Țară: Noua Zeelandă
Limbă: engleză
Sursă: Medsafe (Medicines Safety Authority)
Citric acid 771.868 mg/g; Heavy magnesium oxide 225.128 mg/g; Sodium picosulfate 0.64 mg/g;
Fresenius Kabi New Zealand Limited
Citric acid 771.868 mg/g
0.64 mg/g
Powder for oral solution
Active: Citric acid 771.868 mg/g Heavy magnesium oxide 225.128 mg/g Sodium picosulfate 0.64 mg/g Excipient: Aspartame
Sachet, laminate, 2 x 15.546g, 2 dose units
Restricted
Restricted
AMS Laboratories Pty Ltd
Package - Contents - Shelf Life: Sachet, laminate, 2 x 15.546g - 2 dose units - 36 months from date of manufacture stored at or below 30°C - Sachet, laminate, 3 x 15.546g - 3 dose units - 36 months from date of manufacture stored at or below 30°C
1999-07-13
CMI FOR PICOPREP October 2010 Filename:PicCMI261010-cleanmarked Page 1 of 4 Change: Company name change PICOPREP Sodium Picosulfate Powder for Oral Solution CONSUMER MEDICINE INFORMATION WARNING Serious dehydration and/or electrolyte disturbance may occur in some “at risk” Patients. Please read the section headed “Before you take PicoPrep” WHAT IS IN THIS LEAFLET? This leaflet answers some common questions about PicoPrep. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking PicoPrep against the expected benefits it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again WHAT PICOPREP IS USED FOR? PicoPrep is used to remove the bowel contents and cleanse it prior to the doctor’s examination or surgery. It enables your doctor to see inside easily. It is sometimes used to clear the colon before a special x-ray of the kidneys. It does this by acting in the intestine and colon causing a watery stool or bowel motion which removes the bowel contents. This may be a little uncomfortable but is necessary for the examination. It depends on what type of examination you are having as to what procedure is to be used. One type is that a special instrument is insert Citiți documentul complet
NEW ZEALAND DATA SHEET Data Sheet – PicoPrep® powder for oral solution - June 2019 Page 1 of 6 WARNING LIFE-THREATENING DEHYDRATION AND/OR ELECTROLYTE DISTURBANCES MAY OCCUR IN “AT RISK” GROUPS. SEE CONTRAINDICATIONS AND PRECAUTIONS. 1 PRODUCT NAME PicoPrep® powder 15.5 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 oxide - heavy, has a chemical formula of MgO, a MW of 40.3 and a CAS No. 1309-48-4; • 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 sachet contains sodium picosulfate 10 mg, magnesium oxide 3.5 g, citric acid anhydrous 12.0 g and aspartame 36 mg. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Powder for oral solution. PicoPrep® powder for oral solution is a white crystalline powder packed in sachets each containing 15.546 g. When dissolved in water it produces a solution with a mild citric acid taste. 4 CLINICAL PARTICULARS 4.1 Therapeutic indications PicoPrep® 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 surgery. 4.2 Dose and method of administration Information for Patients The first bowel motion should occur approximately 2 to 3 hours after commencing dose. Onset may be sooner in individual patients. This action cleanses the bowel before examination. It should be prepared and taken according to the directions on the box or in the Dosage and Administration section. No food or drink should be taken for at least six (6) hours before the examination. It is important that the patient follow the recommended dosing schedule and take adequate fluids to ensure hydration. NEW ZEALAND DATA SHEET Data Sheet – PicoPrep® powder for or Citiți documentul complet