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

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), CYSTEINE HYDROCHLO

Mevcut itibaren:

B. Braun Medical Inc.

Uygulama yolu:

INTRAVENOUS

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

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 be

Ürün özeti:

TrophAmine® pharmacy bulk package is supplied sterile and nonpyrogenic in 500 mL flexible plastic bags, packaged 12 per case. Not made with natural rubber latex, DEHP or PVC. Store in the closed corrugated case; do not expose TrophAmine® and/or TrophAmine®-containing admixed parenteral nutrition (PN) solution to light. Do not remove container from overwrap until ready to use. Do not use if overwrap has been opened or damaged. Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. It is recommended that the product be stored at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature]. Solution that has been frozen must not be used.

Yetkilendirme durumu:

New Drug Application

Ürün özellikleri

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 INJECTION)
PHARMACY BULK PACKAGE –
NOT FOR DIRECT INFUSION
PROTECT FROM LIGHT.
DESCRIPTION
TrophAmine® (10% Amino Acid Injection) is a sterile, nonpyrogenic,
hypertonic solution
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_
10%
Isoleucine USP
0.82 g
Leucine USP
1.4 g
Lysine
0.82 g
(added as Lysine Acetate USP
1.2 g)
Methionine USP
0.34 g
Phenylalanine USP
0.48 g
Threonine USP
0.42 g
Tryptophan USP
0.2 g
Valine USP
0.78 g
Cysteine
<0.016 g
(as Cysteine HCl∙H O USP
<0.024 g)
Histidine USP
0.48 g
Tyrosine
0.24 g
(added as Tyrosine USP
0.044 g
and N-Acetyl-L-Tyrosine
0.24 g)
_NONESSENTIAL AMINO ACIDS_
Alanine USP
0.54 g
Arginine USP
1.2 g
Proline USP
0.68 g
Serine USP
0.38 g
®
2
*
*
*
†
‡
§
Glycine USP
0.36 g
L-Aspartic Acid
0.32 g
L-Glutamic Acid
0.5 g
Taurine
0.025 g
Water for Injection USP
qs
pH adjusted with Glacial Acetic Acid USP
pH: 5.5 (5.0–6.0)
Calc. Osmolarity (mOsmol/liter)
866
Total Amino Acids (grams/liter)
100
Total Nitrogen (grams/liter)
15.5
Protein Equivalent (grams/liter)
97
ELECTROLYTES (MEQ/LITER)
Acetate (CH COO )
96.2
Chloride
<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 well
tolerated nitrogen source
for nutritional support and therapy for infants and young pediatric
patients. When
administered in conjunction with cysteine hydrochloride, TrophAmine®
results in the
normalization of the plasma amino acid conce