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 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, 10 micrograms (dose for children) is indicated for use in neonates, infants, children and adolescents up to the age of 15 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. Hepavax-Gene TF does not prevent liver infections caused by other pathogens. 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. It is expected that vaccination against hepatitis B also protects against hepatitis D, caused by the HDV virus, as hepatitis D occurs at the same time as HBV infection. The Hepavax-Gene TF does not 1
prevent liver infections caused by other pathogens, such as: hepatitis A (HAV), C (HCV), E (HEV) viruses and other microorganisms causing liver disease. Due to the long incubation period of hepatitis B, there is a possibility of administer the vaccine during the disease's incubation period. In such a case, the vaccine may not prevent the development of the infection. 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 lower in men, patients undergoing dialysis and in patients with immune system disorders. In patients who are affected by this problem, determination of antibody levels after carrying out the primary vaccination should be considered. If there is no immune response, or if it is weaker, there may be a need to administer additional doses. 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. Hepavax-Gene TF can be administered concomitantly with hepatitis B virus immunoglobulin. Other vaccines and immunoglobulins used at the same time should be administered into different injection sites and with separate syringes and needles. In patients undergoing immunosuppressive treatment (which suppresses activity of the immune system), response to the vaccine may be reduced. On the basis of clinical observations, it has been shown that Hepavax-Gene TF can be used to complete the primary immunisation course or as a booster dose in subjects who have previously received other hepatitis B vaccine; 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 data from the use of Hepavax-Gene TF in pregnant women. The vaccine can be administered to a pregnant woman only in the case of an obvious risk of hepatitis B virus infection and when the benefits exceed the risk associated with using the vaccine. There is insufficient information on the excretion of Hepavax-Gene TF in human milk. The vaccine can be administered to a breast-feeding woman only in the case of an obvious risk of hepatitis B virus infection and if the benefits exceed the risk associated with using the vaccine. 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 concerning the impact of the vaccine on the ability to drive and use machines have been performed. 3. How to use Hepavax-Gene TF 2
The Hepavax-Gene TF will be given by a doctor or a nurse as an intramuscular injection into a thigh muscle in neonates, infants and younger children, and into the upper arm in older children and adolescents. 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 an optimal immunological response fast (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. 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 It has not been determined if there is a need to administer a booster dose to healthy individuals who have received full primary vaccination. If, however, locally immunization schedules include booster vaccination, its performance should be considered. Patients belonging to high-risk groups are recommended to check the level of antibodies regularly. If the level of anti-hbs antibodies drops below the protective minimum (10 IU/l), booster vaccination should be carried out. 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 wider use of this vaccine. During the conducted clinical trials, the following cases of side effects were 3
reported: Very common (they may occur in 1 case per 10 doses of the vaccine or more often): At the injection site: pain, redness, hardening Uncommon (more rarely than in 1 case per 100 doses of the vaccine): Headache, dizziness Pharyngitis, cough, rhinitis Diarrhoea Erythematous rash, pruritus Fatigue, malaise, flu-like symptoms, fever Very rare (more rarely than in 1 case per 10 000 doses of the vaccine): Decreased appetite Reduced concentration, paraesthesias (tingling sensation), sleepiness Heart palpitations Abdominal pain, nausea Joint pain, backache, neck pain, muscle pain In premature infants (born in the 28th week of pregnancy or earlier) longer intervals between breaths may occur within 2 3 days after vaccination. Hypersensitivity and anaphylactic reactions, such as: rash, pruritus, urticaria, oedema, angiooedema, dyspnoea, bronchospasm were also observed rarely. 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, 02-222 Warszawa, tel.: +48 22 49 21 301, faks: +48 22 49 21 309, e-mail: 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 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)* 10 micrograms 4
adsorbed on aluminium hydroxide, hydrated 0.25 milligrams Al 3+ * obtained by means of Hansenula polymorpha yeast DNA recombination (RB11 strain; Yu305 substrain) 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 8 30-224 Krakow, Poland Tel: +48 12 37 69 200 Fax: +48 12 37 69 205 e-mail: marketing@biomed.pl This leaflet was last revised in: November 2016 ------------------------------------------------------------------------------------------------------------------------- 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. Exceptionally, the vaccine can be administered subcutaneously in patients with bleeding tendency (e.g. haemophilia). The vaccine should not be administered to the gluteal muscle or intracutaneously, because sufficient protection may not be obtained. Caution: Due to the risk of anaphylactic shock associated with vaccination (extremely rare), as after administering other injectable vaccines, the vaccination room should be equipped with a standard shock-controlling set. 5