TROPHAMINE- isoleucine, leucine, lysine acetate, methionine, phenylalanine, threonine, tryptophan, valine, cysteine hydrochlorid

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), CYSTEINE HYDROCHLO

Disponible des:

B. Braun Medical Inc.

Designació comuna internacional (DCI):

ISOLEUCINE

Composición:

ISOLEUCINE 0.49 g in 100 mL

Vía de administración:

INTRAVENOUS

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

TrophAmine® is indicated for the nutritional support of infants (including those of low birth weight) and young pediatric patients requiring TPN via either central or peripheral infusion routes. Parenteral nutrition with TrophAmine® is indicated to prevent nitrogen and weight loss or treat negative nitrogen balance in infants and young pediatric patients 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 nutritional support, and vein tolerance. See WARNINGS , PRECAUTIONS, Pediatric Use , and DOSAGE AND ADMINISTRATION . Central venous infusion should b

Resumen del producto:

TrophAmine® is supplied sterile and nonpyrogenic in 500 mL glass containers with solid stoppers. Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. It is recommended that the product be stored at room temperature (25°C); however, brief exposure up to 40°C does not adversely affect the product. Protect from light until use.

Estat d'Autorització:

New Drug Application

Fitxa tècnica

TROPHAMINE- ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE,
PHENYLALANINE,
THREONINE, TRYPTOPHAN, VALINE, CYSTEINE HYDROCHLORIDE, HISTIDINE,
TYROSINE, N-
ACETYL-TYROSINE, ALANINE, ARGININE, PROLINE, SERINE, GLYCINE, ASPARTIC
ACID,
GLUTAMIC ACID, AND TAURINE SOLUTION
B. BRAUN MEDICAL INC.
----------
TROPHAMINE
(AMINO ACID INJECTIONS)
PROTECT FROM LIGHT UNTIL USE.
DESCRIPTION
TrophAmine (6% and 10% Amino Acid Injections) are sterile,
nonpyrogenic, hypertonic
solutions containing crystalline amino acids.
All amino acids designated USP are the "L"-isomer with the exception
of Glycine USP,
which does not have an isomer.
Each 100 mL contains:
_ESSENTIAL AMINO ACIDS_
6%
10%
Isoleucine USP
0.49 g
0.82 g
Leucine USP
0.84 g
1.4 g
Lysine
0.49 g
0.82 g
(added as Lysine Acetate USP
0.69 g
1.2 g)
Methionine USP
0.20 g
0.34 g
Phenylalanine USP
0.29 g
0.48 g
Threonine USP
0.25 g
0.42 g
Tryptophan USP
0.12 g
0.20 g
Valine USP
0.47 g
0.78 g
Cysteine
<0.014 g
<0.016 g
(as Cysteine HCl∙H O USP
<0.020 g
<0.024 g)
Histidine USP
0.29 g
0.48 g
Tyrosine
0.14 g
0.24 g
(added as Tyrosine USP
0.044 g
0.044 g
and N-Acetyl-L-Tyrosine
0.12 g
0.24 g)
_NONESSENTIAL AMINO ACIDS_
Alanine USP
0.32 g
0.54 g
Arginine USP
0.73 g
1.2 g
Proline USP
0.41 g
0.68 g
Serine USP
0.23 g
0.38 g
Glycine USP
0.22 g
0.36 g
L-Aspartic Acid
0.19 g
0.32 g
L-Glutamic Acid
0.30 g
0.50 g
Taurine
0.015 g
0.025 g
®
®
2
*
*
†,‡
*
†
‡
§
Sodium Metabisulfite NF (as an antioxidant)
<0.050 g
<0.050 g
Water for Injection USP
qs
qs
pH adjusted with Glacial Acetic Acid USP
pH: 5.5 (5.0–6.0)
Calc. Osmolarity (mOsmol/liter)
525
875
Total Amino Acids (grams/liter)
60
100
Total Nitrogen (grams/liter)
9.3
15.5
Protein Equivalent (grams/liter)
58
97
ELECTROLYTES (MEQ/LITER)
Sodium
5
5
Acetate (CH COO )
54.4
90.7
Chloride
<3
<3
CLINICAL PHARMACOLOGY
TrophAmine provides a mixture of essential and nonessential amino
acids as well as
taurine and a soluble form of tyrosine, N-Acetyl-L-Tyrosine (NAT).
This amino acid
composition has been specifically formulated to provide a w