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.
The risk of 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 this risk.
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 Vivaglobin subcutaneous?
This medication is used to boost the body's natural defense system against infection in persons with a weakened immune system (primary immune deficiency). Immune globulin contains natural substances called antibodies (a type called IgG) that come from healthy human blood (plasma). These antibodies help protect your body against infections and help you to fight an infection if you get sick.
Read the Patient Information Leaflet provided by your pharmacist before you start using immune globulin and each time you get a refill. If you have any questions, consult your doctor or pharmacist.
This medication is given slowly by injection under the skin (subcutaneous infusion) as directed by your doctor, usually once weekly or every 2 weeks. Do not inject this medication into a blood vessel. Dosage is based on your medical condition, weight, and response to treatment.
If you are giving this medication yourself, learn all preparation and usage instructions for the medication and infusion pump from your health care professional and the product directions. Learn how to store and discard needles and medical supplies safely. If any of the information is unclear, consult your health care professional.
Do not shake the vials. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. Change the location of the injection site(s) with each dose to avoid problem areas under the skin. The recommended sites for injection are the abdomen, thighs, upper arms, and hips.
Patients who are getting immune globulin for the first time, those who are switched from another brand of immune globulin, or those who have not received immune globulin in the past 2 months may be at risk of developing fever, chills, nausea, vomiting, and rarely shock. It is recommended that these patients receive their first dose of this medication in the doctor's office/clinic so they can be monitored for these side effects.
Use this medication regularly to get the most benefit from it. To help you remember, use it on the same day when scheduled (weekly or every 2 weeks). It may help to mark your calendar with a reminder.
See also Warning section.
Mild swelling, redness, or itching at the injection site may occur and usually lessen as your body adjusts to the medication. Headache, upset stomach, fever, nausea, diarrhea, sore throat, cough, or 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: change in the amount of urine, sudden weight gain, fast heartbeat.
Though very unlikely to occur, this product may contain substances such as viruses that could cause infections because it is made from human blood (plasma). Careful screening of blood donors, special manufacturing methods, and tests are all used to reduce this risk. Discuss the benefits and risks of treatment with your doctor. Tell your doctor immediately if you develop any signs of an infection such as: persistent fever, persistent sore throat, unusual tiredness, yellowing eyes/skin, dark urine.
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention 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.
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 using this medication, tell your doctor or pharmacist your medical history, especially of: a certain type of immune system deficiency (selective IgA deficiency with known antibody against IgA).
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.
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.
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.
Do not share this medication with others.
Laboratory and/or medical tests (e.g., IgG levels) should be performed periodically to monitor your progress. 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 immediately to establish a new dosing schedule. Do not double the dose to catch up.
Different brands of this medication have different storage needs. Check the product package for instructions on how to store your brand, or ask your pharmacist. Once a vial is opened, throw away any unused portion immediately. Do not freeze. 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 October 2013. Copyright(c) 2013 First Databank, Inc.
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