Država: Avstralija
Jezik: angleščina
Source: Department of Health (Therapeutic Goods Administration)
Pneumococcal purified capsular polysaccharides
Pfizer Australia Pty Ltd
Medicine Registered
PREVENAR 13 ® _Pneumococcal polysaccharide conjugate vaccine, 13-valent adsorbed_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Prevenar 13. It does not contain all the available information. It does not take the place of talking to your doctor, clinic nurse or pharmacist. All vaccinations have benefits and risks. Your doctor or clinic nurse has weighed the risks of you or your child receiving Prevenar 13 against the benefits this vaccination is expected to provide. IF YOU HAVE ANY QUESTIONS ABOUT THIS VACCINATION, ASK YOUR DOCTOR, CLINIC NURSE OR PHARMACIST. KEEP THIS LEAFLET. YOU MAY NEED TO READ IT AGAIN. WHAT PREVENAR 13 IS USED FOR Prevenar 13 is a vaccine, which is a type of medicine that helps to protect (immunise) people from certain infectious diseases. It does this by preparing the body's defences to fight the infection, before you catch the bacteria or virus. Prevenar 13 is usually recommended for use in babies and children from 6 weeks to 17 years of age, or in adults 50 year and older. Prevenar 13 is a mixture of the outer sugar coating (polysaccharide) from 13 different strains or serotypes of bacteria called Streptococcus pneumoniae. Each serotype is joined to a non-toxic protein to make it work more effectively. Streptococcus pneumoniae bacteria are one of the causes of • meningitis (a serious brain infection that could cause death or brain damage) • bacteraemia (infection of the blood) • pneumonia • otitis media (an ear infection that can cause pain and temporary hearing loss and may require you or your child to have an ear operation). Prevenar 13 can protect against 13 of the strains of Streptococcus pneumoniae that can cause these diseases. Prevenar 13 does not replace the need for vaccination with Haemophilus influenzae type b (Hib) or meningococcal vaccines that protect against other important causes of meningitis. You cannot catch any of the above diseases from the vaccine itself, because it is not made with li Preberite celoten dokument
Version: pfppreei10813 Supersedes: pfppreei10613 Page 1 of 21 PRODUCT INFORMATION Prevenar 13 ® NAME OF THE MEDICINE Prevenar 13 Pneumococcal polysaccharide conjugate vaccine, 13-valent adsorbed DESCRIPTION The vaccine is a ready to use homogeneous white suspension for intramuscular injection, supplied as a pre-filled syringe. _ACTIVE INGREDIENTS_ Each 0.5 mL dose contains: 2.2 µg of pneumococcal purified capsular polysaccharides for serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F and 23F 4.4 µg of pneumococcal purified capsular polysaccharides for serotype 6B. Each serotype is individually conjugated to non-toxic diphtheria CRM 197 protein and adsorbed on aluminium phosphate (0.565 mg). _EXCIPIENTS _ Succinic acid, polysorbate 80, aluminium phosphate, sodium chloride in water for injections. PHARMACOLOGY _Streptococcus pneumoniae_ is an important cause of morbidity and mortality in persons of all ages worldwide. It is a leading cause of death and illness in infants, among the elderly, and in persons who have certain underlying medical conditions. The organism causes invasive infections, including bacteraemia and meningitis, pneumonia and other lower respiratory tract infections, and upper respiratory tract infections including otitis media and sinusitis. _INFANTS AND CHILDREN LESS THAN 5 YEARS OF AGE_ Based on serotype surveillance performed before the introduction of Prevenar, Prevenar 13 is estimated to cover 93.3% of serotypes causing IPD (Invasive Pneumococcal Disease) among children less than 5 years of age in Australia (Watson M. et al., _Communicable Disease _ _Intelligence_ 2004; 28(4): 455-464) and Preberite celoten dokument