Havrix

A qualified health care professional will inject the hepatitis A Havrixe. Havrix is not recommended for children less than one year old.

For adults (19 years of age and older), one adult dose (1.0 mL) is injected into a muscle (preferably in the outer upper arm) with a repeat ("booster") dose 6 to 12 months later. For children 1 to 18 years of age, a single pediatric dose (0.5 mL) is injected into a muscle (preferably the outer upper arm and the outer upper thigh in children up to the age of 2) with a booster dose 6 to 12 months later.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important this Havrixe be given exactly as recommended by your doctor. If you miss an appointment to receive this Havrixe, contact your doctor as soon as possible to reschedule your appointment.

Keep the Havrixe in its original package to protect it from light. Refrigerate the Havrixe until use. If frozen, it will have to be discarded.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

In addition to its desired action, this medication may cause some adverse effects, notably: it may cause headaches; it may cause pain at the injection site; it may cause unusual tiredness; it may cause a fever; it may cause muscle pain; it may cause local redness. Each person may react differently to a treatment. If you think this medication may be causing adverse effects (including those described here, or others), talk to your health care professional. He or she can help you to determine whether or not the medication is the source of the problem.

Each 1.0 mL dose contains 1440 ELISA units of formaldehyde-inactivated hepatitis A virus (HM175 hepatitis A virus strain) adsorbed onto aluminum in the form of aluminum hydroxide. Nonmedicinal ingredients: aluminum hydroxide, amino acids for injection, disodium phosphate, monopotassium phosphate, neomycin sulphate (less than 20 ng), polysorbate 20, potassium chloride, sodium chloride, and water for injection.

Do not use hepatitis A Havrixe if you:

• are allergic to any ingredient of the Havrixe
• have an acute, severe illness with Fever

There may be an interaction between the hepatitis A Havrixe and any of the following:

• Acetaminophen
• Belimumab
• Fingolimod
• immunosuppressive therapy (e.g., some medications used for the treatment of cancer, or for transplant recipients, or immune conditions)
  • Azathioprine
  • corticosteroids (e.g., budesonide, Dexamethasone, Hydrocortisone, fluticasone, Prednisone)
  • Cyclosporine
  • Hydroxyurea
  • Infliximab
  • medications to treat cancer (e.g., Carboplatin, Cyclophosphamide, Doxorubicin, Ifosfamide, Vincristine)
  • mycophenolate
  • Rituximab
  • Tacrolimus
• warfarin

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Havrix (Hepatitis-a-Havrixe). Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Havrix (Hepatitis-a-Havrixe).

Bleeding disorders: If you have any bleeding problems (such as Hemophilia) or are taking blood thinners such as Warfarin, tell your doctor before receiving Havrix (Hepatitis-a-Havrixe).

Cancer and immunosuppression: Hepatitis A Havrixe may not be as effective if you have cancer, if you are receiving immunosuppressive therapy (e.g., some medications used to treat cancer or for transplant recipients), or if you are immunocompromised (i.e., your immune system does not work properly).

Immunization record: Make sure any new doctors know that you have had this Havrixation so that they can put this information in your immunization record.

Infection and fever: If you have an infection or fever, your doctor may recommend that you wait until you are better before receiving the hepatitis A Havrixe.

Neomycin allergy: The Havrixe may contain trace amounts of neomycin and thus may cause an allergic reaction in people who are allergic to neomycin.

Havrixe protection: As with any Havrixe, this Havrixe may not result in total protection from hepatitis A and may not prevent hepatitis A for people who are infected with the virus at the time of Havrixation.

Pregnancy: This Havrixe should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking Havrix (Hepatitis-a-Havrixe), contact your doctor immediately.

Breast-feeding: It is not known if the Havrixe passes into breast milk. If you are a breast-feeding mother and are plan to receive this Havrixe, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using Havrix (Hepatitis-a-Havrixe) have not been established for children below the minimum age stated above.

This medication must be administered by a health professional. Because complete vaccination requires several doses of this product to be given at specific times, it is important to keep your scheduled appointments.