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GamaSTAN S/D intramuscular

GENERIC NAME(S): IMMUNE GLOBULIN,GAMMA(IGG)

WARNINGS:

This medication may rarely cause serious blood clots (such as pulmonary embolism, stroke, heart attack, deep vein thrombosis). You may be at increased risk for blood clots if you are an older adult, are severely dehydrated, have a catheter in a vein close to your heart for administering medications, or have a history of blood clots, heart/blood vessel disease, heart failure, stroke, or if you are immobile (such as very long plane flights or bedridden). If you use estrogen-containing products, these may also increase your risk. Before using this medication, discuss the risks and benefits and if you have any of these conditions, report them to your doctor or pharmacist.

Being adequately hydrated before and after receiving this medication may help reduce your risk of blood clots.

Get medical help right away if any of these side effects occur: shortness of breath/rapid breathing, chest/jaw/left arm pain, unusual sweating, sudden dizziness/fainting, pain/swelling/warmth in the arm/leg, sudden/severe headache, slurred speech, weakness on one side of the body, sudden vision changes, or confusion.

Who should not take GamaSTAN S/D intramuscular?
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Uses

This medication is used to provide protection (antibodies) against certain virus infections (hepatitis A, measles, chickenpox, rubella) in people who have not been vaccinated or have not had the infection before. It is also used to strengthen the body's natural defense system (immune system) to lower the risk of infection in persons with a certain immune system problem (immunoglobulin deficiency). This medication is made from healthy human blood that has high levels of certain defensive substances (antibodies), which help fight infections. Routine vaccination is usually the best way to protect against infection. Talk with your doctor about a recommended vaccination schedule.

How to use GamaSTAN S/D intramuscular

This medication is injected into a muscle as directed by your doctor. The dosage and schedule of injections depends on your medical condition, weight, and response to treatment. Large doses (more than 10 milliliters) should be divided into 2 or more injections and given at separate injection sites.

This medication is given as soon as possible after you have had contact with (been exposed to) someone with hepatitis A, measles, chicken pox, or rubella. If you wait too long after being exposed, the medication may not be effective. Not everyone who is exposed to these infections should receive immunoglobulin. Discuss the risks and benefits with your doctor.

If you are traveling to an area where hepatitis A is common, this medication may be given along with the hepatitis A vaccine (in a separate injection). This medication will help protect you until your body can make antibodies from the vaccine. If you cannot use the hepatitis A vaccine, you may need to receive more doses of immune globulin if you are staying in the area for a long time (more than 3 months). Do not receive live virus vaccines (e.g., measles) at the same time as immune globulin. (See also Precautions section.) Ask your doctor or pharmacist for more details and a recommended vaccination schedule.

If you are giving this medication to yourself at home, learn all preparation and usage instructions from your health care professional. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. Learn how to store and discard medical supplies safely.

If you are using this medication for an immune system problem, it is usually given every 3 to 4 weeks or as directed by your doctor. Use this medication regularly in order to get the most benefit from it. Keep all your medical/lab appointments.

Side Effects

See also Warning section.

Muscle stiffness, redness, warmth, pain, and tenderness at the injection site may occur. Fever, chills, headache, and joint pain may also occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: unusual tiredness, change in the amount of urine, pink/bloody/frothy urine, sudden weight gain.

Rarely, this product may contain substances that could cause infections because it is made from human blood. Though the risk is very low due to careful screening of blood donors, discuss the risks and benefits with your doctor. Tell your doctor immediately if you develop any signs of infection such as persistent sore throat/fever, yellowing eyes/skin, or dark urine.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

See also Warning section.

Before using this medication, tell your doctor or pharmacist if you are allergic to it; or to other immunoglobulin products (such as IVIG); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: a certain immune system problem (immunoglobulin A deficiency), bleeding/blood clotting problems (such as low platelets, hemophilia), kidney disease.

Tell your doctor of any recent or planned immunizations/vaccinations. This medication may prevent a good response to certain live viral vaccines (such as measles, mumps, rubella, varicella). If you have recently received any of these vaccines, your doctor may have you tested for a response or have you vaccinated again later. If you plan on getting any of these vaccines, your doctor will instruct you about the best time to receive them so you get a good response.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.

Interactions

See also Warning section.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include: drugs that may harm the kidneys (e.g., aminoglycosides such as gentamicin).

Overdose

If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes

Do not share this medication with others.

Laboratory and/or medical tests (e.g., kidney function tests) may be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

Missed Dose

Because this medication provides protection for only a limited time (1 to 3 months), additional doses may be necessary based on the situation. Discuss this with your doctor.

Storage

Store in the refrigerator between 36-46 degrees F (2-8 degrees C). Do not freeze. Discard any unused portion. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Information last revised June 2013. Copyright(c) 2013 First Databank, Inc.

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This medicine is a clear vial.

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Selected from data included with permission and copyrighted by First Databank, Inc. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, expect as may be authorized by the applicable terms of use.

CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.

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