Volulyte - Consumer Medicine Information
|Manufacture:||Fresenius Kabi USA, LLC|
|Condition:||Anaphylactic Shock (Anaphylaxis), Fainting (Syncope), Hypovolemia, Low Blood Sugar (Hypoglycemia)|
|Form:||Liquid solution, Intravenous (IV)|
|Ingredients:||6% hydroxyethyl starch 130/0.4 in an isotonic electrolyte injection, magnesium chloride hexahydrate, potassium chloride, sodium acetate trihydrate, sodium chloride, water for injections|
6% hydroxyethyl starch 130/0.4 in an isotonic electrolyte injection
About This Medication
What the Medication is Used For
Volulyte, a solution for administration into the vein, is used for the treatment of low blood volume (not enough fluid in your blood).
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 toouch 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 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.
Approximate concentration of electrolytes per litre: Sodium (Na+) 137 mmol, Potassium (K+) 4 mmol, Magnesium (Mg++) 1.5 mmol, Chloride (Cl-) 110 mmol, and acetate (CH3COO-) 34 mmol.
What Dosage Form it Comes In
Solution for infusion. 6% hydroxyethyl starch 130/0.4 in an isotonic electrolyte injection is supplied in 250 ml and 500 ml plastic bags for intravenous infusion.
Warnings and Precautions
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.
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
Volulyte in the same intravenous line with other drugs should be avoided.
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 administered by intravenous infusion only. The dosage and duration of treatment should be individualized. The physician will determine the appropriate dosing.
|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
- 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.
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 Volulyte, 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 to administration. Solutions showing haziness, particulate matter, precipitate, discoloration or leakage should not be used. Discard unused portion.
Do not use Volulyte after expiry date. 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.
3 ways to report:
- 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
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 Volulyte
- 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).
Fresenius Kabi Canada Ltd.45 Vogell Rd., Suite 200
Richmond Hill, ON L4B 3P6