Maa: Ruotsi
Kieli: ruotsi
Lähde: Läkemedelsverket (Medical Products Agency)
alanin; arginin; asparaginsyra; cystein; fenylalanin; glukosmonohydrat; glutaminsyra; glycin; histidin; isoleucin; kalciumkloriddihydrat; kaliumacetat; leucin; lysinmonohydrat; magnesiumacetattetrahydrat; metionin; natriumglycerofosfat, hydratiserat; olivolja, raffinerad; ornitinhydroklorid; prolin; serin; sojaolja, raffinerad; taurin; treonin; tryptofan; tyrosin; valin
Baxter Medical AB
B05BA10
alanine; arginine; aspartic acid; cysteine; phenylalanine; glukosmonohydrat; glutamic acid; glycine; histidine; isoleucine; kalciumkloriddihydrat; acid; leucine; lysinmonohydrat; magnesiumacetattetrahydrat; methionine; natriumglycerofosfat, hydrated; olive oil, refined; ornitinhydroklorid; proline; serine; soybean oil, refined; taurine; threonine; tryptophan; tyrosine; valine
Infusionsvätska, emulsion
metionin 1,4 mg Aktiv substans; ornitinhydroklorid 1,85 mg Aktiv substans; fenylalanin 2,45 mg Aktiv substans; prolin 1,75 mg Aktiv substans; serin 2,33 mg Aktiv substans; taurin 0,35 mg Aktiv substans; treonin 2,16 mg Aktiv substans; tryptofan 1,17 mg Aktiv substans; tyrosin 0,45 mg Aktiv substans; valin 4,43 mg Aktiv substans; glukosmonohydrat 550 mg Aktiv substans; histidin 2,21 mg Aktiv substans; glycin 2,33 mg Aktiv substans; glutaminsyra 5,83 mg Aktiv substans; cystein 1,1 mg Aktiv substans; lysinmonohydrat 7,2 mg Aktiv substans; leucin 5,83 mg Aktiv substans; isoleucin 3,9 mg Aktiv substans; alanin 4,66 mg Aktiv substans; natriumglycerofosfat, hydratiserat 6,15 mg Aktiv substans; magnesiumacetattetrahydrat 0,63 mg Aktiv substans; kalciumkloriddihydrat 3,45 mg Aktiv substans; kaliumacetat 3,83 mg Aktiv substans; sojaolja, raffinerad 25 mg Aktiv substans; glycerol Hjälpämne; olivolja, raffinerad 100 mg Aktiv substans; asparaginsyra 3,5 mg Aktiv substans; arginin 4,89 mg Aktiv substans
Receptbelagt
Förpacknings: Trekammarpåse, 1 x 300 ml; Trekammarpåse, 10 x 300 ml
Godkänd
2016-05-12
PACKAGE LEAFLET: INFORMATION FOR THE USER NUMETA G13E 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 G13E is and what it is used for 2. What you need to know before your child is given Numeta G13E 3. How Numeta G13E is given 4. Possible side effects 5. How to store Numeta G13E 6. Contents of the pack and other information 1. WHAT NUMETA G13E IS AND WHAT IT IS USED FOR Numeta G13E is a specialised nutrition emulsion designed for preterm newborns. 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 G13E must only be used under medical supervision. 2. WHAT YOU NEED TO KNOW BEFORE YOUR CHILD IS GIVEN NUMETA G13E YOUR CHILD SHOULD NOT BE GIVEN NUMETA G13E, IN THE FOLLOWING CASES: WITH THE GLUCOSE AND AMINO ACID/ELECTROLYTE SOLUTIONS MIXED TOGETHER IN THE BAG (“2 IN 1”): - If your child is allergic to egg, soya, peanuts or to any ingredient of this medicine or component of the container (listed in section 6). - If your child’s body has problems using building blocks of protein. - If your child has high concentrations of any of the electrolytes included in Numeta G13E in their blood. - Numeta G13E (or other calcium containing solutions) must not be given at the Lue koko asiakirja
Page 1 of 26 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Numeta G13E 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 300 mL 80 mL 160 mL 60 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, 240 mL solution) or three (amino acids, glucose and lipid, 3 chamber bag, 300 mL emulsion) chambers are provided in the following table. COMPOSITION ACTIVE SUBSTANCE ACTIVATED 2CB (240 ML) ACTIVATED 3CB (300 ML) AMINO ACID CHAMBER Alanine 0.75 g 0.75 g Arginine 0.78 g 0.78 g Aspartic acid 0.56 g 0.56 g Cysteine 0.18 g 0.18 g Glutamic acid 0.93 g 0.93 g Glycine 0.37 g 0.37 g Histidine 0.35 g 0.35 g Isoleucine 0.62 g 0.62 g Leucine 0.93 g 0.93 g Lysine monohydrate (equivalent to Lysine) 1.15 g (1.03 g) 1.15 g (1.03 g) Methionine 0.22 g 0.22 g Ornithine hydrochloride (equivalent to Ornithine) 0.30 g (0.23 g) 0.30 g (0.23 g) Phenylalanine 0.39 g 0.39 g Proline 0.28 g 0.28 g Serine 0.37 g 0.37 g Taurine 0.06 g 0.06 g Threonine 0.35 g 0.35 g Page 2 of 26 COMPOSITION ACTIVE SUBSTANCE ACTIVATED 2CB (240 ML) ACTIVATED 3CB (300 ML) Tryptophan 0.19 g 0.19 g Tyrosine 0.07 g 0.07 g Valine 0.71 g 0.71 g Potassium acetate 0.61 g 0.61 g Calcium chloride dihydrate 0.55 g 0.55 g Magnesium acetate tetrahydrate 0.10 g 0.10 g Sodium glycerophosphate hydrated 0.98 g 0.98 g GLUCOSE CHAMBER Glucose Lue koko asiakirja