Patient Medication Information: uses, side effects, how to take - Immune Serum Globulin (Human)
ABOUT THIS MEDICATION
What the medication is used for:
IMMUNE SERUM GLOBULIN (HUMAN) may be used if you have not had a vaccine for hepatitis A, measles, chickenpox, rubella, or other infections and have been around people who have been sick with these illnesses.
What it does:
IMMUNE SERUM GLOBULIN (HUMAN) provides antibodies to help prevent or lessen the severity of hepatitis A, measles, chickenpox, rubella, or other infections.
When it should not be used:
You should not use this medicine if your body does not make enough immunoglobulin A (IgA), which could cause you to have an allergic reaction to blood products that contain IgA.
You should not be given IMMUNE SERUM GLOBULIN (HUMAN) if you have any bleeding disorder that would make it unsafe for you to be given an injection into the muscles.
What the medicinal ingredient is:
The medicinal ingredient of IMMUNE SERUM GLOBULIN (HUMAN) is 15-18% human immune globulin protein.
What the nonmedicinal ingredients are:
IMMUNE SERUM GLOBULIN (HUMAN) also contains the amino acid glycine (at a concentration of 0.21-0.32 M), which acts as a stabilizer.
What dosage forms it comes in:
IMMUNE SERUM GLOBULIN (HUMAN) comes in 5 mL and 10 mL vials.
WARNINGS AND PRECAUTIONS
Serious Warnings and Precautions
- IMMUNE SERUM GLOBULIN (HUMAN) must be injected into muscles only. It should not be injected directly into blood vessels (intravenously) or under the skin (subcutaneously).
- Products made from human plasma may contain infectious agents such as viruses. However, the manufacturing process of IMMUNE SERUM GLOBULIN (HUMAN) is designed to inactivate and eliminate possible infectious agents. You should discuss the risks and benefits of this product with your healthcare provider.
- Immune Globulin (Human) products have been reported to be associated with heart and blood circulation problems such as heart attack, stroke and blood clots (thrombosis). You should talk to your doctor if you have risk factors for these kinds of conditions. Some of these risk factors include obesity, old age, high blood pressure, diabetes, or a history of heart disease. Thrombosis may occur even in the absence of known risk factor.
BEFORE you use IMMUNE SERUM GLOBULIN (HUMAN) talk to your doctor or pharmacist if:
you are pregnant or breastfeeding
- you have had an allergic reaction to immune globulin or any of the other ingredients in the medicine
INTERACTIONS WITH THIS MEDICATION
IMMUNE SERUM GLOBULIN (HUMAN) may interfere with some vaccines. Talk with your healthcare professional if you will receive any type of vaccine within 6 months of IMMUNE SERUM GLOBULIN (HUMAN) treatment.
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
Your doctor will determine the amount of IMMUNE SERUM GLOBULIN (HUMAN) that is right for you and when your shots should be given. An intramuscular or IM injection is a shot given into a muscle, usually in the buttocks. A doctor, nurse or other caregiver trained to give injections will give your treatment.
Overdose
Although there is no information on the effects of IMMUNE SERUM GLOBULIN (HUMAN) overdose, experience with similar medicines suggests that the only effect would be pain and tenderness at the needle injection site.
Missed Dose
It is important that you receive IMMUNE SERUM GLOBULIN (HUMAN) 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
Pain may occur where the injection is given. Talk with your doctor if the pain is severe.
You should talk with your healthcare professional if you experience rash or hives (swelling, redness, intense itching, and burning). or if you develop swelling of the lips, other parts of the parts of the mouth and throat, eyelids, genitals, hands or feet
Allergic reactions, although rare, have been reported following the injection of human immune globulin. Talk with your doctor immediately if you experience any of these side effects:
- wheezing or trouble breathing
- chest tightness
- severe abdominal cramps
- severe vomiting
- severe diarrhea
This is not a complete list of side effects. For any unexpected effects while taking IMMUNE SERUM GLOBULIN (HUMAN), contact your doctor or pharmacist.
HOW TO STORE IT
IMMUNE SERUM GLOBULIN (HUMAN) should be stored at 2-8°C. It should not be frozen or used past the expiration date.
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 |
| 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. | |
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