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

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

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

Mevcut itibaren:

Hospira, Inc.

Uygulama yolu:

INTRAVENOUS

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

Aminosyn-PF 10%, 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 10% 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. Centr

Ürün özeti:

Aminosyn -PF 10%, Sulfite-Free, (an amino acid injection — pediatric formula) is supplied as a Pharmacy Bulk Package in 1000 mL flexible plastic containers NDC 0409-4179-05. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from freezing. It is recommended that the product be stored at room temperature (25°C). Avoid exposure to light. Revised: June, 2008 Printed in USA EN-1817 Hospira, Inc., Lake Forest, IL 60045 USA

Yetkilendirme durumu:

New Drug Application

Ürün özellikleri

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
HOSPIRA, INC.
----------
AMINOSYN -PF 10%
SULFITE-FREE
_AN AMINO ACID INJECTION - PEDIATRIC FORMULA_
PHARMACY BULK PACKAGE − NOT FOR DIRECT INFUSION.
Flexible Plastic Container
R only
DESCRIPTION
Aminosyn -PF 10%, Sulfite-Free, (an amino acid injection — pediatric
formula) is a sterile,
nonpyrogenic solution for intravenous infusion. Aminosyn-PF 10% 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 formulation is described below:
AMINOSYN-PF 10%
AN AMINO ACID INJECTION — PEDIATRIC FORMULA
ESSENTIAL AMINO ACIDS (MG/100 ML)
Isoleucine
760
Leucine
1200
Lysine (acetate)*
677
Methionine
180
Phenylalanine
427
Threonine
512
Tryptophan
180
Valine
673
* Amount cited is for lysine alone and does not include the acetate
salt.
NONESSENTIAL AMINO ACIDS (MG/100 ML)
Alanine
698
Arginine
1227
Aspartic Acid
527
Glutamic Acid
820
Glycine
385
Histidine
312
Proline
812
Serine
495
Taurine
70
Tyrosine
44
®
x
®
ELECTROLYTES (MEQ/L)
Sodium (Na )
None
Potassium (K )
None
Chloride (Cl
)
None
Acetate (C H O )
46
PRODUCT CHARACTERISTICS
Protein Equivalent (Approx. grams/L)
100
Total Nitrogen (grams/L)
15.2
Osmolarity (mOsmol/L)
788
pH (range)
5.5 (5.0 to 6.5)
Specific Gravity
1.03
From lysine acetate.
The formulas for the individual amino acids present in Aminosyn-PF 10%
are as follows:
ESSENTIAL AMINO ACIDS
Isoleucine
CH CH CH(CH )CH(NH )COOH
Leucine
(CH ) CHCH CH(NH )COOH
Lysine Acetate
H N(CH ) CH(NH )COOH • CH COOH
Methionine
CH S(CH ) CH(NH )COOH
Phenylalanine
Threonine
CH CH(OH)CH(NH )COOH
Tryptophan
Valine
(CH ) CHCH(NH )COOH
NONESSENTIAL AMINO ACIDS
Alanine
CH CH(NH )COOH
Arginine
H NC(NH)NH(CH ) CH(NH )COOH
L-Aspartic Acid
HOOCCH CH(NH )COOH
L-Glutamic Acid
HOOC(CH ) CH(NH )COOH