HAVRIX PACKAGE INSERT PDF

Older adults Infants and children Childhood vaccination against diseases such as measles, meningitis and pneumonia, helps protect the developing immune systems of infants and prevents million childhood deaths every year Adolescents and adults Waning immunity from pediatric vaccinations and changes in lifestyle, for example moving to college, military service or pregnancy, can lead to an increased risk of infectious disease. Our portfolio helps protect people against diseases like meningitis and HPV Travellers Exposure to new environments and diseases can put travelers at an increased risk of serious illness. Our portfolio for older adults includes vaccines against diseases like influenza and whooping cough Find out more information about our products If you are a healthcare professional seeking further information about our products, let us guide you to the relevant GSK website. If you are a member of the public seeking product information, please note that this may not be available to you in your country. Please follow the steps to see if product information is available to you.

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Shake well to obtain a slightly opaque, white suspension before withdrawal and use. Thoroughly agitate to maintain suspension of the vaccine. Discard if the suspension does not appear homogenous or if extraneous particulate matter remains or discoloration is observed.

For adults, adolescents, and children older than 2 years of age, the deltoid muscle is the preferred site for intramuscular injection. For children 12 through 23 months of age, the anterolateral area of the thigh is the preferred site for intramuscular injection.

Single-Dose Vial Use Withdraw dose of vaccine from the single-dose vial using a sterile needle and syringe. Prefilled Syringe Use The following are instructions for using the prefilled single-dose syringes: Shake well before use. Attach the needle by twisting in a clockwise direction until the needle fits securely on the syringe. Dispose of the syringe and needle in approved sharps container.

Dosage Forms and Strengths Sterile suspension available in four presentations: 0. Warnings and Precautions Prevention and Management of Allergic Vaccine Reactions Have appropriate medical treatment and supervision available to manage possible immediate-type hypersensitivity reactions, such as anaphylaxis, should an acute reaction occur.

Hypersensitivity to Latex Use caution when vaccinating latex-sensitive individuals since the vial stopper and the syringe plunger stopper contain dry natural latex rubber that may cause allergic reactions. Altered Immunocompetence Immunocompromised persons, including individuals receiving immunosuppressive therapy, may have a diminished immune response to Vaqta and may not be protected against HAV infection after vaccination [see Drug Interactions 7.

Adverse Reactions Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a vaccine cannot be directly compared to rates in the clinical trials of another vaccine and may not reflect the rates observed in practice.

Subjects were given one or two doses of the vaccine. The second booster dose was given 6 months or more after the first dose. Children — 12 through 23 Months of Age In two open-label clinical trials involving healthy children 12 through 23 months of age who received one or two 25U doses of Vaqta, subjects were monitored for local adverse reactions and fever for 5 days and systemic adverse events for 14 days after each vaccination by diary cards.

In one trial, 89 children were enrolled and received Vaqta alone. The race distribution of the study subjects who received at least one dose of Vaqta in these studies was as follows: The distribution of subjects by gender was

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U.S. Food and Drug Administration

Persons using assistive technology might not be able to fully access information in this file. For assistance, please send e-mail to: mmwrq cdc. Type Accommodation and the title of the report in the subject line of e-mail. Previously, pediatric use of Havrix was approved for use in persons aged years.

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Prescription Drugs

These may include: chronic care hospital staff employees and children in daycare centres food handlers hemophiliacs and other people who receive blood products members of the First Nations Aboriginal peoples military personnel people engaging in high-risk sexual activity people who eat high-risk foods e. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here. Your doctor may have suggested this medication for conditions other than those listed in these drug information articles.

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