Country: আয়ার্লণ্ড
ভাষা: ইংরেজি
সূত্র: HPRA (Health Products Regulatory Authority)
MACROGOL 3350, SODIUM CHLORIDE, SODIUM HYDROGEN CARBONATE (E500), POTASSIUM CHLORIDE
Norgine Limited
A06AD65
MACROGOL 3350, SODIUM CHLORIDE, SODIUM HYDROGEN CARBONATE (E500), POTASSIUM CHLORIDE
6.9 Grams
Powder for Oral Solution
Product subject to prescription which may be renewed (B)
Osmotically acting laxatives
Authorised
2006-01-27
22601504 1 CR/15/0257 MOVICOL Paediatric Plain 09/12/15 UK/Ireland PIL Hengoed NOR-LFT4-V1 157 x 290mm 690 N/A N/A 500871A02 Black Page 1 of 2 FONTS USED: Frutiger LT Std-55 Roman Frutiger LT Std-56 Italic Frutiger LT Std-57 Condensed Frutiger LT Std-65 Bold Frutiger LT Std-66 Bold Italic Frutiger LT Std-67 Bold Condensed Frutiger LT Std-75 Black Frutiger LT Std-76 Black Italic Helvetica-Regular AVERAGE TEXT SIZE (BODY TEXT): 9.0 pt Package leaflet: Information for the patient MOVICOL ® PAEDIATRIC _PLAIN_ _6.9G SACHET, POWDER FOR ORAL SOLUTION_ READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TO GIVE THIS MEDICINE TO YOUR CHILD 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 your child. Do not pass it on to others. It may harm them, even if their signs of illness are the same as your child’s. • If your child gets any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. IF YOU NEED THE INFORMATION ON THIS LEAFLET IN AN ALTERNATIVE FORMAT, SUCH AS LARGE PRINT, PLEASE RING FROM THE UK: 0800 198 5000. FROM IRELAND: 00 44 1895 826 606 WHAT IS IN THIS LEAFLET: 1. What Movicol Paediatric Plain is and what it is used for 2. What you need to know before you give Movicol Paediatric Plain 3. How to give Movicol Paediatric Plain 4. Possible side effects 5. How to store Movicol Paediatric Plain 6. Contents of the pack and other information 1. WHAT MOVICOL PAEDIATRIC PLAIN IS AND WHAT IT IS USED FOR The name of this medicine is Movicol Paediatric Plain 6.9g sachet, powder for oral solution. It is a laxative for the treatment of chronic constipation in children aged 2 to 11 years and for the treatment of very bad constipation (called faecal impaction) in children ag সম্পূর্ণ নথি পড়ুন
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Movicol Paediatric Plain 6.9 g sachet, powder for oral solution. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each sachet of MOVICOL Paediatric Plain contains the following active substances: The content of electrolyte ions per sachet when made up to 62.5 ml of solution is as follows: 3 PHARMACEUTICAL FORM Powder for oral solution. Free flowing white powder. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the treatment of chronic constipation in children 2 to 11 years of age. For the treatment of faecal impaction in children from the age of five years, defined as refractory constipation with faecal loading of the rectum and/or colon. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY CHRONIC CONSTIPATION The usual starting dose is 1 sachet daily for children aged 2 to 6 years, and 2 sachets daily for children aged 7 – 11 years. The dose should be adjusted up or down as required to produce regular soft stools. If the dose needs increasing this is best done every second day. The maximum dose needed does not normally exceed 4 sachets a day. Treatment of children with chronic constipation needs to be or a prolonged period (at least 6 – 12 months). However, safety and efficacy of MOVICOL Paediatric Plain has only been proved for a period of up to three months. Treatment should be stopped gradually and resumed if constipation recurs. FAECAL IMPACTION A course of treatment for faecal impaction with MOVICOL Paediatric Plain is for up to 7 days as follows: DAILY DOSAGE REGIMEN: Macrogol 3350 6.563 g Sodium Chloride 0.1754 g Sodium Hydrogen Carbonate 0.0893 g Potassium Chloride 0.0251 g Sodium 65 mmol/l Chloride 53 mmol/l Potassium 5.4 mmol/l Bicarbonate 17 mmol/l H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ সম্পূর্ণ নথি পড়ুন