VOLUVEN- hydroxyethyl starch 130/0.4 injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

HYDROXYETHYL STARCH 130/0.4 (UNII: 1GVO236S58) (HYDROXYETHYL STARCH 130/0.4 - UNII:1GVO236S58)

Available from:

Hospira, Inc.

INN (International Name):

HYDROXYETHYL STARCH 130/0.4

Composition:

HYDROXYETHYL STARCH 130/0.4 6 g in 100 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Voluven ® (6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride injection) is indicated for the treatment and prophylaxis of hypovolemia in adults and children. It is not a substitute for red blood cells or coagulation factors in plasma. - Do not use hydroxyethyl starch (HES) products, including Voluven ® , in critically ill adult patients, including patients with sepsis, due to increased risk of mortality and renal replacement therapy (RRT). - Do not use HES products, including Voluven ® , in patients with severe liver disease. - Do not use HES products, including Voluven ® , in patients with known hypersensitivity to hydroxyethyl starch [see General Warnings and Precautions (5.1) ] - Do not use HES products in clinical conditions with volume overload. - Do not use HES products in patients with pre-existing coagulation or bleeding disorders. - Do not use HES products in patients with renal failure with oliguria or anuria not related

Product summary:

Voluven ® (6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride injection) for intravenous infusion is supplied in the following primary container and carton sizes: Polyolefin bag ( free flex ® ) with overwrap: 500 mL           NDC 0409-1029-11 Carton of 15 x 500 mL                                                        NDC 0409-1029-01 Carton of 20 x 500 mL                                                        NDC 0409-1029-02 Store at 15° to 25°C (59° to 77°F). Do not freeze.

Authorization status:

New Drug Application

Summary of Product characteristics

VOLUVEN- HYDROXYETHYL STARCH 130/0.4 INJECTION, SOLUTION
HOSPIRA, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
VOLUVEN
SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR VOLUVEN
.
VOLUVEN
(6% HYDROXYETHYL STARCH 130/0.4 IN 0.9% SODIUM CHLORIDE INJECTION),
FOR ADMINISTRATION BY
INTRAVENOUS INFUSION
INITIAL U.S. APPROVAL: 2007
WARNING: MORTALITY RENAL REPLACEMENT THERAPY
SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING.
IN CRITICALLY ILL ADULT PATIENTS, INCLUDING PATIENTS WITH SEPSIS, USE
OF HYDROXYETHYL STARCH (HES)
PRODUCTS, INCLUDING VOLUVEN
, INCREASES RISK OF MORTALITY RENAL REPLACEMENT THERAPY
DO NOT USE HES PRODUCTS, INCLUDING VOLUVEN
, IN CRITICALLY ILL ADULT PATIENTS, INCLUDING PATIENTS WITH
SE PSIS.
INDICATIONS AND USAGE
Voluven
is a plasma volume substitute indicated for the treatment and
prophylaxis of hypovolemia in adults and children.
( 1)
DOSAGE AND ADMINISTRATION
ADMINISTER BY INTRAVENOUS INFUSION ONLY.
Daily dose and rate of infusion depend on the patient’s blood loss,
hemodynamics and on the hemodilution effects. ( 2)
RECOMMENDED DAILY DOSE
Adults ( 2.1)
Up to 50 mL/kg body weight
RECOMMENDED DAILY DOSE
MEAN DAILY DOSE ± SD IN CLINICAL TRIALS (2.2)
Pediatric age groups ( 2.2)
Up to 50 mL/kg body weight in all age groups
-
< 2 years
16 ± 9 mL/kg body weight
2 – 12 years
36 ± 11 mL/kg body weight
> 12 years
-
Initiate infusion slowly due to possible anaphylactoid reactions ( 2,
5.1)
®
®
®
®
®
®
See full prescribing information for pediatric administration ( 2.2,
8.4)
DOSAGE FORMS AND STRENGTHS
500 mL FREE_flex_
flexible plastic intravenous solution container. Each 100 mL contains
6 g hydroxyethyl starch 130/0.4 in
isotonic sodium chloride injection. ( 3)
CONTRAINDICATIONS
Do not use hydroxyethyl starch (HES) products, including Voluven
, in critically ill adult patients, including patients
with sepsis due to increased risk of mortality and renal replacement
therapy. ( 4)
Do not use HES produ