What Voluven is used for and how to use it
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Voluven - Consumer Medicine Information

Manufacture: Fresenius Kabi USA, LLC
Country: Canada
Condition: Low Blood Sugar (Hypoglycemia)
Class: Plasma expanders
Form: Liquid solution, Intravenous (IV)
Ingredients: Poly (O-2-hydroxyethyl) starch, sodium chloride, sodium hydroxide, hydrochloric acid, water for injection, Na +, Cl-

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

About This Medication

What the Medication is Used for

Voluven, a solution for administration into the vein, is used for the treatment of low blood volume (not enough fluid in your blood). 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 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 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.

Approximate concentration of electrolytes per litre: Chloride (Cl-) 154 mmol, Sodium (Na+) 154 mmol.

What Dosage Form it Comes In

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

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 notnto 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.

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

Based on limited studies interactions are not known, however, mixing with other drugs should be avoided.

Proper Use of This Medication

Voluven is administered by intravenous infusion only. The dosage and duration of treatment should be individualized. The physician will determine the appropriate dosing.

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/effect Talk with your doctor or nursing staff Doctor will stop treatment
Only if severe In 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

Use only clear solutions and undamaged containers.

Parenteral drug products should be inspected visually for clarity,particulate matter, precipitate, discoloration and leakage prior toadministration. Solutions showing haziness, particulate matter, precipitate, discoloration or leakage should not be used. Discardunused portion.

Do not use Voluven after expiry date.

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.

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.

  • Online at MedEffect
  • 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 informationabout how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

More Information

  • 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 (http://hc-sc.gc.ca/index-eng.php); the manufacturer’s website (http://www.fresenius-kabi.ca), or by calling 1-877-821-7724 (toll-free-telephone).