NDC | 0338-9566-08, 0338-9570-08, 0338-9587-04 |
Set ID | ae826725-59da-491a-9955-319cd0dae116 |
Category | HUMAN PRESCRIPTION DRUG LABEL |
Packager | Baxter Healthcare Corporation |
Generic Name | |
Product Class | Amino Acid |
Product Number | |
Application Number |
- HEALTH CARE PROVIDER LETTER
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PACKAGE/LABEL PRINCIPAL DISPLAY PANEL
Code B6670C 2 x 500 ml
Baxter Logo
Clintec Logo Clinimix® N9G20E
- solution for infusion5.5% 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 6.0Amino Acids (5.5%)
with electrolytesVolume 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 mmolGlucose (20%)
with calciumVolume 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 mmolOther ingredients:
Amino acids solution: Acetic acid, Water for injections
Glucose solution: Hydrochloric acid, Water for injectionsLot
Concentration of amino acids after mixing
(1 litre):
Essential amino acidsL-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 gNon-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 gFor 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 Kingdom88-25-44-604
Expiry date
1600
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Code B6669C
2 x 500 mlBaxter Logo
CLINIMIX® N9G15E
Solution for infusionClintec 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 mmolGlucose (15%)
with calciumVolume 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 injectionsLot
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 gFor 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 KingdomTH-35-01-978
EXP
1600
1000
800
600
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Code FKB6654V 2000 ml
Baxter Logo
CLINIMIX N14G30E
Solution for infusionWith 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 gSodium acetate 3H2O 5.94 g
Dibasic potassium phosphate 5.22 g
Sodium chloride 1.54 g
Magnesium chloride 6H2O 1.02 g
Glucose anhydrous (as monohydrate) 300 g
Calcium chloride 2H2O 0.66 gAcetic 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/l8.5% 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 compartmentsRead the package leaflet before use
Keep out of the reach and sight of childrenFor 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 seriesFrom 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 userPL 00116/0300
PA 167/98/4Baxter Healthcare Limited
Caxton Way
Thetford
Norfolk
IP24 3SE
United KingdomPOM Symbol
CLINIMIX N14G30E
Solution for infusion 2000 mlTH-35-01-780
EXP
2600
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1600
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INGREDIENTS AND APPEARANCE
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 solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0338-9566 Route of Administration INTRAVENOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ISOLEUCINE (UNII: 04Y7590D77) (ISOLEUCINE - UNII:04Y7590D77) ISOLEUCINE 1.65 g in 1 L LEUCINE (UNII: GMW67QNF9C) (LEUCINE - UNII:GMW67QNF9C) LEUCINE 2.01 g in 1 L VALINE (UNII: HG18B9YRS7) (VALINE - UNII:HG18B9YRS7) VALINE 1.60 g in 1 L LYSINE (UNII: K3Z4F929H6) (LYSINE - UNII:K3Z4F929H6) LYSINE 2.00 g in 1 L METHIONINE (UNII: AE28F7PNPL) (METHIONINE - UNII:AE28F7PNPL) METHIONINE 1.10 g in 1 L PHENYLALANINE (UNII: 47E5O17Y3R) (PHENYLALANINE - UNII:47E5O17Y3R) PHENYLALANINE 1.54 g in 1 L THREONINE (UNII: 2ZD004190S) (THREONINE - UNII:2ZD004190S) THREONINE 1.16 g in 1 L TRYPTOPHAN (UNII: 8DUH1N11BX) (TRYPTOPHAN - UNII:8DUH1N11BX) TRYPTOPHAN 0.50 g in 1 L