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

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698), POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152, CHLORIDE ION - UNII:Q32ZN48698)

Sẵn có từ:

ICU Medical Inc.

Tuyến hành chính:

INTRAVENOUS

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

Potassium Chloride in Sodium Chloride Injection, USP is indicated as a source of water and electrolytes. Potassium Chloride in Sodium Chloride Injection, USP is contraindicated in patients with: - Known hypersensitivity to potassium chloride and/or sodium chloride (see WARNINGS). - Clinically significant hyperkalemia (see WARNINGS). For information on risk of air embolism – see PRECAUTIONS. To Open Tear outer wrap at notch and remove solution container. If supplemental medication is desired, follow directions below before preparing for administration. Visually inspect the container. If the outlet port protector is damaged, detached, or not present, discard container as solution path sterility may be impaired. 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. Check for minute leaks by squeezing inner bag firmly. If leaks are found, discard solution as sterility may be impaired. If supplemental medication is desired, follow directions below. 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: See full directions on administration set carton. - Suspend container from hanger. - Squeeze and release drip chamber to establish proper fluid level in chamber. - 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. - Regulate rate of administration with flow control clamp. WARNING: Do not use flexible container in series connections. Revised: July, 2022 ICU Medical, Inc., Lake Forest, Illinois, 60045, USA IFU0000531

Tóm tắt sản phẩm:

20 mEq/L Potassium Chloride in 0.45% Sodium Chloride Injection, USP is supplied in 1000 mL single-dose flexible plastic containers (NDC 0409-9257-39) (NDC 0990-9257-39). 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.

Tình trạng ủy quyền:

Abbreviated New Drug Application

Đặc tính sản phẩm

POTASSIUM CHLORIDE IN SODIUM CHLORIDE- SODIUM CHLORIDE AND POTASSIUM
CHLORIDE INJECTION, SOLUTION
ICU MEDICAL INC.
----------
POTASSIUM CHLORIDE IN SODIUM CHLORIDE INJECTION, USP
FLEXIBLE PLASTIC CONTAINER
Rx only
DESCRIPTION
Potassium Chloride in Sodium Chloride Injection, USP is a sterile,
nonpyrogenic, solution
for fluid and electrolyte replenishment in a single dose container for
intravenous
administration. It contains no antimicrobial agents. Composition,
osmolarity, pH and ionic
concentration are shown in Table 1.
TABLE 1:
20 MEQ/ L
POTASSIUM
CHLORIDE
IN 0.45%
SODIUM
CHLORIDE
INJ., USP
COMPOSITION
(G/L)
CALCULATED
OSMOLARITY
(MOSMOL/L)
PH
(RANGE)
IONIC CONCENTRATIONS
(MEQ/L)
NDC
NO.
SIZE
(ML)
SODIUM
CHLORIDE
(NACL)
POTASSIUM
CHLORIDE
(KCL)
SODIUM
(NA+)
POTASSIUM
(K+)
CHLORIDE
(CL-)
0409-
9257-
39
1000
4.5
1.49
194
4.8
(3.5 to
6.5)
77
20
97
0990-
9257-
39
1000
4.5
1.49
194
4.8
(3.5 to
6.5)
77
20
97
The flexible plastic container is fabricated from a specially
formulated polyvinyl chloride
(PL 146 Plastic). 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. However, the safety of the
plastic has been
confirmed in tests in animals according to USP biological tests for
plastic containers.
CLINICAL PHARMACOLOGY
Potassium Chloride in Sodium Chloride Injection, USP has value as a
source of water and
electrolytes. It is capable of inducing diuresis depending on the
clinical condition of the
patient.
INDICATIONS AND USAGE
Potassium Chloride in Sodium Chloride Injection, USP is indicated as a
source of water
and electrolytes.
CONTRAINDICATIONS
Potassium Chloride in Sodium Chloride Injection, USP is
contraindicated in patients with:
Known hypersensitivity to potassium chloride and/or sodium chloride
(see
WARNINGS).
Clinically significant hyperkalemia (see WARNINGS).
WARNINGS
HYPERSENSITIV