injection,\u00a0suspension\u00a0in pre-filled\u00a0syringe
Diphtheria\u00a0vaccine, tetanus, pertussis (\u00a0acellular\u00a0component), and (inactivated) polio<\/p>\n\n\n\n
Repevax (Tdap-IPV) is a vaccine.\u00a0Vaccines are used to protect against infectious diseases.\u00a0They work by getting the body to produce its protection (\u00a0antibodies\u00a0) against bacteria and\u00a0viruses\u00a0that cause the diseases to be fought.<\/p>\n\n\n\n
This vaccine is used for children over 3 years of age, adolescents, and for adults as a booster dose to protect against\u00a0diphtheria, tetanus, pertussis, and polio after a complete basic vaccination (primary vaccination series).<\/p>\n\n\n\n
The use of Repevax during pregnancy provides protection that can be transmitted to the baby in the womb and protect the baby against whooping cough during the first months of life.<\/p>\n\n\n\n
Restrictions <\/strong>on the protection afforded by the vaccine<\/strong><\/p>\n\n\n\n Repevax protects against the mentioned diseases only if they are caused by the bacteria and\u00a0viruses\u00a0for which the vaccine is intended.\u00a0You or your child can still get similar diseases if they are caused by other bacteria and\u00a0viruses.<\/p>\n\n\n\n Scratch wax does not contain live bacteria or\u00a0viruses, and it can not cause any of the infectious diseases that it protects against.<\/p>\n\n\n\n Note that no vaccine gives all vaccinated people complete, lifelong protection.<\/p>\n\n\n\n To make sure that Repevax is suitable for you or your child, inform your doctor or nurse if any of the following apply to you or your child. If there is anything you do not understand in this leaflet, ask your doctor or nurse to explain it.<\/p>\n\n\n\n Tell your doctor or nurse before vaccination if you or your child has:<\/p>\n\n\n\n Fainting may occur after, or even before, any needle injection.\u00a0Therefore, tell your doctor or nurse if you or your child have fainted from a previous\u00a0injection.<\/p>\n\n\n\n Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.<\/p>\n\n\n\n Because Repevax does not contain any live bacteria or\u00a0viruses, it can generally be given at the same time as other vaccines or\u00a0immunoglobulins, but in a different place.\u00a0According to studies, Repevax can be given concomitantly with the following vaccines: an inactivated influenza vaccine, a\u00a0hepatitis\u00a0B vaccine, or a\u00a0recombinant\u00a0human papillomavirus vaccine.\u00a0The vaccines should be given to different\u00a0extremities.<\/p>\n\n\n\n If you or your child are being treated with a medicine that affects your or your child’s blood or immune system (such as blood thinners,\u00a0steroids,\u00a0chemotherapy drugs\u00a0), read the instructions given above in the section \u201cWarnings and Precautions\u201d.<\/p>\n\n\n\n Tell your doctor or nurse if you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby.\u00a0Your doctor will help you decide if you should receive Repevax during pregnancy.<\/p>\n\n\n\n No studies have been performed on whether the vaccine affects the ability to drive or use machines. The vaccine has no or negligible effect on the ability to drive and use machines.<\/p>\n\n\n\n You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention.\u00a0One of the factors that can affect your ability in these respects is the use of drugs due to their effects and\/or\u00a0side effects.\u00a0Descriptions of these effects and\u00a0side effects\u00a0can be found in other sections.