SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE injection

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

SODIUM FERRIC GLUCONATE COMPLEX (UNII: CC9149U2QX) (FERRIC CATION - UNII:91O4LML611)

Διαθέσιμο από:

Hikma Pharmaceuticals USA Inc.

INN (Διεθνής Όνομα):

SODIUM FERRIC GLUCONATE COMPLEX

Σύνθεση:

FERRIC CATION 12.5 mg in 1 mL

Οδός χορήγησης:

INTRAVENOUS

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

Sodium ferric gluconate complex in sucrose injection is indicated for the treatment of iron deficiency anemia in adult patients and in pediatric patients age 6 years and older with chronic kidney disease receiving hemodialysis who are receiving supplemental epoetin therapy. Sodium ferric gluconate complex in sucrose injection is contraindicated in patients with known hypersensitivity to sodium ferric gluconate or any of its components. Reactions have included anaphylaxis [see Warnings and Precautions (5.1) ]. Risk Summary Parenteral iron administration may be associated with hypersensitivity reactions [see Warnings and Precautions (5.1) ], which may have serious consequences, such as fetal bradycardia (see Clinical Considerations ). Advise pregnant women of the potential risk to the fetus. Available data from postmarketing reports with sodium ferric gluconate complex in sucrose injection use in pregnancy are insufficient to assess the risk of major birth defects and miscarriage. Sodium ferric gluconate comple

Περίληψη προϊόντος:

How Supplied Storage Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature]. Do not freeze. Keep out of the reach of children.

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE- SODIUM FERRIC GLUCONATE
COMPLEX IN SUCROSE INJECTION
HIKMA PHARMACEUTICALS USA INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
SODIUM FERRIC GLUCONATE
COMPLEX IN SUCROSE INJECTION SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR
SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE INJECTION.
SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE INJECTION, FOR INTRAVENOUS
USE
INITIAL U.S. APPROVAL: 1999
INDICATIONS AND USAGE
Sodium ferric gluconate complex in sucrose injection is an iron
replacement product for treatment of iron
deficiency anemia in adult patients and in pediatric patients age 6
years and older with chronic kidney
disease receiving hemodialysis who are receiving supplemental epoetin
therapy. (1)
DOSAGE AND ADMINISTRATION
Adult Patients - The recommended adult dosage is 10 mL (125 mg of
elemental iron) diluted in 100 mL
of 0.9% sodium chloride administered by intravenous infusion over 1
hour per dialysis session or
undiluted as a slow intravenous injection (at a rate of up to 12.5
mg/min) per dialysis session. (2.2)
Pediatric Patients - The recommended pediatric dosage is 0.12 mL/kg
(1.5 mg/kg of elemental iron)
diluted in 25 mL 0.9% sodium chloride and administered by intravenous
infusion over 1 hour per dialysis
session. (2.3)
Do not mix sodium ferric gluconate complex in sucrose injection with
other medications or add to
parenteral nutrition solutions for intravenous infusion.
Administer in 0.9% saline. (2)
DOSAGE FORMS AND STRENGTHS
Injection: 62.5 mg/5 mL (12.5 mg/mL) in single dose vial. (3)
CONTRAINDICATIONS
Known hypersensitivity to sodium ferric gluconate or any of its
inactive components. (4)
WARNINGS AND PRECAUTIONS
Hypersensitivity Reactions: Monitor patients for signs and symptoms of
hypersensitivity during and after
sodium ferric gluconate complex in sucrose injection administration
for at least 30 minutes and until
clinically stable following completion of the infusion. Only
adm