País: Nova Zelanda
Idioma: anglès
Font: Medsafe (Medicines Safety Authority)
Citric acid 12.2 g; Magnesium carbonate monohydrate 7.4 g; Sodium picosulfate 10.3mg
Fresenius Kabi New Zealand Limited
Powder for oral solution
Active: Citric acid 12.2 g Magnesium carbonate monohydrate 7.4 g Sodium picosulfate 10.3mg Excipient: Orange flavour FACB076 Sweetener sweetesse 97
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Picoprep Orange is indicated for bowel emptying and cleansing by means of total gastrointestinal tract perfusion in preparation for gastrointestinal examination (such as colonoscopy, barium enema x-ray examination), prior to intravenous pyelograms (IVP) or colorectal surgery.
Package - Contents - Shelf Life: Sachet, laminate, 20 g powder in aluminium laminated with LDPE/paper - 2 dose units - 24 months from date of manufacture stored at or below 25°C 0 hours opened stored at 2° to 8°C (Refrigerate, do not freeze) - Sachet, laminate, 20 g powder in aluminium laminated with LDPE/paper - 3 dose units - 24 months from date of manufacture stored at or below 25°C 0 hours opened stored at 2° to 8°C (Refrigerate, do not freeze) - Sachet, laminate, 20 g powder in aluminium laminated with LDPE/paper - 50 dose units - 24 months from date of manufacture stored at or below 25°C 0 hours opened stored at 2° to 8°C (Refrigerate, do not freeze)
2020-03-09
Page 1 of 5 PICOPREP ORANGE ® NEW ZEALAND CONSUMER MEDICINE INFORMATION WARNING LIFE THREATENING DEHYDRATION AND/OR ELECTROLYTE DISTURBANCES MAY OCCUR IN SOME PEOPLE. READ THE SECTION WITH THE HEADING “BEFORE YOU TAKE THIS MEDICINE”. WHAT IS IN THIS LEAFLET? READ THIS LEAFLET CAREFULLY BEFORE TAKING YOUR MEDICINE This leaflet answers some common questions about PICOPREP ORANGE. It does not contain all the information that is known about PICOPREP ORANGE. It does not take the place of talking to your doctor, prescriber or pharmacist. Ask your doctor, prescriber or pharmacist: if there is anything you do not understand in this leaflet, if you are worried about taking your medicine, or to obtain the most up-to- date information. All medicines have risks and benefits. Your doctor, prescriber or pharmacist will have weighed the risks of you taking PICOPREP ORANGE against the benefits they expect it will have for you. Pharmaceutical companies cannot give you medical advice or an individual diagnosis. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT THIS MEDICINE IS USED FOR THIS MEDICINE BELONGS TO A GROUP OF MEDICINES CALLED BOWEL PREPARATIONS. PICOPREP ORANGE is used to remove the bowel contents and cleanse it prior to gastrointestinal examination (such as colonoscopy, barium enema x-ray examination), prior to intravenous pyelograms (IVP) or colorectal surgery, in adults and children 9 years of age and over. PICOPREP ORANGE contains sodium picosulfate, citric acid and magnesium carbonate. Citric acid reacts with magnesium carbonate to form magnesium citrate. Sodium picosulfate and magnesium citrate both act as laxatives in the intestine. Sodium picosulfate works by being broken down by intestinal bacteria and then acting on the lining in your intestine to stimulate bowel movements. This results in watery stool or bowel motions which removes the bowel contents and ensures the bowel is clean before the examination or procedure. The bowel needs to be clean before the examination o Llegiu el document complet
NEW ZEALAND DATA SHEET Page 1 of 7 WARNING LIFE-THREATENING DEHYDRATION AND/OR ELECTROLYTE DISTURBANCES MAY OCCUR IN “AT RISK” GROUPS. SEE SECTION 4.3 CONTRAINDICATIONS AND 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE. 1 PRODUCT NAME PICOPREP ORANGE ® powder 20 g sachet 2 QUALITATIVE AND QUANTITATIVE COMPOSITION The active ingredients are: sodium picosulfate has a chemical formula of C 18 H 13 NNa 2 O 8 S 2 ,H 2 O, a MW of 499.4 and a CAS No. 10040-45-6 (anhydrous) magnesium carbonate hydrate, has a chemical formula of MgCO 3 •H 2 O, a MW of 102.3 and a CAS No.23389-33-5; citric acid which has a chemical formula of C 6 H 8 O 7 , a MW of 192.1 and a CAS No. 77-92-9. Each PICOPREP ORANGE ® sachet contains sodium picosulfate 10.3 mg, magnesium carbonate hydrate 7.4 g and citric acid 12.2 g, as the active ingredients. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Powder for solution. For oral use. PICOPREP ORANGE ® contains 20 g of white to creamy yellow powder which when dissolved in water produces 250 mL of solution with a mild citric acid taste. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS PICOPREP ORANGE ® is indicated for bowel emptying and cleansing by means of total gastrointestinal tract perfusion in preparation for gastrointestinal examination (such as colonoscopy, barium enema x-ray examination), prior to intravenous pyelograms (IVP) or colorectal surgery, in adults and children 9 years of age and over. 4.2 DOSE AND METHOD OF ADMINISTRATION PRIOR TO THE PROCEDURE During the day patients should drink at least one glass (approx. 250 mL) of Recommended Clear Fluids (see APPENDIX I), in addition to the water taken with PICOPREP ORANGE ® , each hour until bedtime to maintain hydration. It is recommended that patients follow a modified diet, such as a low-fibre diet, up until they take the medication. Upon taking the medication, the patient may only have Recommended Clear Fluids. It is recommended that patients cease taking any fluids two ( Llegiu el document complet