POTASSIUM CHLORIDE IN SODIUM CHLORIDE- sodium chloride and potassium chloride injection, solution

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37), POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152)

Tillgänglig från:

ICU Medical Inc.

Administreringssätt:

INTRAVENOUS

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

These solutions are indicated in patients requiring parenteral administration of potassium chloride and sodium chloride. 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. 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.

Produktsammanfattning:

Intravenous solutions with potassium chloride (I.V. solution with KCl) are supplied in single-dose flexible plastic containers. See Table: Potassium Chloride in 0.9% Sodium Chloride Inj., USP COMPOSITION Approx. Ionic Concentrations (g/L) Calculated (mEq/L) NDC No. mEq Potassium Size (mL) Sodium Chloride Potassium Chloride Osmolarity (mOsmol/L) pH (range) Sodium (Na + ) Potassium (K + ) Chloride (Cl¯) Approximate kcal/L 0409–7115–09 20 mEq 1000 9 1.49 348 4.8 (3.5 to 6.5) 154 20 174 0990–7115–09 20 mEq 1000 9 1.49 348 4.8 (3.5 to 6.5) 154 20 174 0409–7116–09 40 mEq 1000 9 2.98 388 4.8 (3.5 to 6.5) 154 40 194 0990–7116–09 40 mEq 1000 9 2.98 388 4.8 (3.5 to 6.5) 154 40 194 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. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from freezing. Revised: March, 2020 IFU0000168 ICU Medical, Inc., Lake Forest, Illinois, 60045, USA

Bemyndigande status:

New Drug Application

Produktens egenskaper

POTASSIUM CHLORIDE IN SODIUM CHLORIDE- SODIUM CHLORIDE AND POTASSIUM
CHLORIDE INJECTION, SOLUTION
ICU MEDICAL INC.
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INTRAVENOUS SOLUTIONS
WITH POTASSIUM CHLORIDE
Potassium Chloride in 0.9% Sodium Chloride Injection, USP
FLEXIBLE PLASTIC CONTAINER
Rx only
DESCRIPTION
Intravenous solutions with potassium chloride (I.V. solutions with
KCl) are sterile and
nonpyrogenic solutions in water for injection. They are for
administration by intravenous
infusion only.
See Table for summary of content and characteristics of these
solutions.
The solutions contain no bacteriostat, antimicrobial agent or added
buffer and each is
intended only for use as a single-dose injection. When smaller doses
are required the
unused portion should be discarded.
These solutions are parenteral fluid and/or electrolyte replenishers.
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.
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 inside the
plastic container also
can leach out certain of its chemical components in very small amounts
before the
expiration period is attained. However, the safety of the plastic has
been confirmed by
tests in animals according to USP biological standards for plastic
containers.
CLINICAL PHARMACOLOGY
When administered intravenously, these solutions provide a source of
water and
potassium chloride with 0.9% sodium chloride.
Intravenous solutions containing potassium chloride are particularly
intended to provide
needed potassium cation (K ). Potassium is the chief cation of body
cells (160 mEq/liter
of intracellular water). It is found in low concentration in plasma
and extracellular fluids
(3.5 to 5.0 mEq/liter in a hea