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HAVRIX (Hepatitis A Vaccine) is a sterile suspension of inactivated virus for intramuscular administration. The virus (strain HM175) is propagated in MRC-5 human diploid cells. After removal of the cell culture medium, the cells are lysed to form a suspension. This suspension is purified through ultrafiltration and gel permeation chromatography procedures. Treatment of this lysate with formalin ensures viral inactivation. Viral antigen activity is referenced to a standard using an enzyme linked immunosorbent assay (ELISA), and is therefore expressed in terms of ELISA Units (EL.U.).
Each 1-mL adult dose of vaccine consists of 1440 EL.U. of viral antigen, adsorbed on 0.5 mg of aluminum as aluminum hydroxide.
Each 0.5-mL pediatric dose of vaccine consists of 720 EL.U. of viral antigen, adsorbed onto 0.25 mg of aluminum as aluminum hydroxide.
HAVRIX (hepatitis a vaccine, inactivated) contains the following excipients: Amino acid supplement (0.3% w/v) in a phosphate-buffered saline solution and polysorbate 20 (0.05 mg/mL). From the manufacturing process, HAVRIX (hepatitis a vaccine, inactivated) also contains residual MRC-5 cellular proteins (not more than 5 mcg/mL), formalin (not more than 0.1 mg/mL), and neomycin sulfate (not more than 40 ng/mL), an aminoglycoside antibiotic included in the cell growth media.
HAVRIX (hepatitis a vaccine, inactivated) is formulated without preservatives.
The tip cap and the rubber plunger of the needleless prefilled syringes contain dry natural latex rubber. The vial stopper is latex-free.
What are the possible side effects of hepatitis A vaccine (Havrix, Vaqta)?
You should not receive a booster vaccine if you have ever had a life-threatening allergic reaction after the first shot.
Keep track of any and all side effects you have after receiving this vaccine. When you receive a booster dose, you will need to tell the doctor if the previous shots caused any side effects.
Becoming infected with hepatitis A is much more dangerous to your health than receiving the vaccine to protect against it. Like any medicine, this vaccine can cause side effects, but the risk of serious side...
Read All Potential Side Effects and See Pictures of Havrix »
What are the precautions when taking hepatitis a vaccine, inactivated (Havrix)?
Before getting hepatitis A vaccine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as neomycin, formalin, latex in some vials/prefilled syringes), 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: bleeding problems (such as hemophilia, low platelets, anticoagulant treatment), current illness with fever.
If you have decreased immune function from other medications (see also Drug Interactions) or other illness (such as HIV, leukemia, lymphoma, other cancer), your body may not make enough antibodies to protect you from hepatitis A...
Read All Potential Precautions of Havrix »
Havrix Consumer (continued)
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. Report all side effects to your doctor before you receive the next injection.
Tell your doctor immediately if this rare but serious side effect occurs: seizures.
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.
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 getting hepatitis A vaccine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as neomycin, formalin, latex in some vials/prefilled syringes), 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: bleeding problems (such as hemophilia, low platelets, anticoagulant treatment), current illness with fever.
If you have decreased immune function from other medications (see also Drug Interactions) or other illness (such as HIV, leukemia, lymphoma, other cancer), your body may not make enough antibodies to protect you from hepatitis A infection. Antibody levels should be checked after the vaccine series.
During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.
It is unknown whether this drug passes into breast milk. Consult your doctor before breast-feeding.
Havrix Patient Information Including Side Effects
Brand Names: Havrix, Vaqta
Generic Name: hepatitis A adult vaccine (Pronunciation: HEP a TYE tis)
- What is hepatitis A vaccine (Havrix)?
- What are the possible side effects of hepatitis A vaccine (Havrix)?
- What is the most important information I should know about hepatitis A vaccine (Havrix)?
- What should I discuss with my healthcare provider before receiving this vaccine (Havrix)?
- How is this vaccine given (Havrix)?
- What happens if I miss a dose (Havrix)?
- What happens if I overdose (Havrix)?
- What should I avoid before or after getting this vaccine (Havrix)?
- What other drugs will affect hepatitis A vaccine (Havrix)?
