Երկիր: Մալայզիա
Լեզու: անգլերեն
Աղբյուրը: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
SODIUM LACTATE; L-Isoleucine USP; L-Leucine USP; L-Phenylalanine USP; L-Threonine USP; L-Tryptophan USP; L-Histidine USP; L-Proline USP; L-Serine USP; L-Valine USP; L-Tyrosine USP; L-Methionine USP; L-Alanine USP; L-Arginine USP; L-Lysine HCI USP; Calcium Chloride Dihydrate USP; Sodium Chloride, USP; Glycine, USP; Magnesium Chloride Hexahydrate USP
BAXTER HEALTHCARE (MALAYSIA) SDN. BHD.
SODIUM LACTATE; L-Isoleucine USP; L-Leucine USP; L-Phenylalanine USP; L-Threonine USP; L-Tryptophan USP; L-Histidine USP; L-Proline USP; L-Serine USP; L-Valine USP; L-Tyrosine USP; L-Methionine USP; L-Alanine USP; L-Arginine USP; L-Lysine HCI USP; Calcium Chloride Dihydrate USP; Sodium Chloride, USP; Glycine, USP; Magnesium Chloride Hexahydrate USP
2000ml mL
BAXTER HEALTHCARE SA, SINGAPORE BRANCH
-- - _BAXTER_ NUTRINEAL PD-4PERITONEAL DIALYSISSOLUTION WITH1.1%AMINOACIDS For intraperitoneal administration only PATIENTLEAFLET COMPOSITION Each 1000mL contains: - Amino Acids L-Serine L-Isoleucine L-Leucine L-Lysine Hydrochloride L-Methionine L-Phenylalanine L-Threonine L-Tryptophan - L-Valine L-Alanine L-Arginine Glycine L-Histidine L-Proline L-Tyrosine - Sodium Chloride - Calcium Chloride Dihydrate - Magnesium Chloride Hexahydrate - Sodium Lactate - Hydrochloric Acid - Water for injections Osmolarity: Ionic formula Sodium Calcium Magnesium ~actate ~hlorides Amino Acids 0.510 g 0.850 g 1.020 g 0.955 g 0.850 g 0.570 g 0.646 g 0.270 g 1.393 g 0.951 g 1.071 g 0.510 g 0.714 g 0.595 g 0.300 g 5.380 g 0.184 g 0.051 g 4.48 g q.s. pH = 6.3 q.s. _366 mOsm/1_(Calculated excluding HCI) 132 mmol/l 1.25 mmol/l _0.25 mmol/l_ 40 mmolll 105 mmol/l 87 mmolll PHARMACEUTICAL FORM Peritoneal dialysis solution contained in bags. CLINICAL PARTICULARS 1. TheraDeutic Indications Nutritional supplement for malnourished renal failure patients (albumin concentration lower than 35 g/litre) being maintained on peritoneal dialysis. 2. Posology and Method of Administration For intraperitoneal administration only. This route requires the use of a specific catheter and an appropriate administration set which connects the solution container to the patient's catheter. Overpouch must be removed and solution warmed to body temperature before use. Dosage schedule, frequency of treatment and duration of dwell should be selected by the prescribing physician according to the patient's clinical status. Recommended dietary allowance of protein is approximately 1.2-1.3 _g/kg_ for dialysed adults and 2-3_ g/kg_ for infants. Higher amounts may be necessary in several catabolic states. For information, a 2-litre bag of NUTRINEALwith 1.1% amino acids provides 22 g of amino acids which are equivalent to 0.30_ g/kg/day_ for a 70 kg adult. 3. Contraindicatlons Some clinical conditions such as recent abdominal surgery and gastrointestinal disturbances have to Կարդացեք ամբողջական փաստաթուղթը
NUTRINEAL PD‐4 PERITONEAL DIALYSIS SOLUTION WITH 1.1% AMINO ACIDS FOR INTRAPERITONEAL ADMINISTRATION ONLY PATIENT LEAFLET COMPOSITION Each 1000mL contains Amino Acids L‐Serine 0.510 g L‐Isoleucine 0.850 g L‐Leucine 1.020 g L‐Lysine (as Hydrochloride) 0.955 g L‐Methionine 0.850 g L‐Phenylalanine 0.570 g L‐Threonine 0.646 g L‐Tryptophan 0.270 g L‐Valine 1.393 g L‐Alanine 0.951 g L‐Arginine 1.071 g Glycine 0.510 g L‐Histidine 0.714 g L‐Proline 0.595 g L‐Tyrosine 0.300 g Sodium Chloride 5.380 g Calcium Chloride Dihydrate 0.184 g Magnesium Chloride Hexahydrate 0.051 g Sodium Lactate 4.48 g Hydrochloric Acid q.s. pH = 6.3 Water for Injections q.s. Osmolarity: 366 mOsmol/l (Calculated excluding HCI) Ionic formula Sodium 132 mmol/l Calcium 1.25 mmol/l Magnesium 0.25 mmol/l Lactate 40 mmol/l Chlorides 105 mmol/l Amino Acids 87 mmol/l PHARMACEUTICAL FORM Peritoneal dialysis solution contained in bags. PRODUCT DESCRIPTION Nutrineal contains 40mM of sodium lactate, 1.25mM of calcium and 0.25mM of magnesium, available in plasticized PL146‐2 poly (vinyl chloride) VIAFLEX flexible bag. CLINICAL PARTICULARS 1. THERAPEUTIC INDICATIONS Nutritional supplement for malnourished renal failure patients (albumin concentration lower than 35g/litre) being maintained on peritoneal dialysis. 2. DOSAGE AND METHOD OF ADMINISTRATION Administration: ‐ NUTRINEAL is intended for intraperitoneal administration only. Not for intravenous administration. ‐ The intraperitoneal administration route requires the use of a specific peritoneal dialysis catheter and an appropriate administration set which connects the solution container to the patient’s catheter. ‐ NUTRINEAL should be administered at a rate that is comfortable for the patient. The volume administered is determined by the prescribing physician. ‐ The mode of therapy, frequency of treatment, exchange volume, duration of dwell and length of dialysis should be initiated and supervised by the prescribing physician. ‐ Treatme Կարդացեք ամբողջական փաստաթուղթը