Land: Malta
Sprog: engelsk
Kilde: Medicines Authority
CALCIUM CHLORIDE, DIHYDRATE, PHENYLALANINE, HISTIDINE, ARGININE, THREONINE, TRYPTOPHAN, TYROSINE, VALINE, GLYCINE, METHIONINE, ISOLEUCINE, LYSINE HYDROCHLORIDE, MAGNESIUM CHLORIDE, HEXAHYDRATE, SERINE, PROLINE, SODIUM CHLORIDE, SODIUM LACTATE
Baxter Holding B.V. Kobaltweg 49, 3542CE Utrecht, Netherlands
B05DB
TRYPTOPHAN 270 mg/l CALCIUM CHLORIDE DIHYDRATE 184 mg/l ARGININE 1071 mg/l ALANINE 951 mg/l PHENYLALANINE 570 mg/l HISTIDINE 714 mg/l THREONINE 646 mg/l GLYCINE 510 mg/l METHIONINE 850 mg/l ISOLEUCINE 850 mg/l LYSINE HYDROCHLORIDE 955 mg/l MAGNESIUM CHLORIDE HEXAHYDRATE 51 mg/l SERINE 510 mg/l LEUCINE 1020 mg/l PROLINE 595 mg/l SODIUM CHLORIDE 5380 mg/l SODIUM LACTATE 4480 mg/l TYROSINE 300 mg/l VALINE 1393 mg/l
SOLUTION FOR PERITONEAL DIALYSIS
TRYPTOPHAN 270 mg/l CALCIUM CHLORIDE DIHYDRATE 184 mg/l ARGININE 1071 mg/l ALANINE 951 mg/l PHENYLALANINE 570 mg/l HISTIDINE 714 mg/l THREONINE 646 mg/l GLYCINE 510 mg/l METHIONINE 850 mg/l ISOLEUCINE 850 mg/l LYSINE HYDROCHLORIDE 955 mg/l MAGNESIUM CHLORIDE HEXAHYDRATE 51 mg/l SERINE 510 mg/l LEUCINE 1020 mg/l PROLINE 595 mg/l SODIUM CHLORIDE 5380 mg/l SODIUM LACTATE 4480 mg/l TYROSINE 300 mg/l VALINE 1393 mg/l
POM
BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS
Authorised
2005-12-29
1 PACKAGE LEAFLET: INFORMATION FOR THE USER NUTRINEAL PD4 1.1% AMINO ACIDS, SOLUTION FOR PERITONEAL DIALYSIS READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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. - If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. WHAT IS IN THIS LEAFLET 1. What Nutrineal is and what it is used for 2. What you need to know before you use Nutrineal 3. How to use Nutrineal 4. Possible side effects 5. How to store Nutrineal 6. Contents of the pack and other information 1. WHAT NUTRINEAL IS AND WHAT IT IS USED FOR Nutrineal is a solution for peritoneal dialysis which does not contain glucose. It removes water and waste products from the blood and corrects different abnormal components of blood. Nutrineal may be prescribed for you : • if you have kidney failure which needs peritoneal dialysis • in particular if you are malnourished. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE NUTRINEAL Your doctor will assess whether Nutrineal is a suitable solution for your peritoneal dialysis treatment. He will have taken into account any factors in your medical history which might exclude the use of peritoneal dialysis solutions. DO NOT USE NUTRINEAL You must NOT use Nutrineal • If you are allergic to any amino acids or any of the other ingredients of this medicine (listed in section 6). • If your blood urea level is above 38 mmol/l. • If you suffer from a disorder affecting amino acid metabolism. • If your blood potassium level is too low. • If you show uraemic symptoms such as loss of appetite, nausea or vomiting. • If your blood bicarbonate levels are too low. • If you suffer from liver insufficiency. • If you already have severe lactic acidosis (too much acid in the blood) • If you have a surgically uncorrectable problem affecting your abdominal wall or cavity or uncorrectable problem th Læs hele dokumentet
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Nutrineal PD4 with 1.1% amino acids. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION L-Tyrosine 300 mg/l L-Tryptophan 270 mg/l L-Phenylalanine 570 mg/l L-Threonine 646 mg/l L-Serine 510 mg/l L-Proline 595 mg/l Glycine 510 mg/l L-Alanine 951 mg/l L-Valine 1393 mg/l L-Methionine 850 mg/l L-Isoleucine 850 mg/l L-Leucine 1020 mg/l L-Lysine hydrochloride 955 mg/l L-Histidine 714 mg/l L-Arginine 1071 mg/l Calcium chloride dihydrate 184 mg/l Magnesium chloride hexahydrate 51 mg/l Sodium S-Lactate 4480 mg/l Sodium Chloride 5380 mg/l For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for Peritoneal Dialysis 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Nutrineal is recommended as a non-glucose based peritoneal dialysis solution as part of a peritoneal dialysis regimen for the treatment of chronic renal failure patients. In particular, it is recommended for the malnourished peritoneal dialysis patients. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION ADMINISTRATION Nutrineal is intended for intraperitoneal administration only. Not for intravenous administration. Peritoneal dialysis solutions may be warmed in the overpouch to 37°C to enhance patient comfort. However, only dry heat (for example, heating pad, warming plate) should be used. Solutions should not be heated in water due to an increased risk of contamination. Solutions should not be heated in a microwave oven due to the potential for damage to the solutions container and patient injury or discomfort. Aseptic technique should be employed throughout the peritoneal dialysis procedure. Do not administer if the solution is discoloured, cloudy, contains particulate matter or shows evidence of leakage, or if seals are not intact. The drained fluid should be inspected for the presence of fibrin or cloudiness, which may indicate the presence of peritonitis. For single use only. POSOLOGY The mode of therapy, frequency of treatment, exchange volume, duration of dwell and length Læs hele dokumentet