Negara: Inggris
Bahasa: Inggris
Sumber: MHRA (Medicines & Healthcare Products Regulatory Agency)
Macrogol '3350'; Sodium; Chloride; Bicarbonate; Potassium
Viatris UK Healthcare Ltd
A06AD65
Macrogol '3350'; Sodium; Chloride; Bicarbonate; Potassium
105gram/1litre ; 65mmol/1litre ; 53mmol/1litre ; 17mmol/1litre ; 5.4mmol/1litre
Powder for oral solution
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 01060400; GTIN: 5016695007175
Page 1 of 5 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT MOLATIVE PAEDIATRIC 6.9 G POWDER FOR ORAL SOLUTION macrogol 3350, sodium chloride, sodium hydrogen carbonate, potassium chloride _ _ READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START GIVING YOUR CHILD 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 your child only. 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 or pharmacist. This includes any possible side effects not listed in this leaflet. WHAT IS IN THIS LEAFLET 1. What Molative Paediatric is and what it is used for 2. What you need to know before you give Molative Paediatric 3. How to give Molative Paediatric 4. Possible side effects 5. How to store Molative Paediatric 6. Contents of the pack and other information 1. WHAT MOLATIVE PAEDIATRIC IS AND WHAT IT IS USED FOR The name of this medicine is Molative Paediatric 6.9 g, powder for oral solution. It is a laxative (a medicine used to help your child pass stools) for the treatment of long-term (chronic) constipation in children aged 2 to 11 years. Also, this medicine is used for the treatment of faecal impaction, in children aged 5 to 11 years (a condition where large amounts of stool builds up in the rectum and/or colon which cannot be passed easily by your child). Molative Paediatric helps your child to have a comfortable bowel movement even if they have been constipated for a long time. 2. WHAT YOU NEED TO KNOW BEFORE YOU GIVE MOLATIVE PAEDIATRIC DO NOT GIVE MOLATIVE PAEDIATRIC IF YOUR DOCTOR HAS TOLD YOU THAT YOUR CHILD: is allergic to macrogol 3350, sodium chloride, sodium hydrogen carbonate, potassium chloride or any of the other ingredients of this medicine (listed in section 6). has a blockage in their intestine (gut obstruction, ileus) Baca dokumen lengkapnya
OBJECT 1 MOLATIVE PAEDIATRIC 6.9 G POWDER FOR ORAL SOLUTION Summary of Product Characteristics Updated 19-Dec-2017 | Generics UK T/A Mylan 1. Name of the medicinal product Molative Paediatric 6.9 g Powder for Oral Solution 2. Qualitative and quantitative composition Each sachet of Molative Paediatric contains the following active ingredients: Macrogol 3350 6.563 g Sodium Chloride 175.4 mg Sodium Hydrogen Carbonate 89.3 mg Potassium Chloride 23.3 mg The content of electrolyte ions per sachet when made up to 62.5 ml of solution is as follows: Sodium 65 mmol/l Chloride 53 mmol/l Potassium 5 mmol/l Bicarbonate 17 mmol/l Excipient with known effect: Each sachet contains sorbitol. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Powder for oral solution Single-dose sachet containing a free flowing white crystalline 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 Molative Paediatric 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 Molative Paediatric is for up to 7 days as follows: _DAILY DOSAGE REGIMEN:_ NUMBER OF MOLATIVE PAEDIATRIC SACHETS Age (years) Day 1 Da Baca dokumen lengkapnya