Generic Name: immune globulin (human) (i-MUNE GLOB-ue-lin)
Brand Name: Vivaglobin
Vivaglobin may increase the risk of blood clots. The risk may be increased in older patients, if you will be confined to a bed or chair for a period of time, if you take estrogen products, or if you have certain catheters. The risk may also be increased if you have a condition that may increase your risk of blood clots, thick blood, heart problems, or a history of blood clots. Blood clots can occur if you do not have any of these conditions. Tell your doctor right away if you develop one-sided numbness or weakness; pain, redness, tenderness, warmth or swelling in the arms or legs; change in color of an arm or leg; chest pain or discomfort; shortness of breath; fast heartbeat; or coughing up blood. Discuss any questions or concerns with your doctor.
Vivaglobin is used for:
Providing antibodies to help prevent infection in certain patients who have a weakened immune system. It may also be used for other conditions as determined by your doctor.
Vivaglobin is an immune globulin. It works by providing antibodies that fight infection
Do NOT use Vivaglobin if:
- you are allergic to any ingredient in Vivaglobin or to other immune globulin medicines
- you have had a severe allergic reaction (eg, severe rash, hives, difficulty breathing, dizziness) to blood or products that are produced from blood
- you have immunoglobulin A (IgA) deficiency and you have antibodies against IgA
Contact your doctor or health care provider right away if any of these apply to you.
Before using Vivaglobin:
Some medical conditions may interact with Vivaglobin. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have recently received any vaccinations
- if you have heart problems, blood vessel problems (eg, narrowed arteries), thick blood, a blood clotting disorder, or a history of stroke, heart attack, or blood clots
- if you have kidney problems, diabetes, dehydration or low blood volume, a blood infection, abnormal proteins in the blood, or asthma
- if you have been or may be exposed to measles
- if you will be confined to a bed or a chair for a long period of time
Some MEDICINES MAY INTERACT with Vivaglobin. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Medicines that may harm the kidney (eg, aminoglycoside antibiotics [eg, gentamicin], amphotericin B, cyclosporine, nonsteroidal anti-inflammatory drugs [NSAIDs, eg, ibuprofen], tacrolimus, vancomycin) because the risk of kidney side effects may be increased. Ask your doctor if you are unsure if any of your medicines might harm the kidney
- Hydantoins (eg, phenytoin) because unexpected hypersensitivity reactions may occur
- Live vaccines (eg, measles, mumps, and rubella) because their effectiveness may be decreased by Vivaglobin
This may not be a complete list of all interactions that may occur. Ask your health care provider if Vivaglobin may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use Vivaglobin:
Use Vivaglobin as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Vivaglobin is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using Vivaglobin at home, a health care provider will teach you how to use it. Be sure you understand how to use Vivaglobin. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
- Do not use Vivaglobin if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
- Do not shake Vivaglobin.
- Do not mix Vivaglobin with any other medicine.
- Inject Vivaglobin under the skin, NOT into a muscle or vein. Inject into the abdomen, thigh, upper arm, or outer hip. Rotate injection sites with each dose of Vivaglobin.
- Throw away any medicine that is left in the vial after you use a dose of Vivaglobin.
- Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
- If you miss a dose of Vivaglobin, contact your doctor for instructions.
Ask your health care provider any questions you may have about how to use Vivaglobin.
Important safety information:
- Patients who receive Vivaglobin for the first time, who switch from another brand of immune globulin, or who have not received immune globulin therapy within the past 8 weeks may have a risk of developing fever, chills, nausea, or vomiting. Rarely, this may lead to shock. Tell your doctor right away if you experience any of these side effects.
- Aseptic meningitis syndrome (AMS) has been reported to occur rarely in association with immunoglobulin medicines. This syndrome usually begins within several hours to 2 days following treatment. Symptoms include severe headache, neck stiffness, drowsiness, fever, painful eye movements, sensitivity to light, nausea, and vomiting.
- Do not receive a live vaccine (eg, measles, mumps) while you are taking Vivaglobin. Talk with your doctor before you receive any vaccine.
- Vivaglobin is made from human plasma. There is an extremely low risk of developing a viral infection or Creutzfeldt-Jakob disease (CJD) after using Vivaglobin. Discuss any questions or concerns with your doctor.
- Vivaglobin may interfere with certain lab tests. Be sure your doctor and lab personnel know you are using Vivaglobin.
- Lab tests, including antibody levels, may be performed while you use Vivaglobin. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Use Vivaglobin with extreme caution in CHILDREN younger than 2 years old; safety and effectiveness in these children have not been established.
- PREGNANCY and BREAST-FEEDING: It is not known if Vivaglobin can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Vivaglobin while you are pregnant. It is not known if Vivaglobin is found in breast milk. If you are or will be breast-feeding while you use Vivaglobin, check with your doctor. Discuss any possible risks to your baby.
Possible side effects of Vivaglobin:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur:
Cough; diarrhea; headache; nausea; pain, swelling, muscle stiffness, or redness at the injection site; sore throat; weakness.
Severe allergic reactions (rash; itching; hives; difficulty breathing or swallowing; tightness in the chest; swelling of the mouth, hands, face, lips, eyes, throat, or tongue); calf pain or tenderness; chest pain or tightness; confusion; coughing up blood; dark urine; eye pain or sensitivity to light; fainting; fast or irregular heartbeat; fever; numbness of an arm or a leg; one-sided weakness; red, swollen, blistered, or peeling skin; seizures; severe headache, dizziness, or stomach pain; shortness of breath or trouble breathing; speech problems; symptoms of kidney problems (eg, decreased urination, lower back or flank pain, swelling or bloating, sudden weight gain); unusual bruising or bleeding; unusual tiredness or weakness; vision problems; wheezing; yellowing of the skin or eyes.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.Proper storage of Vivaglobin:
Store Vivaglobin in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze. Do not use Vivaglobin if the expiration date on the container has passed. Keep Vivaglobin out of the reach of children and away from pets.
- If you have any questions about Vivaglobin, please talk with your doctor, pharmacist, or other health care provider.
- Vivaglobin is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
- Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take Vivaglobin or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Vivaglobin. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Vivaglobin. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Vivaglobin.
Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.
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