{"effective_time":"20191130","health_care_provider_letter":["HEALTH CARE PROVIDER LETTER DHCP 1 DHCP 2 DHCP 3 DHCP 4 DHCP 5 DHCP 6 DHCP 7 DHCP 8 DHCP 9 DHCP 10 DHCP 11 DHCP 12 DHCP 13 DHCP 14 DHCP 15 DHCP 16"],"id":"830c8677-04ad-4014-a368-ddb6b819c9e3","openfda":{},"package_label_principal_display_panel":["PACKAGE/LABEL PRINCIPAL DISPLAY PANEL Container Label Code B6670C 2 x 500 ml Baxter Logo Clintec Logo Clinimix® N9G20E - solution for infusion 5.5% Amino Acids with Electrolytes (500 ml) and Glucose 20% with Calcium (500 ml) Vertical Peel Seal Design Characteristics of the mixture (1 litre): Nitrogen 4.6 g Total calories 510 kcal Glucose calories 400 kcal Osmolarity 980 mOsm/1 pH 6.0 Amino Acids (5.5%) with electrolytes Volume 500 ml Amino acids 28 g Glucose anhyd. - Nitrogen 4.6 g Glucose calories - Sodium 35 mmol Potassium 30 mmol Magnesium 2.5 mmol Calcium - Chloride 35 mmol Phosphate 15 mmol Acetate 50 mmol Glucose (20%) with calcium Volume 500 ml Amino acids - Glucose anhyd. 100 g Nitrogen - Glucose calories 400 kcal Sodium - Potassium - Magnesium - Calcium 2.3 mmol Chloride 4.5 mmol Phosphate - Acetate - Final Mixture Volume 1000 ml Amino acids 28 g Glucose anhyd. 100 g Nitrogen 4.6 g Glucose calories 400 kcal Sodium 35 mmol Potassium 30 mmol Magnesium 2.5 mmol Calcium 2.3 mmol Chloride 40 mmol Phosphate 15 mmol Acetate 50 mmol Other ingredients: Amino acids solution: Acetic acid, Water for injections Glucose solution: Hydrochloric acid, Water for injections Lot Concentration of amino acids after mixing (1 litre): Essential amino acids L-Leucine 2.01 g L-Valine 1.60 g L-Phenylalanine 1.54 g L-Histidine 1.32 g L-Methionine 1.10 g L-Threonine 1.16 g L-Lysine HCI 2.00 g L-Tryptophan 0.50 g L-Isoleucine 1.65 g Non-essenlial amino acids L-Alanine 5.70 g L-Proline 1.87 g L-Arginine 3.17 g L-Serine 1.38 g Glycine 2.84 g L-Tyrosine 0.11 g For intravenous administration. Sterile, non pyrogenic solutions. Store in outer carton. Do not freeze. Do not use unless solution is clear, peel seal is intact and container is undamaged. Do not connect in series. Do not administer before or after administration of blood through the same infusion equipment. Warning: This solution is hypertonic and can cause venous irritation. Administer only after breaking the seal and mixing the contents of both compartments. The binary mixture is stable for 7 days at 2 to 8°C followed by 48 hours below 25°C. Following additions, the admixture should not be kept for more than 24 hours at 2 to 8°C. Refer to leaflet. Additives may be incompatible. Keep all medicines out of reach of children. Do not reconnect partially used bag. Baxter Healthcare Ltd Caxton Way Thetford Norfolk IP24 3SE United Kingdom 88-25-44-604 Expiry date 1600 1000 800 600 400 200 Container Label Code B6669C 2 x 500 ml Baxter Logo CLINIMIX® N9G15E Solution for infusion Clintec Logo 5.5% Amino Acids with Electrolytes (500 ml) and Glucose 15% with Calcium (500 ml) Vertical Peel Seal Design Characteristics of the mixture (1 litre): Nitrogen 4.6 g Total calories 410 kcal Glucose calories 300 kcal Osmolarity 845 mOsm/l pH 6.0 Amino Acids (5.5%) with electrolytes Volume 500 ml Amino acids 28 g Glucose anhyd. - Nitrogen 4.6 g Glucose calories - Sodium 35 mmol Potassium 30 mmol Magnesium 2.5 mmol Calcium - Chloride 35 mmol Phosphate 15 mmol Acetate 50 mmol Glucose (15%) with calcium Volume 500 ml Amino acids - Glucose anhyd. 