Help keep hepatitis A and B out of your travel plans.

Transcription

1 Help keep hepatitis A and B out of your travel plans.

2 Hepatitis A and B: Facts for Canadian travellers. Many common travel activities may put travellers at risk for hepatitis A and B. Hepatitis A and B are two serious liver diseases caused by the hepatitis A and B viruses. You may get hepatitis A on vacation from: These viruses are endemic (constantly present) in much of the developing world. Many popular holiday destinations such as the Caribbean are considered risk areas for unprotected travellers. Travelling to the Caribbean? You could be at risk of hepatitis A or B, even at 5-star resorts. Eating food handled by an infected restaurant worker. Eating raw or undercooked seafood/shellfish from contaminated water. Eating salads and produce rinsed in contaminated water. Ingesting contaminated water or ice. Bathing, showering or swimming in contaminated water. Hepatitis A can survive up to 10 months in water. HEPATITIS A You may get hepatitis B on vacation through: C ountries or areas with moderate to high risk Manicures using contaminated spa tools. An unexpected accident requiring first aid. Adapted from Hepatitis A, countries at risk map, World Health Organization, Contaminated tattooing tools. Unprotected sex with an infected partner. HEPATITIS B Routine grooming with contaminated tools. Hepatitis B can survive on surfaces for at least 7 days. C ountries or areas with moderate to high risk Adapted from Hepatitis B, countries at risk map, World Health Organization,

3 Recognizing the possible symptoms of hepatitis A or B infection. * Symptoms Hepatitis A Hepatitis B Fever 7 Fatigue 7 7 Nausea 7 7 Jaundice (yellowing of the skin and whites of the eyes) 7 7 Loss of appetite 7 7 Vomiting 7 7 Abdominal discomfort 7 7 Joint pain 7 Dark urine 7 7 Clay-coloured stool Not all infected adults experience symptoms. That means you could contract hepatitis A or B and spread it to others, without realizing it. 7 Understanding the possible consequences of hepatitis A or B infection. * Hepatitis A: Hepatitis A can range from a mild illness lasting 1-2 weeks to a severely disabling disease lasting several months. While most people recover, approximately 25% of infected adults are hospitalized. Hepatitis B: While most people recover from the initial infection, 10% of infected adults become lifelong carriers. If this happens, you may pass the virus on to others for the rest of your life without having symptoms yourself. Carriers are also at a high risk of developing chronic liver disease that may lead to cirrhosis and liver cancer. Vaccination is the best way to help protect against hepatitis A and B diseases. Who should get vaccinated against hepatitis A and B? According to the Canadian Immunization Guide, vaccination is recommended for all those who wish to decrease their risk of contracting hepatitis A and B, and including travellers to countries where there is a high risk of hepatitis A or B. Ask your healthcare professional if vaccination is suitable for you. Vaccination may not be suitable for everyone. 100% protection cannot be guaranteed and additional doses may be required. Side effects and allergic reactions may occur. Ask your healthcare professional if vaccination is right for you. To report an adverse event, please call * TWINRIX, ENGERIX-B, and HAVRIX are not indicated to treat the symptoms or serious 3 consequences associated with hepatitis A or B. 4

4 TWINRIX is the only dual hepatitis A and B vaccine. What is TWINRIX? TWINRIX is a vaccine that can help protect you against both hepatitis A and B. It s given as a series of shots (injections) by a healthcare professional. TWINRIX may be used in adults, adolescents, children, and infants over one year of age. How does TWINRIX work? TWINRIX works by causing the body to produce its own protection (antibodies) against hepatitis A and B diseases. Who should not get TWINRIX? TWINRIX should not be given if you or your child have: Experienced any health problems after previous administration of a vaccine. Experienced a previous allergic reaction to TWINRIX or to any vaccine against hepatitis A or B. Had any allergic reaction to any ingredient contained in the vaccine. (TWINRIX medicinal ingredients and important nonmedicinal ingredients are listed on the next page.) Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue. A severe infection with a high temperature (over 38 C). A minor infection such as a cold should not be a problem, but tell your healthcare professional first. What are the medicinal ingredients in TWINRIX? Inactivated hepatitis A virus. Recombinant hepatitis B virus surface antigen. What are the important nonmedicinal ingredients in TWINRIX? Aluminum hydroxide, aluminum phosphate, sodium chloride and water for injection. Traces of amino acids for injection, formaldehyde, neomycin sulphate, and polysorbate 20. How many doses of TWINRIX will I need? The standard TWINRIX dosing schedule consists of 3 vaccine doses over the course of 6 months. Your healthcare professional will advise you of the appropriate dosing schedule. To help ensure complete protection against hepatitis A and B, make sure you complete all 3 vaccine doses. Last minute traveller? A rapid dosing schedule is also available for adults over the age of 19 who don t have time to complete the standard dosing schedule before their trip. Three vaccine doses are given over 3 weeks, followed by the fourth dose after one year. Talk to your healthcare professional or visit your local travel clinic to ask whether vaccination is right for you. 5 6

