CHROMIUM CHROMIC CHLORIDE injection, solution

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

CHROMIC CHLORIDE (UNII: KB1PCR9DMW) (CHROMIC CATION - UNII:X1N4508KF1)

Διαθέσιμο από:

HF Acquisition Co LLC, DBA HealthFirst

Οδός χορήγησης:

INTRAVENOUS

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

Chromium 4 mcg/mL (Chromic Chloride Injection, USP) is indicated for use as a supplement to intravenous solutions given for TPN. Administration helps to maintain chromium serum levels and to prevent depletion of endogenous stores and subsequent deficiency symptoms. None known. None known.

Περίληψη προϊόντος:

CHROMIUM CHROMIC CHLORIDE INJECTION, USPis supplied in the following dosage forms. NDC 51662-1415-1 CHROMIUM CHROMIC CHLORIDE INJECTION, USP 40 mcg/10 mL (4 mcg/mL) 10 mL VIAL HF Acquisition Co LLC, DBA HealthFirst Mukilteo, WA 98275 Also supplied in the following manufacture supplied dosage forms Chromium (Chromic Chloride Injection, USP) is supplied as follows: Store at 20 to 25ºC (68 to 77ºF). [See USP Controlled Room Temperature.] Distributed by Hospira, Inc., Lake Forest, IL 60045 USA LAB-1065-2.0 Revised: 5/2018

Καθεστώς αδειοδότησης:

New Drug Application

Αρχείο Π.Χ.Π.

CHROMIUM CHROMIC CHLORIDE- CHROMIUM CHROMIC CHLORIDE INJECTION,
SOLUTION
HF ACQUISITION CO LLC, DBA HEALTHFIRST
----------
CHROMIUM CHROMIC CHLORIDE INJECTION, USP 40 MCG/10 ML (4 MCG/ML) 10 ML
VIAL
SPL UNCLASSIFIED
FOR I.V. USE ONLY AFTER DILUTION
Plastic Vial
Rx Only
DESCRIPTION
Chromium 4 mcg/mL (Chromic Chloride Injection, USP) is a sterile,
nonpyrogenic solution intended for
use as an additive to intravenous solutions for total parenteral
nutrition (TPN). Each mL of solution
contains 20.5 mcg chromic chloride, hexahydrate and 9 mg sodium
chloride. The solution contains no
bacteriostat, antimicrobial agent, or added buffer. The pH is 2.0 (1.5
to 2.5); product may contain
hydrochloric acid and/or sodium hydroxide for pH adjustment. The
osmolarity is 0.308 mOsm/mL
(calc.).
Chromic Chloride, USP is chemically designated chromic chloride,
hexahydrate CrCl3• 6H2O, a
crystalline compound soluble in water.
Sodium Chloride, USP is chemically designated NaCl, a white,
crystalline compound freely soluble in
water.
The semi-rigid vial is fabricated from a specially formulated
polyolefin. It is a copolymer of ethylene
and propylene. The safety of the plastic has been confirmed by tests
in animals according to USP
biological standards for plastic containers. The small amount of water
vapor that can pass through the
plastic container wall will not significantly alter the drug
concentration.
CLINICAL PHARMACOLOGY
Trivalent chromium is part of glucose tolerance factor, an essential
activator of insulin-mediated
reactions. Chromium helps to maintain normal glucose metabolism and
peripheral nerve function.
Providing chromium during TPN helps prevent deficiency symptoms
including impaired glucose
tolerance, ataxia, peripheral neuropathy and a confusional state
similar to mild/moderate hepatic
encephalopathy.
Serum chromium is bound to transferrin (siderophilin) in the beta
globulin fraction. Typical blood
levels for chromium range from 1 to 5 mcg/liter, but blood levels are
not considered a meaningful index
of tissue stores.