Lk COLE SUMMARY OF PRODUCT CHARACTERISTICS 1, NAME OF THE MEDICINAL PRODUCT Tetana, suspension for injection Vaccinum tetani adsorbatum ‘Tetanus vaccine, adsorbed 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 dose (0.5 ml) contains: Tetanus toxoid not less than 40 TU adsorbed on aluminium hydroxide, hydrated not more than 0.7 mg AL* Fora fall list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Suspension for injection. ‘The vaccine is a milky, homogenous cream shade suspension. 4, CLINICAL PARTICULARS 4.1 Therapeutic indications ‘The vaccine is indicated for active immunization against tetanus in children, adolescents and adults: © within the National Immunization Program: - _ in case of contraindications for using: DTP, DT or Td vaccines, - asa booster dose, in pregnant women, who have not been vaccinated and who expect the labour under unhygienic conditions, © _ in passive-active prevention of tetanus in case of contaminated wounds and with high risk of Clostridium tetani presence People with AIDS or HIV positive should be vaccinated according to the standard scheme. In case of injury they should always receive human tetanus immunoglobulin (immunoglobulin with a high tetanus antibody titre) or horse tetanus antitoxin regardless of their tetanus vaccination history. This vaccine is intended for the primary and booster immunization. 42 Posology and method of administration A dose of 0.5 ml inject deeply subcutaneously into deltoid muscle or anterolateral part of the thigh. Basic vaccination ‘+ Administer 2 doses of the vaccine, with interval of 4-6 weeks (primary dose). ‘+ The third dose should be given after 6-12 months from the second dose (complementary dose). This dose provides immunity, which is maintained for 5 to 10 years.Booster vaccination Administer 1 dose of the vaccine, but not earlier than 10 years after the last vaccination. Dosage in case of injury: ‘Tetanus vaccination history of the Risk of tetanus occurrence eon Low High elas Td ot T vaccines should be used concomitantly with or . Td orT vaccine should oe aS incomplete cycle of vaccination be used according to * te schedule continuation of vaccination cycle 0,1,6 months unclear history of vaccination with Td or T according to the schedule 0,1,6 months Basic or booster vaccination if over 10 years passed since the last dose Td or T vaccines should be used (1 booster dose) Td or T vaccines should be used (1 booster dose) concomitantly with LIT 250/500 TU or KAT 3000 10 Basic or booster vaccination if 5-10 ‘years passed since the last dose Td or T vaccines should be used (1 booster dose) Td or T vaccines should be used (1 booster dose) Basic or booster vaccination if less than 5 years passed since the last dose Do not use the vaccine Do not use the vaccine. In case of particularly high risk, 1 dose of Td or T vaccine may be used *LIT- human tetanus immunoglobulin **KAT- equine tetanus antitoxin In case of lack or inability to use human immunoglobulin, equine tetanus antitoxin should be administered (after intradermal test), Dosage during pregnancy: Non-vaccinated women or those with incomplete basic vaccination being at risk of giving birth to a child in unhygienic conditions should be vaccinated in the second trimester of pregnancy. Women who received one or two doses of the vaccine before their pregnancy was confirmed, should complete the vaccination cycle during pregnancy. Pregnant women who were vaccinated more than 10 years before should receive a booster dose in the second trimester of the pregnancy.4.3 Contraindications ‘© Hypersensitivity to active substance or to any of the excipients. + Acute febrile illness with fever. Minor forms of infections do not contraindicate the immunization. ‘+ Exacerbation of chronic disease. In such cases, the vaccination should be postponed until the exacerbation subsides, + Possibility of infection (other than tetanus) in incubation period. © Thrombocytopenia or neurological disorders followed by previous dose of the vaccine. Due to the high risk of tetanus infections, contraindications should be limited, especially in case of injury. If there are any contraindications for using Tetana, it is necessary to assess the risk connected with administration of the vaccine in relation to the risk of infection. In case of injury and established contraindications for using Tetana, tetanus immunoglobulin should be administered immediately. 