Ülke: Avrupa Birliği
Dil: İngilizce
Kaynak: EMA (European Medicines Agency)
Diphtheria toxoid, tetanus toxoid, Bordetella pertussis antigens: pertussis toxoid, filamentous haemagglutinin, pertactin, fimbriae Types 2 and 3, hepatitis B surface antigen produced in yeast cells, poliovirus (inactivated): type 1 (Mahoney), type 2 (MEF-1), type 3 (Saukett) produced in Vero cells/ Haemophilus influenzae type b polysaccharide (polyribosylribitol phosphate) conjugated to meningococcal protein.
MCM Vaccine B.V.
J07CA09
diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and Haemophilus type b conjugate vaccine (adsorbed)
Vaccines
Meningitis, Haemophilus; Poliomyelitis; Tetanus; Diphtheria; Whooping Cough; Hepatitis B
Vaxelis (DTaP-HB-IPV-Hib) is indicated for primary and booster vaccination in infants and toddlers from the age of 6 weeks, against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and invasive diseases caused by Haemophilus influenzae type b (Hib). The use of Vaxelis should be in accordance with official recommendations.
Revision: 14
Authorised
2016-02-15
31 B. PACKAGE LEAFLET 32 PACKAGE LEAFLET: INFORMATION FOR THE USER VAXELIS SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE Diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), polio myelitis ( inactivated), and Haemophilus type b conjugate vaccine (adsorbed). READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOUR CHILD IS VACCINATED WITH THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • Keep this leaflet. You may need to read it again. • If you have a ny further questions, ask your doctor, pharmacist or nurse. • This medicine has been prescribed for you r child only. Do not pass it on to others. • If your child 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 Vaxelis is and what it is used for 2. What you need to know before Vaxelis is given to your child 3. How to use Vaxelis 4. Possible side effects 5. How to store Vaxelis 6. Contents of the pack and other information 1. WHAT IS VAXELIS AND WHAT IT IS USED FOR Vaxelis is a vaccine, which helps to protect your child against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and serious diseases caused by Haemophilus influenzae type b. Vaxelis is given to children from the age of six weeks. The vaccine works by causing the body to produce its own protection (antibodies) against the bacteria and viruses that cause the following diseases : • Diphtheria: a bacterial infection that usually first affects the throat , causing pain and swelling which can lead to suffocation. The bacteria also make a toxin (poison) that can damage the heart, kidneys and nerves. • Tetanus (often called lock jaw) : caused by the tetanus bacteria entering a deep wound. The bacteria make a toxin (poiso n) that causes spasms of the muscles, leading to inability to breathe and the possibility of suffocation. • Pertussis (often called whooping cough) : a highly infectious illness that affects the airways. It causes Belgenin tamamını okuyun
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Vaxelis suspension for injection in pre- filled syringe Vaxelis suspension for injection Diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), polio myelitis ( inactivated), and Haemophilus type b conjugate vaccine (adsorbed). 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One dose (0.5 mL) contains: Diphtheria Toxoid 1 not less than 20 IU 6 Tetanus Toxoid 1 not less than 40 IU 6 Bordetella pertussis antigens 1 Pertussis Toxoid (PT) 20 micrograms Filamentous Haemagglutinin (FHA) 20 micrograms Pertactin (PRN) 3 micrograms Fimbriae Types 2 and 3 (FIM) 5 micrograms Hepatitis B surface antigen 2,3 10 micrograms Poliovirus (Inactivated) 4 Type 1 (Mahoney) 40 D antigen units 5 Type 2 (MEF -1) 8 D antigen units 5 Type 3 (Saukett) 32 D antigen units 5 Haemophilus influenzae type b polysaccharide (Polyribosylribitol Phosphate) 3 micrograms Conjugated to meningococcal protein 2 50 micrograms 1 adsorbed on aluminium phosphate (0.17 mg Al 3+ ) 2 adsorbed on amorphous aluminium hydroxyphosphate sulfate (0.15 mg Al 3+ ) 3 produced in yeast ( Saccharomyces cerevisiae ) cells by recombinant DNA technology 4 produced in Vero cells 5 or equivalent antigenic quantity determined by a suitable immunochemical method 6 or equivalent activity determined by an immunogenicity evaluation . The vaccine may contain traces of glutaraldehyde, formaldehyde, neomycin, streptomycin, polymyxin B, and bovine serum albumin which are used during the m anufacturing process (see section 4.3). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Suspension for injection (injection). U niform, cloudy, white to off -white suspension. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Vaxelis (DTaP-HB-IPV- Hib) is indicated for primary a nd booster vaccination in infants and toddlers from the age of 6 weeks , against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and invasive diseases caused by Haemophilus influenzae type b (Hi Belgenin tamamını okuyun