Држава: Аустралија
Језик: Енглески
Извор: Department of Health (Therapeutic Goods Administration)
Neisseria meningitidis serogroup B recombinant lipidated- factor H binding protein subfamily A, Quantity: 60 microgram; Neisseria meningitidis serogroup B recombinant lipidated- factor H binding protein subfamily B, Quantity: 60 microgram
Pfizer Australia Pty Ltd
Neisseria meningitidis serogroup B recombinant lipidated- factor H binding protein subfamily A,Neisseria meningitidis serogroup
Injection, suspension
Excipient Ingredients: water for injections; aluminium phosphate; histidine; sodium chloride; polysorbate 80
Intramuscular
1
(S4) Prescription Only Medicine
Trumenba is indicated in individuals 10 years and older for active immunisation to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroup B.
Visual Identification: Homogenous white suspension; Container Type: Syringe; Container Material: Glass Type I Clear; Container Life Time: 48 Months; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Licence status A
2017-09-14
TRUMENBA ® _Meningococcal group B vaccine_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Trumenba. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you or your child being given Trumenba against the benefits it is expected to have for you or your child. IF YOU HAVE ANY CONCERNS ABOUT THIS VACCINATION, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET. You may need to read it again. WHAT TRUMENBA IS USED FOR Trumenba is a vaccine, a type of medicine used to protect against infectious diseases. Trumenba is used to prevent invasive meningococcal disease caused by bacteria called Neisseria meningitidis serogroup B. The Neisseria meningitidis bacteria can cause serious and sometimes life- threatening infections such as meningitis (inflammation of the covering of the brain and spinal cord) and sepsis (blood poisoning). Trumenba does not help to protect against meningococcal disease caused by other types of Neisseria bacteria. It does not protect against meningitis and blood poisoning caused by other bacteria or viruses. When a person is given Trumenba, the immune system (the body's natural defence system) will produce its own protection (antibodies) against disease. Your body usually takes several weeks after vaccination to develop protection against invasive meningococcal disease. Most people will produce enough antibodies to protect them against invasive meningococcal disease. However, as with all vaccines, 100% protection cannot be guaranteed. Trumenba will not give you or your child meningococcal disease. The chance of a severe reaction from Trumenba is very small, but the risks from not being vaccinated against invasive meningococcal disease may be very serious. Trumenba is used in adults and children aged 10 years and older. BEFORE YOU ARE GIVEN TRUMENBA _WHEN YOU MUST NOT BE GIVEN_ _IT_ YOU SHOULD NOT BE GIVEN TR Прочитајте комплетан документ
Version: pfptrubi10219 Supersedes: pfptrubi11118 Page 1 of 15 AUSTRALIAN PRODUCT INFORMATION - TRUMENBA (MENINGOCOCCAL GROUP B VACCINE) SUSPENSION FOR INJECTION PRE-FILLED SYRINGE 1. NAME OF THE MEDICINE Meningococcal group B vaccine. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 0.5 mL dose contains: _Neisseria meningitidis_ serogroup B recombinant lipidated- factor H binding protein subfamily A 60 µg factor H binding protein subfamily B 60 µg Trumenba is a sterile homogeneous white suspension composed of two recombinant lipidated factor H binding protein (fHBP) variants from _Neisseria meningitidis_ serogroup B, one from fHBP subfamily A and one from subfamily B (A05 and B01, respectively). EXCIPIENT(S) WITH KNOWN EFFECT: • Sodium For the full list of excipients, see Section 6.1 - List of excipients. 3. PHARMACEUTICAL FORM Suspension for injection pre-filled syringe. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Trumenba is indicated in individuals 10 years and older for active immunisation to prevent invasive meningococcal disease caused by _Neisseria meningitidis_ serogroup B. 4.2 DOSE AND METHOD OF ADMINISTRATION The vaccine should be shaken vigorously to ensure that a homogeneous white suspension is obtained. Do not use the vaccine if it cannot be re-suspended. The vaccine should be visually inspected for particulate matter and discoloration prior to administration. This product should not be used if particulate matter or discoloration is found. Version: pfptrubi10219 Supersedes: pfptrubi11118 Page 2 of 15 DOSAGE Standard schedule for routine immunisation: 2 doses (0.5 ml each) administered at 0 and 6 months. Schedule for individuals at increased risk of invasive meningococcal disease: 2 doses (0.5 ml each) administered at least 1 month apart, followed by a third dose at least 4 months after the second dose. The choice of dosing schedule may depend on the risk of exposure and the patient’s susceptibility to meningococcal B disease. METHOD OF ADMINISTRATION For intramuscular injection only Прочитајте комплетан документ