July 30, 2016
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Voluven

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Voluven

Indications
Dosage
How Supplied

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.

DOSAGE AND ADMINISTRATION

Voluven® is administered by intravenous infusion only. The daily dose and rate of infusion depend on the patient’s blood loss, on the maintenance or restoration of hemodynamics and on the hemodilution (dilution effect). Voluven® can be administered repetitively over several days. [see WARNINGS AND PRECAUTIONS]

The initial 10 to 20 mL should be infused slowly, keeping the patient under close observation due to possible anaphylactoid reactions. [see General WARNINGS AND PRECAUTIONS]

Adult Dose

Up to 50 mL of Voluven® per kg of body weight per day (equivalent to 3 g hydroxyethyl starch and 7.7 mEq sodium per kg of body weight). This dose is equivalent to 3500 mL of Voluven® for a 70 kg patient.

Pediatric Dose

The dosage in children should be adapted to the individual patient colloid needs, taking into account the disease state, as well as the hemodynamic and hydration status.

In 41 newborns to infants (< 2 years), a mean dose of 16 ± 9 mL/kg was administered. In 31 children from 2 – 12 years of age a mean dose of 36 ± 11 mL/kg was administered. The dose in adolescents > 12 is the same as the adult dose. [see Pediatric Use]

Directions Of Use for Voluven®

  • Check the solution composition, lot number and expiry date, inspect the container for damage or leakage, if damaged do not use.
  • Check the solution - - Illustration

  • Identify the blue infusion (administration) port.
  • Identify the blue infusion - - Illustration

  • Use opening aid to remove over-wrap.
  • Use opening aid to remove over-wrap - - Illustration

  • Break off the blue tamper-evident cover from the freeflex® infusion port.
  • Break off the blue tamper-evident cover - Illustration

  • Close roller clamp. Insert the spike until the clear plastic collar of the port meets the shoulder of the spike.
  • Insert the spike - Illustration

  • Use a non-vented standard infusion set.
  • Close air inlet.
  • Hang the bag on the infusion stand. Press drip chamber to get fluid level. Prime infusion set. Connect and adjust the flow rate.
  1. Do not remove the freeflex® IV container from its overwrap until immediately before use.
  2. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
  3. Do not administer unless the solution is clear, free from particles and the freeflex® IV container is undamaged.
  4. Voluven® should be used immediately after insertion of the administration set.
  5. Do not vent.
  6. If administered by pressure infusion, air should be withdrawn or expelled from the bag through the medication/administration port prior to infusion.
  7. Discontinue the infusion if an adverse reaction occurs.
  8. It is recommended that administration sets be changed at least once every 24 hours.
  9. For single use only. Discard unused portion.

HOW SUPPLIED

Doage Forms And Strengths

500 mL freeflex® flexible plastic intravenous solution container are available. Each 100 mL contains 6 g hydroxyethyl starch 130/0.4 in isotonic sodium chloride injection.

Storage And Handling

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 (freeflex®) with overwrap: 500 mL

Carton of 15 x 500 mL NDC 0409-1029-01
Carton of 20 x 500 mL NDC 0409-1029-02

Storage

Store at 15° to 25°C (59° to 77°F). Do not freeze.

REFERENCES

  1. Neff TA, Doelberg M, Jungheinrich C, et al. Repetitive large-dose infusion of the novel hydroxyethyl starch HES 130/0.4 in patients with severe head injury. Anest Analg 2003; 96 (5): 1453–9.
  2. Kozek-Langenecker S. Effects of hydroxyethyl starch solutions on hemostasis. Anesthesiology 2005; 103 (3): 654-60.
  3. Standl T, Lochbuehler H, Galli C, et al. HES 130/0.4 (Voluven®) or human albumin in children younger than 2 yr undergoing non-cardiac surgery. A prospective, randomized, open label, multicentre trial. Eur J Anaesthesiol 2008; 25(6): 437-45.
  4. Jungheinrich C, Neff T. Pharmacokinetics of hydroxyethyl starch. Clin Pharmacokinetik 2005; 44 (7): 681-99.
  5. Jungheinrich C, Scharpf R, Wargenau M, et al. The pharmacokinetics and tolerability of an intravenous infusion of the new hydroxyethyl starch 130/0.4 (6%, 500 mL) in mild-to-severe renal impairment. Anesth Analg 2002; 95 (3): 544 – 51.
  6. Leuschner J, Opitz J, Winkler A, Scharpf R, Bepperling F. Tissue storage of 14C-labeled hydroxyethyl starch (HES) 130/0.4 and HES 200/0.5 after repeated intravenous administration to rats. Drugs R D 2003; 4 (6): 331-8.
  7. Gandhi SD, Weiskopf RB, Jungheinrich C et al. Volume replacement therapy during major orthopedic surgery using Voluven® (hydroxyethyl starch 130/0.4) or hetastarch. Anesthesiology 2007; 106(6):1120-7.
  8. Perner A, Haase N, Guttormsen AB, et al. Hydroxyethyl Starch 130/0.4 versus Ringer’s Acetate in Severe Sepsis. N Eng J Med 2012; 367(2): 124-34.
  9. Guidet B, Martinet O, Boulain T, et al. Assessment of hemodynamic efficacy and safety of 6% hydroxyethylstarch 130/0.4 versus 0.9% NaCl fluid replacement in patients with severe sepsis: The CRYSTMAS study. Crit Care 2012; 16(3): R94.
  10. Myburgh JA, Finfer S, Bellomo R, et al. Hydroxyethyl starch or saline for fluid resuscitation in intensive care. N Engl J Med 2012; 367(20): 1901-11.

Manufactured by: Distributed by: Fresenius Kabi Norge AS, P.O. Box 430, NO-1753 Halden, Norway. Revised: Oct 2013.

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 7/13/2016

Indications
Dosage
How Supplied

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