POTASSIUM CHLORIDE IN LACTATED RINGERS AND DEXTROSE- potassium chloride, sodium chloride, calcium chloride, sodium lactate, and dextrose monohydrate injection, solution

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152, CHLORIDE ION - UNII:Q32ZN48698), SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698), CALCIUM CHLORIDE (UNII: M4I0D6VV5M) (CALCIUM CATION - UNII:2M83C4R6ZB, CHLORIDE ION - UNII:Q32ZN48698), SODIUM LACTATE (UNII: TU7HW0W0QT) (SODIUM CATION - UNII:LYR4M0NH37, LACTIC ACID, UNSPECIFIED FORM - UNII:33X04XA5AT), DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK)

Verfügbar ab:

ICU Medical Inc.

Verabreichungsweg:

INTRAVENOUS

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

This solution is indicated in patients requiring parenteral administration of potassium chloride and the replacement of extracellular losses of fluids and electrolytes with minimal carbohydrate calories. Solutions containing potassium chloride are contraindicated in diseases where high potassium levels may be encountered. Solutions containing lactate are NOT FOR USE IN THE TREATMENT OF LACTIC ACIDOSIS. 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. 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. 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. The additive port may be protected by covering with an additive cap. - Mix container contents thoroughly. Mix container contents thoroughly. Preparation for Administration (Use aseptic technique) - Close flow control clamp of administration set. Close flow control clamp of administration set. - Remove cover from outlet port at bottom of container. 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: See full directions on administration set carton. Insert piercing pin of administration set into port with a twisting motion until the set is firmly seated. NOTE: See full directions on administration set carton. - Suspend container from hanger. Suspend container from hanger. - Squeeze and release drip chamber to establish proper fluid level in chamber. Squeeze and release drip chamber to establish proper fluid level in chamber. - Open flow control clamp and clear air from set. Close clamp. Open flow control clamp and clear air from set. Close clamp. - Attach set to venipuncture device. If device is not indwelling, prime and make venipuncture. Attach set to venipuncture device. If device is not indwelling, prime and make venipuncture. - Regulate rate of administration with flow control clamp. Regulate rate of administration with flow control clamp. WARNING: Do not use flexible container in series connections.

Produktbesonderheiten:

Intravenous solution with potassium chloride (I.V. solution with KCl) is supplied in single-dose flexible plastic container. See Table: Potassium Chloride in Lactated Ringer’s and 5% Dextrose Injection, USP   List No. mEq Potassium Added Size (mL) COMPOSITION (g/L) Calculated Osmolarity (mOsmol/L) Dextrose, Hydrous Potassium Chloride Sodium Chloride Sodium Lactate, Anhydrous Calcium Chloride Dihydrate 7111 20 mEq 1000 50 1.79 6 3.1 0.2 563 Potassium Chloride in Lactated Ringer’s and 5% Dextrose Injection, USP        (Continued) pH Approx. Ionic Concentrations (mEq/L) Approx. kcal/L Calcium (Ca++) Sodium (Na+ ) Potassium (K+ ) Chloride (Cl¯) Lactate 4.9 (3.5 to 6.5) 2.7 130 24 129 28 179 ICU Medical is transitioning NDC codes from the "0409" to a "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. Revised: March, 2020 IFU0000167 ICU Medical, Inc., Lake Forest, Illinois, 60045, USA

Berechtigungsstatus:

New Drug Application

Fachinformation

POTASSIUM CHLORIDE IN LACTATED RINGERS AND DEXTROSE- POTASSIUM
CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, SODIUM LACTATE, AND
DEXTROSE
MONOHYDRATE INJECTION, SOLUTION
ICU MEDICAL INC.
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INTRAVENOUS SOLUTIONS WITH POTASSIUM CHLORIDE
_POTASSIUM CHLORIDE IN LACTATED RINGER'S AND 5% DEXTROSE_
_INJECTION, USP_
FLEXIBLE PLASTIC CONTAINER
R only
DESCRIPTION
Intravenous solution with potassium chloride (I.V. solutions with KCl)
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.
The 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/or 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.
Sodium Chloride, USP is chemically designated NaCl, a white
crystalline powder freely
soluble in water.
Calcium Chloride, USP is chemically designated calcium chloride
dihydrate (CaCl
•
2H O), white fragments or granules freely soluble in water.
Sodium Lactate, USP is chemically designated monosodium lactate [CH
CH(OH)COONa],
a 60% aqueous solution miscible in water. It has the following
structural formula:
x
6
12
6
2
2
2
3
Water for Injection, USP is chemically designated H 0.
The flexible plastic container is fabricated from a specially
formulated polyvinylchloride.
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 wa