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

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

Hospira, Inc.

Οδός χορήγησης:

INTRAVENOUS

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

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

Περίληψη προϊόντος:

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 0409-7171-17 Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from freezing. Avoid exposure to light. Revised: November, 2010   Printed in USA                            EN-2701 Hospira, Inc., Lake Forest, IL 60045 USA

Καθεστώς αδειοδότησης:

New Drug Application

Αρχείο Π.Χ.Π.

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
HOSPIRA, INC.
----------
AMINOS YN 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
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
TM
™
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; how