Hepatitis Fact Sheet

HEPATITIS - Hepatitis is a liver disease, initially resulting in possible inflammation of the liver, and frequently leading to more serious conditions including cirrhosis and liver cancer. In the United States there are approximately 300,000 new cases of Hepatitis B Virus (HBV), the most prevalent form of Hepatitis, every year.

Health care workers are 20 times more likely to contract Hepatitis B than the normal population. It is estimated that there are as many as 18,000 new cases of HBV each year among healthcare workers, resulting in 200-300 deaths. While there is no cure for Hepatitis B, a vaccine does exist that can prevent infection.

In healthcare settings HBV is most often transmitted through breaks in the skin or mucous membranes. This usually occurs through needlesticks, human bites, or having infectious material (such as blood or other body fluids) get into existing cuts or abrasions.

The symptoms of HBV infection are very much like a mild "flu." Initially, there is a sense of fatigue, possible stomach pain, loss of appetite, and even nausea. As the disease continues to develop, jaundice (a distinct yellowing of the skin) and a darkened urine will often occur. However, people who are infected with HBV will often show no symptoms for some time.

After exposure it can take 2 - 6 months for Hepatitis B to develop. This is extremely important, since vaccinations begun immediately after exposure to the virus can often prevent infection.

Additional Information on Hepatitis

The Disease

Hepatitis means inflammation of the liver. Several hepatitis viruses are known to cause a systemic infection resulting in major pathologic changes in the liver (e. g., A,B,C,D). Most people with Hepatitis B recover completely, but 6-10% of adults who are infected today in the U. S. will become chronic carriers. CDC estimates that there are approximately 0.75 to 1.0 million chronic carriers of Hepatitis B Virus in the U. S. today. Many of these chronic carriers have no symptoms and appear wall, yet can transmit the virus to others. Those patients who become chronic carriers are at risk of developing primary hepatocellular carcinoma. Among other factors, infection with Hepatitis B may be the single most important factor for the development of the carcinoma.

Hepatitis B Virus can be transmitted by contact with body fluids including blood (including contaminated needles), semen, tears, saliva, urine, breast milk, and vaginal secretions. Health workers are at high risk of acquiring Hepatitis B because of frequent contact with blood or potentially contaminated body fluids and, therefore, vaccination is recommended to prevent illness.

The Vaccine

'Energix-B' (Hepatitis B Vaccine [Recombinant]) is a noninfectious Recombinant DNA Hepatitis B Vaccine. Clinical studies have shown that after three doses 85-97% of healthy adults have been seroprotected.

Persons with immune system abnormalities, such as dialysis patients, have less response to the vaccine, but over 67% of those receiving it do develop antibodies. If you have immune deficiency problems, you should obtain written release from your physician.

Dosing Schedules & Administration

'Energix-B' should be administered by IM injection. The injection should be given in the deltoid region. 'Energix-B' should not be given in the gluteal region; such injections may result in sub optimal response. The usual immunization regimen consists of three (3) doses of vaccine administered initially at 1 and 6 months after initial dose.

Adverse Reactions

'Energix-B' (Hepatitis B Vaccine [Recombinant]) is generally well tolerated. During clinical studies involving over 10,000 individuals distributed over all age groups, no serious adverse reactions attributable to vaccine administration were reported. As with any vaccine, however, it is possible that expanded commercial use of the vaccine could reveal rare adverse reactions not observed in clinical studies. The most frequently reported adverse reactions (1-10%) include injection-site soreness, induration, erythema, swelling, fever, headache, and dizziness. Other more serious adverse reactions have occurred infrequently. If you have any questions about Hepatitis B or about 'Energix-B', please ask.

Contra-indications

Hypersensitivity to yeast or any other component of the vaccine is a contra-indication for use of the vaccine.

Warnings

Patients experiencing hypersensitivity after and 'Energix-B' injection should not receive further injections of 'Energix-B' (see contra-indications).

Pregnancy

Pregnancy Category C: Animal reproductions studies have not been conducted with 'Energix-B'. It is also not known whether 'Energix-B' can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. 'Energix-B' should be given to a pregnant woman only if clearly needed.

Nursing Mothers

It is not known whether 'Energix-B' is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when 'Energix-B' is administered to a nursing mother.

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