This medication may cause serious (rarely fatal) kidney problems. This risk is higher if you have kidney problems, diabetes, a serious blood infection (sepsis), a certain blood problem (paraproteinemia), or a severe loss of body fluids (dehydration), as well as if you are older than 65 years or are using other drugs that may harm the kidneys (such as gentamicin).
This medication may also 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. The risk of kidney problems and blood clots may be decreased by infusing this medication more slowly or by using a less concentrated form of this medication if available. Being adequately hydrated before receiving this medication may also help reduce these risks.
Get medical help right away if any of these side effects occur: sudden weight gain, swelling of the hands/ankles/feet, a change in the amount of urine, 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 Gammaked Vial?
This medication is used in people with a certain type of weakened immune system (primary immune deficiency) to strengthen it and to lower the risk of infection. This medication is made from human blood that has a high level of antibodies which help fight infections.
This product is also used to increase the number of certain blood cells (platelets) in people with a certain blood disorder (idiopathic thrombocytopenic purpura-ITP). Platelets are needed to stop bleeding and to form normal blood clots.
In addition, this medication is used to treat a certain nerve disorder (chronic inflammatory demyelinating polyneuropathy-CIDP). This disorder causes weakness and numbness/tingling/pain in the arms and legs. This medication helps to improve these symptoms and prevents relapse.
If you have primary immune deficiency and respond well to this medication, your doctor may allow you to give this treatment at home. In this case, give this medication by infusion under the skin as directed by your doctor, usually once a week.
Before using at home, learn all preparation and usage instructions for this medication and the infusion pump from the Patient Information Leaflet and your health care professional. Let the medication vials come to room temperature before preparing the infusion. Do not shake the vials. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. Clean the infusion site(s) with an alcohol wipe. Change the site(s) each time to lessen injury under the skin. Learn how to store and discard medical supplies safely. If you have any questions, ask your health care professional.
It is important to receive this medication regularly to get the most benefit from it. It may help to mark your calendar with a reminder. Keep all your medical and lab appointments.
See also Warning section.
Headache, dizziness, fever, chills, back/joint pain, nausea, vomiting, cough, or pain/redness/swelling at the injection site may occur. If any of these effects persist or worsen, tell your doctor or health care professional 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: fast heartbeat, unusual tiredness.
Treatment with this medication may rarely cause a serious inflammation of the brain (aseptic meningitis syndrome) several hours to 2 days after your treatment. Get medical help right away if you develop severe headache, stiff neck, drowsiness, fever, sensitivity to light, eye pain, or nausea/vomiting.
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 or at www.fda.gov/medwatch.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
See also Warning section.
Before using this medication, tell your doctor or pharmacist if you are allergic to it; or to other immune globulin products; 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 having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
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. Also tell your doctor if you plan to travel to areas that have a measles outbreak or if you have been exposed to measles.
This medication is made from human blood. Even though the blood is carefully tested, and this medication goes through a special manufacturing process, there is an extremely small chance that you may get infections from the medication (for example, viruses such as hepatitis). Consult your doctor or pharmacist for more information.
Children may be more sensitive to the side effects of this medication, especially fever and vomiting.
Older adults may be more sensitive to the side effects of the drug, especially kidney problems.
During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.
See also Warning and Precautions sections.
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.
This medication may interfere with certain laboratory tests (including blood type), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this medication.
If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
Laboratory and/or medical tests (such as complete blood counts, blood tests, immunoglobulin levels, kidney/liver function tests, urine volume) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.
For the best possible benefit, it is important to receive each scheduled dose of this medication as directed. If you miss a dose, contact your doctor or pharmacist right away to establish a new dosing schedule.
If you are giving this medication at home, store it in the refrigerator. Do not freeze. Refer to the manufacturer's instructions or your pharmacist for other storage details. Discard any unused portion of an opened vial. 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 July 2016. Copyright(c) 2016 First Databank, Inc.
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