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Details for: OCTALBIN 5%

Company: OCTAPHARMA PHARMAZEUTIKA PRODUKTIONSGES M B H

DIN DIN name Active Ingredient(s) Strength Dosage Form Route of Administration
02302705OCTALBIN 5%ALBUMIN (HUMAN)5 %SOLUTIONINTRAVENOUS
Search Reported Side Effects Report a Side Effect

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

The product is given to patients to restore and maintain circulating blood volume where a deficiency in volume has been demonstrated.

What it does

The main task of albumin is the maintenance of the colloidal osmotic (= oncotic) pressure. This type of pressure arises from the ability of albumin to bind to water. The presence of albumin in the plasma ensures that the liquid remains within the vessels and does not diffuse into the tissue.

Albumin is also a transport protein. It binds substances produced by the body, such as hormones or fatty acids as well as drugs such as penicillin, and transports them around the body.

Albumin also acts as a kind of protein reserve. If the body requires building blocks for the repair of large wounds or in inflammations, albumin can be broken down, and the breakdown products can be used as building blocks for other proteins.

When it should not be used

Octalbin 5% should not be used if you are hypersensitive to albumin preparations or any of the other ingredients of the product

What the medicinal ingredient is

Human albumin from human plasma source

What the non-medicinal ingredients are

Sodium, Potassium, N-acetyl-DL-tryptophan, Caprylic acid, Aluminium, Water for injections

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

What dosage form it comes in

Solution for infusion

Warnings and precautions

Serious Warnings and Precautions

This product is made from human plasma, which may contain infectious agents, such as viruses that cause hepatitis and other viral diseases. Your doctor should discuss the risks and benefits of this product with you before giving you this product.

BEFORE you use Octalbin 5% talk to your doctor or pharmacist:

  • If you are allergic to the active substance or to any of the nonmedicinal ingredients.
Interactions with this medication

No interactions of human albumin with other products are known so far. However, Octalbin 5% solution should not be mixed in the same injection with other drugs, whole blood or packed red cells.

Proper use of this medication

Usual dose

As dosage and treatment duration depend on your clinical situation, your physician will decide on your treatment on an individual basis.

Overdose

If the dosage and rate of infusion are too high, you may develop headache, high blood pressure and discomfort breathing. The infusion should be stopped immediately and your doctor will decide if any other treatment is necessary.

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

Not applicable because Octalbin is administered in a hospital setting by health care professionals.

Side effects and what to do about them
Serious side effects, how often they happen and what to do about them
Symptom / effect Talk with your doctor or pharmacist Only if severe Talk with your doctor or pharmacist In all cases Stop taking drug and talk with your doctor or pharmacist
rare
hypotension    
very rare
headache    
tachycardia    
bradycardia    
hypertension    
flushing    
dyspnoea    
nausea    
urticaria    
angioneurotic edema    
rash      
erythematous hyperhidrosis    
fever    
chills    

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

How to store

Store and transport at +2 °C to +25 °C.
Store in the original container in order to protect from light.
Do not use after expiry date. Do not freeze.
Keep out of the reach of children!

Reporting 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 found at:
http://www.octapharma.ca
or by contacting Octapharma Canada Inc.,
at: 1-888-438-0488

This leaflet was prepared by Octapharma Pharmazeutika
Produktionsges.m.b.H

Last revised: AUGUST 22, 2017.

Date modified: