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

Manufacture: Baxalta
Country: Canada
Condition: Burns, External, Hypoproteinemia, Pancreatitis, Peritonitis, Postoperative Albumin Loss, Shock
Class: Plasma expanders
Form: Liquid solution, Intravenous (IV)
Ingredients: albumin (human), sodium content

BUMINATE 5%

BUMINATE 25%

Albumin (Human), USP

About this Medication

What the medication is used for

BUMINATE is used to used to restore and maintain circulating blood volume, for treating a variety of conditions, including shock, burns, low protein levels, and low albumin levels. It may be used for certain conditions as determined by your doctor.

What it does

BUMINATE works by helping to increase the volume of the blood in the blood vessels.

When it should not be used

BUMINATE should not be used in the following situations

  • if you are allergic to albumin or to any of the ingredients in the product or to any components of the container.
  • if you have heart failure
  • if you have fluid accumulation in your lungs
  • if you have severe and chronic anemia
  • if you have loss of kidney function

What the medicinal ingredient is

Albumin (Human)

What the important nonmedicinal ingredients are:

The sodium content is 145 ± 15 mEq/L.

For a full listing of nonmedicinal ingredients see Part 1 of the product monograph.

What dosage forms it comes in

BUMINATE 5% is supplied in 250 mL and 500 mL bottles containing 12.5 g or 25.0 g of albumin respectively. BUMINATE 25% is supplied in 20 mL, 50 mL, and 100 mL bottles containing 5.0 g, 12.5 g or 25.0 g of albumin, respectively.

Warnings and Precautions

SeriousWarnings and Precautions
Risk of transmitting infectious agents (because BUMINATE 5% and BUMINATE 25% are made from human plasma, a risk of transmitting infectious agents, such as viruses or other agents that can cause infection, cannot be totally excluded.)

Must not be diluted with water for injection (your doctor will use saline or dextrose solutions if it is necessary to dilute BUMINATE 5% or BUMINATE 25%)

BEFORE you use BUMINATE talk to your doctor or pharmacist if:

you have heart failure, fluid accumulation in your lungs, anemia, or kidney problems

you have high blood pressure, abnormally enlarged veins in the lower part of your esophagus, an abnormal tendency to bleed, or swelling of the brain

you have any allergies to albumin or to any of the ingredients in the product or to any components of the container

you are pregnant or breast feeding

Ask your doctor to discuss the risks and benefits of this product before it is administered to you.

Interactionswith this Medication

No interactions are known based upon the absence of data from clinical trials, literature searches, and safety reports; however, BUMINATE should be not mixed with other medication.

Proper Use of this Medication

Usual dose

Albumin is injected into a vein in the arm and is always given under direct supervision of a doctor, usually in a hospital or clinic setting. The dose and the rate at which this albumin is given vary according to the person's individual needs for plasma albumin, and depend on the condition being treated.

Overdose

Fluid overload may occur if the dosage and rate of infusion are too high. This could lead to an increase in weight, swelling in the legs and arms, and/or fluid in the abdomen.

In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Missed Dose

It is important to use this medication exactly as prescribed by your doctor. If you miss an appointment for your treatment, contact your doctor as soon as possible.

Side Effects and what to do about them

Untoward reactions to BUMINATE are extremely rare, although nausea, fever, chills or hives may occasionally occur. Such symptoms usually disappear when the infusion is slowed or stopped for a short period of time. In isolated cases, anaphylactic reactions or shock may occur. In these cases, the infusion should be stopped immediately and an appropriate treatment instituted. If the dose and infusion rate are too high, fluid overload may occur. Signs that this is happening include headache, uncomfortable awareness of your breathing, rapid heartbeat, increased blood pressure or water in the lungs. Your doctor must immediately stop the infusion and check your blood circulation.

This is not a complete list of side effects. For any unexpected effects while taking BUMINATE, contact your doctor or pharmacist.

How to Store it

Store at room temperature, not to exceed 30°C (86°F). Avoid freezing to prevent damage to the bottle.

Reporting Suspected Side Effects

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:

  • Report online at www.healthcanada.gc.ca/medeffect
  • Call toll-free at 1-866-234-2345
  • Complete a Canada Vigilance Reporting Form and:
    • Fax toll-free to 1-866-678-6789, or
    • Mail to: Canada Vigilance Program
      Health Canada
      Postal Locator 0701D
      Ottawa, Ontario
      K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect Canada Web site at www.healthcanada.gc.ca/medeffect.

NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.

More Information

This document plus the full product monograph, prepared for health professionals can be obtained by contacting the sponsor, Baxter Corporation at: 1-800-387-8399.