5 TWINRIX vaccination schedules. Adult Vaccination Schedule Options Standard TWINRIX(1 ml) (19 years and over) Vaccine Dose #2 Vaccine Dose #3 Date of your 1 month after the 6 months after the Rapid TWINRIX (1 ml) (19 years and over) Vaccine Dose #2 Vaccine Dose #3 Vaccine Dose #4* Date of your 1 week after the 3 weeks after the 12 months after the * A fourth dose of TWINRIX 12 months after the first injection is required only for rapid dosing. Pediatric Vaccination Schedule Options Standard TWINRIX Junior (0.5 ml) (1-18 years) Be sure to finish the complete TWINRIX vaccination schedule to help ensure full protection against hepatitis A or B. Where is TWINRIX injected? TWINRIX is given by your healthcare professional as an injection into the muscle in your upper arm or in the front of the thigh in young children. What if a TWINRIX dose is missed? If you miss a scheduled injection, talk to your healthcare professional and arrange another visit. Make sure you finish the complete vaccination course. If not, you may not be fully protected against hepatitis A and B. Vaccine Dose #2 Vaccine Dose #3 Alternate TWINRIX (1 ml) (1-15 years) Vaccine Dose #2 Date of the 1 month after the 6 months after the Date of the 6-12 months after the To find out about other TWINRIX dosing options, talk to your healthcare professional. 7 8

6 What are the potential side effects of TWINRIX? Like all vaccines, TWINRIX may cause side effects. During clinical trials, the following side effects were reported: Adults receiving the standard or rapid TWINRIX dosing schedule: Very common (more than 10% of doses): Pain or discomfort, redness at the injection site, headache and tiredness. Common (1 10% of doses): Swelling at the injection site, diarrhea, nausea, vomiting, and generally feeling unwell. Uncommon (0.1 1% of doses): Fever (over 37.5 C), dizziness, upper respiratory tract infection, and aching muscles. Rare ( % of doses): Swollen glands in the neck, armpit or groin, loss of appetite, pins and needles, low blood pressure, rash and itching, muscle and joint pain and flu-like symptoms, such as high temperature, sore throat, runny nose, cough, and chills. Very Rare (less than 0.01% of doses): Hives. Children receiving the alternate (2 dose) TWINRIX vaccination schedule: Very common (more than 10% of doses): Pain and redness at the injection site, tiredness, headache, irritability, and loss of appetite. Common (1 10% of doses): Swelling at the injection site, fever, drowsiness, stomach and digestive complaints. Do not be alarmed by this list of possible side effects. It is likely that you will have no side effects from vaccination. This is not a complete list of side effects. For any unexpected effects while taking TWINRIX, contact your healthcare professional. Full product information can be found on Twinrix.ca. To report an adverse event for TWINRIX, please call Children receiving the standard TWINRIX Junior dosing schedule: Very common (more than 10% of doses): Pain and redness at the injection site. Common (1 10% of doses): Swelling at the injection site, fever over 37.5 C, irritability, drowsiness, headache, loss of appetite, diarrhea, nausea, vomiting and generally feeling unwell. Uncommon (0.1 1% of doses): Rash. Rare ( % of doses): Swollen glands in the neck, armpit or groin, dizziness and hives. Very Rare (less than 0.01% of doses): Pins and needles, loss of skin sensitivity to pain or touch, numbness of the arms and legs, low blood pressure, rash and itching, aching muscles and joint pain and flu-like symptoms, such as high temperature, sore throat, runny nose, cough and chills. 9 10

7 What should I tell my healthcare professional before receiving TWINRIX? BEFORE receiving TWINRIX, talk to your healthcare professional if you or your child: Are pregnant or think you may be pregnant, or intend to become pregnant. Your healthcare professional will discuss the possible risks and benefits of receiving TWINRIX during pregnancy. Are breastfeeding. It is not known if TWINRIX passes into breast milk, however the vaccine is not expected to cause problems in breastfed babies. Have a poor immune system due to illness or drug treatment. Have a bleeding problem or bruise easily. Are taking any other medicine or have recently received any other vaccine. Have any known allergies. As with other vaccines, a lower immune response is more common in older people, men rather than women, smokers, obese people, and people with long standing illnesses, or people on some types of drug treatments. Your healthcare professional may advise you to have a blood test after you have completed the course of vaccinations to check if you have a satisfactory hepatitis B (antigen) response. If not, your healthcare professional will advise you on the possible need to have extra doses. In these cases, your healthcare professional can determine the right time and schedule of vaccination for you. Fainting (Syncope) may occur following, or even before, any needle injection; therefore, tell the healthcare professional if you or your child fainted with a previous injection so that procedures can be put in place to avoid injury from faints. Can TWINRIX be given with other vaccines? TWINRIX can be given at the same time as either a combined diphtheria, tetanus, acellular pertussis, inactivated poliomyelitis, and Haemophilus influenzae type b vaccine or a combined measles, mumps and rubella vaccine, in the second year of life. TWINRIX Junior can be given at the same time as CERVARIX, a Human Papillomavirus vaccine. Ask your healthcare professional for advice about which vaccines may be given at the same time as TWINRIX or TWINRIX Junior. TWINRIX may not have an optimal effect if used with medicines that suppress the immune system. TWINRIX is a combined hepatitis A and hepatitis B vaccine used in adults, adolescents, children, and infants over one year of age to prevent hepatitis A and hepatitis B diseases. TWINRIX does not protect against hepatitis C or E nor does it treat hepatitis A or B infections. 100% protection cannot be guaranteed and additional doses may be required. Full product information can be found at gsk.ca/twinrix/en. Additional information on TWINRIX can be found at twinrix.ca. To report an adverse event, please call For a listing of some of the side effects associated with TWINRIX, see page 9 of this booklet.? Information about HAVRIX (hepatitis A vaccine) and ENGERIX-B (hepatitis B vaccine) starts on the next page. Contact your healthcare professional if you have any questions about TWINRIX, HAVRIX, or ENGERIX-B

8 HAVRIX: For hepatitis A vaccination. What is HAVRIX? HAVRIX is a hepatitis A vaccine used at any age from 12 months and onwards to prevent hepatitis A disease. Vaccination is the best way to protect against this disease. The first dose of the vaccine should be given at least 2 weeks prior to anticipated exposure to hepatitis A disease. How does HAVRIX work? HAVRIX works by causing the body to produce its own protection (antibodies) against hepatitis A disease. Who should not get HAVRIX? HAVRIX should not be given if you or your child have: A known allergy to any ingredient of the vaccine (HAVRIX medicinal ingredients and important nonmedicinal ingredients are listed below). Shown signs of a serious allergic reaction after a previous dose of this vaccine or any vaccine intended to protect against hepatitis A infection. Shown signs of an allergic reaction. Signs may include skin rash, shortness of breath, and swelling of the face or tongue. Immunization should be postponed if you or your child has a severe fever or infection. What is the medicinal ingredient in HAVRIX? The medicinal ingredient in HAVRIX is inactivated hepatitis A virus. None of the components of the vaccine are infectious. What are the important nonmedicinal ingredients in HAVRIX? HAVRIX contains the following nonmedicinal ingredients: Aluminum hydroxide, amino acids for injection, disodium phosphate, monopotassium phosphate, neomycin sulphate, polysorbate 20, potassium chloride, sodium chloride and water for injection. How many doses of HAVRIX will I need? The first dose of the vaccine should protect anyone with normal immunity within 2-4 weeks after the first injection. To help ensure long-term protection against hepatitis A, a second dose is recommended 6 to 12 months after the first injection. Your healthcare professional will advise you of the appropriate dosing schedule

9 HAVRIX vaccination schedules. Adult Vaccination Schedule HAVRIX 1440 (19 years and over) Vaccine Dose #2* Pediatric Vaccination Schedule HAVRIX 720 Junior (1-18 years) Vaccine Dose #2* Date of your 6-12 months after the Date of the 6-12 months after the * To help protect you or your child long-term, talk to your healthcare professional about getting a second dose of HAVRIX 6 to 12 months after the first injection. Be sure to finish the complete HAVRIX vaccination schedule to help ensure full protection against hepatitis A. Where is HAVRIX injected? HAVRIX is given by your healthcare professional as an injection into the muscle in your upper arm or in the front of the thigh in young children. What if a HAVRIX dose is missed? If you miss a scheduled injection, talk to your healthcare professional to arrange another visit. Make sure you finish the complete vaccination course. If not, you may not be fully protected. What are the potential side effects of HAVRIX? Like all vaccines, HAVRIX may cause side effects. Side effects that may occur are: Very common (more than 10% of doses): Irritability, headache, pain and redness at the injection site, and fatigue. Common (1 10% of doses): Loss of appetite, drowsiness, diarrhea, nausea, and vomiting, swelling or hard lump at the injection site, generally feeling unwell, and fever. Uncommon (0.1 1% of doses): Upper respiratory tract infection, runny or blocked nose, dizziness, rash, aching muscles or muscular stiffness not caused by exercise; and flu-like symptoms, such as high temperature, sore throat, runny nose, cough and chills. If any of the side effects get serious or if you notice any side effects not mentioned above, please tell your healthcare professional. This is not a complete list of side effects. For any unexpected effects while taking HAVRIX, contact your healthcare professional. Full product information can be found at gsk.ca/havrix/en. To report an adverse event please call

10 What should I tell my healthcare professional before receiving HAVRIX? BEFORE receiving HAVRIX, talk to your healthcare professional if you or your child: Have a severe infection with a high temperature (over 38 C). Have any known allergies Is on dialysis for kidney disease. Have a poor immune system due to illness or drug treatment. Are pregnant or breastfeeding. Have a bleeding problem or bruise easily. Please tell your healthcare professional if you are taking or have recently taken any other medicines. Fainting may occur following, or even before, any needle injection; therefore, tell the healthcare professional if you or your child fainted with a previous injection. Can HAVRIX be given with other vaccines? HAVRIX and immune globulin (human) should be administered at separate injection sites. When receiving other vaccines with HAVRIX is considered necessary, the vaccines must be given with different syringes and at different injection sites. Ask your healthcare professional about completing your coverage with hepatitis A vaccination. HAVRIX is a hepatitis A vaccine used in adults, adolescents, children, and infants over one year of age to prevent hepatitis A disease. HAVRIX does not protect against hepatitis B, C, or E nor does it treat hepatitis A infections. 100% protection cannot be guaranteed and additional doses may be required. Full product information can be found at gsk.ca/havrix/en. To report an adverse event, please call: For a listing of some of the side effects associated with HAVRIX, see page 16 of this booklet

11 ENGERIX-B: For hepatitis B vaccination. What is ENGERIX-B? ENGERIX-B is a hepatitis B vaccine used at any age from birth onwards to prevent hepatitis B disease. It s given as a series of shots (injections) by a healthcare professional. How does ENGERIX-B work? ENGERIX-B works by causing the body to produce its own protection (antibodies) against hepatitis B disease. Who should not get ENGERIX-B? ENGERIX-B should not be given if you or your child have: Had any allergic reaction to ENGERIX-B, or any ingredient contained in this vaccine. (ENGERIX-B medicinal ingredients and important nonmedicinal ingredients are listed below). A severe infection with a high temperature (over 38 C). A minor infection such as a cold should not be a problem, but tell your healthcare professional first. What is the medicinal ingredient of ENGERIX-B? Recombinant hepatitis B surface antigen. What are the important nonmedicinal ingredients in ENGERIX-B? Aluminum hydroxide for injection. How many doses of ENGERIX-B will I need? For optimal protection, the recommended standard dosing schedule is three doses given at 0, 1 and 6 months. A rapid dosing schedule that includes three vaccine doses given over 3 weeks (followed by an additional fourth dose to help maintain long-term protection) is available for patients 20 years of age and over. Your healthcare professional will advise you of the appropriate dosing schedule

12 ENGERIX-B vaccination schedules. Adult Vaccination Schedule Options Standard ENGERIX-B (1 ml) (20 years and over) To find out about other ENGERIX-B dosing options, talk to your healthcare professional. Vaccine Dose #2 Vaccine Dose #3 Date of your 1 month after the 6 months after the Be sure to finish the complete ENGERIX-B vaccination schedule to help ensure full protection against hepatitis B. Rapid ENGERIX-B (1 ml) (20 years and over) Vaccine Dose #2 Vaccine Dose #3 Vaccine Dose #4* Pediatric Vaccination Schedule Date of your 1 week after the 3 weeks after the 12 months after the * A fourth dose of ENGERIX-B 12 months after the first injection is required to help maintain prolonged protection against hepatitis B. Standard ENGERIX-B (0.5 ml) (0-19 years) Where is ENGERIX-B injected? ENGERIX-B is given by your healthcare professional as an injection into the muscle in your upper arm or in the front of the thigh in young children. ENGERIX-B should not be given (deep) into the skin or intramuscularly into the buttock because protection may be less. ENGERIX-B should never be given into a vein. What if an ENGERIX-B dose is missed? If you or your child misses a scheduled injection, talk to your healthcare professional and arrange another visit. Vaccine Dose #2 Vaccine Dose #3 Date of the 1 month after the 6 months after the 21 22

13 What are the potential side effects of ENGERIX-B? Like all vaccines, ENGERIX-B may cause side effects. ENGERIX-B has been widely used and the list below includes side effects that are not necessarily linked to the vaccine: Very common (more than 10% of doses): Irritability, pain and redness at the injection site, and tiredness. Common (1 10% of doses): Loss of appetite, headache and drowsiness, nausea, vomiting, diarrhea and abdominal pain, hard lump and swelling at the injection site, fever, and generally feeling unwell. Uncommon (up to 1 in 100 doses): Dizziness, aching muscles, flu-like symptoms, such as high temperature, sore throat, runny nose, cough and chills. Rare (up to 1 in 1000 doses): Paresthesia (abnormal sensation of the skin), Rash, pruritus (itching of the skin), urticaria (hives), arthralgia (pain in the joints), and abnormal liver function tests. Do not be alarmed by this list of possible side effects. It is possible that you or your child will have no side effects from vaccination. This is not a complete list of side effects. For any unexpected effects while taking ENGERIX-B, contact your healthcare professional. Full product information can be found at gsk.ca/engerix/en. To report an adverse event for please call What should I tell my healthcare professional before receiving ENGERIX-B? BEFORE receiving ENGERIX-B talk to your healthcare professional if you or your child: Are pregnant, think you may be pregnant, or intend to become pregnant. Your healthcare professional will discuss the possible risks and benefits of receiving ENGERIX-B during pregnancy. Are breast-feeding. It is not known if ENGERIX-B passes into breast-milk. Has a poor immune system due to illness or drug treatment. Has a severe infection with a high temperature (over 38 C). In these cases, the vaccination will be postponed until you or your child have recovered. A minor infection such as a cold should not be a problem, but talk to your healthcare professional first. Has a bleeding problem or bruise(s) easily. Is taking any other medicine or have recently received any other vaccine. A poor response to the vaccine, possibly without achieving protection against hepatitis B, is more common in older people, men rather than women, smokers, obese people, and people with long standing illnesses, people with type 2 diabetes, or people on some type of drug treatments. Your healthcare professional may advise you or your child to have a blood test after you have or your child has completed the course of vaccinations to check if you have or your child has made a satisfactory response or an adequate (immune) response. If not, your healthcare professional will advise you or your child on the possible need to have extra doses

14 In these cases, your healthcare professional can determine the right time and schedule of vaccination for you or your child. If your child has breathing difficulties, please contact your healthcare professional. This may be more common in the first three days following vaccination if your child is born prematurely (before or at 28 weeks of pregnancy). Fainting may occur following, or even before, any needle injection; therefore, tell the healthcare professional if you or your child fainted with a previous injection. Notes: Can ENGERIX-B be given with other vaccines? The ENGERIX-B pediatric dose can be given at the same time as CERVARIX, a Human Papillomavirus vaccine. Ask your healthcare professional about completing your coverage with hepatitis B vaccination. ENGERIX-B is a hepatitis B vaccine used at any age from birth onwards to prevent hepatitis B disease. ENGERIX-B does not protect against hepatitis A, C, or E nor does it treat hepatitis B infection. 100% protection cannot be guaranteed and additional doses may be required. Full product information can be found at gsk.ca/engerix/en. To report an adverse event, please call: For a listing of some of the side effects associated with ENGERIX-B, see page 23 of this booklet

15 ? Did you know? Hepatitis A and B are two of the most common vaccine-preventable diseases in travellers to developing countries. BEFORE you travel, ask your healthcare professional about vaccination against hepatitis A and B. Vaccination may not be suitable for everyone. 100% protection cannot be guaranteed and additional doses may be required. Side effects and allergic reaction may occur. TWINRIX, ENGERIX-B and HAVRIX are not indicated to treat hepatitis A or B infections. Ask your healthcare professional if vaccination is right for you. To report an adverse event, please call Product DINs TWINRIX TWINRIX Jr HAVRIX HAVRIX Jr ENGERIX-B ENGERIX-B Jr Trademarks are owned by or licensed to the GSK group of companies GSK groups of companies or its licensor /17