Land: Írland
Tungumál: enska
Heimild: HPRA (Health Products Regulatory Authority)
Foslevodopa; Foscarbidopa
AbbVie Limited
N04BA
Foslevodopa; Foscarbidopa
Solution for infusion
Dopa and dopa derivatives
Marketed
2022-09-23
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT PRODUODOPA 240 MG/ML + 12 MG/ML SOLUTION FOR INFUSION foslevodopa and foscarbidopa 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, 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 Produodopa is and what it is used for 2. What you need to know before you use Produodopa 3. How to use Produodopa 4. Possible side effects 5. How to store Produodopa 6. Contents of the pack and other information 7. Instructions for use for Produodopa infusion using the Vyafuser pump 1. WHAT PRODUODOPA IS AND WHAT IT IS USED FOR Produodopa contains two active ingredients, foslevodopa and foscarbidopa, and is used to treat Parkinson’s disease. HOW PRODUODOPA WORKS In the body, foslevodopa is made into ‘dopamine’. This adds to the dopamine already in your brain and spinal cord. Dopamine helps transfer signals between nerve cells. Too little dopamine causes Parkinson’s disease signs like tremor, feeling stiff, slow movement, and problems keeping your balance. Treatment with foslevodopa increases the amount of dopamine in your body. This means it reduces these signs. Foscarbidopa improves the effect of foslevodopa. It also reduces the side effects of foslevodopa. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE PRODUODOPA DO NOT USE PRODUODOPA IF YOU are allergic to foslevodopa, foscarbidopa, or any of the other ingredients in this medicine (listed in section 6) have an eye problem called ‘narrow angle glaucoma’ have severe heart problems have a severe uneven heartbeat (arrhythm Lestu allt skjalið
Health Products Regulatory Authority 09 January 2024 CRN00F1PZ Page 1 of 18 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Produodopa 240 mg/ml + 12 mg/ml solution for infusion 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 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 administration (see Initiation of treatment). The dose may be adjusted to reach a clinical response that maximises the functional "On" time and minimises the number and duration of "Off" episodes and "On" episodes with troublesome dyskinesia. The maximum recommended daily dose of fo Lestu allt skjalið