Šalis: Malta
kalba: anglų
Šaltinis: Medicines Authority
CARBIDOPA, LEVODOPA
AbbVie Ltd Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire, SL6 4UB, United Kingdom
N04BA02
CARBIDOPA 5 mg/ml LEVODOPA 20 mg/ml
GEL
CARBIDOPA 5 mg/ml LEVODOPA 20 mg/ml
POM
ANTI-PARKINSON DRUGS
Withdrawn
2005-10-14
1 PACKAGE LEAFLET: INFORMATION FOR THE USER DUODOPA, 20 MG/ML + 5 MG/ML, INTESTINAL GEL Levodopa andcarbidopa monohydrate 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 or pharmacist. • 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 Duodopa is and what it is used for 2. What you need to know before you take Duodopa 3. How to take Duodopa 4. Possible side effects 5. How to store Duodopa 6. Contents of the pack and other information 1. WHAT DUODOPAISANDWHATITISUSEDFOR WHAT DUODOPA IS USED FOR Duodopa belongs to a group of medicines for treatment of Parkinson’sdisease.Duodopa contains two medicines in a gel: levodopa and carbidopa monohydrate. HOW DUODOPA WORKS • Levodopa is made into dopamine in the body. Dopamine is present in your brain and in your spinal cord. It helps transfer signals between nerve cells. Too little dopamine causes Parkinson’s disease signs like tremor, feeling rigid, slow movements, and problems keeping your balance. • Treatment with levodopa increases the amount of dopamine in your body and so reduces these signs. • Carbidopa monohydrate is added to improve the effect and reduce the undesirable effects of levodopa. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DUODOPA DO NOT TAKE DUODOPA: Perskaitykite visą dokumentą
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Duodopa, 20 mg/ml + 5 mg/ml, intestinal gel 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml contains 20 mg levodopa and 5 mg carbidopa monohydrate. 100 ml contain 2000 mg levodopa and 500 mg carbidopa monohydrate. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Intestinal gel. Off white to slightly yellow gel. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of advanced levodopa-responsive Parkinson’s disease with severe motor fluctuations and hyper-/dyskinesia when available combinations of Parkinson medicinal products have not given satisfactory results. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Duodopa is a gel for continuous intestinal administration. For long-term administration, the gel should be administered with a portable pump directly into the duodenum or upper jejunum by a permanent tube _via_ percutaneous endoscopic gastrostomy with an outer transabdominal tube and an inner intestinal tube. Alternatively, a radiological gastrojejunostomy may be considered if percutaneous endoscopic gastrostomy is not suitable for any reason. Establishment of the transabdominal port and dose adjustments should be carried out in association with a neurological clinic. A temporary nasoduodenal/nasojejunal tube should be considered to determine if the patient responds favourably to this method of treatment before a permanent percutaneous endoscopic gastrostomy with jejunal tube (PEG-J) is placed. In cases where the physician considers this assessment is not necessary, the nasojejunal test phase may be waived and treatment initiated directly with placement of the PEG-J.The dose should be adjusted to an optimal clinical response for the individual pati Perskaitykite visą dokumentą