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Gamastan S/D: Uses, Side Effects and Dosage

Status:
Current status: Cancelled Post Market Facts
Strength:
18 %
Active ingredient:
ATC code:
Similar drugs:

Source: Health Canada – Drug Product Database (DPD) and product monographs · About this document

Patient Medication Information: uses, side effects, how to take - Gamastan S/D

ABOUT THIS MEDICATION

What the medication is used for:

GamaSTAN® S/D 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:

GamaSTAN® S/D 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 GamaSTAN® S/D 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 GamaSTAN® S/D is 15-18% human immune globulin protein.

What the nonmedicinal ingredients are:

GamaSTAN® S/D 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:

GamaSTAN® S/D may be supplied in 2 mL, 5 mL and 10 mL vials.

WARNINGS AND PRECAUTIONS

Serious Warnings and Precautions

  • GamaSTAN® S/D 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 GamaSTAN® S/D 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 GamaSTAN® S/D 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

GamaSTAN® S/D may interfere with some vaccines. Talk with your healthcare professional if you will receive any type of vaccine within 6 months of GamaSTAN® S/D 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 GamaSTAN® S/D that is right for you and when your shots should be given. An intramuscular or IM injection is a shot given into a muscle, IMPORTANT: PLEASE READ

Page 16 of 16 usually the upper arm or thigh, but possibly 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 GamaSTAN® S/D 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 GamaSTAN® S/D 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 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 GamaSTAN® S/D, contact your doctor or pharmacist.

HOW TO STORE IT

GamaSTAN® S/D should be stored at 2-8°C. It should not be frozen or used past the expiration date.

REPORTING SIDE EFFECTS

You can help improve the safe use of health products for Canadians by reporting serious and unexpected side effects to Health Canada. Your report may help to identify new side effects and change the product safety information.

3 ways to report:

  • Online at MedEffect;
  • By calling 1-866-234-2345 (toll-free);

  • By completing a Consumer Side Effect Reporting

    Form and sending it by:

    • Fax to 1-866-678-6789 (toll-free), or

    • Mail to: Canada Vigilance Program Health

      Canada, Postal Locator 1908C Ottawa, ON K1A 0K9

Postage paid labels and the Consumer Side Effect Reporting Form are available at MedEffect.

NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

MORE INFORMATION

Grifols Therapeutics Inc. (Manufacturer)

8368 US 70 Bus. Hwy West

Clayton, NC 27520

Grifols Canada Ltd. (Importer and Distributor) 5060 Spectrum Way, Suite 405

Mississauga, Ontario

L4W 5N5

Last revised:

About this document

Source: Health Canada – Drug Product Database (DPD) and product monographs · DIN (Drug Identification Number): 02230579

Found a mistake? Write to us via the contact page.

The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Gamastan S/D

DIN 02230579
Schedule(s) SCHEDULE D
Active ingredient(s) Immunoglobulin (human) 18 %
Dosage form(s) Solution
Route(s) of administration Intramuscular
Drug class (WHO ATC)
  1. J Antiinfectives for systemic use
    1. J06 Immune sera and immunoglobulins
      1. J06B Immunoglobulins
        1. J06BA Immunoglobulins, normal human
          1. J06BA01 Immunoglobulins, normal human, for extravasc. adm
Company GRIFOLS THERAPEUTICS LLC
Current status Cancelled Post Market
Current status date July 8, 2022

Source: Health Canada – Drug Product Database (DPD) and product monographs, data as of November 1, 2026. Data from the Health Canada Drug Product Database, as published there. Not a substitute for the advice of a doctor or pharmacist.