Quốc gia: Liên Minh Châu Âu
Ngôn ngữ: Tiếng Anh
Nguồn: EMA (European Medicines Agency)
Neisseria meningitidis group C polysaccharide conjugated to tetanus toxoid, Neisseria meningitidis group A polysaccharide conjugated to tetanus toxoid, Neisseria meningitidis group Y polysaccharide conjugated to tetanus toxoid, Neisseria meningitidis group W-135 polysaccharide conjugated to tetanus toxoid
Sanofi Pasteur
J07AH08
meningococcal group A, C, W-135 and Y conjugate vaccine
Vaccines
Meningitis, Meningococcal
MenQuadfi is indicated for active immunisation of individuals from the age of 12 months and older against invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W, and Y.The use of this vaccine should be in accordance with available official recommendations.
Revision: 8
Authorised
2020-11-18
33 B. PACKAGE LEAFLET 34 Package leaflet: Information for the user MenQuadfi, solution for injection Meningococcal group A, C, W and Y conjugate vaccine This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects. Read all of this leaflet carefully before you or your child are given this vaccine because it contains important information for you or your child. 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 or your child only. Do not pass it on to others If you or 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 MenQuadfi is and what it is used for 2. What you need to know before you or your child are given MenQuadfi 3. How MenQuadfi is given 4. Possible side effects 5. How to store MenQuadfi 6. Contents of the pack and other information 1. What MenQuadfi is and what it is used for MenQuadfi (MenACWY) is a vaccine that can be given to children from 1 year of age, adolescents and adults. MenQuadfi helps to protect against infections caused by a type of bacteria (germs) called “Neisseria meningitidis”, specifically against types A, C, W and Y. Neisseria meningitidis bacteria (also called meningococci) can be passed from person to person and can cause serious and sometimes life-threatening infections, such as: Meningitis – an inflammation of the tissues that surround the brain and spinal cord; Septicaemia – an infection of the blood. Both infections can result in serious disease with long lasting effects or possibly death. MenQuadfi should be used in accordance with official national guidelines. How the vaccine works MenQuadfi works by stimulating the vaccinated person Đọc toàn bộ tài liệu
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. 1. NAME OF THE MEDICINAL PRODUCT MenQuadfi solution for injection Meningococcal Group A, C, W and Y conjugate vaccine 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One dose (0.5 mL) contains: Neisseria meningitidis group A polysaccharide 1 10 micrograms Neisseria meningitidis group C polysaccharide 1 10 micrograms Neisseria meningitidis group Y polysaccharide 1 10 micrograms Neisseria meningitidis group W polysaccharide 1 10 micrograms 1 Conjugated to tetanus toxoid carrier protein 55 micrograms For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection. Clear colourless solution. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications MenQuadfi is indicated for active immunisation of individuals from the age of 12 months and older against invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W, and Y. The use of this vaccine should be in accordance with available official recommendations. 4.2 Posology and method of administration Posology Primary vaccination: • Individuals 12 months of age and older: One single dose (0.5 mL). Booster vaccination: • A single 0.5 mL dose of MenQuadfi may be used to boost subjects who have previously received a meningococcal vaccine containing the same serogroups (see section 5.1). • Long-term antibody persistence data following vaccination with MenQuadfi are available up to 7 years after vaccination (see sections 4.4 and 5.1). 3 • There are no data available to indicate the need for or timing of a booster dose of MenQuadfi (see section 5.1). Other paediatric population The safety and immunogenicity of MenQuadfi in individuals under 12 months of age have not yet been established. Method of administration For intramuscula Đọc toàn bộ tài liệu