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BEXSERO Multicomponent Meningococcal Group B Vaccine (Recombinant, Adsorbed) New Zealand Consumer Medicine Information

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BEXSERO Multicomponent Meningococcal Group B Vaccine (Recombinant, Adsorbed) New Zealand Consumer Medicine Information BEXSERO Multicomponent Meningococcal group B vaccine (recombinant, adsorbed) New Zealand Consumer Medicine Information What is in this leaflet help protect against disease caused As with all vaccines, occasionally, by bacteria called Neisseria individuals may react unfavourably Read all of this leaflet carefully meningitidis group B. These bacteria to the vaccine. before you are vaccinated. can cause serious, and sometimes The chance of a severe reaction from life-threatening, infections such as This leaflet answers some common BEXSERO is very small, but the meningitis (inflammation of the questions about BEXSERO. risks from not being vaccinated covering of the brain and spinal cord) against meningococcal disease may It does not contain all the available and sepsis (blood poisoning). be very serious. information. It does not take the The vaccine works by specifically place of talking to your doctor or stimulating the body's natural pharmacist. defense system of the vaccinated The information in this leaflet was person. This results in protection BEXSERO should not last updated on the date listed on the against this disease. be given to a person final page. More recent information The use of this vaccine should be in who has: on the medicine may be available. accordance with the official You should ensure that you speak recommendations. • allergy (hypersensitivity) to the active substances or any of the to your pharmacist or doctor to Please note that BEXSERO can obtain the most up-to-date other ingredients of BEXSERO only protect you or your child from information on the medicine. listed at the end of this leaflet. meningitis caused by Neisseria Signs of an allergic reaction may Those updates may contain important meningitidis group B. information about the medicine and include: BEXSERO is not expected to its use of which you should be aware. • shortness of breath, wheezing provide protection against all or difficulty breathing, All medicines, including vaccines, circulating meningococcal group B have risks and benefits. Your doctor types. • swelling of the face, lips, has weighed the risks of you or your tongue or other parts of the child having BEXSERO against the body, benefits they expect it will have for • skin rash, itching or hives you. How BEXSERO works In addition, BEXSERO should not be If you have any concerns about this administered if: medicine, ask your doctor, nurse BEXSERO works by causing you or • the expiry date printed on the or pharmacist. your child's body to produce its own protection (or antibodies), against the pack has passed Keep this leaflet. meningococcal group B bacteria. • the packaging is torn or shows You may need to read it again. Your or your child's body usually signs of tampering. takes a couple of weeks after If you are not sure whether you or vaccination to develop protection your child should have BEXSERO, against Neisseria meningitidis group talk to your doctor, nurse or B. What BEXSERO is pharmacist. used for If a vaccinated person comes into contact with Neisseria meningitidis BEXSERO is a meningococcal group group B, the body is usually able to B vaccine. destroy it. However, as with all BEXSERO is given to individuals vaccines, 100% protection cannot be from 2 months of age and older to guaranteed. BEXSERO 1 Before you or your Fainting, feeling faint or other stress- Having other vaccines related reactions can occur as a child receives Tell your doctor if you or your response to any needle injection. BEXSERO child has had any vaccines Tell your doctor or nurse if you recently. have experienced this kind of Tell your doctor or pharmacist if BEXSERO may be given at the same reaction previously you have/your child has allergies time as other vaccinations. to: Tell your doctor if you or your When given at the same time as other • active substances or any of the child have or have had any medical vaccines, BEXSERO must be other ingredients of BEXSERO conditions especially the following: administered at a separate injection • the antibiotic kanamycin. If • an immune deficiency condition. site. BEXSERO can be given at the present, the kanamycin level in Little is known about the same time as any of the following the vaccine is low effectiveness of BEXSERO when vaccines components: administered to individuals with • latex. Although no natural rubber diphtheria, tetanus, whooping cough weakened immunity due to the latex is detected in the syringe tip (pertussis), Haemophilus influenzae use of immunosuppressive cap, the safe use of BEXSERO in type b, polio, hepatitis B, medications, or HIV infection, or latex-sensitive individuals has not pneumococcus, measles, mumps, hereditary defects of the body's been established. rubella, chickenpox and natural defence system. It is meningococcus C. Tell your