"The U.S. Food and Drug Administration today approved a new use for Jakafi (ruxolitinib) to treat patients with polycythemia vera, a chronic type of bone marrow disease. Jakafi is the first drug approved by the FDA for this condition.
DOSAGE AND ADMINISTRATION
Voluven® (hydroxyethyl starch in sodium chloride injection) 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® (hydroxyethyl starch in sodium chloride injection) 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]
Up to 50 mL of Voluven® (hydroxyethyl starch in sodium chloride injection) 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® (hydroxyethyl starch in sodium chloride injection) for a 70 kg patient.
Limited clinical data on the use of Voluven® (hydroxyethyl starch in sodium chloride injection) in children are available. In 41 children including newborns to infants ( < 2 years), a mean dose of 16 ± 9 mL/kg was administered. 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. The safety and efficacy of Voluven® (hydroxyethyl starch in sodium chloride injection) have not been established in the age group of 2 to 12 years. Use of Voluven® (hydroxyethyl starch in sodium chloride injection) in children > 12 years is supported by evidence from adequate and well-controlled studies of Voluven® (hydroxyethyl starch in sodium chloride injection) in adults and by data from children < 2 years old. [see Pediatric Use]
Directions for Use of Voluven® (hydroxyethyl starch in sodium chloride injection)
- Check the solution composition, lot number and expiry date, inspect the container for damage or leakage, if damaged do not use.
- Use opening aid to remove over-wrap.
- Identify the blue infusion (administration) port.
- Break off the blue tamper-evident cover from the freeflex ® infusion port.
- Close roller clamp. Insert the spike until the clear plastic collar of the port meets the shoulder of the spike.
- Use a non-vented standard infusion set and 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.
- Do not remove the freeflex ® IV container from its overwrap until immediately before use.
- Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
- Do not administer unless the solution is clear, free from particles and the freeflex® IV container is undamaged.
- Voluven® (hydroxyethyl starch in sodium chloride injection) should be used immediately after insertion of the administration set.
- Do not vent.
- If administered by pressure infusion, air should be withdrawn or expelled from the bag through the medication/administration port prior to infusion.
- Discontinue the infusion if an adverse reaction occurs.
- It is recommended that administration sets be changed at least once every 24 hours.
- For single use only. Discard unused portion.
The safety and compatibility of additives have not been established.
Dosage 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
Store at 15° to 25°C (59° to 77°F). Do not freeze.
Manufactured by: Fresenius Kabi Norge AS, P.O. Box 430, NO-1753, HALDEN, NORWAY. Distributed by: Hospira, Inc. 275, North Field Drive, Lake Forest, Illinois 60045 USA. Made in Norway EN-1597. FDA rev date: 12/27/2007This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 2/1/2008
Additional Voluven Information
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