4.4 Special warnings and precautions for use The vaccination should be preceded by medical examination and a review of medical history with special regard to previously performed and recorded vaccinations. As with other vaccines given in injections, immediate medical care should be readily available in case of an anaphylactic reaction following the administration of the vaccine. In patients undergoing immunosuppressive treatment or with immune deficiency immunological response may be reduced. In such situations vaccination should be postponed until the end of therapy and anti-tetanus antibodies level should be assessed following vaccination. Thiomersal (an organomercuric compound) has been used in the manufacturing process of this ‘medicinal product and residues of it are present in the final product. Therefore, sensitization reactions ‘may occur. Following injection, patient should remain under medical supervision for 30 minutes. Do not administer intravascularly. Make sure the needle is not introduced into the blood vessel 4.5 Interaction with other medicinal products and other forms of interaction Tetana may be administered simultaneously with other vaccines, according to the National Immunization Program, and with immunoglobulins, if necessary. Different vaccines and immunoglobulins used at the same time should be administered into different injection sites and with separate syringes and needles.4.6 Pregnancy and lactation Pregnancy This vaceine may be administered to pregnant women, if there is a need (see se jon 42). Lactation No data. 4.7 Effects on ability to drive and use machines ‘Tetana has no influence on the ability to drive and use machines. 48 Undesirable effects + Sporadically adverse reactions at the site of injection may occur: redness, painful swelling, itching, Itching lymphatic infiltration can also appear. Such reactions are most frequent in repeatedly vaccinated people. Extremely rarely subcutaneous granuloma occur, which sometimes develop into aseptic abscesses (1: 100 000). The granuloma nodules which fail to subside within 6 weeks may be the result of developing hypersensitivity to aluminium. ‘Very rare systemic reactions: headache, increased body temperature, chills, increased sweating and malaise. These symptoms are very rare and usually subside after 24 - 48 hours. ‘Very rare: hypersensitivity reactions and gastrointestinal disorder. Very rare: thrombocytopenia, renal failure, disorders of the central and peripheral nervous system. 49° Overdose ‘Overdose is unlikely, because the packaging contains single dose only. 5. PHARMACOLOGICAL PROPERTIES Pharmacotherapeutic group: tetanus toxoid, ATC code JO7A MOL 5.1 Pharmacodynamic properties ‘The active substance of Tetana is tetanus toxoid (T), adsorbed on aluminium hydroxide. Toxoid is obtained through formaldehyde inactivation of bacterial toxin derived from Clostridium tetani culture. Tetanus toxoid retains antigenic properties of native toxin, but is devoid of pathogenicity. Tetanus toxoid induces response of immune system consisting in production of antibodies (seroconversion) and triggers mechanism of immune memory. Immunizing properties of the vaccine are enhanced by aluminium hydroxide (adjuvant). One dose of Tetana does not protect against tetanus. After two to four weeks following the second dose of this vaccine or DT, Td vaccines, and after the third dose of DTP (primary vaccination), 90% of patients develop the immunity. However, it lasts only for a short period of time. A complementary dose (last dose of the basic immunization) provides immunity for 5 up to 10 years. Booster doses provide a long term protection against the disease. This vaccine complies with WHO requirements for tetanus vaccines,5.2 Pharmacokinetic properties Not applicable. Evaluation of pharmacokinetic properties is not required for vaccines. 5.3 Preclinical safety data Each production lot prior to release is a subject to abnormal toxicity and specific toxicity analyses performed according to World Health Organization (WHO) and European Pharmacopocia requirements. 6. PHARMACEUTICAL PARTICULARS, 6.1 List of excipients Sodium chloride Water for injection Adsorbent, see point 2 62 Incompatibilities Tetana must not be mixed with other vaccines or immunoglobulins in the same syringe. 63° Shelf life 3 years. 64 Special precautions for storage Store in a refrigerator (2°C - 8°C). Do not freeze. Check the expiry date before use. 65 Nature and contents of container 0,5 ml of suspension in a type I glass ampoule. Pack size: 1 or 5 ampoules in a cardboard box. 6.6 Special precautions for disposal After shaking Tetana vaccine is a milky, homogenous, cream shade suspension, Upon storage, a white sediment with a clear supernatant above can be observed. Shake well before use in order to achieve homogenous suspension. The vaccine should be visually inspected for any foreign particulate matter and/or change in physical appearance. The vaccine must not be used if any change in the appearance of the vaccine has taken place. Any unused product or waste material should be disposed of in accordance with local requirements. WV7, MARKETING AUTHORISATION HOLDER 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 8, MARKETING AUTHORISATION NUMBER(S) No. 7869 9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 10/07/1965 27/08/1998 14/10/2003 07/11/2007 10. DATE OF REVISION OF THE TEXT Hamat : MOS. Joy, al