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

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

ICU Medical Inc.

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

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 / NDC 0990-4179-05. 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: August, 2018 ICU Medical, Inc., Lake Forest, Illinois, 60045, USA

Authorization status:

New Drug Application

Summary of Product characteristics

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.
----------
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
®
x
®
Proline
812
Serine
495
Taurine
70
Tyrosine
44
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 AcetateH 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
+
+
−
2
3
2
− a
a
3
2
3
2
3 2
2
2
2
2 4
2
3
3
2 2
2
3
2
3 2
2
3
2