doctor if in the past you possible the effectiveness of or your child have/has reacted to BEXSERO could be reduced in Your doctor may ask you to give any vaccination with any of the such individuals. your child medicines that lower fever following: after BEXSERO has been given. This The safety and efficacy of will help to reduce some of the side • severe allergic reaction BEXSERO in adults above 50 years effects of BEXSERO. • difficulty breathing of age have not been established. There are limited data on the use in Your doctor or pharmacist may have • swelling of the throat patients with chronic medical more information on medicines and Tell your doctor if you have/your conditions. vaccines that require special child has a severe infection with a precautions or should be avoided Tell your doctor if you are high temperature. during vaccination with BEXSERO. pregnant or intend to become If this is the case, then vaccination pregnant soon. will be postponed. The presence of a Your doctor will discuss the possible minor infection, such as a cold, risks and benefits of receiving should not require postponement of How BEXSERO is BEXSERO vaccine during the vaccination, but talk to your given pregnancy. Your doctor may still doctor first. recommend that you receive Tell your doctor if you receive BEXSERO if you are at risk of How it is given treatment that blocks the part of exposure to meningococcal infection. BEXSERO is given as an injection, the immune system known as Tell your doctor if you are usually into your or your child's arm complement activation, such as breastfeeding. or leg muscle. eculizumab. Even if you have been vaccinated with BEXSERO you Your doctor will discuss the possible It is important to follow the remain at increased risk of disease risks and benefits of receiving instructions from your doctor or caused by the Neisseria BEXSERO vaccine during nurse so that you or your child meningitidis group B bacteria. breastfeeding. completes the course of injections. If your child was born prematurely Tell your doctor or pharmacist if If you have any concerns about (before or at 28 weeks of pregnancy), you or your child are taking, or how this vaccine is to be given, talk particularly if they had breathing have recently taken, any other to your doctor, nurse or difficulties, please tell your doctor. medicines, including any that you pharmacist. Stopping breathing or irregular buy without a prescription from breathing for a short time may be your pharmacy, supermarket or How much is given more common in the first three days health food shop. The dose is 0.5 mL given by following vaccination in these babies injection. and they may need special You or your child may be given monitoring. more than one single dose of BEXSERO 2 BEXSERO. Please talk to your paracetamol. Before you or your • feeling faint or fainting doctor, nurse or pharmacist to get child receives vaccination, ask your • fever (adolescents from 11 years more information. doctor about the risks of fever and of age and adults), injection site You should keep a record of your/ how to treat it, including what to reactions like extensive swelling your child's vaccinations. do if fever does not respond to of the vaccinated limb, blisters at initial treatment. or around the injection site and Uncommon: hard lump at the injection site • high fever (40°C or higher), (which may persist for more than Side effects seizures (including febrile one month) seizures due to fever), dry skin, If any of the side effects gets Tell your doctor or pharmacist as paleness (rare after booster). serious, or if you notice any side soon as possible if you or your Rare: effects not listed in this leaflet, child does not feel well after having please tell your doctor. BEXSERO. • Kawasaki disease which may include symptoms such as fever No studies on the effects on the Like all vaccines, BEXSERO can that lasts for more than five days, ability to drive and use machines cause side effects, although not associated with a rash on the have been performed. everybody gets them. trunk of the body, and sometimes However, some of the side effects When BEXSERO is given to you or followed by a peeling of the skin mentioned under section Side Effects your child, the most common side on the hands and fingers, swollen may temporarily affect the ability to effects that you may get are: glands in the neck, red eyes, lips, drive or use machines. • pain at the injection site, redness throat and tongue. Ask your doctor or pharmacist to at the injection site, swelling of • Itchy rash, skin rash. answer any questions you may skin at the injection site, hardness Adolescents (from 11 years of age) have. of skin at the injection site, and Adults generally feeling unwell, headache, fever (38°C or higher) Very common: and feeling irritable. • pain at the injection site Storing BEXSERO The following side effects may occur (including severe pain at injection after receiving this vaccine: site resulting in inability to • Keep BEXSERO away from perform normal daily activity), Infants, toddlers and children (up light.
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