Valsts: Malta
Valoda: angļu
Klimata pārmaiņas: Medicines Authority
Bilthoven Biologicals B.V. Antonie van Leeuwenhoeklaan 9 3721 MA, Bilthoven, Netherlands
J07CA01
DIPHTHERIA TOXOID >5 IU POLIOVIRUS (INACTIVATED) TYPE 1 (MAHONEY STRAIN) 40 DAgU POLIOVIRUS (INACTIVATED) TYPE 2 (MEF-1 STRAIN) 4 DAgU POLIOVIRUS (INACTIVATED) TYPE 3 (SAUKETT STRAIN) 7.5 DAgU TETANUS TOXOID >20 IU
SUSPENSION FOR INJECTION
DIPHTHERIA TOXOID >5 IU POLIOVIRUS (INACTIVATED) TYPE 1 (MAHONEY STRAIN) 40 DAgU POLIOVIRUS (INACTIVATED) TYPE 2 (MEF-1 STRAIN) 4 DAgU POLIOVIRUS (INACTIVATED) TYPE 3 (SAUKETT STRAIN) 7.5 DAgU TETANUS TOXOID >20 IU
POM
VACCINES
Authorised
2024-02-09
Page 1 of 6 PACKAGE LEAFLET: INFORMATION FOR THE USER DIPHTHERIA, TETANUS, POLIOMYELITIS VACCINE, SUSPENSION FOR INJECTION Diphtheria toxoid, tetanus toxoid, polio trivalent bulk READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE 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 medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - 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-IPV vaccine is and what is it used for 2. When you need to know before you use DT-IPV vaccine 3. How should to use DT-IPV vaccine 4. Possible side effects 5. How to store DT-IPV vaccine 6. Contents of the pack and other information 1. WHAT DT-IPV VACCINE IS AND WHAT IS IT USED FOR Diphtheria, Tetanus, Poliomyelitis (DT-IPV) vaccine belongs to the drug group known as vaccines. Most medicines combat the effects of a disease. A vaccine, on the other hand, is given to healthy individuals and helps to protect them against infectious diseases and the problems they cause. DT-IPV vaccine is intended for protection against diphtheria, tetanus and polio. Each of these diseases is caused by a specific bacterium or, in the case of polio, a virus. The vaccine contains each of these pathogens in an inactivated and therefore harmless form. In response to contact with the inactivated pathogens, the cells of the immune system begin to produce antibodies that render the pathogens harmless. What’s more, the immune system remembers the characteristics of the pathogens and how they can be fought against. In this way, vaccination creates long-term protection against diphtheria, tetanus and polio. The moment a person who is vaccinated against DT-IPV comes into contact with the Izlasiet visu dokumentu
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Diphtheria, Tetanus, Poliomyelitis vaccine, suspension for injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 dose (1 mL) contains: - Diphtheria toxoïd* ≥ 5 international units - Tetanus toxoïd* ≥ 20 international units - Polio trivalent bulk • Type I inactivated poliovirus (Mahoney)** 40 D-antigen units • Type 2 inactivated poliovirus (MEF 1)** 4 D-antigen units • Type 3 inactivated poliovirus (Saukett)** 7.5 D-antigen units *) Adsorbed onto 1.5 mg of hydrated aluminium phosphate, equivalent to 12.3 micromoles of Al 3+ **) Grown on Vero cells. For a full list of excipients, see Section 6.1. 3 PHARMACEUTICAL FORM Suspension for injection The colour of the vaccine is orange-red. 4 CLINICAL DATA 4.1 THERAPEUTIC INDICATIONS Active immunisation against diphtheria, tetanus and poliomyelitis. Diphtheria, Tetanus, Poliomyelitis vaccine (DT-IPV) is indicated for use in children from 5 years of age, for adolescents and for adults for primary vaccination and as a re-vaccination after primary vaccination against diphtheria, tetanus and poliomyelitis. The use of DT-IPV must be based on official recommendations. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Dosage One dose contains 1 mL. _Primary vaccination _ Basic immunisation is given by a primary series of two doses, at least 1 month apart, followed by a third dose at least 6 months after the second dose. _Re-vaccination _ A single 1 mL dose _Paediatric patients _ Due to its composition, DT-IPV is not suitable for primary immunisation in children under 5 years of age. Method of administration For instructions of the medicinal product before administration, see section 6.6 The vaccine must be swirled before use. This makes the vaccine cloudy. DT-IPV is administered intramuscularly, preferably in the deltoid muscle 4.3 CONTRAINDICATIONS - Hypersensitivity to the active substances or to (any of) the excipients listed in Section 6.1. - DT-IPV administration should be postponed if someone suffers fr Izlasiet visu dokumentu