Consumer Information for: PLASBUMIN-25
Consumer Information
Information about the product including what the product is used for, dosage, warnings, proper use and side effects. This summary will not tell you everything about the product. Contact your healthcare professional if you have any questions about the product.
What the medication is used for
Albumin is a protein manufactured by the liver. It is most abundant in human plasma. Normally it constitutes about 55% of all plasma proteins. Albumin has multiple functions, including transport of many small molecules in the blood, such as bilirubin, calcium, and magnesium. Albumin also binds to toxins and heavy metals, thereby preventing damage they might otherwise cause to your body. One of albumin's major roles is in the maintenance of "osmotic or oncotic pressure" that causes fluid to remain within the blood stream instead of leaking out into the tissues.
Possible causes of a decrease in the level of albumin in the blood include liver or kidney disease or increased loss of albumin from circulation (e.g., due to shock). A diseased liver produces less albumin. In kidney disease, albumin can escape into the urine in large amounts. Severe malnutrition or a very low protein diet can also reduce the albumin level.
If the concentration of albumin gets very low, fluid moves from the blood vessels into the tissues, resulting in swelling in the ankles (edema). This fluid can also accumulate in the abdomen (ascites) and in the lungs (pulmonary edema).
What it does
PLASBUMIN®-25 given by intravenous administration can help restore the fluid balance and help improve the problems that led to the low albumin level.
When it should not be used
You should not use PLASBUMIN®-25 if you are allergic to albumin or to any ingredient in the formulation or component of the container.
You should not use PLASBUMIN®-25 if you have a history of the following conditions:
- congestive heart failure (the heart does not pump enough blood to the other organs)
- renal insufficiency (a loss of kidney function)
- stabilized chronic anemia (a decrease in the ability of red blood cells to carry oxygen for a prolonged period)
See also SIDE EFFECTS AND WHAT TO DO ABOUT THEM.
What the medicinal ingredient is
PLASBUMIN®-25 contains human albumin (at a concentration of 25%).
What the non-medicinal ingredients are
PLASBUMIN®-25 also contains sodium caprylate (at a concentration of 0.08 mmol/g albumin), acetyltryptophan (at a concentration of 0.08 mmol/g albumin), which act as stabilizers.
What dosage form it comes in
PLASBUMIN®-25 comes in 100 mL vials (with rubber stoppers).
Warnings and precautions
PLASBUMIN®-25 like other products made from human plasma, part of our blood, may contain viruses or other agents that can cause infection and illness. However, the processes used to make PLASBUMIN®-25 are specifically designed with the ability to reduce these agents if they are present. You should discuss the risks and benefits of this product with your healthcare provider.
BEFORE you use PLASBUMIN®-25 talk to your doctor or pharmacist if:
- you are pregnant or breastfeeding
- you have had an allergic reaction to immune globulin or any of the other ingredients in the medicine
- you have had a history of congestive heart failure, renal insufficiency, or stabilized chronic anemia
Interactions with this medication
PLASBUMIN®-25 should not be mixed with protein hydrolysates, amino acid solutions or solutions containing alcohol. PLASBUMIN®-25 should not be mixed with whole blood, packed red cells, and other medicinal products.
See also ABOUT THIS MEDICATION: When it should not be used, and SIDE EFFECTS AND WHAT TO DO ABOUT THEM.
Proper use of this medication
Usual dose
Your doctor will determine the amount of PLASBUMIN®-25 that is right for you and when your treatments should be given. A doctor, nurse or other caregiver trained to give injections will give you your treatment.
Overdose
If you or your healthcare professional suspects that you have received an overdose of PLASBUMIN®-25, additional supportive treatment may be required.
Missed Dose
It is important that you receive PLASBUMIN®-25 as instructed by your healthcare professional. You should consult him/her if a treatment appointment is missed.
Side effects and what to do about them
Side effects following PLASBUMIN®-25 treatment are rare; however, high plasma protein levels may cause allergic reactions. Talk with your doctor immediately and stop your treatment if you experience any of these side effects:
- wheezing or trouble breathing
- chest tightness
- severe abdominal cramps
- severe vomiting
- severe diarrhea
- rash or hives (swelling, redness, intense itching, and burning)
- swelling of the lips, other parts of the mouth and throat, eyelids, genitals, hands or feet
This is not a complete list of side effects. For any unexpected effects while taking PLASBUMIN®-25, contact your doctor or pharmacist.
How to store
PLASBUMIN®-25 should be stored at room temperature not exceeding 30°C (86°F). It should not be frozen or used past the expiration date. The product should be used within 4 hours after the container has been entered.
Reporting side effects
| To monitor drug safety, Health Canada through the Canada Vigilance Program collects information on serious and unexpected side effects of drugs. If you suspect you have had a serious or unexpected reaction to this drug you may notify Canada Vigilance: | |||
| By toll-free telephone: | 866-234-2345 | ||
| By toll-free fax: | 866-678-6789 | ||
| Online: | www.healthcanada.gc.ca/medeffect | ||
| By email: | CanadaVigilance@hc-sc.gc.ca | ||
| By regular mail: | Canada Vigilance National Office Marketed Health Products Safety and Effectiveness Information Bureau Marketed Health Products Directorate Health Products and Food Branch Health Canada Tunney’s Pasture, AL 0701C Ottawa ON K1A 0K9 |
||
| NOTE: Should you require information related to the management of the side effect, please contact your health care provider before notifying Canada Vigilance. 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 Grifols Canada Ltd., at 1-866-482-5226.
This leaflet was prepared by:
Grifols Therapeutics Inc. (Manufacturer)
8368 US 70 Bus. Hwy West
Clayton, NC 27520
Grifols Canada Ltd. (Importer and Distributor)
5060 Spectrum Way, Suite 405
Mississauga, Ontario
L4W 5N5
Last revised: [to be determined]
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