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

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

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

Disponible des:

ICU Medical Inc.

Vía de administración:

INTRAVENOUS

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Aminosyn-PF 7%, Sulfite-Free, (an amino acid injection — pediatric formula) is indicated for the nutritional support of infants (including those of low birth weight) and young children requiring TPN via either central or peripheral infusion routes. Parenteral nutrition with Aminosyn-PF 7% is indicated to prevent nitrogen and weight loss or treat negative nitrogen balance in infants and young children where (1) the alimentary tract by the oral gastrostomy, or jejunostomy route, cannot or should not be used or adequate protein intake is not feasible by these routes, (2) gastrointestinal absorption of protein is impaired; or (3) protein requirements are substantially increased as with extensive burns. Dosage, route of administration, and concomitant infusion of non-protein calories are dependent on various factors, such as nutritional and metabolic status of the patient, anticipated duration of parenteral nutrition support, and vein tolerance. See DOSAGE AND ADMINISTRATION for additional information. Central

Resumen del producto:

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 25ºC (68 to 77ºF). [See USP Controlled Room Temperature.] Protect from freezing. Avoid exposure to light. Revised: August, 2018 EN-4682 ICU Medical, Inc., Lake Forest, Illinois, 60045 USA

Estat d'Autorització:

New Drug Application

Fitxa tècnica

AMINOSYN-PF- ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE,
PHENYLALANINE,
THREONINE, TRYPTOPHAN, VALINE, ALANINE, ARGININE, ASPARTIC ACID,
GLUTAMIC ACID,
GLYCINE, HISTIDINE, PROLINE, SERINE, TAURINE, AND TYROSINE INJECTION,
SOLUTION
ICU MEDICAL INC.
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AMINOSYN -PF 7%
SULFITE-FREE
_AN AMINO ACID INJECTION - PEDIATRIC FORMULA_
Flexible Plastic Container
Rx only
DESCRIPTION
Aminosyn -PF 7%, Sulfite-Free, (an amino acid injection — pediatric
formula) is a sterile,
nonpyrogenic solution for intravenous infusion. Aminosyn -PF 7% is
oxygen sensitive.
The formulation is described below:
AMINOSYN-PF 7%
AN AMINO ACID INJECTION — PEDIATRIC FORMULA
ESSENTIAL AMINO ACIDS (MG/100 ML)
Isoleucine
534
Leucine
831
Lysine (acetate)*
475
Methionine
125
Phenylalanine
300
Threonine
360
Tryptophan
125
Valine
452
* Amount cited is for lysine alone and does not include the acetate
salt.
NONESSENTIAL AMINO ACIDS (MG/100 ML)
Alanine
490
Arginine
861
L-Aspartic Acid
370
L-Glutamic Acid
576
Glycine
270
Histidine
220
Proline
570
Serine
347
Taurine
50
Tyrosine
44
®
®
®
ELECTROLYTES (MEQ/L)
Sodium (Na ) (mEq/L)
None
Potassium (K ) (mEq/L)
None
Chloride (Clˉ) (mEq/L)
None
Acetate (C H O ˉ) (mEq/L)32.5
From lysine acetate.
PRODUCT CHARACTERISTICS
Protein Equivalent (Approx. grams/L)70
Total Nitrogen (grams/L)
10.69
Osmolarity (mOsmol/L)
561
pH (range)
5.5 (5.0 to 6.5)
The formulas for the individual amino acids present in Aminosyn-PF 7%
are as follows:
ESSENTIAL AMINO ACIDS
Isoleucine, USP
C H
NO
Leucine, USP
C H
NO
Lysine Acetate, USPC H
N O • CH COOH
Methionine, USP
C H
NO S
Phenylalanine, USP C H
NO
Threonine, USP
C H NO
Tryptophan, USP
C
H
N O
Valine, USP
C H
NO
NONESSENTIAL AMINO ACIDS
Alanine, USP
C H NO
Glycine, USP
C H NO
Arginine, USP
C H
N O
L-Aspartic Acid C H NO
HO CCH CH(NH )CO H
L-Glutamic AcidC H NO
HO CCH CHCH(NH )CO H
Histidine, USP
C H N O
Proline, USP
C H NO
Serine, USP
C H NO
Taurine
C H NO S
Tyrosine, USP
C H
NO
The flexible plastic container is fabricated from a specially
formulated polyvinylchloride.