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Voluven: Uses, Side Effects and Dosage

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Prescription (Rx)
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6 %
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Source: Health Canada – Drug Product Database (DPD) and product monographs · About this document

Patient Medication Information: uses, side effects, how to take - Voluven

ABOUT THIS MEDICATION

What the medication is used for:

VOLUVEN® is a plasma volume substitute that is used in adults to restore blood volume when you have lost blood. It is used when other products called crystalloids are not considered sufficient to be used alone to restore your blood volume. VOLUVEN® is not a substitute for red blood cells or clotting factors in plasma.

What it does:

VOLUVEN® belongs to a group of medicines known as plasma volume expanders. VOLUVEN® works for several hours by increasing the volume of circulating blood.

When it should not be used:

Your doctor will not administer VOLUVEN® if:

  • you have too much fluid in your body
  • you have a serious generalized infection
  • you have been told that you have pulmonary edema where too much fluid is in your lungs
  • you are critically ill (e.g. you need to stay in an intensive care unit)
  • you have been told that you have congestive heart failure (a condition in which your heart cannot pump enough blood to other organs of your body)
  • you have pre-existing blood clotting or bleeding disorders
  • you have kidney impairment and you produce little or no urine and if this is not caused by low blood volume
  • you are receiving dialysis treatment (an artificial kidney treatment)
  • you have severe liver disease
  • you suffer from bleeding within or around the brain (intracranial bleeding)
  • you have severely elevated levels of either sodium or chloride in your blood
  • you are allergic (hypersensitive) to hydroxyethyl starch or any of the other ingredients.

What the medicinal ingredient is:

6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride injection.

What the non-medicinal ingredients are:

Sodium chloride, Water for injections; pH adjusted with sodium hydroxide or hydrochloric acid.

What dosage form it comes in:

Solution (for infusion): 6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride injection supplied in 250 mL and 500 mL plastic bags or in glass infusion bottles.

WARNINGS AND PRECAUTIONS

BEFORE VOLUVEN is administered to you talk to your doctor or nursing staff if:

  • You have heart or kidney problems.
  • You have bleeding disorders.

Other warnings and precautions:

  • Your doctor will be careful not to exceed the recommended dose as this may cause fluid overload which may change blood conditions such as the ability for the blood to clot (coagulation), or alter blood factors (hematocrit, blood proteins).
  • Your doctor may monitor your kidney function, electrolytes in your blood and fluid balance to maintain adequate hydration.
  • Your doctor regularly monitors your liver function.
  • If your kidney function shows signs of problems during therapy, your doctor will stop giving you this medicine. If, for other reasons you are in hospital for long-term, your doctor may need to monitor your kidney function for up to 90 days.
  • If you are given this medicine repeatedly or in open heart surgery your doctor will monitor the ability of your blood to clot. If it shows signs of problems during therapy your doctor will stop giving you this medicine.
  • This medicine may temporarily increase the level of the enzyme serum amylase and could interfere with the diagnosis of inflammation of the pancreas (pancreatitis).
  • Itching or allergic reactions to VOLUVEN® may occur.
  • Tell your doctor about any unusual symptoms that you develop.

Serious Warnings and Precautions

The use of hydroxyethyl starch (HES) products, including VOLUVEN in critically ill patients, including patients with sepsis increases the risk of death and for renal (kidney) replacement therapy.

HES products, including VOLUVEN should not be given in critically ill patients, including patients with sepsis.

Use in Pregnancy

VOLUVEN® should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Women

It is not known whether HES 130/0.4 is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when VOLUVEN® is being considered for a nursing mother.

You and your doctor must decide whether to continue/discontinue breast-feeding or to discontinue/continue therapy with VOLUVEN® by taking into account the benefit of breast-feeding to the child and the benefit of VOLUVEN® therapy to the nursing mother.

INTERACTIONS WITH THIS MEDICATION

It is not known if VOLUVEN interacts with other medications.