ARGININE (UNII: 94ZLA3W45F) (ARGININE - UNII:94ZLA3W45F) ARGININE 3.17 g in 1 L HISTIDINE (UNII: 4QD397987E) (HISTIDINE - UNII:4QD397987E) HISTIDINE 1.32 g in 1 L ALANINE (UNII: OF5P57N2ZX) (ALANINE - UNII:OF5P57N2ZX) ALANINE 5.70 g in 1 L GLYCINE (UNII: TE7660XO1C) (GLYCINE - UNII:TE7660XO1C) GLYCINE 2.84 g in 1 L PROLINE (UNII: 9DLQ4CIU6V) (PROLINE - UNII:9DLQ4CIU6V) PROLINE 1.87 g in 1 L SERINE (UNII: 452VLY9402) (SERINE - UNII:452VLY9402) SERINE 1.38 g in 1 L TYROSINE (UNII: 42HK56048U) (TYROSINE - UNII:42HK56048U) TYROSINE 0.11 g in 1 L SODIUM ACETATE (UNII: 4550K0SC9B) (SODIUM CATION - UNII:LYR4M0NH37, ACETATE ION - UNII:569DQM74SC) SODIUM ACETATE 2.16 g in 1 L POTASSIUM PHOSPHATE, DIBASIC (UNII: CI71S98N1Z) (PHOSPHATE ION - UNII:NK08V8K8HR, POTASSIUM CATION - UNII:295O53K152) POTASSIUM PHOSPHATE, DIBASIC 2.61 g in 1 L SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE 1.12 g in 1 L MAGNESIUM CHLORIDE (UNII: 02F3473H9O) (MAGNESIUM CATION - UNII:T6V3LHY838, CHLORIDE ION - UNII:Q32ZN48698) MAGNESIUM CHLORIDE 0.51 g in 1 L DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK) DEXTROSE MONOHYDRATE 100.00 g in 1 L CALCIUM CHLORIDE (UNII: M4I0D6VV5M) (CALCIUM CATION - UNII:2M83C4R6ZB, CHLORIDE ION - UNII:Q32ZN48698) CALCIUM CHLORIDE 0.33 g in 1 L Inactive Ingredients Ingredient Name Strength ACETIC ACID (UNII: Q40Q9N063P) WATER (UNII: 059QF0KO0R) HYDROCHLORIC ACID (UNII: QTT17582CB) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0338-9566-08 8 in 1 CARTON 10/25/2017 10/02/2019 1 1 L in 1 BAG; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved drug for use in drug shortage 10/25/2017 11/30/2019 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 solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0338-9570 Route of Administration INTRAVENOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ISOLEUCINE (UNII: 04Y7590D77) (ISOLEUCINE - UNII:04Y7590D77) ISOLEUCINE 1.65 g in 1 L LEUCINE (UNII: GMW67QNF9C) (LEUCINE - UNII:GMW67QNF9C) LEUCINE 2.01 g in 1 L VALINE (UNII: HG18B9YRS7) (VALINE - UNII:HG18B9YRS7) VALINE 1.60 g in 1 L LYSINE (UNII: K3Z4F929H6) (LYSINE - UNII:K3Z4F929H6) LYSINE 2.00 g in 1 L METHIONINE (UNII: AE28F7PNPL) (METHIONINE - UNII:AE28F7PNPL) METHIONINE 1.10 g in 1 L PHENYLALANINE (UNII: 47E5O17Y3R) (PHENYLALANINE - UNII:47E5O17Y3R) PHENYLALANINE 1.54 g in 1 L THREONINE (UNII: 2ZD004190S) (THREONINE - UNII:2ZD004190S) THREONINE 1.16 g in 1 L TRYPTOPHAN (UNII: 8DUH1N11BX) (TRYPTOPHAN - UNII:8DUH1N11BX) TRYPTOPHAN 0.50 g in 1 L ARGININE (UNII: 94ZLA3W45F) (ARGININE - UNII:94ZLA3W45F) ARGININE 3.17 g in 1 L HISTIDINE (UNII: 4QD397987E) (HISTIDINE - UNII:4QD397987E) HISTIDINE 1.32 g in 1 L ALANINE (UNII: OF5P57N2ZX) (ALANINE - UNII:OF5P57N2ZX) ALANINE 5.70 g in 1 L GLYCINE (UNII: TE7660XO1C) (GLYCINE - UNII:TE7660XO1C) GLYCINE 2.84 g in 1 L PROLINE (UNII: 9DLQ4CIU6V) (PROLINE - UNII:9DLQ4CIU6V) PROLINE 1.87 g in 1 L SERINE (UNII: 452VLY9402) (SERINE - UNII:452VLY9402) SERINE 1.38 g in 1 L TYROSINE (UNII: 42HK56048U) (TYROSINE - UNII:42HK56048U) TYROSINE 0.11 g in 1 L SODIUM ACETATE (UNII: 4550K0SC9B) (SODIUM CATION - UNII:LYR4M0NH37, ACETATE ION - UNII:569DQM74SC) SODIUM ACETATE 2.16 g in 1 L POTASSIUM PHOSPHATE, DIBASIC (UNII: CI71S98N1Z) (PHOSPHATE ION - UNII:NK08V8K8HR, POTASSIUM CATION - UNII:295O53K152) POTASSIUM PHOSPHATE, DIBASIC 2.61 g in 1 L SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE 1.12 g in 1 L MAGNESIUM CHLORIDE (UNII: 02F3473H9O) (MAGNESIUM CATION - UNII:T6V3LHY838, CHLORIDE ION - UNII:Q32ZN48698) MAGNESIUM CHLORIDE 0.51 g in 1 L DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK) DEXTROSE MONOHYDRATE 75.00 g in 1 L CALCIUM CHLORIDE (UNII: M4I0D6VV5M) (CALCIUM CATION - UNII:2M83C4R6ZB, CHLORIDE ION - UNII:Q32ZN48698) CALCIUM CHLORIDE 0.33 g in 1 L Inactive Ingredients Ingredient Name Strength ACETIC ACID (UNII: Q40Q9N063P) WATER (UNII: 059QF0KO0R) HYDROCHLORIC ACID (UNII: QTT17582CB) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0338-9570-08 8 in 1 CARTON 10/25/2017 09/30/2019 1 1 L in 1 BAG; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved drug for use in drug shortage 10/25/2017 11/30/2019 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 solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0338-9587 Route of Administration INTRAVENOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ISOLEUCINE (UNII: 04Y7590D77) (ISOLEUCINE - UNII:04Y7590D77) ISOLEUCINE 5.10 g in 2 L LEUCINE (UNII: GMW67QNF9C) (LEUCINE - UNII:GMW67QNF9C) LEUCINE 6.20 g in 2 L VALINE (UNII: HG18B9YRS7) (VALINE - UNII:HG18B9YRS7) VALINE 4.93 g in 2 L LYSINE (UNII: K3Z4F929H6) (LYSINE - UNII:K3Z4F929H6) LYSINE 4.93 g in 2 L METHIONINE (UNII: AE28F7PNPL) (METHIONINE - UNII:AE28F7PNPL) METHIONINE 3.40 g in 2 L PHENYLALANINE (UNII: 47E5O17Y3R) (PHENYLALANINE - UNII:47E5O17Y3R) PHENYLALANINE 4.76 g in 2 L THREONINE (UNII: 2ZD004190S) (THREONINE - UNII:2ZD004190S) THREONINE 3.57 g in 2 L TRYPTOPHAN (UNII: 8DUH1N11BX) (TRYPTOPHAN - UNII:8DUH1N11BX) TRYPTOPHAN 1.53 g in 2 L ARGININE (UNII: 94ZLA3W45F) (ARGININE - UNII:94ZLA3W45F) ARGININE 9.78 g in 2 L HISTIDINE (UNII: 4QD397987E) (HISTIDINE - UNII:4QD397987E) HISTIDINE 4.08 g in 2 L ALANINE (UNII: OF5P57N2ZX) (ALANINE - UNII:OF5P57N2ZX) ALANINE 17.60 g in 2 L GLYCINE (UNII: TE7660XO1C) (GLYCINE - UNII:TE7660XO1C) GLYCINE 8.76 g in 2 L PROLINE (UNII: 9DLQ4CIU6V) (PROLINE - UNII:9DLQ4CIU6V) PROLINE 5.78 g in 2 L SERINE (UNII: 452VLY9402) (SERINE - UNII:452VLY9402) SERINE 4.25 g in 2 L TYROSINE (UNII: 42HK56048U) (TYROSINE - UNII:42HK56048U) TYROSINE 0.34 g in 2 L SODIUM ACETATE (UNII: 4550K0SC9B) (SODIUM CATION - UNII:LYR4M0NH37, ACETATE ION - UNII:569DQM74SC) SODIUM ACETATE 5.94 g in 2 L POTASSIUM PHOSPHATE, DIBASIC (UNII: CI71S98N1Z) (PHOSPHATE ION - UNII:NK08V8K8HR, POTASSIUM CATION - UNII:295O53K152) POTASSIUM PHOSPHATE, DIBASIC 5.22 g in 2 L SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE 1.54 g in 2 L MAGNESIUM CHLORIDE (UNII: 02F3473H9O) (MAGNESIUM CATION - UNII:T6V3LHY838, CHLORIDE ION - UNII:Q32ZN48698) MAGNESIUM CHLORIDE 1.02 g in 2 L DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK) DEXTROSE MONOHYDRATE 300.00 g in 2 L CALCIUM CHLORIDE (UNII: M4I0D6VV5M) (CALCIUM CATION - UNII:2M83C4R6ZB, CHLORIDE ION - UNII:Q32ZN48698) CALCIUM CHLORIDE 0.66 g in 2 L Inactive Ingredients Ingredient Name Strength ACETIC ACID (UNII: Q40Q9N063P) WATER (UNII: 059QF0KO0R) HYDROCHLORIC ACID (UNII: QTT17582CB) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0338-9587-04 4 in 1 CARTON 10/25/2017 11/30/2019 1 2 L in 1 BAG; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved drug for use in drug shortage 10/25/2017 11/30/2019 Labeler - Baxter Healthcare Corporation (005083209) Establishment Name Address ID/FEI Business Operations Baxter Healthcare Ltd 221478644 ANALYSIS(0338-9566, 0338-9570, 0338-9587) , LABEL(0338-9566, 0338-9570, 0338-9587) , MANUFACTURE(0338-9566, 0338-9570, 0338-9587) , PACK(0338-9566, 0338-9570, 0338-9587) , STERILIZE(0338-9566, 0338-9570, 0338-9587)