Package leaflet: Information for the user

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Howard Walters
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1 Package leaflet: Information for the user Hepavax-Gene TF, suspension for injection Hepatitis B vaccine (rdna) 20 micrograms of hepatitis B surface antigen (HBsAg)/1.0 ml; 1 dose (1.0 ml) Read all of this leaflet carefully before you start using this vaccine because it contains important information for you. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor, pharmacist or nurse. This vaccine has been prescribed for you only. Do not pass it on to others. If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. What is in this leaflet 1. What Hepavax-Gene TF is and what it is used for 2. What you need to know before you use Hepavax-Gene TF 3. How to use Hepavax-Gene TF 4. Possible side effects 5. How to store Hepavax-Gene TF 6. Contents of the pack and other information 1. What Hepavax-Gene TF is and what it is used for Hepavax-Gene TF, 20 micrograms is indicated for use in adolescents over the age of 15 and adults for the prevention of hepatitis B. The vaccine contains purified hepatitis B surface antigen. After administration the vaccine causes increase of immunity by producing antibodies and protects from infections caused by all known subtypes of the hepatitis B virus. Individuals who should be vaccinated due to the risk of hepatitis B virus infection are specified by the National Immunization Program. 2. What you need to know before you use Hepavax-Gene TF Do not use Hepavax-Gene TF: if you are allergic to hepatitis B surface antigen or any of the other ingredients of this vaccine (listed in section 6). Signs of an allergy may include: itchy rash, dyspnoea, swelling of the face and tongue, if you had allergy signs after a previous use of Hepavax-Gene TF, if you have severe illnesses with fever. A mild infection, such as e.g. a cold, should not be a contraindication to vaccination, but you should inform your doctor first. Warnings and precautions Talk to your doctor or nurse before using Hepavax-Gene TF, if you experienced side effects described in section 4, or any other alarming reactions after a previous dose of vaccine. The vaccination should be preceded by a clinical examination and a review of medical history with special regard to your general health condition and previous vaccinations. This precaution allows to anticipate possible risk of side effects after vaccine administration. 1

2 The Hepavax-Gene TF does not prevent liver infections caused by other pathogens, such as: hepatitis A, hepatitis C, hepatitis E viruses and other pathogens causing liver disease. Due to the long incubation period for hepatitis B, it is possible to administer vaccine during unrecognized infection. Vaccination may not prevent hepatitis B in such individuals. A number of factors, such as e.g. age (over 40 years), obesity, smoking, can have an impact on decreasing immune response. Immune response can also be reduced in patients with dialysis and immunological disorders. In patients who are affected by this problem, an impaired immune response to primary vaccination is possible and additional doses or booster vaccinations may be needed. Important information about some of the ingredients of Hepavax-Gene TF The vaccine contains less than 1 mmol (39 mg) potassium per dose, which means that the medicine is essentially "potassium-free". The vaccine contains less than 1 mmol (23 mg) sodium per dose, which means that the medicine is essentially "sodium-free". Other medicines and Hepavax-Gene TF Hepavax-Gene TF can be administered at the same time as other vaccines if it follows the National Immunization Program. If administered concomitantly, the different vaccines should be given with different syringes and injected at different sites. Hepavax-Gene TF can be administered concomitantly with hepatitis B virus immunoglobulin, and should be administered at a separate injection site with a separate syringe. In patients undergoing immunosuppressive treatment (which suppresses activity of the immune system), response to the vaccine may be impaired. Clinical experience shown that Hepavax-Gene TF can be used for completing the primary immunisation course started with other hepatitis B vaccines or as a booster vaccination; see section 3 of the leaflet. Tell your doctor if you are taking, have recently taken or might take any other medicines. Pregnancy and breast-feeding There are no adequate data from the use of Hepavax-Gene TF in pregnant women. There is no evidence of risk to the fetus. However, the vaccine should be only used during pregnancy when there is a clear risk of hepatitis B infection when the benefit for mother outweighs the risk for baby. It is unknown whether Hepavax-Gene TF is excreted in human milk. The excretion of Hepavax-Gene TF in milk has not been studied in animals. Hepavax-Gene is a recombinant vaccine. Recombinant vaccines are considered to pose no risk for mothers who are breast feeding or for their infants. However, Hepavax-Gene TF should be administered during breast-feeding only when there is a clear risk of hepatitis B infection and when the benefit for mother outweighs the risk for baby. If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this vaccine. Driving and using machines No studies on the effects on the ability to drive and use machines have been performed. 2

3 3. How to use Hepavax-Gene TF The Hepavax-Gene TF will be given by a doctor or a nurse as an intramuscular injection into the upper arm. Dosage: Primary vaccination Primary vaccination consists of 3 doses, which can be used according to two schedules: Schedule: 0, 1, 6 months The first dose: on a selected day The second dose: 1 month after administration of the first dose The third dose: 6 months after administration of the first dose Schedule: 0, 1, 2 months The accelerated dosage schedule of Hepavax-Gene TF makes it possible to obtain a rapid onset of protection (e.g. in individuals before a surgical procedure or planning to visit countries with a high risk of infection with hepatitis B). The first dose: The second dose: The third dose: on a selected day 1 month after administration of the first dose 2 months after administration of the first dose In order to achieve optimal immunity, it is recommended to administer a fourth dose after 12 months of the administration of the first dose while the accelerated schedule was applied. Make sure that you have received a full course of the vaccination consisting of three or four doses of the vaccine. If you do not receive all doses, you may not be fully protected against the disease. Booster vaccination As with usage of other hepatitis B vaccines, the duration of the protective effect of HBV antibodies after Hepavax-Gene TF vaccination in healthy people is unknown at present and the need for a booster dose is not yet defined. If, however, locally immunization schedules include booster vaccination, its performance should be considered. Antibody levels of subjects at risk can be assessed at regular intervals and appropriate boosters administered when titers fall below minimal protective levels (< 10 IU/L). If you use more Hepavax-Gene TF than you should No case of overdose has been reported. If you have doubts, ask your doctor. If you stop using Hepavax-Gene TF If you have any further questions on the use of this vaccine, ask your doctor, pharmacist or nurse. 4. Possible side effects Like all vaccines, this vaccine can cause side effects, although not everybody gets them. There were no reports of severe side effects during clinical trials conducted with the use of the vaccine. As with other vaccines, side effects not observed in clinical trials may be reported during a 3

