DELFLEX- dextrose monohydrate, sodium chloride, sodium lactate, calcium chloride, magnesium chloride solution

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK), SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698), SODIUM LACTATE (UNII: TU7HW0W0QT) (SODIUM CATION - UNII:LYR4M0NH37, LACTIC ACID - UNII:33X04XA5AT), CALCIUM CHLORIDE (UNII: M4I0D6VV5M) (CALCIUM CATION - UNII:2M83C4R6ZB, CHLORIDE ION - UNII:Q32ZN48698), MAGNESIUM CHLORIDE (UNII: 02F3473H9O) (MAGNESIUM CATION - UNII:T6V3LHY838, CHLORIDE ION - UNII:Q32ZN48698)

Disponível em:

Fresenius Medical Care North America

DCI (Denominação Comum Internacional):

DEXTROSE MONOHYDRATE

Composição:

DEXTROSE MONOHYDRATE 1.5 g in 100 mL

Via de administração:

INTRAPERITONEAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

DELFLEX® is indicated in the treatment of chronic kidney failure in patients being maintained on peritoneal dialysis. None. Risk Summary DELFLEX solutions consist of electrolytes, lactate, and bicarbonate at physiological levels, and glucose to facilitate ultrafiltration. While there are no adequate and well controlled studies in pregnant women, appropriate administration of DELFLEX with monitoring of fluid, electrolyte, acid-base and glucose balance, is not expected to cause fetal harm. Animal reproduction studies have not been conducted with DELFLEX. The estimated background risk of major birth defects and miscarriage for the indicated population are unknown. All pregnancies have a background risk of birth defect, loss or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Risk Summary The components of DELFLEX solutions are excreted in human milk. Appropriat

Resumo do produto:

DELFLEX peritoneal dialysis solutions are available in the sizes and formulations shown in Table 1 [see Dosage Forms and Strengths ( 3)] . Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (between 59°F and 86°F). See USP Controlled Room Temperature. Brief exposure to temperatures up to 40°C (104°F) may be tolerated provided the mean kinetic temperature does not exceed 25°C (77°F); however, such exposure should be minimized. Keep DELFLEX and all medicines out of the reach of children.

Status de autorização:

New Drug Application

Características técnicas

DELFLEX- DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE,
CALCIUM
CHLORIDE, MAGNESIUM CHLORIDE SOLUTION
FRESENIUS MEDICAL CARE NORTH AMERICA
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DELFLEX SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR DELFLEX
DELFLEX (DEXTROSE) PERITONEAL DIALYSIS SOLUTION
INITIAL U.S. APPROVAL: 1984
DELFLEX LOW MAGNESIUM, LOW CALCIUM (DEXTROSE) PERITONEAL DIALYSIS
SOLUTION
INITIAL U.S. APPROVAL: 1992
INDICATIONS AND USAGE
For treatment of chronic kidney failure. ( 1)
DOSAGE AND ADMINISTRATION
For intraperitoneal dialysis only. ( 2)
DOSAGE FORMS AND STRENGTHS
DELFLEX solutions are available in multiple compositions, calculated
osmolarity, pH, and ionic
concentrations. See full prescribing information for detailed
descriptions of each formulation. ( 3, 11)
CONTRAINDICATIONS
None (4)
WARNINGS AND PRECAUTIONS
Monitor patient for electrolyte, fluid, and nutrition imbalances. (
5.1)
Encapsulating Peritonitis Sclerosis (EPS) ( 5.2)
Peritonitis: Initiate appropriate antimicrobial therapy ( 5.2)
Monitor for Lactic Acidosis in patients at risk. ( 5.3)
ADVERSE REACTIONS
Adverse reactions may include peritonitis, catheter site infection,
electrolyte and fluid imbalances,
hypovolemia, hypervolemia, hypertension, disequilibrium syndrome,
muscle cramping, abdominal pain,
abdominal distension, and abdominal discomfort. ( 6)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT FRESENIUS MEDICAL CARE
NORTH AMERICA
AT 1-800-323-5188 OR FDA AT 1-800-FDA-1088 OR _WWW.FDA.GOV/MEDWATCH._
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 3/2023
FULL PRESCRIBING INFORMATION: CONTENTS*
1. INDICATIONS AND USAGE
2. DOSAGE AND ADMINISTRATION
2.1 Basic Dosing Information
2.2 Administration Instructions
2.3 Compatible Medications
3. DOSAGE FORMS AND STRENGTHS
4. CONTRAINDICATIONS
5. WARNINGS AND PRECAUTIONS
5.1 Electrolyte, Fluid and Nutrition Imbalances
5.2 Peritonitis and Encapsulating Peritoneal Sclerosis
5.3 Lactic Acidosis
5.4 Ove