Package leaflet: Information for the user

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1 8U004E Package leaflet: Information for the user DT Diphtheria-tetanus vaccine adsorbed suspension for injection Diphtheria and tetanus vaccine, adsorbed Tetanus toxoid not less than 40 IU and diphtheria toxoid not less than 30 IU/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 DT Diphtheria-tetanus vaccine adsorbed is and what it is used for 2. What you need to know before you use DT Diphtheria-tetanus vaccine adsorbed 3. How to use DT Diphtheria-tetanus vaccine adsorbed 4. Possible side effects 5. How to store DT Diphtheria-tetanus vaccine adsorbed 6. Contents of the pack and other information 1. What DT Diphtheria-tetanus vaccine adsorbed is and what it is used for DT Diphtheria-tetanus vaccine adsorbed protects against diphtheria and tetanus (caused by Corynebacterium diphtheriae and Clostridium tetani). Active substances are diphtheria toxoid and tetanus toxoid (inactive compounds derived from bacteria). Following vaccine administration child s organism produces antibodies protecting against the diseases. The vaccine is indicated for active immunization of children against diphtheria and tetanus. Primary vaccination Children, who have not received primary course of vaccination (ie. obligatory, consisting of three doses) against diphtheria and tetanus. Primary vaccination with DT vaccine is used in children with contraindication for pertussis vaccination. Booster vaccination Children, who received complete primary course of vaccination against diphtheria and tetanus. The adequate level of immunisation is achieved after administration of all doses of the vaccine according to the National Immunization Program, which contains information about these vaccinations. The vaccine complies with the requirements of the European Pharmacopoeia and the World Health Organization (WHO). 2. What you need to know before you use DT Diphtheria-tetanus vaccine adsorbed Do not use DT Diphtheria-tetanus vaccine adsorbed: 1

2 if your child is allergic to diphtheria toxoid and/or tetanus toxoid or any of the other ingredients of this vaccine (listed in section 6). Symptoms may include: itchy rush, shortness of breath, swelling of face and tongue, if there are acute disease states with fever. Mild infection such as a common cold, should not be a contraindication for vaccine administration, but it is necessary to inform your doctor before, if there are chronic diseases in exacerbation phase. In these cases vaccination should be performed after regression of a disease exacerbation, if thrombocytopenia (increased risk of bleeding and bruising) or neurological disorders occurred after previous vaccination against tetanus and/or diphtheria. If any contraindication exist it is necessary to assess the risk connected with administration of DT Diphtheria-tetanus vaccine adsorbed in relation to the risk of infection. Warnings and precautions Talk to your doctor or nurse before using DT Diphtheria-tetanus vaccine adsorbed, if you notice any side effects mentioned in point 4. or any other side effects after the previous dose of the vaccine. The vaccination should be preceded by a clinical examination and a review of medical history with special regard to general health condition and previous vaccinations. This precaution allows to anticipate possible risk of side effects of DT Diphtheria-tetanus vaccine adsorbed administration. Following injection, your child should remain under medical supervision for 30 minutes. The vaccine contains thiomersal as a preservative and it is possible that your child may experience an allergic reaction. Tell your doctor about any known child s allergies. Tell your doctor if your child have experienced any health problems after previous administration of a vaccine. Other medicines and DT Diphtheria-tetanus vaccine adsorbed DT Diphtheria-tetanus vaccine adsorbed 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. In children undergoing immunosuppressive treatment or with immune deficiency immunological response may be reduced. In such situations your doctor may decide to postpone the vaccination until the end of therapy and to assess anti-diphtheria and anti-tetanus antibodies level following vaccination. Tell your doctor if your child is taking or have recently taken or might take any other medicines. Pregnancy and breast-feeding Not applicable. The vaccine is used in children only. Driving and using machines Not applicable. The vaccine is used in children only. 3. How to use DT diphtheria-tetanus vaccine adsorbed The vaccine will be administered by doctor or nurse as a deep subcutaneous injection. The vaccine must never be administered intravascularly. Dosage in primary and booster vaccination Primary vaccination 2

