The recommended minimum interval between doses in this age group has recently changed to 8 weeks (from 4 weeks). Download Bexsero PI (PDF-231KB) Dintre subiecţii cărora li s-a administrat seria de doze de Bexsero din cadrul imunizării primare, la 3 285 s-a Ask your doctor for advice whether it is beneficial for you to receive Bexsero. Ibuprofen may be given as an alternative to paracetamol. For adolescents aged 15-20 years, two doses 8 weeks apart is best. Vakcina veikia stimuliuodama natūralų žmogaus organizmo pasipriešinimą infekcijai. Our evidence review concludes that the MenB, Bexsero® vaccine will provide signficant direct protection for those most at risk. Clinical Infectious Diseases. 2021;73(1):e233-e7. Ūminis kraujagyslių funkcijos nepakankamumas (staigus raumenų suglebimas), silpnesnė nei įprastai reakcija ar budrumo stoka, blyškumas ar melsva odos spalva mažiems vaikams. Meningococcal group A rarely causes disease in NZ. – The interval between each injection should be at least 2 months. Lancet. Atidžiai perskaitykite visą šį lapelį, prieš pradėdami vartoti vaistą ar prieš tai, kai jis bus skiriamas Jūsų vaikui, nes jame pateikiama Jums ar Jūsų vaikui svarbi informacija. Bexsero can be administered at the same visit as other vaccines in separate syringes and at separate injection sites. Bexsero beskytter kun mod type B meningokokker, som imidlertid er årsagen til den mest udbredte meningokok-meningitis i Danmark. For this reason, your healthcare provider may ask you to sit or lie down for 15 minutes after receiving BEXSERO. In 2022, group B was the prominent type causing 80% of group-identified cases, and group Y and group W made up the other cases. 4.6 Fertility, pregnancy and lactation Pregnancy Insufficient clinical data on exposed pregnancies are available. If you want to ask a question or request information from EMA, please Send a question to the European Medicines Agency. 2 Qualitative and Quantitative Composition. Medical indications|Products|Therapy Area, All Medical indications|All Products|All Therapy Area, Bexsero: Help protect against a broad population¹. Infants 6 months to 11 months of age should receive two injections of the vaccine followed by an additional injection (booster). Visit our Public site, Not a healthcare professional? Laikyti šaldytuve (2 °C – 8 °C). Medsafe. Community Pharmaceutical Schedule [Internet]. Provided they are medically stable and there are no contraindications to vaccination, preterm infants should receive vaccines according to the recommended schedule at their chronological age. Tarp kiekvienos dozės turi būti ne trumpesnė kaip 1 mėnesio pertrauka. Added version v05.00 - see change history on page 2. Martinon-Torres F, Carmona Martinez A, Simko R, Marquez PI, Arimany J-L, Gimenez-Sanchez F, et al. Lancet Infect Dis. Gali būti tiekiamos ne visų dydžių pakuotės. Bexsero is approved for use from 8 weeks of age, however, infants eligible to funded meningococcal vaccination and high risk of meningococcal disease can receive Bexsero from 6 weeks of age.The recommended number of Bexsero doses is determined by the age of the individual when they receive their first Bexsero vaccination. Please note this could take up to 10 days. This site is intended for US healthcare professionals only. Among BEXSERO recipients, 4843 were infants and children (less than 2 years of age), and 1584 were adolescents and adults (from 11 years of age), respectively. in the vaccine is low. If the child is miserable or distressed because of a fever or injection site pain 6 hours after the third dose of paracetamol and is otherwise well: The parent can continue to administer the paracetamol doses with a minimum of 6 hours between doses until the discomfort resolves or 48 hours after vaccination, whichever occurs first, No more than four doses of paracetamol can be given in a 24-hour period, A child who is miserable or distressed because of a fever or injection site pain 48 hours or more after vaccination is advised to be seen by their doctor, Make sure the room is not too hot or too cold, Hold a cool damp cloth or an ice pack well wrapped in a dry cloth on the injection site, Anyone with severe allergy (anaphylaxis) to a previous dose of the vaccine or any component of the vaccine. Keep this vaccine out of the sight and reach of children. The following information is intended for healthcare professionals only: Upon storage a fine off-white deposit may be observed in the pre-filled syringe containing the suspension. You may receive an additional injection (booster). 