\u00a0Read all the information in this leaflet for guidance.\u00a0If you are not sure, talk to your doctor or pharmacist.<\/p>\n\n\n\n Repevax contains 1.01 mg of alcohol ( ethanol ) per dose of 0.5 ml. The low amount of alcohol in this medicine does not produce any noticeable effects.<\/p>\n\n\n\n When is the vaccine given to you or your child?<\/strong><\/p>\n\n\n\n Your doctor will decide based on the following information if Repevax is suitable for you or your child:<\/p>\n\n\n\n Your doctor will decide how long it should be between vaccinations.<\/p>\n\n\n\n If you are pregnant, your doctor will help you decide if you should receive Repevax during pregnancy.<\/p>\n\n\n\n Administration and method of administration<\/strong><\/p>\n\n\n\n Who gives you the Repevax vaccine?<\/p>\n\n\n\n The Repevax vaccine should only be given by healthcare professionals who have been trained to give vaccines and who work in a clinic or clinic that has equipment for the treatment of very rare acute, severe allergic reactions.<\/p>\n\n\n\n Dosage<\/p>\n\n\n\n For all age groups, Repevax is intended for receiving an\u00a0injection\u00a0(half a milliliter).<\/p>\n\n\n\n If you or your child suffers from an injury that requires preventative measures against tetanus, your doctor may decide to give Repevax, with or without tetanus immunoglobulin.<\/p>\n\n\n\n Scratch wax can be used for revaccination. Your doctor will advise you on re-vaccination.<\/p>\n\n\n\n Method of administration<\/p>\n\n\n\n The doctor or nurse injects the vaccine into the muscle on the outside of the upper arm (deltoid muscle).<\/p>\n\n\n\n The doctor or nurse\u00a0does not<\/strong>\u00a0inject the vaccine into a blood vessel, into the gluteal muscle, or under the skin.\u00a0If you or your child has a blood clotting disorder, your doctor or nurse may decide to inject the vaccine under your skin, although it may cause a stronger local reaction, such as a small lump under your skin.<\/p>\n\n\n\n If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.<\/p>\n\n\n\n Like all medicines, Repevax can cause\u00a0side effects, although not everybody gets them.<\/p>\n\n\n\n Severe allergic reactions<\/strong><\/p>\n\n\n\n If any of these symptoms first appear after you have left the vaccination site, contact your doctor IMMEDIATELY:<\/strong><\/p>\n\n\n\n These symptoms generally appear within a very short time after vaccination, ie when you or your child is still in the clinic or doctor’s office. Severe allergic reactions are very rare (may affect up to 1 in 10,000 people) regardless of the vaccine used.<\/p>\n\n\n\n Other side effects are<\/u><\/strong><\/p>\n\n\n\n In clinical trials, the following side effects\u00a0have been observed in certain age groups.<\/p>\n\n\n\n Children from 3 to 6 years of age<\/p>\n\n\n\n Very common (may affect more than 1 user in 10):<\/p>\n\n\n\n Common (may affect up to 1 in 10 people):<\/p>\n\n\n\n Adolescents (from 11 years of age) and adults<\/p>\n\n\n\n It is a little more likely that young people get side effects than adults. Most side effects occur within 3 days after vaccination.<\/p>\n\n\n\n Very common (may affect more than 1 user in 10): <\/p>\n\n\n\n Common (may affect up to 1 in 10 people): <\/p>\n\n\n\n The following side effects have also been reported in different age groups during the time that Repevax has been on the market. How common these side effects are cannot be stated exactly, as the data are based on voluntary reporting and the number of vaccinated persons is only an estimate.