ISOLYTE S PH 7.4- sodium chloride, sodium gluconate, sodium acetate, potassium chloride, magnesium chloride, sodium phosphate, d

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698), SODIUM GLUCONATE (UNII: R6Q3791S76) (SODIUM CATION - UNII:LYR4M0NH37, GLUCONIC ACID - UNII:R4R8J0Q44B), SODIUM ACETATE (UNII: 4550K0SC9B) (SODIUM CATION - UNII:LYR4M0NH37, ACETATE ION - UNII:569DQM74SC), POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152, CHLORIDE ION - UNII:Q32ZN48698), MAGNESIUM CHLORIDE (UNII: 02F3473H9O) (MAGNESIUM CATION - UNII:T6V3LHY838, CHLORIDE ION - UNI

Beszerezhető a:

B. Braun Medical Inc.

INN (nemzetközi neve):

SODIUM CHLORIDE

Összetétel:

SODIUM CHLORIDE 0.53 g in 100 mL

Az alkalmazás módja:

INTRAVENOUS

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

This solution is indicated for use in adults as a source of electrolytes and water for hydration, and as an alkalinizing agent. Contraindications: None known. Accurate clinical and laboratory estimation of fluid and electrolyte balance in order to access benefit/risk ratio are essential prior to administration of this solution (see WARNINGS and PRECAUTIONS ).

Termék összefoglaló:

Isolyte® S pH 7.4 (Multi-Electrolyte Injection) is supplied sterile and nonpyrogenic in EXCEL® Containers. The 1000 mL containers are packaged 12 per case and the 500 mL containers are packaged 24 per case. Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. It is recommended that the product be stored at room temperature (25°C); however, brief exposure up to 40°C does not adversely affect the product.

Engedélyezési státusz:

New Drug Application

Betegtájékoztató

ISOLYTE S PH 7.4- SODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE,
POTASSIUM CHLORIDE,
MAGNESIUM CHLORIDE, SODIUM PHOSPHATE, DIBASIC, AND POTASSIUM PHOSPHATE
INJECTION, SOLUTION
B. Braun Medical Inc.
----------
DIRECTIONS FOR USE OF EXCEL®
CONTAINER
Caution: Do not use plastic containers in series connection.
To Open
Tear overwrap down at notch and remove solution container. Check for
minute leaks by squeezing
solution container firmly. If leaks are found, discard solution as
sterility may be impaired. If supplemental
medication is desired, follow directions below before preparing for
administration.
NOTE: Before use, perform the following checks:
•
Inspect each container. Read the label. Ensure solution is the one
ordered and is within the
expiration date.
•
Invert container and carefully inspect the solution in good light for
cloudiness, haze, or particulate
matter. Any container which is suspect should not be used.
•
Use only if solution is clear and container and seals are intact.
Preparation for Administration
1.
Remove plastic protector from sterile set port at bottom of container.
2.
Attach administration set. Refer to complete directions accompanying
set.
To Add Medication
Warning: Some additives may be incompatible.
To Add Medication Before Solution Administration
1.
Prepare medication site.
2.
Using syringe with 18–22 gauge needle, puncture medication port and
inner diaphragm and inject.
3.
Squeeze and tap ports while ports are upright and mix solution and
medication thoroughly.
To Add Medication During Solution Administration
1.
Close clamp on the set.
2.
Prepare medication site.
3.
Using syringe with 18–22 gauge needle of appropriate length (at
least 5/8 inch), puncture
resealable medication port and inner diaphragm and inject.
4.
Remove container from IV pole and/or turn to an upright position.
5.
Evacuate both ports by tapping and squeezing them while container is
in the upright position.
6.
Mix solution and medication thoroughly.
7.
Return container to in use position and continue admi

Termékjellemzők

ISOLYTE S PH 7.4- SODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE,
POTASSIUM CHLORIDE, MAGNESIUM CHLORIDE, SODIUM PHOSPHATE, DIBASIC, AND
POTASSIUM PHOSPHATE INJECTION, SOLUTION
B. BRAUN MEDICAL INC.
----------
ISOLYTE S PH 7.4
(MULTI-ELECTROLYTE INJECTION)
DESCRIPTION
Each 100 mL of Isolyte S pH 7.4 (Multi-Electrolyte Injection)
contains:
Sodium Chloride USP 0.53 g; Sodium Gluconate USP 0.5 g
Sodium Acetate Trihydrate USP 0.37 g; Potassium Chloride USP 0.037 g
Magnesium Chloride Hexahydrate USP 0.03 g
Dibasic Sodium Phosphate Heptahydrate USP 0.012 g
Monobasic Potassium Phosphate NF 0.00082 g; Water for Injection USP qs
pH may be adjusted with Glacial Acetic Acid USP or Sodium Hydroxide NF
pH: 7.4 (7.0–7.8) Calculated Osmolarity: 295 mOsmol/liter
Concentration of Electrolytes (mEq/liter): Sodium 141; Potassium 5
Magnesium 3; Chloride 98;
Phosphate (HPO ) 1; Acetate (CH COO ) 27 Gluconate
(HOCH (CHOH) COO ) 23
Isolyte S pH 7.4 is sterile, nonpyrogenic, and contains no
bacteriostatic or antimicrobial
agents. This product is intended for intravenous administration.
The formulas of the active ingredients are:
INGREDIENTS
MOLECULAR
FORMULA
MOLECULAR
WEIGHT
Sodium Chloride USP
NaCl
58.44
Sodium Acetate Trihydrate USP
CH COONa•3H O 136.08
Potassium Chloride USP
KCl
74.55
Magnesium Chloride Hexahydrate USP
MgCl
•6H O
203.30
Dibasic Sodium Phosphate Heptahydrate USP Na HPO •7H O
268.07
Monobasic Potassium Phosphate NF
KH PO
136.09
Sodium Gluconate USP
218.14
Not made with natural rubber latex, PVC or DEHP.
The plastic container is made from a multilayered film specifically
developed for
parenteral drugs. It contains no plasticizers and exhibits virtually
no leachables. The
solution contact layer is a rubberized copolymer of ethylene and
propylene. The
container is nontoxic and biologically inert. The container-solution
unit is a closed system
®
®
1
3
–
2
4
–
®
3
2
2
2
2
4
2
2
4
and is not dependent upon entry of external air during administration.
The container is
overwrapped to provide protection from t