50 mikrogramů 50 mikrogramů 25 mikrogramů. Vaccines work by ‘teaching’ the immune system (the body’s natural defences) how to defend itself against a disease. The most common side effects are pain, redness or hardness at the injection site; muscle pain; fatigue; headache; nausea; and joint pain. Event Account activated - pending validation. Wellington:PHARMAC. 2016;34(7):875-80. Stiprinamojidozė bus suleista antraisiais gyvenimo metais, praėjus ne mažiau kaip 2 mėnesiams nuo antrosios dozės. Laikyti gamintojo pakuotėje, kad vaistas būtų apsaugotas nuo šviesos. You may need to read it again. Of those who get it 10-20% get severe organ and tissue damage and can require life-long care; while 10-15% who get it die. The bad news is its price: £75 per dose. For optimal user experience, please view this site in Chrome, Firefox, Safari, or Edge. Bexsero yra B grupės meningokokų vakcina. You can change your cookie settings at any time. Here is a babies father discussing his experience at the clinic. A summary of the review follows, and you can read the full review here. Those with bleeding disorders, such as haemophilia. Bexsero, a multicomponent recombinant vaccine against meningococcal group B disease only is available in New Zealand. The most common vaccine responses include fever and discomfort or pain around the injection site. Bexsero should be administered with caution to individuals with coagulation defects. Jeigu apie šį vaistą norite sužinoti daugiau, kreipkitės į vietinį registruotojo atstovą: GlaxoSmithKline Pharmaceuticals SA/NV Tél/Tel: + 32 10 85 52 00, Šis pakuotės lapelis paskutinį kartą peržiūrėtas {MM/YYYY}. VACANCY: Senior Māori Advisor: Support Māori health planning and implementation on immunisation for IMAC. There are limited data on the use of Bexsero in patients with chronic medical conditions or with weakened immunity. What BEXSERO is and what it is used for, 2. 3 DOSAGE FORMS AND STRENGTHS BEXSERO is a suspension for intramuscular injection in 0.5-mL single-dose prefilled What you need to know before you or your child receive Bexsero, 6. PLoS One. All rights reserved. Vakcína proti meningokokům skupiny B (rDNA, komponentní, adsorbovaná) 2. Fever (>38.5°C) is a common reaction following any vaccine, but is more common with Bexsero® in young children aged less than 2 years. While fever occurs after administration of many vaccines, during pre-market evaluation of the vaccine, the TGA identified that Bexsero commonly induced fever in infants . Jei žinote, kad Jūs arba Jūsų vaikas esate alergiški lateksui, pasakykite tai gydytojui arba slaugytojui. Immunisation generates circulating antibodies. Jeigu pasireiškė šalutinis poveikis (net jeigu jis šiame lapelyje nenurodytas), kreipkitės į gydytoją arba slaugytoją. We’d like to set additional cookies to understand how you use GOV.UK, remember your settings and improve government services. Bexsero was first approved for use in Europe in 2013, since then the vaccine has been approved for use in more than 40 countries including Australia, the United Kingdom and the United States. – Kawasaki disease which may include symptoms such as fever that lasts for more than five days, associated with a skin rash on the trunk of the body, and sometimes followed by a peeling of the skin on the hands and fingers, swollen glands in the neck, red eyes, lips, throat and tongue, Adolescents (from 11 years of age) and adults, – pain at the injection site resulting in inability to perform normal daily activity. It can be given as part of other routine vaccinations for infants and children, along with prophylactic paracetemol. Bexsero is provided as a 0.5mL suspension in a pre-filled syringe in a single-dose pack. Clinical experience with the meningococcal B vaccine, Bexsero: Prospects for reducing the burden of meningococcal serogroup B disease. 2017;35(2):395-402. Q: Isn't my child already protected having previously received a meningococcal conjugate (MenACWY) vaccine? When giving two intramuscular (IM) injections in the same limb in infants, the vastus lateralis is preferred because of its greater muscle mass. Not a healthcare professional? There are 13 known meningococcal serogroups, distinguished by differences in surface polysaccharides of the bacterium's outer membrane capsule. Protect from light. The suspension is white opalescent liquid. BEXSERO is indicated for active immunisation against invasive disease caused by N. meningitidis group B strains. News stories, speeches, letters and notices, Reports, analysis and official statistics, Data, Freedom of Information releases and corporate reports. Dose 3 not needed if dose 2 is administered at least 6 months