75 g Nitrogen - Glucose calories 300 kcal Sodium - Potassium - Magnesium - Calcium 2.3 mmol Chloride 4.5 mmol Phosphate - Acetate - Final Mixture Volume 1000 ml Amino acids 28 g Glucose anhyd. 75 g Nitrogen 4.6 g Glucose calories 300 kcal Sodium 35 mmol Potassium 30 mmol Magnesium 2.5 mmol Calcium 2.3 mmol Chloride 40 mmol Phosphate 15 mmol Acetate 50 mmol Other ingredients: Amino acids solution: Acetic acid, Water for injections Glucose solution: Hydrochloric acid, Water for injections Lot Concentration of amino acids after mixing (1 litre): Essential amino acids L-Leucine 2.01 g L-Valine 1.60 g L-Phenylalanine 1.54 g L-Histidine 1.32 g L-Methionine 1.10 g L-Threonine 1.16 g L-Lysine HCl 2.00 g L-Tryptophan 0.50 g L-Isoleucine 1.65 g Non-essential amino acids L-Alanine 5.70 g L-Proline 1.87 g L-Arginine 3.17 g L-Serine 1.38 g Glycine 2.84 g L-Tyrosine 0.11 g For intravenous administration. Sterile, non pyrogenic solutions. Store in outer carton. Do not freeze. Do not use unless solution is clear, peel seal is intact and container is undamaged. Do not connect in series. Do not administer before or after administration of blood through the same infusion equipment. Warning: This solution is hypertonic and can cause venous irritation. Administer only after breaking the seal and mixing the contents of both compartments. The binary mixture is stable for 7 days at 2 to 8°C followed by 48 hours below 25°C. Following additions, the admixture should not be kept for more than 24 hours at 2 to 8°C. Refer to leaflet. Additives may be incompatible. Keep all medicines out of reach of children. Do not reconnect partially used bag. Baxter Healthcare Ltd Caxton Way Thetford Norfolk IP24 3SE United Kingdom TH-35-01-978 EXP 1600 1000 800 600 400 200 Container Label Code FKB6654V 2000 ml Baxter Logo CLINIMIX N14G30E Solution for infusion With Electrolytes Formula for 2000 ml after mixing: L-alanine 17.60 g L-arginine 9.78 g Glycine 8.76 g L-histidine 4.08 g L-isoleucine 5.10 g L-leucine 6.20 g L-lysine 4.93 g (as lysine hydrochloride) (6.16 g) L-methionine 3.40 g L-phenylalanine 4.76 g L-proline 5.78 g L-serine 4.25 g L-threonine 3.57 g L-tryptophan 1.53 g L-tyrosine 0.34 g L-valine 4.93 g Sodium acetate 3H 2 O 5.94 g Dibasic potassium phosphate 5.22 g Sodium chloride 1.54 g Magnesium chloride 6H 2 O 1.02 g Glucose anhydrous (as monohydrate) 300 g Calcium chloride 2H 2 O 0.66 g Acetic acid, hydrochloric acid, water for injections 2000 ml of final mixture provides the following: Amino acids 85 g Nitrogen 14.0 g Glucose 300 g Total calories 1540 kcal Glucose calories 1200 kcal Na+ 70 mmol K+ 60 mmol Mg++ 5.0 mmol Ca++ 4.5 mmol Acetate 140 mmol Chloride 80 mmol Phosphate 30 mmol pH 6 Osmolarity 1415 mOsm/l 8.5% Amino Acids with Electrolytes (1000 ml) and Glucose 30% with Calcium (1000 ml) WARNING: Do not infuse without opening the seal and mixing the contents of the two compartments Read the package leaflet before use Keep out of the reach and sight of children For intravenous administration Do not freeze Store in the outer packaging in order to protect from light Do not use unless solution is clear and container undamaged For single use Do not store partly used bags and discard all equipment after use Do not administer before or after administration of blood through the same infusion equipment Additives may be incompatible Check compatibility before use Do not connect in series From a microbiological point of view, it is recommended that the product be used immediately after mixing However, the chemical and physical stability of