Most WinRho® SDF patients do not experience any drug related adverse effects. Among the few who do, the most commonly reported effects include headache, chills and fever. Rare side effects such as vomiting, nausea, low blood pressure, an increase in your heart beat, joint pain, anemia (decrease in red blood cells), intravascular hemolysis (destruction of red blood cells), back pain, shaking chills, hemoglobinuria (brownish discolouration of urine), and acute renal insufficiency (kidney failure) may also occur. If you experience any of the following symptoms after receiving WinRho® SDF, you should call your doctor immediately:
- back pain,
- discolored or darkened urine,
- decreased urine production,
- jaundice
- swelling,
- shortness of breath.
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | ||||
| Symptom / effect | Talk with your doctor or pharmacist | Stop taking drug and call your doctor or pharmacist | ||
| Only if severe | In all cases | |||
| Common | Discomfort or swelling at injection site, elevation in temperature | √ | ||
| Uncommon | Allergic reaction Back pain, discoloured urine, darkened urine, decreased urine output, jaundice, swelling, shortness of breath |
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This is not a complete list of side effects. For any unexpected effects while taking WinRho® SDF, contact your doctor or pharmacist.
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: cadrmp@hc-sc.gc.ca
Or, by regular mail:
National AR Centre
Marketed Health Products Safety and Effectiveness
Information Division
Marketed Health Products Directorate
Tunney’s Pasture, AL 0701C
Ottawa ON K1A 0K9
NOTE: Before contacting Health Canada, you should contact your physician or pharmacist.
Serious Warnings and Precautions
- WinRho® SDF is made from human plasma, which may contain the causative agents of viral disease. The risk of getting a disease from this product has been reduced by screening plasma donors, testing for the presence of certain viruses and by utilizing manufacturing steps that inactivate and remove certain viruses. However, there is still a possibility that plasma products could transmit disease
- In rare cases WinRho® SDF may cause intravascular hemolysis or its complications. Before using WinRho® SDF, discuss the risks and the benefits with your doctor.
- The liquid formulation of WinRho® SDF contains maltose. Maltose in similar products has been shown to give falsely high blood glucose levels in certain types of blood glucose testing systems.
- Allergic or anaphylactic reactions are rare. These reactions can occur in patients with a history of allergies to blood products or in patients lacking the IgA blood protein.
Please see Consumer Information brochure for more information.
