POTASSIUM CHLORIDE IN DEXTROSE- dextrose monohydrate and potassium chloride injection, solution injection, solution

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK), POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152, CHLORIDE ION - UNII:Q32ZN48698)

Dostępny od:

ICU Medical Inc.

Droga podania:

INTRAVENOUS

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

This solution is indicated in patients requiring parenteral administration of potassium chloride with minimal carbohydrate calories. Solutions containing potassium chloride are contraindicated in diseases where high potassium levels may be encountered. To Open Tear outer wrap at notch and remove solution container. If supplemental medication is desired, follow directions below before preparing for administration. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually. To Add Medication - Prepare additive port. - Using aseptic technique and an additive delivery needle of appropriate length, puncture resealable additive port at target area, inner diaphragm and inject. Withdraw needle after injecting medication. - The additive port may be protected by covering with an additive cap. - Mix container contents thoroughly. Preparation for Administration (Use aseptic technique) - Close flow control clamp of administration set. - Remove cover from outlet port at bottom of container. - Insert piercing pin of administration set into port with a twisting motion until the set is firmly seated. NOTE: When using a vented administration set, replace bacterial retentive air filter with piercing pin cover. Insert piercing pin with twisting motion until shoulder of air filter housing rests against the outlet port flange. - Suspend container from hanger. - Squeeze and release drip chamber to establish proper fluid level in chamber. - Attach venipuncture device to set. - Open clamp to expel air from set and venipuncture device. Close clamp. - Perform venipuncture. - Regulate rate of administration with flow control clamp. WARNING: Do not use flexible container in series connections.

Podsumowanie produktu:

Potassium Chloride in Dextrose Injection, USP solution is supplied in single-dose flexible plastic containers. See Table: ICU Medical is transitioning NDC codes from the "0409" to "0990" labeler code. Both NDC codes are expected to be in the market for a period of time. May contain HCl for pH adjustment. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from freezing.

Status autoryzacji:

New Drug Application

Charakterystyka produktu

POTASSIUM CHLORIDE IN DEXTROSE- DEXTROSE MONOHYDRATE AND POTASSIUM
CHLORIDE INJECTION, SOLUTION INJECTION, SOLUTION
ICU MEDICAL INC.
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POTASSIUM CHLORIDE
IN DEXTROSE INJECTION, USP
20 mEq/liter Potassium Chloride in 5% Dextrose Injection
Rx only
DESCRIPTION
Potassium Chloride in Dextrose Injection, USP is a sterile and
nonpyrogenic solution in
water for injection. This solution is for administration by
intravenous infusion only.
See Table for summary of content and characteristics of this solution.
This solution contains no bacteriostat, antimicrobial agent or added
buffer and is
intended only for use as a single-dose injection. When smaller doses
are required the
unused portion should be discarded.
This solution is a parenteral fluid, nutrient and electrolyte
replenisher.
Dextrose, USP is chemically designated D-glucose monohydrate (C H
O ∙ H O), a
hexose sugar freely soluble in water. It has the following structural
formula:
Potassium Chloride, USP is chemically designated KCl, a white granular
powder freely
soluble in water.
Water for Injection, USP is chemically designated H O.
The flexible plastic container is fabricated from a specially
formulated polyvinyl chloride.
Water can permeate from inside the container into the overwrap but not
in amounts
sufficient to affect the solution significantly. Solutions in contact
with the plastic
container may leach out certain chemical components from the plastic
in very small
amounts; however, biological testing was supportive of the safety of
the plastic
container materials. Exposure to temperatures above 25°C/77°F 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.
CLINICAL PHARMACOLOGY
When administered intravenously, this solution provides a source of
water and
potassium chloride with carbohydrate.
6
12
6
2
2
Solutions containing carbohydrate in the form of dextrose restore