PRISMASOL BGK0/2.5- calcium chloride, magnesium chloride, dextrose monohydrate, lactic acid, sodium chloride, and sodium bicarb

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Vedd Meg Most

Letöltés Termékjellemzők (SPC)
24-01-2014

Aktív összetevők:

Calcium Chloride (UNII: M4I0D6VV5M) (Calcium Cation - UNII:2M83C4R6ZB, Chloride Ion - UNII:Q32ZN48698), Magnesium Chloride (UNII: 02F3473H9O) (Magnesium Cation - UNII:T6V3LHY838, Chloride Ion - UNII:Q32ZN48698), Dextrose monohydrate (UNII: LX22YL083G) (Anhydrous Dextrose - UNII:5SL0G7R0OK), Lactic Acid (UNII: 33X04XA5AT) (Lactic Acid - UNII:33X04XA5AT), Sodium Chloride (UNII: 451W47IQ8X) (Sodium Cation - UNII:LYR4M0NH37, Chloride Ion - UNII:Q32ZN48698), Sodium Bicarbonate (UNII: 8MDF5V39QO) (Sodium Cation -

Beszerezhető a:

Gambro Renal Products

INN (nemzetközi neve):

Calcium Chloride

Összetétel:

Calcium Chloride 0.139 g in 1 L

Az alkalmazás módja:

INTRAVENOUS

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

There is no known contraindication to the use of PrismaSol solution. Pregnancy Category C. PrismaSol solution is a replacement solution of electrolytes, bicarbonate and dextrose and is pharmacologically inactive. Animal reproduction studies have not been conducted with PrismaSol solution. While there are no adequate and well controlled studies in pregnant women, appropriate administration of PrismaSol solution with monitoring of fluid, electrolyte, acid-base and glucose balance, is not expected to cause fetal harm, or affect reproductive capacity. Maintenance of normal acid-base balance is important for fetal well being. PrismaSol solution is a replacement solution of electrolytes, bicarbonate and dextrose and is pharmacologically inactive. The components of PrismaSol solution are excreted in human milk. Appropriate administration of PrismaSol solution with monitoring of fluid, electrolyte, acid-base and glucose balance, is not expected to harm a nursing infant. Safety and effectiveness have been established

Termék összefoglaló:

PrismaSol solution is supplied in a two compartment bag made of polyolefin. Polyolefin does not contain the chemical component di-2-ethyl hexyl phthalate (DEHP). The 5000 mL bag is composed of a small compartment (250 mL) and a large compartment (4750 mL). The two compartments are separated by a peel seal. The bag is overwrapped with a transparent overwrap. Not all formulations may be marketed. Storage conditions Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature] Do not freeze or expose to excessive heat. Do not use if precipitate has formed or if container seals have been damaged.

Engedélyezési státusz:

New Drug Application

Termékjellemzők

                                PRISMASOL BGK0/2.5- CALCIUM CHLORIDE, MAGNESIUM CHLORIDE, DEXTROSE
MONOHYDRATE, LACTIC
ACID, SODIUM CHLORIDE, AND SODIUM BICARBONATE SOLUTION
PRISMASOL BGK4/2.5- CALCIUM CHLORIDE, MAGNESIUM CHLORIDE, DEXTROSE
MONOHYDRATE, LACTIC
ACID, SODIUM CHLORIDE, SODIUM BICARBONATE, AND POTASSIUM CHLORIDE
SOLUTION
PRISMASOL BGK2/3.5- CALCIUM CHLORIDE, MAGNESIUM CHLORIDE, DEXTROSE
MONOHYDRATE, LACTIC
ACID, SODIUM CHLORIDE, SODIUM BICARBONATE, AND POTASSIUM CHLORIDE
SOLUTION
PRISMASOL BGK2/0- MAGNESIUM CHLORIDE, DEXTROSE MONOHYDRATE, LACTIC
ACID, SODIUM
CHLORIDE, SODIUM BICARBONATE, AND POTASSIUM CHLORIDE SOLUTION
PRISMASOL B22GK4/0- MAGNESIUM CHLORIDE, DEXTROSE MONOHYDRATE, LACTIC
ACID, SODIUM
CHLORIDE, SODIUM BICARBONATE, AND POTASSIUM CHLORIDE SOLUTION
PRISMASOL BK0/0/1.2- MAGNESIUM CHLORIDE, LACTIC ACID, SODIUM CHLORIDE,
AND SODIUM
BICARBONATE SOLUTION
PRISMASOL BGK4/0/1.2- MAGNESIUM CHLORIDE, DEXTROSE MONOHYDRATE, LACTIC
ACID, SODIUM
CHLORIDE, SODIUM BICARBONATE, AND POTASSIUM CHLORIDE SOLUTION
GAMBRO RENAL PRODUCTS
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PRISMASOL SOLUTION SAFELY AND EFFECTIVELY.
SEE FULL PRESCRIBING INFORMATION FOR PRISMASOL SOLUTION.
PRISM ASO L SOLUTION, FOR INTRAVENOUS ADMINISTRATION.
INITIAL U.S. APPROVAL: 2006
INDICATIONS AND USAGE
PrismaSol solution is indicated: (1)
As a replacement solution in Continuous Renal Replacement Therapy
(CRRT)
In case of drug poisoning when CRRT is used
DOSAGE AND ADMINISTRATION
The mode of therapy, solute formulations, flow rates and length of
therapy should be selected by the physician responsible
for managing treatment depending on the clinical condition of the
patient as well as the patient's fluid, electrolyte, acid base
and glucose balance. (2)
DOSAGE FORMS AND STRENGTHS
1000 mL of the reconstituted PrismaSol solution contains (in mEq/L
except where noted): (3)
BGK 0/2.5
BGK 4/2.5
BGK 2/3.5
BGK 2/0
Ca
2.5
2.5
3.5
0
HCO
32
32
32
32
K
0
4.0
2.0
2.0
Mg
1.5
1.5
1.0
1.0
Na
140
140
140
140
Cl
10
                                
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