hep-a-TYE-tis A VAX-een, in-AK-ti-vay-ted, hep-a-TYE-tis B VAX-een re-KOM-bin-ant
Hepatitis A and hepatitis B combination vaccine is used to prevent infection caused by the hepatitis A and hepatitis B virus. The vaccine works by causing your body to produce its own protection (antibodies) against the disease.
Hepatitis A is a serious disease of the liver that can cause death. It is caused by the hepatitis A virus (HAV), and is spread most often through infected food or water. Hepatitis A may also be spread by close person-to-person contact with infected persons (such as between persons living in the same household). Although some infected persons do not appear to be sick, they are still able to spread the virus to others.
Hepatitis A is less common in the U.S. and other areas of the world that have a higher level of sanitation and good water and sewage (waste) systems. However, it is a significant health problem in parts of the world that do not have such systems. If you are traveling to certain countries or remote (out-of-the-way) areas, hepatitis A vaccine will help protect you from hepatitis A disease.
Hepatitis B is caused by hepatitis B virus (HBV), and is spread by contact with body fluids, such as blood, saliva, semen, or vaginal fluids; by needle sticks or sharing needles; or from mother to child.
Hepatitis A and hepatitis B combination vaccine is recommended for all persons 18 years of age or older who are at risk from infection from their jobs or some behaviors, or from traveling to the following parts of the world:
Hepatitis A and Hepatitis B combination vaccine is also recommended for:
This vaccine is to be given only by or under the supervision of a doctor.
In deciding to use a vaccine, the risks of taking the vaccine must be weighed against the good it will do. This is a decision you and your doctor will make. For this vaccine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Appropriate studies have not been performed on the relationship of age to the effects of hepatitis A and hepatitis B combination vaccine in the pediatric population. Safety and efficacy have not been established.
Appropriate studies on the relationship of age to the effects of hepatitis A and hepatitis B combination vaccine have not been performed in the geriatric population. However, no geriatric-specific problems have been documented to date.
|All Trimesters||C||Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.|
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other medical problems
The presence of other medical problems may affect the use of this vaccine. Make sure you tell your doctor if you have any other medical problems, especially:
A nurse or other trained health professional will give you this vaccine. This vaccine is given as a shot into your muscles.
This vaccine is usually given as 3 doses. After the first dose, two more doses are given 1 month and 6 months after the first dose, unless your doctor tells you otherwise.
It is important that you receive all doses at the right time. If you miss your scheduled shot, call your doctor to make another appointment as soon as possible.
It is very important that you return to your doctor's office at the right time for all of the doses. Be sure to notify your doctor of any unwanted effects that occur after you receive this vaccine.
This vaccine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Tell your doctor right away if you have a rash, itching, swelling of the tongue and throat, or trouble breathing after you get the injection.
Tell your doctor if you are allergic to latex. The needle cover and the rubber plunger of the prefilled syringe contains dry natural latex rubber, which may cause an allergic reaction in people with a latex allergy.
This vaccine may not protect you against hepatitis A or hepatitis B infection if you are already infected with the virus at the time you receive the shot.
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor or nurse immediately if any of the following side effects occur:
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.