4 wider use of this vaccine. During the conducted clinical trials, the following cases of side effects were reported: Adult subjects Very common (may occur in 1 case for 10 doses or more): - mylagia - injection site pain, fatigue Common (less than 1 case for 10 doses of vaccine): - rash, pruritis - arthralgia - malaise, injection site pruritus, injection site erythema, injection site swelling, fever (at least 38 C) Uncommon (less than 1 case per 100 doses of vaccine): - headache, - nausea, vomiting, abdominal pain, diarrhea - increase in body temperature, influenza like illness Rare (less than 1 case per 1000 doses of vaccine): - dizziness - somnolence - hypotension - rhinitis - stomatitis - injection site burning For adult subjects, the most common injection site reactions were: pain (28.5%), itching (4.1%), and erythema (2.4%). The most common systemic reactions were: fatigue (14.6%), myalgia (13.9%), and malaise (8.3%). Fever (at least 38 ) was reported in 1% of adult subjects. Pediatric subjects Common (less than 1 case for 10 doses of vaccine): - nasopharyngitis - vomiting - fever (at least 38 C), increase in body temperature, crying, injection site erythema, induration, injection site swelling, injection site pain Uncommon (less than 1 case per 100 doses of vaccine): - allergic reaction - feeding disorder - mental status changes - headache - cough, rhinorrhea - diarrhea, nausea - abdominal distension, dyspepsia (including infantile spitting up) - rash (including pustular rash), eczema, mucous membrane disorder - altered activity level, fatigue Rare (less than 1 case per 1000 doses of vaccine): - lymphadenopathy 4

5 - anorexia - convulsions, somnolence - abdominal pain - pruritus, urticarial - myalgia For pediatric subjects, the most common injection site reactions were: erythema (2.8%), induration(1.9%), swelling (1.5%), and pain (1.4%). The most common systemic reactions were: fever (at least 38 ) (3.6%), and crying (2.8%). Postmarketing data In postmarketing reports, hypersensitivity reactions, including edema and angioedema, were observed with unknown frequencies (cannot be estimated from the available data). Both local and systemic side effects were temporary (2 3 days), of mild and moderate intensity. The reported side effects were comparable with side effects reported after the use of other hepatitis B vaccines. Other side effects may occur in some individuals after using Hepavax-Gene TF. Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any side effects not listed in this leaflet. You can also report side effects directly via Departament Monitorowania Niepożądanych Działań Produktów Leczniczych Urzędu Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181C, Warszawa, tel.: , faks: , ndl@urpl.gov.pl Adverse reactions can also be reported to the Marketing Authorisation Holder. By reporting side effects you can help provide more information on the safety of this medicine. 5. How to store Hepavax-Gene TF Store in a refrigerator (2 C 8 C). Do not freeze. Store in the original package in order to protect from light. Keep this vaccine out of the sight and reach of children. Do not use this vaccine after the expiry date (EXP) which is stated on the carton. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment. 6. Contents of the pack and other information What Hepavax-Gene TF contains The active substance is: Hepatitis B surface antigen (HBsAg)* 20 micrograms adsorbed on aluminium hydroxide, hydrated 0.5 milligrams Al 3+ * obtained by means of Hansenula polymorpha yeast DNA recombination (RB11 strain; Yu305 substrain) 5

6 The other ingredients are sodium chloride, potassium dihydrogen phosphate, disodium hydrogen phosphate dodecahydrate, water for injections. What Hepavax-Gene TF looks like and contents of the pack Hepavax-Gene TF is homogeneous, slightly opalescent, white suspension in glass vials. The vaccine is available in packs of 1, 10 or 50 vials. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder: Janssen-Cilag International NV Turnhoutseweg 30 B-2340 Beerse, Belgium Manufacturer which releases the batch for marketing: IBSS BIOMED S.A. Al. Sosnowa Krakow, Poland Tel: Fax: marketing@biomed.pl This leaflet was last revised in: july The following information is intended for healthcare professionals only Hepavax-Gene TF administration Shake before use to obtain a homogeneous, slightly opalescent, white suspension. The vaccine should be visually inspected for any foreign particulate matter and/or abnormal change in physical appearance. In the event of any change, the vaccine should not be used. The vaccine must never be administered intravascularly. The vaccine should not be administered to the gluteal muscle or intracutaneously, because sufficient protection may not be obtained. Exceptionally, the vaccine can be injected subcutaneously in patients with bleeding tendency (e.g. haemophilia). Caution: As with all injectable vaccines, appropriate medical treatment should always be readily available in case of a rare anaphylactic shock following the administration of the vaccine. The subjects should be monitored by a healthcare professional for 30 minutes after vaccination. Syncope (fainting) can occur in association with administration of injectable vaccines. Syncope can be accompanied by falls. Procedures should be in place to avoid falling injury. If syncope develops, individuals should be observed until the symptoms resolve. 6

Package leaflet: Information for the user

Package leaflet: Information for the user Hepavax-Gene TF, suspension for injection Hepatitis B vaccine (rdna) 10 micrograms of hepatitis B surface antigen (HBsAg)/0.5 ml; 1 dose (0.5 ml) Read all of this