respiratory syncytial virus immune globulin,human (rsv-igiv)-inj, Respigam
GENERIC NAME: RESPIRATORY SYNCYTIAL VIRUS IMMUNE GLOBULIN,HUMAN (RSV-IGIV)-INJ (res-PIR-a-tor-ee SIN-sish-al VYE-rus i-MUNE-GLOB-ue-lin)
BRAND NAME(S): Respigam
USES: This medication is used in infants who have lung disease (e.g., bronchopulmonary dysplasia) or who were born prematurely. It is used to prevent severe lung infections caused by a certain virus (RSV). This medication is made from healthy human blood that has a high level of certain defensive substances (antibodies). These antibodies help the body to fight infections caused by RSV. Using this medication has been shown to reduce the severity of the RSV infection, thereby reducing the number and length of hospital stays caused by RSV.
HOW TO USE: This medication is given by injection into a vein by a health care professional. Dosage is based on your child's weight, medical condition, and response to treatment.The health care professional will start the medication slowly while monitoring your child closely. If there are few or no side effects, the medication will be given faster.This medication is usually given before the start of the RSV season, then given monthly throughout the RSV season (e.g., November through April, depending on area).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.Your child should receive this medication regularly to get the most benefit from it. To help you remember, mark the days on the calendar when your child needs to receive the medication.
SIDE EFFECTS: Fever, nausea/vomiting, dizziness, flushing, chest tightness, muscle/joint pain, or pain/swelling at the injection site may occur. Tell your child's doctor or pharmacist promptly if any of these effects occur, persist, or worsen. The infusion may need to be stopped or given more slowly.Remember that the doctor has prescribed this medication because he or she has judged that the benefit to your child is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell the doctor right away if you have any serious side effects, including: change in the amount of urine, swelling ankles/feet, sudden weight gain, shortness of breath, fast heartbeat, changes in skin color/temperature.This medication is made from human blood. Even though donors are carefully screened and this medication goes through a special manufacturing process, there is a very small chance that your child may get infections from the medication (e.g., viral infections such as hepatitis). Tell the doctor immediately if your child develops any signs of hepatitis/another infection, including fever, persistent sore throat, unusual tiredness, persistent nausea/vomiting, yellowing eyes/skin, dark urine.Treatment with this medication may rarely cause a serious swelling of the brain (aseptic meningitis syndrome) several hours to 2 days after treatment. Get medical help right away if your child develops severe headache, drowsiness, high fever, eye pain/sensitivity to light, muscle stiffness, or severe 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 the 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.
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PRECAUTIONS: Before receiving RSV-IGIV, tell your child's doctor or pharmacist if he or she is allergic to it; or to other human immunoglobulin preparations; or if he or she has 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 your child receives this medication, tell the doctor or pharmacist his or her medical history, especially of: a certain immune system problem (IgA deficiency), a certain blood problem (paraproteinemia), kidney disease, diabetes, too much/little body water (e.g., swelling of arms/legs, dehydration), a serious blood infection (sepsis), heart disease.Tell the 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 your child has recently received any of these vaccines, the doctor may have your child tested for a response or have your child vaccinated again later. If your child plans on getting any of these vaccines, the doctor will decide on the best time to receive them so your child gets 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.
DRUG INTERACTIONS: Drug interactions may change how your child's medications work or increase your child's risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products your child uses (including prescription/nonprescription drugs and herbal products) and share it with your child's 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. Symptoms of overdose may include: swelling ankles/feet, trouble breathing.
NOTES: Laboratory and/or medical tests (e.g., heart/respiratory rate, kidney function) should be performed periodically to monitor your child's progress or check for side effects. Consult the doctor for more details.
STORAGE: Consult the product instructions and your pharmacist for storage details. 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 March 2013. Copyright(c) 2013 First Databank, Inc.
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