It is delivered through this tube continuously 24 hours a day. SOME PEOPLE USING THIS MEDICINE MAY HAVE PROBLEMS AROUND THE SKIN WHERE THE CANNULA GOES INTO THEIR BODY. THESE COULD BE: - A SKIN INFECTION. A skin infection can become serious when it enters the blood and spreads all over the body. This is called sepsis. - A SKIN REACTION. This is when the skin becomes irritated / inflamed. - 3 - THIS PATIENT GUIDE WILL HELP YOU AND YOUR CAREGIVER LEARN ABOUT: How to choose your infusion site How to recognize an infusion site infection or infusion site reaction What you can do to help reduce the chance of an infusion site infection or infusion site reaction What you should do if you have an infusion site infection or infusion site reaction Where you can find more information about your medicine - 4 - • • • • Avoid your belt line because this area may be irritated by the pressure of the belt against the skin Avoid any skin that is scarred, hard, or has stretch marks Avoid any skin folds or creases on your skin where it naturally bends a lot Use a new infusion set (cannula/tubing), every time you change your infusion site. HOW TO CHOOSE YOUR INFUSION SITE Changing your infusion site regularly is important. This is because it helps your skin stay healthy and lets the medicine be delivered correctly. You can use your stomach for the infusion site unless your doctor tells you to use Izlasiet visu dokumentu
1 PRD API DEC 23 CL 1. NAME OF THE MEDICINAL PRODUCT Produodopa ™ 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml contains 240 mg foslevodopa and 12 mg foscarbidopa. 10 ml contain 2400 mg foslevodopa and 120 mg foscarbidopa. Foslevodopa and foscarbidopa are prodrugs equivalent to approximately 170 mg levodopa and 9 mg carbidopa per 1 ml. Excipient with known effect Produodopa contains approximately 1.84 mmol (42.4 mg) sodium per ml. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for infusion (infusion). Produodopa is a clear to slightly opalescent solution in a glass vial. The solution should be free from particulates. Produodopa may vary from colourless to yellow to brown and may have a purple or red tint. Variations in colour are expected and have no impact on product quality. The solution may become darker in colour after piercing of the vial stopper or while in the syringe. The pH is approximately 7.4. Osmolality is approximately 2200 to 2500 mOsmol/kg but may range up to 2700 mOsmol/kg. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of advanced levodopa- responsive Parkinson’s disease with severe motor fluctuations and hyperkinesia or dyskinesia when available combinations of Parkinson medicinal products have not given satisfactory results. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology PATIENT SAFETY INFORMATION CARD The marketing of Produodopa is subject to a risk management plan (RMP) including a ‘Patient safety information card’. The ‘Patient safety information card’, emphasizes important safety information that the patient should be aware of before and during treatment. Please explain to the patient the need to review the card before starting treatment. 2 PRD API DEC 23 CL Produodopa is administered as a continuous subcutaneous infusion, 24 hours per day. The recommended starting infusion rate of Produodopa is determined by converting the daytime levodopa intake to levodopa equivalents (LE) and then increasing it to account for a 24-hour Izlasiet visu dokumentu