Nchi: Nyuzilandi
Lugha: Kiingereza
Chanzo: Medsafe (Medicines Safety Authority)
Citric acid 12.77 mg/g; Macrogol 3350 755.68 mg/g (as Macrogol 3350 prepared solution contains 6% w/w); Potassium chloride 10.55 mg/g; Sodium chloride 37.33 mg/g; ; Sodium sulfate 80.62 mg/g; 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 12.77 mg/g
Combination
Active: Citric acid 12.77 mg/g Macrogol 3350 755.68 mg/g (as Macrogol 3350 prepared solution contains 6% w/w) Potassium chloride 10.55 mg/g Sodium chloride 37.33 mg/g Sodium sulfate 80.62 mg/g Excipient: Ascorbic acid Aspartame Lemon flavour QL58817 Active: Citric acid 771.868 mg/g Heavy magnesium oxide 225.128 mg/g Sodium picosulfate 0.64 mg/g Excipient: Aspartame
Combination pack, Composite pack containing 1 x 70 g Glycoprep-C sachet and 2 x 15.5 g Picoprep sachets, 1 dose unit
Restricted
Restricted
AMS Laboratories Pty Ltd
Indicated for bowel emptying and cleansing by means of total gastrointestinal tract perfusion in preparation for gastrointestinal examination
Package - Contents - Shelf Life: Combination pack, Composite pack containing 1 x 70 g Glycoprep-C sachet and 2 x 15.5 g Picoprep sachets - 1 dose units - 2 years from date of manufacture stored at or below 25°C - Sachet, laminate, 2 x 15.5 g Picoprep - 31 g - 36 months from date of manufacture stored at or below 30°C - Sachet, laminate, 1 x 70g Glycoprep-C - 70 g - 2 years from date of manufacture stored at or below 25°C
2007-10-05
1 PREPKIT-C ® CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some of the common questions people ask about Prepkit-C. It does not contain all the information that is known about Prepkit-C. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor will have weighed the risks of you taking Prepkit-C against the benefits they expect 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 PREPKIT-C IS USED FOR Prepkit-C is used for bowel cleansing in conjunction with intravenous pyelograms (IVP), abdominal x-ray examinations, surgery and colonoscopy. The bowel needs to be clean before your doctor can examine it properly. Prepkit-C produces watery stools or bowel motions within 2 to 3 hours after the first administration and may cause frequent loose bowel motions during the night. THIS MEDICINE BELONGS TO A GROUP OF MEDICINES CALLED BOWEL PREPARATIONS. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. BEFORE YOU TAKE PREPKIT-C _ _ _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE PREPKIT-C IF YOU HAVE AN ALLERGY TO: Any of the ingredients listed at the end of this leaflet Any similar medicines to Prepkit-C Some symptoms of an allergic reaction may include: Shortness of breath Wheezing or difficulty breathing Swelling of the face, lips, tongue or other parts of the body Skin rash, itching or hives DO NOT TAKE PREPKIT-C IF YOU HAVE, OR HAVE HAD, ANY OF THE FOLLOWING MEDICAL CONDITIONS: Gastrointestinal obstruction or blockage Gastric retention A hole in the stomach, large intestine or small intestine Toxic megacolon, a type of bloating A condition known as Paralytic Ileus where the small bowel doesn’t work properly Inflammation of the bowel A body weight less than 20kg CAUTION SHOULD BE EXERCISED IN “AT RISK” PATIENTS Soma hati kamili
NEW ZEALAND DATA SHEET Data Sheet – Prepkit-C® powder for oral solution - June 2019 Page 1 of 7 WARNING: Life threatening dehydration and / or electrolyte disturbances may occur in “at risk” groups. See Contraindications and Precautions. 1 PRODUCT NAME Prepkit-C® (Combination pack) 2 QUALITATIVE AND QUANTITATIVE COMPOSITION The active ingredients in Glycoprep-C® Sachet Powder for Solution are: • macrogol 3350 has a chemical formula of HOCH 2 [CH 2 OCH 2 ]m. CH 2 OH (where ‘m’ equals 45 to 70). • sodium chloride has a chemical formula of NaCl, a MW of 58.44 and a CAS No. 7647-14-5. • potassium chloride has a chemical formula of KCl, a MW of 74.6 and a CAS No. 7447-40-7. • sodium sulfate has a chemical formula of Na 2 SO4, a MW of 142.0 and a CAS No. 7757-82-6. The active ingredients in PicoPrep® Sachet Powder for Solution 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 Glycoprep-C® 70 g sachet contains macrogol 3350 (polyethylene glycol) 52.9 g, sodium chloride 2.6 g, potassium chloride 740 mg, sodium sulfate (anhydrous) 5.6 g and ascorbic acid 6.0 g. This solution also contains citric acid (anhydrous), aspartame and flavouring. Total sodium content 2.83 g. Each PicoPrep® 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. Prepkit-C® is a combination kit containing one sachet of Glycoprep-C® 70 g powder for solution to produce one litre of solution and two sachets of PicoPrep® 15.5 g powder for solution. They both contain dry white crystalline powders which, when dissolved in water, produce solutions with a lemon like taste. 4 Soma hati kamili