Details for: VOLULYTE
Company: FRESENIUS KABI CANADA LTD
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02357291 | VOLULYTE | HYDROXYETHYL STARCH 130/0.4 | 6 % | SOLUTION | INTRAVENOUS |
Summary Reports
Summary Safety Review - Hydroxyethyl starch (voluven and volulyte) - Assessing the Potential Risk of Acute Kidney Injury in Non-Critically Ill Patients
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
VOLULYTE® is a plasma volume substitute that is used in adults to restore the 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. VOLULYTE® is not a substitute for red blood cells or clotting factors in plasma.
What it does
VOLULYTE® belongs to a group of medicines known as plasma volume expanders. VOLULYTE® works for several hours by increasing the volume of circulating blood.
When it should not be used
Your doctor will not administer VOLULYTE® 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 potassium, 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 an isotonic electrolyte injection.
What the non-medicinal ingredients are
Magnesium chloride hexahydrate, Potassium chloride, Sodium acetate trihydrate, 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 an isotonic electrolyte injection supplied in 250 ml and 500 ml plastic bags
Warnings and precautions
Serious Warnings and Precautions
The use of hydroxyethyl starch (HES) products, including
VOLULYTE in critically ill patients, including patients with
sepsis increases the risk of death and for renal (kidney)
replacement therapy.
HES products, including VOLULYTE should not be
given in critically ill patients, including patients with
sepsis.
BEFORE VOLULYTE® 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 will be particularly careful if you have elevated levels of potassium, sodium, magnesium, or chloride in your blood. 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 VOLULYTE® may occur.
- Tell your doctor about any unusual symptoms that you develop.
Use in Pregnancy
VOLULYTE® should be used during pregnancy only if the
potential benefit justifies the potential risk to the fetus.
Nursing Women
It is not known whether VOLULYTE® is excreted in human milk.
Because many drugs are excreted in human milk, caution should
be exercised when VOLULYTE
® 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
VOLULYTE® by taking into account the benefit of breast-feeding
to the child and the benefit of VOLULYTE
® therapy to the nursing
mother.
Interactions with this medication
It is not known if VOLUVEN interacts with other medications.
Some medicinal products can cause potassium or sodium retention
when taken at the same time as VOLULYTE®. Tell your doctor all
the medications you are taking including prescription, non-prescription and natural health products.
Proper use of this medication
VOLULYTE® 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 VOLULYTE.
It is given by injection into your vein as an infusion (intravenous
infusion).
Overdose
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 VOLULYTE® and can interfere with the diagnosis of inflammation of the pancreas (pancreatitis); however, VOLULYTE® does not cause pancreatitis.
| Symptom / effect | Talk to your healthcare professional Only if severe | Talk to your healthcare professional In all cases | Doctor will stop treatment |
|---|---|---|---|
| Rare | |||
| Allergic reactions with symptoms such as mild flu- like symptoms; i.e. 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 VOLULYTE® , contact your doctor or nursing staff
How to store
VOLULYTE is stored by your healthcare professional.
Store: freeflex®
bag at 15 °C – 25 °C
The product should be used immediately after opening. Do not
freeze.
Do not use VOLULYTE® after expiry date.
Reporting side effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
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.
More information
- Talk to your doctor or pharmacist.
- Find the full Product Monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website; the manufacturer’s website (http://www.fresenius-kabi.ca), or by calling 1-877-821-7724 (toll-free-telephone).
Fresenius Kabi Canada Ltd.
165 Galaxy Blvd, Suite 100
Toronto, ON, M9W 0C8
Last revised: February 17, 2020
Volulyte and freeflex are registered trademarks of Fresenius
Kabi
AG.