国: アイルランド
言語: 英語
ソース: HPRA (Health Products Regulatory Authority)
Alanine; Arginine ; Aspartic Acid; Cysteine; Glutamic acid ; Glycine; Histidine; Isoleucine; Leucine ; Lysine; Methionine; Ornithine hydrochloride; Phenylalanine; Proline; Serine; Taurine; Threonine; Tryptophan; Tyrosine; Valine; Sodium chloride ph.eur.; Potassium acetate; Calcium chloride dihydrate; Magnesium acetate tetrahydrate; Sodium glycerophosphate, hydrated; Glucose; Refined olive oil + refined soybean oil
Baxter Holding B.V.
B05BA; B05BA10
Alanine; Arginine ; Aspartic Acid; Cysteine; Glutamic acid ; Glycine; Histidine; Isoleucine; Leucine ; Lysine; Methionine; Ornithine hydrochloride; Phenylalanine; Proline; Serine; Taurine; Threonine; Tryptophan; Tyrosine; Valine; Sodium chloride ph.eur.; Potassium acetate; Calcium chloride dihydrate; Magnesium acetate tetrahydrate; Sodium glycerophosphate, hydrated; Glucose; Refined olive oil + refined soybean oil
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Emulsion for infusion
Solutions for parenteral nutrition; combinations
Marketed
2011-12-05
BLACK BAXTER CONFIDENTIAL - INTERNAL USE ONLY Part Number: BE-30-04-036 Date: 07SEP23 Proofread No.: P01 Designer: M.T Page: 1 of 6 Colour Reference: BE-30-04-036 1a Package leaflet: Information for the user Numeta G16%E emulsion for infusion 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 child’s doctor, pharmacist or nurse. • If your child gets any side effects, talk to your child’s doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4. What is in this leaflet: 1. What Numeta G16%E is and what it is used for 2. What you need to know before your child is given Numeta G16%E 3. How Numeta G16%E is given 4. Possible side effects 5. How to store Numeta G16%E 6. Contents of the pack and other information 1. What Numeta G16%E is and what it is used for Numeta G16%E is a specialised nutrition emulsion designed for full term newborns and children up to 2 years. It is given through a tube which is placed in your child’s vein, when your child is not able to eat all of his or her nutrition by mouth. Numeta is presented in the form of a three chamber bag in which the separate chambers contain: a 50 % glucose solution a 5.9% paediatric amino acid solution, with electrolytes a 12.5% lipid (fat) emulsion Depending on your child’s needs, two or three of these solutions are mixed together in the bag before it is given to your child. Numeta G16%E must only be used under medical supervision. 2. What you need to know before your child is given Numeta G16%E Your child should not be given Numeta G16%E, in the following cases: With 2 solutions mixed together in the bag (“2 in 1”): • If your child is allergic to egg proteins, soya, peanuts or to any ingredient in the glucose or amino acids chamber (listed in section 6). • If your child’s body has problems using building blocks of protein. • If yo 完全なドキュメントを読む
Health Products Regulatory Authority 26 February 2021 CRN009NTR Page 1 of 19 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Numeta G16%E emulsion for infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION This medicinal product is presented in the form of a three chamber bag. Each bag contains a sterile non-pyrogenic combination of a glucose solution, a paediatric amino acids solution, with electrolytes, and a lipid emulsion, as described below. CONTAINER SIZE 50% GLUCOSE SOLUTION 5.9% AMINO ACIDS SOLUTION WITH ELECTROLYTES 12.5% LIPID EMULSION 500 mL 155 mL 221 mL 124 mL If lipid administration is undesirable, the design of the bag allows the possibility to activate only the peel seal between the amino acids/electrolytes and glucose chambers, leaving the peel seal between the amino acids and lipid chambers intact. The content of the bag can subsequently be infused with or without lipids. The composition of the drug product after mixing of the two (amino acids and glucose, 2 chamber bag, 376 mL solution) or three (amino acids, glucose and lipid, 3 chamber bag, 500 mL emulsion) chambers are provided in the following table. COMPOSITION ACTIVE SUBSTANCE ACTIVATED 2CB (376 ML) ACTIVATED 3CB (500 ML) AMINO ACID CHAMBER Alanine 1.03g 1.03g Arginine 1.08g 1.08g Aspartic acid 0.77g 0.77g Cysteine 0.24g 0.24g Glutamic acid 1.29g 1.29g Glycine 0.51g 0.51g Histidine 0.49g 0.49g Isoleucine 0.86g 0.86g Leucine 1.29g 1.29g Lysine monohydrate (equivalent to Lysine) 1.59g (1.42g) 1.59g (1.42g) Methionine 0.31g 0.31g Ornithine hydrochloride (equivalent to Ornithine) 0.41g (0.32g) 0.41g (0.32g) Phenylalanine 0.54g 0.54g Proline 0.39g 0.39g Serine 0.51g 0.51g Taurine 0.08g 0.08g Threonine 0.48g 0.48g Tryptophan 0.26g 0.26g Tyrosine 0.10g 0.10g Valine 0.98g 0.98g Sodium chloride 0.30g 0.30g Potassium acetate 1.12g 1.12g Calcium chloride dihydrate 0.46g 0.46g Magnesium acetate tetrahydrate 0.33g 0.33g Sodium glycerophosphate hydrated 0.98g 0.98g GLUCOSE CHAMBER Glucose monohydrate (equivalent to glucose anhydrous) 85 完全なドキュメントを読む