3 Primary vaccination consists of three doses of vaccine: First dose at the turn of the third and the fourth month of life Second dose in the fifth month of life (6 weeks after the first vaccination) Third dose between the sixteenth and the eighteen month of life (11-13 months after the second dose) Booster vaccination 1 dose in the sixth year of life. In the seventh year of life in case of lack of possibility to perform vaccination in the sixth year of child s life. Children older than seven years should be vaccinated with tetanus-diphtheria vaccine with reduced tetanus toxoid (Td vaccine). If you use more DT Diphtheria-tetanus vaccine adsorbed than you should Overdose in unlikely. The packaging contains single dose only. If you have any further questions, please contact your doctor. If you stop using DT Diphtheria-tetanus vaccine adsorbed If you have any further questions on the use of this vaccine, ask your doctor, pharmacist or nurse. 4. Possible side effects Like all medicines, this vaccine can cause side effects, although not everybody gets them: Frequency not known (cannot be estimated from the available data): Hypersensitivity Headache, this symptom usually subside within hours Gastrointestinal disorders General disorders: excess sweating, shivers, increased body temperature, malaise. These symptoms usually subside within hours Administration site conditions: redness, swelling and/or pain, itching at administration site. There may also appear itching with lymphocytic infiltration. This type of reactions usually appear in repeatedly vaccinated patients. Subcutaneous nodules granulomas may also appear, sometimes transforming into aseptic abscesses (frequency of 1/ ). Granulomas that do not disappear within 6 weeks may be a result of developing hypersensitivity to aluminium. These symptoms usually subside within hours. In very premature infants (born 28 th week of gestation) there may appear longer pauses in breathing within 2-3 days following vaccination. Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible 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. Side effects can also be reported to the Marketing Authorisation Holder. By reporting side effects you can help provide more information on the safety of this vaccine. 5. How to store DT diphtheria-tetanus vaccine adsorbed 3

4 Store in an upright position in a refrigerator (2 C - 8 C ). Do not freeze. Dispose of the vaccine, once it has been frozen. 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 packaging. The expiry date refers to the last day of that month. 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 DT Diphtheria-tetanus vaccine adsorbed contains The active substances are: Diphtheria toxoid 1 not less than 30 IU Tetanus toxoid 1 not less than 40 IU 1 adsorbed on aluminium hydroxide, hydrated not more than 0.7 mg Al 3+ The other excipients are: thiomersal, sodium chloride, water for injection. What DT diphtheria-tetanus vaccine adsorbed looks like and contents of the pack The vaccine is a milky, homogenous, cream shade suspension in glass ampoules. Upon storage, a white sediment forms at the bottom of the ampoule and clear supernatant (liquid) above. 5 ampoules in a cardboard box. Marketing Authorisation Holder and Manufacturer IBSS BIOMED S.A. Al. Sosnowa Krakow, Poland Tel: Fax: bdu@biomed.pl This leaflet was last revised in: July The following information is intended for healthcare professionals only Administration of DT Diphtheria-tetanus vaccine adsorbed Shake before use to achieve homogenous suspension. The vaccine should be visually inspected for any foreign particulate matter and/or any changes in physical appearance. In case of any changes, do not use the vaccine. A dose of 0.5 ml should be administered as a deep subcutaneous injection (intramuscular administration of the vaccine is also recommended in order to minimize local reactions associated with presence of adjuvant). Deltoid muscle or anterolateral part of the thigh are recommended injection sites. Do not inject intravascularly! Make sure that the needle is not introduced into a blood vessel. 4

5 Note: 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. If diphtheria vaccine is contraindicated, tetanus vaccine should only be administered. Monovalent diphtheria vaccine may be used, if there are no contraindications to use it and tetanus vaccine is contraindicated. 5

Package leaflet: Information for the user

Package leaflet: Information for the user Clodivac, suspension for injection Diphtheria and tetanus vaccine, adsorbed, reduced antigen content Not less than 40 IU of tetanus toxoid and not less than 5