PHOXILLUM BK4/2.5- calcium chloride, magnesium chloride, sodium chloride, potassium chloride, sodium phosphate, dibasic, and so

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

Calcium Chloride (UNII: M4I0D6VV5M) (Calcium cation - UNII:2M83C4R6ZB, Chloride Ion - UNII:Q32ZN48698), Magnesium Chloride (UNII: 02F3473H9O) (Magnesium Cation - UNII:T6V3LHY838, Chloride Ion - UNII:Q32ZN48698), Sodium Chloride (UNII: 451W47IQ8X) (Sodium Cation - UNII:LYR4M0NH37, Chloride Ion - UNII:Q32ZN48698), Potassium Chloride (UNII: 660YQ98I10) (Potassium Cation - UNII:295O53K152, Chloride Ion - UNII:Q32ZN48698), Sodium Phosphate, Dibasic (UNII: GR686LBA74) (Sodium Cation - UNII:LYR4M0NH37, Phosphate I

Dostupné z:

Gambro Renal Products

INN (Medzinárodný Name):

Calcium Chloride

Zloženie:

Calcium Chloride 0.139 g in 1 L

Spôsob podávania:

INTRAVENOUS

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

PRISMASOL and PHOXILLUM solutions are indicated in pediatric and adult patients for use as a replacement solution in Continuous Renal Replacement Therapy (CRRT) to replace plasma volume removed by ultrafiltration and to correct electrolyte and acid-base imbalances.They may also be used in case of drug poisoning when CRRT is used to remove dialyzable substances. None Pregnancy Category C Animal reproduction studies have not been conducted with PRISMASOL and PHOXILLUM solutions. While there are no adequate and well controlled studies in pregnant women, appropriate administration of PRISMASOL and PHOXILLUM solutions 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. The components of PRISMASOL and PHOXILLUM solutions are excreted in human milk. Appropriate administration of PRISMASOL and PHOXILLUM solutions with monitoring of fluid, electrolyte, acid-

Prehľad produktov:

PRISMASOL and PHOXILLUM solutions are supplied in a two-compartment bag made of polyvinyl chloride (PVC). 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 red frangible pin. The bag is overwrapped with a transparent overwrap. See Table 2 for the concentrations of the active ingredients in each compartment for each product [see Description (11)]. Not all formulations may be marketed. Storage conditions Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15º-30ºC (59º-86ºF). [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.

Stav Autorizácia:

New Drug Application

Súhrn charakteristických

PHOXILLUM BK4/2.5- CALCIUM CHLORIDE, MAGNESIUM CHLORIDE, SODIUM
CHLORIDE, POTASSIUM
CHLORIDE, SODIUM PHOSPHATE, DIBASIC, AND SODIUM BICARBONATE SOLUTION
PHOXILLUM B22K4/0- MAGNESIUM CHLORIDE, SODIUM CHLORIDE, POTASSIUM
CHLORIDE, SODIUM
PHOSPHATE, DIBASIC, AND SODIUM BICARBONATE SOLUTION
GAMBRO RENAL PRODUCTS
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PRISMASOL AND PHOXILLUM SAFELY AND
E FFE C TIVE LY.
SEE FULL PRESCRIBING INFORMATION FOR PRISMASOL AND PHOXILLUM.
PRISMASOL RENAL REPLACEMENT SOLUTION
PRISMASOL INITIAL U.S. APPROVAL: 2006
PHOXILLUM RENAL REPLACEMENT SOLUTION
PHOXILLUM INITIAL U.S APPROVAL: 2015
RECENT MAJOR CHANGES
Dosage and Administration
01/2015
Warnings and Precautions
01/2015
INDICATIONS AND USAGE
PRISMASOL and PHOXILLUM solutions are indicated:
As a replacement solution in Continuous Renal Replacement Therapy
(CRRT) and in case of drug poisoning when
CRRT is used to remove dialyzable substances (1)
DOSAGE AND ADMINISTRATION
Therapy must be individualized based on the patient's clinical
condition, fluid, electrolyte, acid-base and glucose balance
(2.1)
Solution must be mixed prior to use (2.2)
Use only with extracorporeal dialysis equipment appropriate for CRRT
(2.3)
DOSAGE FORMS AND STRENGTHS
PRISMASOL and PHOXILLUM are available in multiple combinations of
ingredients and in multiple variations of strengths.
See full Prescribing Information for detailed descriptions of each
formulation. (2, 3, 11)
CONTRAINDICATIONS
None (4)
WARNINGS AND PRECAUTIONS
Hemodynamic status and fluid, electrolyte and acid-base balance should
be monitored. Abnormalities may be corrected
by the use of appropriate formulations of PRISMASOL and PHOXILLUM
solutions (5.1)
Antidiabetic therapy may need adjustment during treatment with
dextrose containing formulations (5.2)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT GAMBRO AT
1-800-651-2623 OR FDA 1-800-FDA-1088 OR
WWW.FDA.G O V/MEDWATCH
REVISED: 2/2015
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDI