Details for: OCTALBIN 5%
Company: OCTAPHARMA PHARMAZEUTIKA PRODUKTIONSGES M B H
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02302705 | OCTALBIN 5% | ALBUMIN (HUMAN) | 5 % | SOLUTION | INTRAVENOUS |
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.
Missed Dose
Not applicable because Octalbin is administered in a hospital setting by health care professionals.
Side effects 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.