Country: Израел
Језик: Енглески
Извор: Ministry of Health
GLYCINE; L- ALANINE; L- ASPARTIC ACID; L- CYSTEINE; L- GLUTAMIC ACID; L- ISOLEUCINE; L- LEUCINE; L- LYSINE; L- METHIONINE; L- ORNITHINE HYDROCHLORIDE; L- PHENYLALANINE; L- PROLINE; L- SERINE; L- THREONINE; L- TRYPTOPHAN; L- TYROSINE; L- VALINE; L-ARGININE; L-HISTIDINE; TAURINE
REMEDIX CARE LTD
B05XB03
SOLUTION FOR INFUSION
L- VALINE 0.76 G / 100 ML; L- TYROSINE 0.045 G / 100 ML; L- TRYPTOPHAN 0.2 G / 100 ML; L- THREONINE 0.37 G / 100 ML; TAURINE 0.06 G / 100 ML; L- SERINE 0.4 G / 100 ML; L- PROLINE 0.3 G / 100 ML; L- PHENYLALANINE 0.42 G / 100 ML; L- ORNITHINE HYDROCHLORIDE 0.318 G / 100 ML; L- METHIONINE 0.24 G / 100 ML; L- LYSINE 1.1 G / 100 ML; L- LEUCINE 1.0 G / 100 ML; L- ISOLEUCINE 0.67 G / 100 ML; L-HISTIDINE 0.38 G / 100 ML; GLYCINE 0.4 G / 100 ML; L- GLUTAMIC ACID 1.0 G / 100 ML; L- CYSTEINE 0.189 G / 100 ML; L- ASPARTIC ACID 0.6 G / 100 ML; L-ARGININE 0.84 G / 100 ML; L- ALANINE 0.8 G / 100 ML
I.V
Required
BAXTER S.A., BELGIUM
LYSINE
LYSINE
Primene 10 % is indicated in 1) children and infants 2) neonates at term or premature of normal or low birth weight when oral or enteral nutrition is impossible insufficient or contraindicated.משטר מינון: 3/7/2019 שינוי בפרק 4.2 בעלון ללא שינוי ברשיון הנמוקים לבקשה: בהתאם לעלון רפרנס SPC-UK ו-Clinical overview
2014-08-31
_ _ _:ךיראת_ _ _ _רבוטקוא_ _ _ _2019_ _ _ ה/דבכנ ת/חקור ,ה/אפור ןולעב םיאבה םינוכדעה לע העידומ עבט תרבח אפורל רישכתה לש _ _ ןמירפ ® % 10 PRIMENE ® 10% SOLUTION FOR INFUSION CONTAINS:_ _ Each liter of the infusion solution contains: L-Isoleucine 6.70 g L-Leucine 10.0 g L-Valine 7.60 g L-Lysine 11.00 g L-Methionine 2.40 g L-Phenylalanine 4.20 g L-Threonine 3.70 g L-Tryptophan 2.00 g L-Arginine 8.40 g L-Histidine 3.80 g L-Alanine 8.00 g L-Aspartic Acid 6.00 g L-Cysteine 1.89 g L-Glutamic Acid 10.00 g Glycine 4.00 g L-Proline 3.00 g L-Serine 4.00 g L-Tyrosine 0.45 g L-Ornithine Hydrochloride 3.18 g Taurine 0.6 g אפורל ןולעב םינוכדע ------------------------------------------------------------------------------------------------------------ :םושירה תדועתב הרשואש יפכ היוותה Primene 10 % is indicated in 1) children and infants 2) neonates at term or premature of normal or low birth weight when oral or enteral nutrition is impossible insufficient or contraindicated. עידוהל וננוצרב םינולעהש כדוע ונ םיירקיעה םינוכדעה םילולכ ןלהלש טוריפב , תונמוסמ תופסות( דבלב םודאב :) :אפורל ןולעב םינוכדע […] 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE _Allergic Reactions / Hypersensitivity Reactions _ Anaphylactic/anaphylactoid reactions and other hypersensitivity/infusion reactions have been reported with amino acid solutions administered as a component of parenteral nutrition (see section 4.8). The infusion must be stopped immediately if any signs or symptoms of a reaction develop. _Precipitates in Patients Receiving Parenteral Nutrition _ Pulmonary vascular precipitates have been reported in patients receiving parenteral nutrition. In some cases, fatal outcomes have occurred. Excessive addition of calcium and phosphate increases the risk of the formation of calcium phosphate precipitates. Precipitates have been rep Прочитајте комплетан документ
SUMMARY OF PRODUCT CHARACTERISTICS Primene 10% Solution for Infusion 1. NAME OF THE MEDICINAL PRODUCT Primene 10% 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each liter of the infusion solution contains: L-Isoleucine 6.70 g L-Leucine 10.0 g L-Valine 7.60 g L-Lysine 11.00 g L-Methionine 2.40 g L-Phenylalanine 4.20 g L-Threonine 3.70 g L-Tryptophan 2.00 g L-Arginine 8.40 g L-Histidine 3.80 g L-Alanine 8.00 g L-Aspartic Acid 6.00 g L-Cysteine 1.89 g L-Glutamic Acid 10.00 g Glycine 4.00 g L-Proline 3.00 g L-Serine 4.00 g L-Tyrosine 0.45 g L-Ornithine Hydrochloride 3.18 g Taurine 0.6 g For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for infusion. A clear, colourless solution. Primene 10% has a pH of 5.5 and an osmolarity of 780 mOsmol/L. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Primene 10% is indicated in 1) children and infants 2) neonates, at term or premature, of normal or low birth weight when oral or enteral nutrition is impossible, insufficient or contraindicated. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Parenteral nutrition initiation and duration as well as dosage (dose and rate of administration) depends on a patient’s • age, weight, clinical condition, • nitrogen requirements, • ability to metabolize the constituents of Primene 10%, • additional nutrition that may be provided parenterally and/or enterally. The usual range is: POSOLOGY MAXIMAL ADMINISTRATION RATE g/kg/day (24 hours) ml/kg/day (24 hours) ml/kg/min 1.5 to 3.5 g of amino acids or 0.23 to 0.53 g of nitrogen 15 to 35 0.05 The administration rate should never exceed 0.05 ml/kg/min. Recommended flow rates Neonates and infants: continuous infusion (over 24 hours). Children up to 12 years: - continuous infusion over 24 hours; - cyclic infusion (over about 12 hours in 24) The flow rate should be adjusted according to the dosage, the characteristics of the infusion solution, the total volume intake per 24 hours and the infusion duration. The flow rate should be increased gradually during t Прочитајте комплетан документ