Patient Medication Information: uses, side effects, how to take - Thrombate III
ABOUT THIS MEDICATION
What the medication is used for:
Hereditary antithrombin III deficiency is a genetic disease which leads to low levels of antithrombin III protein in the blood. Without enough antithrombin III in the blood, abnormal blood clots may form, which may damage organs.
THROMBATE III® is used for patients with hereditary antithrombin III deficiency when they have surgery, are pregnant or in labour, or have a blood clot.
What it does:
THROMBATE III® replaces some of the antithrombin III protein missing from patients with hereditary antithrombin III deficiency.
When it should not be used:
You should not be given THROMBATE III® if you have had an allergic reaction to a previous antithrombin III injection, or to any of the other ingredients in the medicine.
What the medicinal ingredient is:
THROMBATE III® contains human antithrombin III protein.
What the nonmedicinal ingredients are:
THROMBATE III® also contains sodium, chloride, the amino acid alanine, and heparin. It does not contain any preservative.
What dosage forms it comes in:
THROMBATE III® comes in 500 IU single dose vials.
THROMBATE III® 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 THROMBATE III® are specifically designed with the ability to destroy or remove these agents if they are present. You should discuss the risks and benefits of this product with your healthcare provider.
BEFORE you use THROMBATE III® talk to your doctor or pharmacist if:
- you are pregnant or breastfeeding
- you have had an allergic reaction to antithrombin III or any of the other ingredients in the medicine
INTERACTIONS WITH THIS MEDICATION
THROMBATE III® increases the effects of heparin. Talk with your healthcare professional if you are currently receiving heparin.
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
The exact amount and timing of doses varies for each patient. Your doctor will determine the amount of THROMBATE III® that is right for you and when your treatments are to be scheduled. A doctor, nurse or other caregiver trained to give injections will give your treatment.
Missed Dose
It is important that you receive THROMBATE III® as instructed by your healthcare professional. If your doctor tells you that more than one treatment is required, you should consult him/her if a treatment appointment is missed.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
In clinical studies with patients using THROMBATE III®, the most common side effects were abdominal cramps, bowel fullness, bruising and swelling, chest pain, chest tightness, chills, dizziness, fever, film over eye(s), foul taste, hives, shortness of breath, light-headedness, and nausea.
Contact your doctor immediately if, while undergoing THROMBATE III® treatment or following treatment, you experience any of these side effects:
- chills or fever
- chest tightness
- chest pain
- hives
- shortness of breath
- severe abdominal cramps
- severe dizziness or light-headedness
- severe nausea
This is not a complete list of side effects. For any unexpected effects while taking THROMBATE III®, contact your doctor or pharmacist.
HOW TO STORE IT
THROMBATE III® should be stored at temperatures not to exceed 25°C. It should not be frozen or used past the expiration date.
REPORTING SUSPECTED 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 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 the distributor, Grifols Canada Ltd., at: 1-866-482-5226
Grifols Therapeutics Inc. (Manufacturer) 8368 US 70 Bus. Hwy West Clayton, NC 27520
Grifols Canada Ltd. (Distributor and Importer) 5060 Spectrum Way, Suite 405
Mississauga, Ontario L4W 5N5