NEPHRAMINE- histidine, isoleucine, leucine, lysine, methionine, phenylalanine, threonine, tryptophan, valine, cysteine, and sodi

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

HISTIDINE (UNII: 4QD397987E) (HISTIDINE - UNII:4QD397987E), 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

Tillgänglig från:

B. Braun Medical Inc.

INN (International namn):

HISTIDINE

Sammansättning:

HISTIDINE 0.25 g in 100 mL

Administreringssätt:

INTRAVENOUS

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

5.4% NephrAmine® (Essential Amino Acid Injection) is indicated for adult and pediatric use, in conjunction with other measures, to provide nutritional support for uremic patients, particularly when oral nutrition is infeasible or impractical. See WARNINGS, PRECAUTIONS, Pediatric Use , Special Precautions in Pediatric Patients , and DOSAGE AND ADMINISTRATION . NephrAmine® is contraindicated in patients with severe, uncorrected electrolyte and acid-base imbalance, hyperammonemia, decreased (subcritical) circulating blood volume, inborn errors of amino acid metabolism, or hypersensitivity to one or more amino acids present in the solution.

Produktsammanfattning:

5.4% NephrAmine® (Essential Amino Acid Injection) is supplied sterile and nonpyrogenic in glass containers with solid stoppers packaged 12 per case.                       NDC                             REF                        Size 5.4% NephrAmine® (Essential Amino Acid Injection) (Canada DIN 02029464)               0264-1909-55                     S9092-SS                250 mL 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.

Bemyndigande status:

New Drug Application

Bipacksedel

VALINE, CYSTEINE, AND SODIUM BISULFITE INJECTION, SOLUTION
B. Braun Medical Inc.
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DIRECTIONS FOR USE OF B. BRAUN GLASS CONTAINERS
WITH SOLID STOPPERS
Designed for use with a vented set. Use 18 to 22 gauge needle size for
admixing or withdrawing solutions
from the glass bottle.
1.
Before use, perform the following checks:
• Inspect each container. Read the label. Ensure solution is the one
ordered and is within the
expiration date.
• Invert container and carefully inspect the solution in good light
for cloudiness, haze, or particulate
matter; check the bottle for cracks or other damage. In checking for
cracks, do not be confused by
normal surface marks and seams on the bottom and sides of the bottle.
These are not flaws. Look for
bright reflections that have depth and penetrate into the wall of the
bottle. Reject any such bottle.
2.
To remove the outer closure, lift the tear tab and pull up, over, and
down until it is below the stopper
(see Figure 1). Use a circular pulling motion on the tab until it
breaks away.
3.
Grasp and remove the metal disk, exercising caution not to touch the
exposed sterile stopper surface.
Warning: Some additives may be incompatible. Consult with pharmacist.
When introducing
additives, use aseptic techniques. Mix thoroughly. Do not store.
4.
When adding medication to the container prior to administration, swab
the target area of the rubber
stopper, inject medication and mix thoroughly by gentle agitation.
5.
Refer to Directions for Use of the set being used. Insert the set
spike into the bottle through the target
area of the rubber stopper. Allow the fluid to flow and remove air
from the tubing before
administration begins. Hang the container.
6.
After admixture and during administration, re-inspect the solution
frequently. If any evidence of
solution contamination or instability is found or if the patient
exhibits any signs of fever, chills or
other reactions not readily explainable, discontinue administration
immediately and notify the
physician.
7.
Spiking, additions, or

Produktens egenskaper

NEPHRAMINE- HISTIDINE, ISOLEUCINE, LEUCINE, LYSINE, METHIONINE,
PHENYLALANINE, THREONINE,
TRYPTOPHAN, VALINE, CYSTEINE, AND SODIUM BISULFITE INJECTION, SOLUTION
B. BRAUN MEDICAL INC.
----------
5.4% NEPHRAMINE
(ESSENTIAL AMINO ACID INJECTION)
PROTECT FROM LIGHT UNTIL USE.
DESCRIPTION
5.4% NephrAmine® (Essential Amino Acid Injection) is a sterile,
nonpyrogenic solution containing
crystalline essential amino acids plus histidine. Each 250 mL unit
provides Rose's recommended daily
intake of essential amino acids plus 625 mg of histidine, considered
essential for uremics. The total
nitrogen content of a 250 mL unit is approximately 1.6 grams (10 g of
protein equivalent) in 14 grams of
amino acids. All amino acids designated USP are the "L" isomer.
Each 100 mL contains:
Histidine USP ..............................................0.25 g
Isoleucine USP..............................................0.56 g
Leucine USP.................................................0.88 g
Lysine...........................................................0.64
g
(added as Lysine Acetate USP....................0.90 g)
Methionine USP............................................0.88 g
Phenylalanine USP.........................................0.88 g
Threonine USP..............................................0.40 g
Tryptophan USP...........................................0.20 g
Valine USP....................................................0.64 g
Cysteine....................................................<0.014 g
(as Cysteine HCl•H O USP....................<0.020 g)
Sodium Bisulfite (as an antioxidant)..............<0.05 g
Water for Injection USP......................................qs
pH adjusted with Sodium Hydroxide NF as required.
pH: 6.5 (6.0–7.0); Calculated Osmolarity: 435 mOsmol/liter
Total Nitrogen: Approx. 0.65 g/100 mL
Concentration of Electrolytes (mEq/liter): Sodium 5
Chloride <3; Acetate Approx. 44
1
2
®
1
2
2
Rose WC: The sequence of events leading to the establishment of the
amino acid needs of man. AM J PUBLIC
HEALTH; 1968: 5