البلد: ماليزيا
اللغة: الإنجليزية
المصدر: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
SODIUM DIHYDROGEN PHOSPHATE DIHYDRATE; DISODIUM PHOSPHATE DODECAHYDRATE
PHARMAFORTE (MALAYSIA) SDN. BHD.
SODIUM DIHYDROGEN PHOSPHATE DIHYDRATE; DISODIUM PHOSPHATE DODECAHYDRATE
45ml ml
Casen-Recordati S.L.
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ CASEN PHOSPHO-SODA 24.4 G / 10.8 G ORAL SOLUTION DISODIUM PHOSPHATE DODECAHYDRATE - SODIUM DIHYDROGEN PHOSPHATE DIHYDRATE 1 WHAT IS IN THIS LEAFLET 1. What Phospho-soda is used for 2. How Phospho-soda works 3. Before you use Phospho-soda 4. How to use Phospho-soda 5. While you are using it 6. Side effects 7. Storage and Disposal of Phospho- soda 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT PHOSPHO-SODA IS USED FOR Phospho-Soda is a laxative. It is used in case of severe constipation. You must also adapt your eating habits if you suffer from constipation. Phospho-Soda is used to prepare the bowel for a surgical procedure or a bowel examination. You must talk to a doctor if you do not feel better or if you feel worse. HOW PHOSPHO-SODA WORKS It works by osmotic processes to increase fluid retention in small bowel lumen. BEFORE YOU USE PHOSPHO-SODA - _When you must not use it _ _ _ Do not use this product if you are allergic to the active substance or any of the other ingredients of this medicine - If you suffer from nausea or stomach ache; in this case there is actually a risk of kidney failure; - If you are younger than 18 years, you cannot use Phospho-Soda as bowel cleansing (but you can use it as laxative. _ _ - In case of: kidney disease; overactivity of the parotid glands (primary hyperparathyroidism) associated with high concentrations of calcium in blood. symptomatic heart disease; ascites (fluid accumulation in the abdominal cavity); known or suspected occlusion in the stomach or the bowel; colon hypertrophy (megacolon); perforation in the gastrointestinal tract; bowel occlusion (ileus); progressing inflammatory bowel disease (such as Crohn's disease or bleeding rectal colitis). - Phospho-Soda cannot be used in combination with other laxatives containing sodium phosphate. _ _ _- Before you start to use it _ _ _ Talk to your doctor or pharmacist before using Phospho-Soda - اقرأ الوثيقة كاملة
00000000 CASEN PHOSPHO-SODA 24.4 g / 10.8 g oral solution Name & Dosage Form: CASEN PHOSPHO-SODA 24.4g/10.8g oral solution Therapeutic Class: Laxative. Bowel preparation. Therapeutic Code: A06AD17 Description: Oral solution. Colourless solution with ginger and lime flavour without precipita - tion or impurities. Names and strengths of Active Ingredients: Disodium Phosphate dodecahydrate 10.8 g – Sodium dihydrogen phosphate dihydrate 24.4 g per 45 mL bottle. Disodium Phosphate dodecahydrate 0.24 g – Sodium dihydrogen phosphate dihydrate 0.542 g per 1 mL. Pharmacology (Summary of Pharmacodynamics & Pharmacokinetics): CASEN PHOSPHO-SODA is a saline laxative that works by osmotic processes to increase fluid retention in small bowel lumen. The resultant fluid accumulation in the ileum causes distention and induces in turn bowel movement and evacuation. The start of these peristaltic movements depends on the patient and occurs 1 to 2 hours after administration. Administration of oral sodium phosphates solution caused transient serum elec - trolyte shifts in healthy volunteers. An open-label study was performed with twen- ty-four healthy adult volunteers who received oral sodium phosphates solution to evaluate the time course and degree of electrolyte shifts in two age and two gender groups. The study was designed to mimic the bowel preparation regimen commonly used prior to colonoscopy, including a clear liquid diet, timing of sodi - um phosphate doses and proper hydration. The followed regimen of 2 x 45 ml of oral sodium phosphate and additional clear liquids was in line with the approved dosing regimen of the product. The study population was balanced for gender and age. One-half of the study participants were aged 65 years or older. Results showed an increase in serum concentrations of sodium and phosphate but a decrease of potassium and calcium after each dose. The mean serum phosphate concentration for all subjects was 3.33 mg/dL at baseline, then it peaked at 6.26 mg/dL at hour 3, decreased to 4.70 mg/dL just اقرأ الوثيقة كاملة