GENERIC NAME: HAEMOPHILUS B/HEPATITIS B VACCINE - INJECTION (HEE-moe-FIL-us/HEP-a-TYE-tis vak-SEEN)
BRAND NAME(S): Comvax
USES: This medication is used in infants to help prevent infection from a certain bacteria (Haemophilus influenzae type b) and the hepatitis B virus. Haemophilus influenzae b bacteria can cause a serious, sometimes fatal brain infection (meningitis) and lung infection (pneumonia). Hepatitis B infection can cause serious problems including liver failure, persistent hepatitis B infection, cirrhosis, and liver cancer. Protecting against these infections can prevent these problems.This vaccine contains killed Haemophilus bacteria and a man-made piece of the hepatitis B virus. It does not contain live virus, so your infant cannot get either of these infections from the vaccine. This vaccine causes the body to make immune defensive substances (antibodies) that can protect you from these infections.This vaccine is recommended for all infants 6 weeks to 15 months old who are born to mothers who do not have current hepatitis B infection.This vaccine is not for use in adults.
HOW TO USE: Read the Vaccine Information Statement available from your health care provider before receiving the vaccine. If you have any questions, consult your health care provider.This vaccine is usually given by injection into a muscle by a health care professional.A series of 3 injections is usually used when the infant is aged 2 months, 4 months, and 12 to 15 months. Your doctor will give you a vaccination schedule, which must be followed closely for best effectiveness. If your infant has an infection with fever at the time a vaccination is scheduled, your doctor may choose to delay the injection until he/she is better.If your infant is exposed to hepatitis B at birth, a different vaccine and other treatments should be used. Consult your doctor for more information.
SIDE EFFECTS: Pain/redness/swelling at the injection site, fever, irritability, increased crying, loss of appetite, and increased sleeping may occur. Less common side effects may include bruising at the injection site, vomiting, runny nose, stuffy nose, cold symptoms, cough, and diarrhea. If any of these effects persist or worsen, tell your infant's doctor or pharmacist promptly.Infrequently, temporary symptoms such as fainting/dizziness/lightheadedness, vision changes, numbness/tingling, or seizure-like movements have happened after vaccine injections. Tell your health care provider right away if your child has any of these symptoms soon after receiving an injection. Sitting or lying down may relieve symptoms.Remember that your child's doctor has prescribed this medication because he or she has judged that the benefit to your infant is greater than the risk of side effects. Many infants using this medication do not have serious side effects. Report all side effects to the doctor before your infant receives the next injection.Tell your infant's doctor immediately if any of these unlikely but serious side effects occur: unusually fast/irregular heartbeat.Tell your infant's doctor immediately if any of these rare but very serious side effects occur: inability to make muscles of the legs/arms/face work (paralysis), seizures, easy bruising/bleeding, mental/mood changes (e.g., unusual behavior, severe drowsiness, stiff neck, closing eyes/turning away from bright light).A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice your infant having any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), 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.Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US, you may report side effects to the Vaccine Adverse Event Reporting System (VAERS) at 1-800-822-7967. In Canada, you may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Before using this medication, tell the doctor or pharmacist if your child is allergic to it; or to yeast or latex; or if your child 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 the doctor or pharmacist your infant's medical history, especially of: bleeding problems (e.g., hemophilia, low platelets, anticoagulant treatment), current illness with fever.If your child has decreased immune function from other medications (see also Drug Interactions) or other illness (e.g., HIV, leukemia, lymphoma, other cancer), the child's body may not make enough antibodies to protect them from Haemophilus influenza b or hepatitis B infection. Antibody levels should be checked after the vaccine series.
DRUG INTERACTIONS: Your infant's doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring your child for them. Do not start, stop, or change the dosage of any of your child's medicines before checking with your doctor or pharmacist first.Before your infant receives this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products your child may use, especially of medications that can decrease immune function: corticosteroids (e.g., prednisone), cancer chemotherapy, organ transplant drugs (e.g., cyclosporine, tacrolimus).If your infant is currently receiving any of these medications listed above, tell your infant's doctor or pharmacist before starting the Haemophilus influenzae b/hepatitis B vaccine series.Other vaccines may be given at the same time as this vaccine, but should be given with separate syringes and at different injection sites.Certain lab tests that use a certain lab method (latex agglutination) may be affected by this medication for at least 30 days after the injection, possibly causing false test results. Make sure that all of your infant's doctors and laboratory personnel know that your infant has received this vaccine.This document does not contain all possible interactions. Therefore, before using this product, tell the doctor or pharmacist of all the products your infant uses. Keep a list of all infant's medications with you, and share the list with your doctor and pharmacist.
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: Laboratory and/or medical tests (e.g., hepatitis B antibody levels) may be performed periodically for some patients at risk of a poor response to the vaccine. Consult your child's doctor for more details.
Information last revised March 2013. Copyright(c) 2013 First Databank, Inc.
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