after dose 1. However, the active component of the MeNZB vaccine has contributed to the successful development of Bexsero. Q: Is my infant going to need to come back for repeated visits to complete routine vaccinations? in the case of infants who have been exposed to TNF-a inhibitors and other immunosuppressive biological medicines in utero, PHE advise that any live attenuated vaccination (e.g. muscle or joint pain; nausea, diarrhea; or. Trumenba® is a 3-dose series administered at 0, 1-2, and 6 months. Trumpalaikis kvėpavimo sustojimas arba nereguliarus kvėpavimas tokiems kūdikiams gali pasireikšti dažniau per pirmąsias tris paras po paskiepijimo vakcina ir todėl jiems gali prireikti specialaus stebėjimo; Jeigu Jums arba Jūsų vaikui yra alergija antibiotikui kanamicinui. Practitioners should follow local policy and procedures to access authorised PGD documents. Prymula R, Esposito S, Zuccotti GV, Xie F, Toneatto D, Kohl I, et al. Bexsero injekční suspenze v předplněné injekční stříkačce. Bexsero has no or negligible influence on the ability to drive and use machines. Vaccination is  also recommended for adolescents and young adults at increased risk of meningococcal disease due to life-style factors. Fact sheet: Meningococcal vaccines for Australians [Internet]. Two main studies showed that Bexsero was effective at stimulating an immune response to N. meningitidis group B. Taip apsisaugoma nuo ligos. There is no evidence the MenB reduced nasopharyngeal carriage of disease causing meningococci. Stopping breathing or irregular breathing for a short time may be more common in the first three days following vaccination in these babies and they may need special monitoring. It targets disease caused by strains of Neisseria meningitidis serogroup B (Men B). Prophylactic antibiotics are required to prevent breakthrough disease in children receiving eculizumab. Boosters and extra boosters can be considered dependent upon risk. These bacteria can cause serious, and sometimes life . Délaissée par son mari et débordée par ses deux adorables bambins, Eliza Welch n'a plus ni l . Pour rappel, selon l'avis du HCSP du 25 octobre 2013 relatif à l'utilisation du vaccin BEXSERO, les personnespour lesquelles la vaccination contre les IIMde sérogroupe B est recommandée sont: les personnels des laboratoires de recherche travaillant spécifiquement sur leméningocoque ; – if your child was born prematurely (before or at 28 weeks of pregnancy), particularly if they had. Following vaccination, 90% of haematopoietic stem cell transplant (HSCT) recipients had bactericidal antibody response to at least one vaccine antigen (ranging from 15% to 78%). Group B is predominant in NZ, with 14 PorA subtypes detected. Recombinant Neisseria meningitidis group B NHBA fusion protein 1, 2, 3, Recombinant Neisseria meningitidis group B NadA protein 1, 2, 3, Recombinant Neisseria meningitidis group B fHbp fusion protein 1, 2, 3, Outer membrane vesicles (OMV) from Neisseria meningitidis group B strain, NZ98/254 measured as amount of total protein containing the PorA P1.4 2, produced in E. coli cells by recombinant DNA technology, adsorbed on aluminium hydroxide (0.5 mg Al3+), NHBA (Neisserial Heparin Binding Antigen), NadA (Neisseria adhesin A), fHbp (factor H binding protein). Bexsero is a vaccine used to protect individuals from the age of two months against invasive meningococcal disease caused by one group of the bacterium Neisseria meningitidis (group B). The vaccine contains three recombinant protein antigens, plus the principal component of the historical MeNZB vaccine that acts as an adjuvant for the other antigens. Jeigu Jūs ar Jūsų vaikas vartojate ar neseniai vartojote kitų vaistų arba dėl to nesate tikri, apie tai pasakykite gydytojui arba slaugytojui. Please note this could take upto 10 days. CDC also recommends meningococcal vaccination for other children and adults who are at increased risk for . Your child should receive an initial course of two or three injections of the vaccine followed by an additional injection (booster). For more information about using Bexsero, see the package leaflet or contact your doctor or pharmacist. Šios bakterijos gali sukelti sunkias, kartais pavojų gyvybei keliančias infekcines ligas, pvz., meningitą (galvos ir nugaros smegenų dangalų uždegimą) ar sepsį (kraujo užkrėtimą). 2. In case of delay, the booster should not be given later than 24 months of age. Your doctor or nurse may ask you to give your child medicines that lower fever at the time and after Bexsero has been given. Vaccine. 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