PROPER USE OF THIS MEDICATION

VOLUVEN® is given to you by your doctor. Your doctor will decide the best dose for you and for how long you will need to be treated with VOLUVEN.

It is given by injection into your vein as an infusion (intravenous infusion)

Overdose:

In case of drug overdose, your doctor will stop the infusion immediately and, if necessary, administer therapies that remove water from the body and may contact the regional Poison Control Centre immediately.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

  • Itching
  • Abnormal blood test results, such as decrease of hematocrit or plasma proteins
  • The level of serum amylase can rise during administration of VOLUVEN® and can interfere with the diagnosis of inflammation of the pancreas (pancreatitis); however, VOLUVEN® does not cause pancreatitis.
SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM
Symptom / effectTalk with your doctor or nursing staffDoctor will stop treatment
Only if severeIn all cases
Rare
Allergic reactions with symptoms such as mild flu-like symptoms; ie fever, headache, slow heartbeat, fast heartbeat, bronchitis, fluid in the lungs unrelated to heart problems.
✓✓
Unusual bruising or bleeding
✓✓

This is not a complete list of side effects. If you have any unexpected effects after receiving VOLUVEN®, contact your doctor or nursing staff.

HOW TO STORE IT

VOLUVEN is stored by your healthcare professional.

Store:

  • Glass infusion bottle: at 15 °C – 25 °C
  • freeflex® bag storage: at 15 °C – 25 °C

The product should be used immediately after opening.

Do not freeze.

Do not use VOLUVEN® after expiry date.

REPORTING SIDE EFFECTS

You can help improve the safe use of health products for Canadians by reporting serious and unexpected side effects to Health Canada. Your report may help to identify new side effects and change the product safety information.

3 ways to report:

  • Online at MedEffect (https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html);
  • By calling 1-866-234-2345 (toll-free);

  • By completing a Consumer Side Effect Reporting Form and sending it by:

    • Fax to 1-866-678-6789 (toll-free), or

    • Mail to: Canada Vigilance Program

      Health Canada, Postal Locator 0701E Ottawa, ON

      K1A 0K9

      Postage paid labels and the Consumer Side Effect Reporting Form are available at MedEffect.

NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

IF YOU WANT MORE INFORMATION ABOUT VOLUVEN®

  • Talk to your healthcare professional
  • Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada Website (https://health-products.canada.ca/dpd-bdpp/index-eng.jsp); the manufacturer’s website (http://www.fresenius-kabi.ca), or by calling 1-877-821-7724 (toll-free-telephone).
FK_RGB

Fresenius Kabi Canada Ltd.

Canada165 Galaxy Blvd, Suite 100

Toronto, ON M9W 0C8

Last revised: February 17, 2020

Voluven and freeflex are registered trademarks of Fresenius Kabi AG.

About this document

Source: Health Canada – Drug Product Database (DPD) and product monographs · DIN (Drug Identification Number): 02278057

Revision date stated in the text: February 17, 2020

Found a mistake? Write to us via the contact page.

The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Voluven

Rx or OTC
Prescription (Rx)?
DIN 02278057
Schedule(s) PRESCRIPTION
Active ingredient(s) Hydroxyethyl starch 130/0.4 6 %
Dosage form(s) Solution
Route(s) of administration Intravenous
Drug class (WHO ATC)
  1. B Blood and blood forming organ drugs
    1. B05 Blood substitutes and perfusion solutions
      1. B05A Blood and related products
        1. B05AA Blood substitutes and plasma protein fractions
          1. B05AA07 Hydroxyethylstarch
Company FRESENIUS KABI CANADA LTD
Current status Marketed
Current status date April 18, 2015

Source: Health Canada – Drug Product Database (DPD) and product monographs, data as of November 1, 2026. Data from the Health Canada Drug Product Database, as published there. Not a substitute for the advice of a doctor or pharmacist.