<\/p>\n\n\n\n Lymph node disorders, allergic\/severe allergic reactions, seizures, fainting, paralysis of the whole body or a part of the body (Guillain-Barr\u00e9 syndrome), paralysis of the face, spinal cord inflammation, nerve inflammation in the arm (brachial neuritis), temporary decreased or altered sensation in the vaccinated body part, dizziness, pain in the vaccinated body part, extensive swelling in\u00a0extremity\u00a0one (often in combination with\u00a0redness\u00a0and sometimes with blisters), general malaise, pallor, hard lump (hardening) at the injection site, abdominal pain.<\/p>\n\n\n\n Keep out of sight and reach of children.<\/p>\n\n\n\n Scratch wax should be used before the expiry date which is stated on the label after \u201cEXP\u201d. The expiration date is the last day of the specified month.<\/p>\n\n\n\n Store in a refrigerator (2 \u00b0 C – 8 \u00b0 C). Do not freeze. Discard the vaccine if it has been frozen.<\/p>\n\n\n\n Store the syringe in the outer carton. Sensitive to light.<\/p>\n\n\n\n Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.<\/p>\n\n\n\n This vaccine contains aluminum phosphate as an\u00a0adjuvant.\u00a0Adjuvants\u00a0are ingredients found in some vaccines to accelerate, improve and\/or prolong the protective effect of the vaccine. Other ingredients are: phenoxyethanol,\u00a0ethanol, polysorbate 80, water for injections<\/p>\n\n\n\n Repevax is a\u00a0solution for injection, a\u00a0suspension\u00a0supplied in a pre-filled\u00a0syringe\u00a0(0.5 ml):<\/p>\n\n\n\n Not all pack sizes may be marketed.<\/p>\n\n\n\n The vaccine is normally a uniform, cloudy white suspension in which a precipitate may form during storage. Once shaken, the vaccine is a smooth, white solution.<\/p>\n\n\n\n Sanofi Pasteur <\/p>\n\n\n\n 14 Henry Vall\u00e9e Space<\/p>\n\n\n\n 69007 Lyon<\/p>\n\n\n\n France<\/p>\n\n\n\n Manufacturer<\/strong><\/p>\n\n\n\n Sanofi Pasteur <\/p>\n\n\n\n 14 Henry Vall\u00e9e Space<\/p>\n\n\n\n 69007 Lyon<\/p>\n\n\n\n France<\/p>\n\n\n\n or<\/p>\n\n\n\n Sanofi-Aventis Zrt.<\/p>\n\n\n\n Campona utca.1 (Harbor Park)<\/p>\n\n\n\n H-1225 Budapest<\/p>\n\n\n\n Hungary<\/p>\n\n\n\nWhat you need to know before giving Repevax to you or your child<\/h2>\n\n\n\n
Do not use Repevax if you or your child<\/h2>\n\n\n\n
Warnings and cautions<\/h2>\n\n\n\n
Other medicines and Repevax<\/h2>\n\n\n\n
Pregnancy, breastfeeding, and fertility<\/h2>\n\n\n\n
Driving and using machines<\/h2>\n\n\n\n
Scratch wax contains ethanol<\/h2>\n\n\n\n
How and when Repevax is given<\/h2>\n\n\n\n
Possible side effects<\/h2>\n\n\n\n
How to store Repevax<\/h2>\n\n\n\n
Contents of the pack and other information<\/h2>\n\n\n\n
Content declaration<\/h2>\n\n\n\n
Diphtheria toxoid<\/td> at least 2 IU (2 Lf)<\/td><\/tr> Tetanus toxoid<\/td> at least 20 IU (5 Lf)<\/td><\/tr> Pertussis antigens:<\/td><\/tr> Pertussis toxoid<\/td> 2.5 micrograms<\/td><\/tr> Filamentous hemagglutinin<\/td> 5 micrograms<\/td><\/tr> Pertactin<\/td> 3 micrograms<\/td><\/tr> Fimbria type 2 and 3<\/td> 5 micrograms<\/td><\/tr> Inactivated poliovirus (grown in Vero cells):<\/td><\/tr> Type 1 (Mahoney)<\/td> 40 D antigen units<\/td><\/tr> Type 2 (MEF1)<\/td> 8 D antigen units<\/td><\/tr> Type 3 (Sackett)<\/td> 32 D antigen units<\/td><\/tr> Adsorbed\u00a0to an aluminum embossed<\/td> 1.5 mg (0.33 mg Al3 +)<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n What the medicine looks like and the contents of the pack<\/h2>\n\n\n\n
Marketing Authorisation Holder<\/h2>\n\n\n\n