AMINOSYN II- isoleucine, leucine, lysine acetate, methionine, phenylalanine, threonine, tryptophan, valine, alanine, arginine, a

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

ISOLEUCINE (UNII: 04Y7590D77) (ISOLEUCINE - UNII:04Y7590D77), LEUCINE (UNII: GMW67QNF9C) (LEUCINE - UNII:GMW67QNF9C), LYSINE ACETATE (UNII: TTL6G7LIWZ) (LYSINE - UNII:K3Z4F929H6), METHIONINE (UNII: AE28F7PNPL) (METHIONINE - UNII:AE28F7PNPL), PHENYLALANINE (UNII: 47E5O17Y3R) (PHENYLALANINE - UNII:47E5O17Y3R), THREONINE (UNII: 2ZD004190S) (THREONINE - UNII:2ZD004190S), TRYPTOPHAN (UNII: 8DUH1N11BX) (TRYPTOPHAN - UNII:8DUH1N11BX), VALINE (UNII: HG18B9YRS7) (VALINE - UNII:HG18B9YRS7), ALANINE (UNII: OF5

から入手可能:

ICU Medical Inc.

投与経路:

INTRAVENOUS

処方タイプ:

PRESCRIPTION DRUG

適応症:

Aminosyn II, Sulfite-Free, (an amino acid injection) infused with dextrose by peripheral vein infusion is indicated as a source of nitrogen in the nutritional support of patients with adequate stores of body fat, in whom, for short periods of time, oral nutrition cannot be tolerated, is undesirable, or inadequate. SUPPLEMENTAL ELECTROLYTES, IN ACCORDANCE WITH THE PRESCRIPTION OF THE ATTENDING PHYSICIAN, MUST BE ADDED TO AMINOSYN II SOLUTIONS WITHOUT ELECTROLYTES. Aminosyn II can be administered peripherally with dilute (5 to 10%) dextrose solution and I.V. fat emulsion as a source of nutritional support. This form of nutritional support can help to preserve protein and reduce catabolism in stress conditions where oral intake is inadequate. Aminosyn II is also indicated for central vein infusion to prevent or reverse negative nitrogen balance in patients where the alimentary tract, by the oral, gastrostomy or jejunostomy route cannot or should not

製品概要:

Aminosyn II is supplied as a Pharmacy Bulk Package in a 2000 mL flexible container for continuous admixture compounding procedures. Two concentrations are available: Aminosyn II 15%, Sulfite-Free NDC 0990-7171-17 ICU Medical is transitioning NDC codes from the "0409" to a "0990" labeler code. Both NDC codes are expected to be in the market for a period of time. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from freezing. Avoid exposure to light. Revised: June, 2018                               EN-4657 ICU Medical, Inc., Lake Forest, Illinois, 60045, USA

認証ステータス:

New Drug Application

製品の特徴

AMINOSYN II- ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE,
PHENYLALANINE,
THREONINE, TRYPTOPHAN, VALINE, ALANINE, ARGININE, ASPARTIC ACID,
GLUTAMIC ACID,
HISTIDINE, PROLINE, SERINE, N-ACETYLTYROSINE, AND GLYCINE INJECTION,
SOLUTION
ICU MEDICAL INC.
----------
AMINOSYN II
_AN AMINO ACID INJECTION, SULFITE-FREE_
PHARMACY BULK PACKAGE – NOT FOR DIRECT INFUSION.
FLEXIBLE PLASTIC CONTAINER
Rx only
DESCRIPTION
Aminosyn II, Sulfite-Free, (an amino acid injection) is a sterile,
nonpyrogenic solution
for intravenous infusion. Aminosyn II is oxygen sensitive. The
Pharmacy Bulk Package is
a sterile dosage form which contains multiple single doses for use
only in a pharmacy
bulk admixture program. The formulations are described below:
ESSENTIAL AMINO ACIDS (MG/100 ML)
AMINOSYN II
10%
15%
Isoleucine
660
990
Leucine
1000
1500
Lysine (acetate)*
1050
1575
Methionine
172
258
Phenylalanine
298
447
Threonine
400
600
Tryptophan
200
300
Valine
500
750
*Amount cited is for lysine alone and does not include the acetate.
NONESSENTIAL AMINO ACIDS (MG/100
ML)
Alanine
993
1490
Arginine
1018
1527
L-Aspartic Acid
700
1050
L-Glutamic Acid
738
1107
Histidine
300
450
Proline
722
1083
Serine
530
795
N-Acetyl-L-Tyrosine
270
405
TM
™
Glycine
500
750
OTHER CHARACTERISTICS
Protein Equivalent
(approx.
grams/liter)
100
150
Total Nitrogen
(grams/liter)
15.3
23.0
Osmolarity
(mOsmol/liter,
actual)
840
1270
pH
5.8 (5.0 –
6.5)
5.8 (5.0 –
6.5)
Specific Gravity
1.03
1.05
Electrolytes
(mEq/L)
Sodium
(Na )
38
50
Acetate
(C H O )
71.8
107.6
Solution contains sodium hydroxide for pH adjustment.
Figure includes Na from the pH adjustor.
Includes acetate from lysine acetate.
The flexible plastic container is fabricated from a specially
formulated polyvinylchloride.
Water can permeate from inside the container into the overwrap but not
in amounts to
affect the solution significantly. Solutions in contact with the
plastic container may leach
out certain chemical components from the plastic in very small
amounts; however,
biological testing was supportive o