the mixed solution has been demonstrated for 7 days (between 2°C and 8°C) followed by 48 hours at temperature not exceeding 25°C If not used immediately, the in use storage time and conditions are the responsibility of the user PL 00116/0300 PA 167/98/4 Baxter Healthcare Limited Caxton Way Thetford Norfolk IP24 3SE United Kingdom POM Symbol CLINIMIX N14G30E Solution for infusion 2000 ml TH-35-01-780 EXP 2600 2000 1600 1000 800 600 400 200 Clinimix FKB6670C Representative Container Label 1 of 2 Clinimix FKB6670C Representative Container Label 2 of 2 Clinimix FKB6669C Representative Container Label 1 of 2 Clinimix FKB6669C Representative Container Label 2 of 2 Clinimix FKB6654V Representative Container Label 1 of 2 Clinimix FKB6654V Representative Container Label 2 of 2"],"set_id":"ae826725-59da-491a-9955-319cd0dae116","spl_product_data_elements":["Clinimix Isoleucine, Leucine, Valine, Lysine, Methionine, Phenylalanine, Threonine, Tryptophan, Arginine, Histidine, Alanine, Glycine, Proline, Serine, Tyrosine, Sodium acetate, Dibasic potassium phosphate, Sodium chloride, Magnesium Chloride, Dextrose Monohydrate, Calcium chloride ISOLEUCINE ISOLEUCINE LEUCINE LEUCINE VALINE VALINE LYSINE LYSINE METHIONINE METHIONINE PHENYLALANINE PHENYLALANINE THREONINE THREONINE TRYPTOPHAN TRYPTOPHAN ARGININE ARGININE HISTIDINE HISTIDINE ALANINE ALANINE GLYCINE GLYCINE PROLINE PROLINE SERINE SERINE TYROSINE TYROSINE SODIUM ACETATE SODIUM CATION ACETATE ION POTASSIUM PHOSPHATE, DIBASIC PHOSPHATE ION POTASSIUM CATION SODIUM CHLORIDE SODIUM CATION CHLORIDE ION MAGNESIUM CHLORIDE MAGNESIUM CATION CHLORIDE ION DEXTROSE MONOHYDRATE ANHYDROUS DEXTROSE CALCIUM CHLORIDE CALCIUM CATION CHLORIDE ION ACETIC ACID WATER HYDROCHLORIC ACID Clinimix Isoleucine, Leucine, Valine, Lysine, Methionine, Phenylalanine, Threonine, Tryptophan, Arginine, Histidine, Alanine, Glycine, Proline, Serine, Tyrosine, Sodium acetate, Dibasic potassium phosphate, Sodium chloride, Magnesium chloride, Dextrose Monohydrate, Calcium chloride ISOLEUCINE ISOLEUCINE LEUCINE LEUCINE VALINE VALINE LYSINE LYSINE METHIONINE METHIONINE PHENYLALANINE PHENYLALANINE THREONINE THREONINE TRYPTOPHAN TRYPTOPHAN ARGININE ARGININE HISTIDINE HISTIDINE ALANINE ALANINE GLYCINE GLYCINE PROLINE PROLINE SERINE SERINE TYROSINE TYROSINE SODIUM ACETATE SODIUM CATION ACETATE ION POTASSIUM PHOSPHATE, DIBASIC PHOSPHATE ION POTASSIUM CATION SODIUM CHLORIDE SODIUM CATION CHLORIDE ION MAGNESIUM CHLORIDE MAGNESIUM CATION CHLORIDE ION DEXTROSE MONOHYDRATE ANHYDROUS DEXTROSE CALCIUM CHLORIDE CALCIUM CATION CHLORIDE ION ACETIC ACID WATER HYDROCHLORIC ACID Clinimix Isoleucine, Leucine, Valine, Lysine, Methionine, Phenylalanine, Threonine, Tryptophan, Arginine, Histidine, Alanine, Glycine, Proline, Serine, Tyrosine, Sodium acetate, Dibasic potassium phosphate, Sodium chloride, Magnesium chloride, Dextrose Monohydrate, Calcium chloride ISOLEUCINE ISOLEUCINE LEUCINE LEUCINE VALINE VALINE LYSINE LYSINE METHIONINE METHIONINE PHENYLALANINE PHENYLALANINE THREONINE THREONINE TRYPTOPHAN TRYPTOPHAN ARGININE ARGININE HISTIDINE HISTIDINE ALANINE ALANINE GLYCINE GLYCINE PROLINE PROLINE SERINE SERINE TYROSINE TYROSINE SODIUM ACETATE SODIUM CATION ACETATE ION POTASSIUM PHOSPHATE, DIBASIC PHOSPHATE ION POTASSIUM CATION SODIUM CHLORIDE SODIUM CATION CHLORIDE ION MAGNESIUM CHLORIDE MAGNESIUM CATION CHLORIDE ION DEXTROSE MONOHYDRATE ANHYDROUS DEXTROSE CALCIUM CHLORIDE CALCIUM CATION CHLORIDE ION ACETIC ACID WATER HYDROCHLORIC ACID"],"version":"3"}