{"effective_time":"20200630","health_care_provider_letter":["HEALTH CARE PROVIDER LETTER Dear Healthcare Provider Letter image 1 Dear Healthcare Provider Letter image 2 Dear Healthcare Provider Letter image 3 Dear Healthcare Provider Letter image 4 Dear Healthcare Provider Letter image 5 Dear Healthcare Provider Letter image 6 Dear Healthcare Provider Letter image 7 Dear Healthcare Provider Letter image 8 Dear Healthcare Provider Letter image 9 Dear Healthcare Provider Letter image 10 Dear Healthcare Provider Letter image 11"],"id":"97a316be-3f08-42f2-bd25-b1e721276aa4","openfda":{},"package_label_principal_display_panel":["PACKAGE/LABEL PRINCIPAL DISPLAY PANEL Code FKB6642 3000 ml Baxter Logo SYNTHAMIN 17 without Electrolytes 10% Amino Acid Intravenous Infusion VIAFLEX container Hypertonic POM symbol Sterile, nonpyrogenic Formula per 1000 ml Essential amino acids L-Leucine 7.30 g L-Isoleucine 6.00 g L-Lycine (as hydrochloride salt) 5.80 g L-Valine 5.80 g L-Phenylatanine 5.80 g L-Histidine 4.80 g L-Threonine 4.20 g L-Methionine 4.00 g L-Trypotophan 1.80 g Other Ingredients Water for injections QS Sodium Acetate pH Adj Glacial Acetic Acid pH Adj Non-essential amino acids L-Alanine 20.70 g L-Arginine 11.50 g Amino acetic Acid (glycine) 10.30 g L-Proline 6.80 g L-Serine 5.00 g L-Tyrosine 400 mg Total nitrogen per litre (approx) 18.5 g mmol per litre (approx.) Acetate 82 Chloride 40 balanced by ions from amino acids Bulk source container for pharmacy use Not for direct intravenous infusion Refer to operating instructions for Automix high speed compounders before use For use under medical supervision Do not use unless solution is clear and colourless or slightly yellow, and container is undamaged Check additive compatibility before use It is not recommended that additions are made to this container Do not administer simultaneously with blood Discontinue infusion if adverse reaction occurs Do not store above 25°C Protect from light during storage Keep out of the sight and reach of children For single use only Discard any usused portion Discard all equipment after use Do not reconnect partially used bags Baxter Healthcare Ltd Caxton Way Thetford Norfolk IP24 3SE PL 00116/0296 TH-35-01-970 LOT EXP 2700 2400 2100 1800 1500 1200 900 600 300 Drug Shortage Synthamin Container Label"],"set_id":"3d0063d8-d404-4d4a-abff-8b1adf510042","spl_product_data_elements":["Synthamin leucine, isoleucine, lysine, valine, phenylalanine, histidine, threonine, methionine, tryptophan, alanine, arginine, glycine, proline, serine, tyrosine LEUCINE LEUCINE ISOLEUCINE ISOLEUCINE LYSINE LYSINE VALINE VALINE PHENYLALANINE PHENYLALANINE HISTIDINE HISTIDINE THREONINE THREONINE METHIONINE METHIONINE TRYPTOPHAN TRYPTOPHAN ALANINE ALANINE ARGININE ARGININE GLYCINE GLYCINE PROLINE PROLINE SERINE SERINE TYROSINE TYROSINE WATER SODIUM ACETATE ACETIC ACID"],"version":"3"}