- Where can I get more information?
What is hepatitis A vaccine (Havrix)?
Hepatitis is a serious disease caused by a virus. Hepatitis A is spread through contact with the stool (bowel movements) of a person infected with the hepatitis A virus. This usually occurs by eating food or drinking water that has become contaminated as a result of handling by an infected person.
Hepatitis causes inflammation of the liver, vomiting, and jaundice (yellowing of the skin or eyes). Hepatitis can lead to liver cancer, cirrhosis, or death.
The hepatitis A adult vaccine is used to help prevent this disease in adults. The vaccine works by exposing you to a small amount of the virus, which causes the body to develop immunity to the disease. This vaccine will not treat an active infection that has already developed in the body.
Vaccination with hepatitis A adult vaccine is recommended for all adults who travel in certain areas of the world where hepatitis A is a common disease.
Other risk factors for hepatitis include: being a homosexual male; having chronic liver disease; using intravenous (IV) drugs; receiving treatment for hemophilia or other bleeding disorders; working in a research laboratory or around animals (especially monkeys) where you may be exposed to the hepatitis A virus; or being in an area where there has been an outbreak of hepatitis A.
Like any vaccine, the hepatitis A vaccine may not provide protection from disease in every person.
What are the possible side effects of hepatitis A vaccine (Havrix)?
You should not receive a booster vaccine if you have ever had a life-threatening allergic reaction after the first shot.
Keep track of any and all side effects you have after receiving this vaccine. When you receive a booster dose, you will need to tell the doctor if the previous shots caused any side effects.
Becoming infected with hepatitis A is much more dangerous to your health than receiving the vaccine to protect against it. Like any medicine, this vaccine can cause side effects, but the risk of serious side effects is extremely low.
Call your doctor at once if you have any of these serious side effects:
- high fever;
- fast or uneven heartbeats; or
- behavior changes.
Less serious side effects include:
- low fever;
- headache;
- dizziness, tired feeling;
- nausea, vomiting, stomach pain, diarrhea, loss of appetite;
- joint pain;
- sore throat; or
- swelling, redness, or a hard lump where the shot was given.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report vaccine side effects to the US Department of Health and Human Services at 1-800-822-7967.
What is the most important information I should know about hepatitis A vaccine (Havrix)?
Hepatitis A vaccine will not protect you against infection with hepatitis B, C, and E, or other viruses that affect the liver. It may also not protect you from hepatitis A if you are already infected with the virus, even if you do not yet show symptoms.
You will most likely receive 2 separate injections of the hepatitis A vaccine at 6 months apart, depending on your exposure or risk of infection. Children should receive their first hepatitis A vaccine between 12 months and 23 months of age.
Your individual booster schedule may be different from these guidelines. Follow your doctor's instructions or the schedule recommended by the health department of the state you live in.
Vaccination with hepatitis A adult vaccine is recommended for all adults who travel in certain areas of the world where hepatitis A is a common disease.
Other risk factors for hepatitis include: being a homosexual male; having chronic liver disease; using intravenous (IV) drugs; receiving treatment for hemophilia or other bleeding disorders; working in a research laboratory or around animals (especially monkeys) where you may be exposed to the hepatitis A virus; or being in an area where there has been an outbreak of hepatitis A.
Be sure you receive all recommended doses of this vaccine. If you do not receive the full series of vaccines, you may not be fully protected against the disease.
You can still receive a vaccine if you have a cold or fever. In the case of a more severe illness with a fever or any type of infection, wait until you get better before receiving this vaccine.
You should not receive a booster vaccine if you had a life-threatening allergic reaction after the first shot.
Keep track of any and all side effects you have after receiving this vaccine. When you receive a booster dose, you will need to tell the doctor if the previous shots caused any side effects.
Becoming infected with hepatitis A is much more dangerous to your health than receiving the vaccine to protect against it. Like any medicine, this vaccine can cause side effects, but the risk of serious side effects is extremely low.
- Havrix
- Vaqta
Related Drugs Index:
Havrix, Hepatitis, Vaccine, Inactivated, Buy Havrix