CLINISOL- lysine, leucine, phenylalanine, valine, histidine, isoleucine, methionine, threonine, tryptophan, alanine, arginine, g

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

LYSINE ACETATE (UNII: TTL6G7LIWZ) (LYSINE - UNII:K3Z4F929H6), LEUCINE (UNII: GMW67QNF9C) (LEUCINE - UNII:GMW67QNF9C), PHENYLALANINE (UNII: 47E5O17Y3R) (PHENYLALANINE - UNII:47E5O17Y3R), VALINE (UNII: HG18B9YRS7) (VALINE - UNII:HG18B9YRS7), HISTIDINE (UNII: 4QD397987E) (HISTIDINE - UNII:4QD397987E), ISOLEUCINE (UNII: 04Y7590D77) (ISOLEUCINE - UNII:04Y7590D77), METHIONINE (UNII: AE28F7PNPL) (METHIONINE - UNII:AE28F7PNPL), THREONINE (UNII: 2ZD004190S) (THREONINE - UNII:2ZD004190S), TRYPTOPHAN (UNII: 8D

Saatavilla:

Baxter Healthcare Corporation

INN (Kansainvälinen yleisnimi):

LYSINE ACETATE

Koostumus:

LYSINE 1.18 g in 100 mL

Antoreitti:

INTRAVENOUS

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

15% CLINISOL - sulfite-free (Amino Acid) Injection Pharmacy Bulk Package is indicated as an adjunct in the offsetting of nitrogen loss or in the treatment of negative nitrogen balance in patients where: (1) the alimentary tract cannot or should not be used, (2) gastrointestinal absorption of protein is impaired, or (3) metabolic requirements for protein are substantially increased, as with extensive burns. Hypersensitivity to one or more amino acids Severe liver disease or hepatic coma Anuria Metabolic disorders involving impaired nitrogen utilization

Tuoteyhteenveto:

15% CLINISOL - sulfite-free (Amino Acid) Injection Pharmacy Bulk Package is available in VIAFLEX plastic containers as follows. 2B6187 500 mL NDC 0338-0502-03 2B6189 2000 mL NDC 0338-0502-06 Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. It is recommended the product be stored at room temperature (25ºC/77ºF).

Valtuutuksen tilan:

Abbreviated New Drug Application

Valmisteyhteenveto

CLINISOL- LYSINE, LEUCINE, PHENYLALANINE, VALINE, HISTIDINE,
ISOLEUCINE,
METHIONINE, THREONINE, TRYPTOPHAN, ALANINE, ARGININE, GLYCINE,
PROLINE,
GLUTAMIC ACID, SERINE, ASPARTIC ACID, TYROSINE INJECTION, SOLUTION
BAXTER HEALTHCARE CORPORATION
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15% CLINISOL - SULFITE-FREE (AMINO ACID) INJECTION
PHARMACY BULK PACKAGE
NOT FOR DIRECT INFUSION
IN VIAFLEX PLASTIC CONTAINER
DESCRIPTION
15% CLINISOL - sulfite-free (Amino Acid) Injection Pharmacy Bulk
Package is a sterile,
clear, nonpyrogenic, hypertonic solution of essential and nonessential
amino acids. A
Pharmacy Bulk Package is a container of a sterile preparation for
parenteral use that
contains many single doses. The contents are intended for use in a
pharmacy admixture
program and are restricted to the preparation of admixtures for
intravenous infusion.
The VIAFLEX plastic container is fabricated from a specially
formulated polyvinyl chloride
(PL 146 Plastic). Exposure to temperatures above 25ºC/77ºF during
transport and
storage will lead to minor losses in moisture content. Higher
temperatures lead to
greater losses. It is unlikely that these minor losses will lead to
clinically significant
changes within the expiration period. The amount of water that can
permeate from
inside the container into the overwrap is insufficient to affect the
solution significantly.
Solutions in contact with the plastic container can leach out certain
of its chemical
components in very small amounts within the expiration period, e.g.,
di-2-ethylhexyl
phthalate (DEHP), up to 5 parts per million; however, the safety of
the plastic has been
confirmed in tests in animals according to USP biological test for
plastic containers as
well as by tissue culture toxicity studies.
Each 100 mL of 15% CLINISOL - sulfite-free (Amino Acid) Injection
Pharmacy Bulk
Package contains:
Amino Acids
Total Nitrogen
pH
15.0 g
2.37 g
6.0 (5.0 to 7.0)
(pH adjusted with glacial acetic acid)
ESSENTIAL AMINO ACIDS
Lysine - (from Lysine Acetate) C H
N O
Leucine - C H
NO
Phenylalanine – C H
NO
Valine - C