Immunine VH - Consumer Medicine Information
|Class:||Miscellaneous coagulation modifiers|
|Form:||Liquid solution, Intravenous (IV)|
|Ingredients:||freeze dried Factor IX, Factor II, VII and X (<0.02 IU / 1 IU factor IX), Tween 80, Sodium Chloride, Sodium Citrate and Sterile Water for Injection|
(Factor IX Concentrate (Human), Vapor Heated, IMMUNO)
About this medication
What the medication is used for
IMMUNINE VH is a Factor IX protein used for therapeutic and prophylactic (preventative) use in patients suffering from congenital (haemophilia B) or acquired factor IX deficiency.
What it does
IMMUNINE VH is administered by intravenous (IV) therapy and provides an increase in plasma levels of factor IX. IMMUNINE VH can temporarily correct the coagulation defect of patients with factor IX deficiency and therefore stop the bleeding episodes.
When it should not be used
IMMUNINE VH should not be used if:
- You suffer from DIC and/or hyperfibrinolysis; or
- You have a known allergy to heparin or history of heparin induced thrombocytopenia; or
- If you experience hypersensitive reactions occurs during administration of IMMUNINE VH; or
- You are pregnant or nursing mothers (only use if clearly needed); or
- You have had a recent myocardial infarction, stroke or thromboembolic events.
What the medicinal ingredient is
IMMUNINE VH contains freeze dried Factor IX concentrate of high purity containing traces of Factors II, VII and X (<0.02 IU / 1 IU factor IX).
What the important nonmedicinal ingredients are
Factor II, VII and X (<0.02 IU / 1 IU factor IX), Tween 80, Sodium Chloride, Sodium Citrate and Sterile Water for Injection.
For a full listing of nonmedicinal ingredients see Part 1 of the product monograph.
What dosage forms it comes in
IMMUNINE VH is a sterile freeze dried powder and supplied in a single dose vial accompanied by a vial of Sterile Water for Injection, EP as diluent, a sterile transfer needle, and a sterile filter needle. It is available in the following package sizes:
|Sterile Water for Injection EP|
|480 to 720||5|
The number of IU Factor IX is stated on the label of each vial.
Warnings and precautions
Because IMMUNINE VH is made from human plasma, a risk of transmitting infectious agents cannot be totally excluded. This also applies to unknown or emerging viruses and other pathogens.
The use of IMMUNINE VH may lead to hypersensitivity reactions. Hypersensitivity reactions refer to undesirable reactions produced by the normal immune system such as allergies. At first signs or symptoms of hypersensitivity reactions, IMMUNINE VH treatment should be stopped and medical care should be started as appropriate.
Your body may form inhibitors to factor IX. An inhibitor is an antibody (part of your body’s normal immune defenses) that forms in response to infusions of factor IX that prevents the factor IX from working properly. These inhibitors can lead to a reduced response or to no response to factor IX therapy. Consult with your healthcare provider to make sure you are carefully monitored with blood tests for the development of inhibitors.
The use of factor IX may lead to the development of blood clots in your veins. This is particularly dangerous if you have disseminated intravascular coagulation (DIC) or fibrinolysis. If you have DIC or are at risk of DIC, please discuss with your doctor whether the use of IMMUNINE VH is right for you.
BEFORE you use IMMUNINE VH talk to your doctor or pharmacist if:
- You have known allergies to this drug, to heparin, or to any ingredient in the formulation or component of the product
- You have thromboembolism, DIC, or fibrinolysis
- You are pregnant or may be pregnant
- You are a nursing mother
Interactions with this medication
No interactions with other drugs are currently known. IMMUNINE VH should not be mixed with other drugs.
Proper use of this medication
The dose of the treatment depends on the severity of factor IX deficiency, the location and extent of the bleeding, and the patient’s clinical condition. The treatment should be carried out by a doctor who is familiar with the treatment of haemophilia.
Overdosage may increase your risk of myocardial infarction, DIC, venous thrombosis, and pulmonary embolism.
IMMUNINE VH, should not be administered at a rate exceeding mL/min.
|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.|
Side effects and what to do about them
- Although rare, severe allergic reactions may occur.
- If you develop fever, skin rashes, nausea, retching, shortness of breath, a drop in blood pressure or shock you should stop the use of IMMUNINE VH and contact your doctor or visit the Emergency Department immediately.
- Mild allergic reactions may be managed with antihistamine.
The following side effects have been reported:
- Allergic reaction
- Myocardial Infarction, Tychycardia
- Shortness of Breath
- Skin rashes
This is not a complete list of side effects. For any unexpected effects while taking IMMUNINE VH, contact your doctor or pharmacist.
How to store it
IMMUNINE VH should be stored in the refrigerator at a temperature between 2°C and 8°C.
IMMUNINE VH may be temporarily stored at room temperature (up to +25°C) for a period of up to 3 months. Record the period of storage at room temperature below the expiration date indicated on the package label. Dispose of the product if stored at room temperature for three months or longer.
IMMUNINE VH must not be used beyond the expiration date indicated on each pack.
The reconstituted solution contains no preservatives and should be used immediately after preparation. Dispose of any unused portion. Do not refrigerate any unused portion.
Reporting suspected side effects
To monitor drug safety, Health Canada collects information on serious and unexpected effects of drugs. If you suspect you have had a serious or unexpected reaction to this drug you may notify Health Canada by:
toll-free telephone: 866-234-2345
toll-free fax 866-678-6789
By email: email@example.com
By regular mail:
National AR Centre Marketed Health Products Safety and Effectiveness
Marketed Health Products Directorate
Tunney’s Pasture, AL 0701E
Ottawa ON K1A 0K9
NOTE: Before contacting Health Canada, you should contact your physician or pharmacist.
This document plus the full product monograph, prepared for health professionals can be found at:
http://www.baxter.com or by contacting the sponsor, Baxter Corporation at: 1-800-387-8399.