Country: অস্ট্রেলিয়া
ভাষা: ইংরেজি
সূত্র: Department of Health (Therapeutic Goods Administration)
Tetanus toxoid, Quantity: 20 microgram/mL; Meningococcal polysaccharide group C, Quantity: 20 microgram/mL
Pfizer Australia Pty Ltd
aluminium hydroxide hydrate,Meningococcal polysaccharide group C,Tetanus toxoid
Injection, suspension
Excipient Ingredients: sodium chloride; water for injections; aluminium hydroxide hydrate
Intramuscular
20 x Pre-filled syringes, 10 x Pre-filled syringes, 1 x Pre-filled syringe
(S4) Prescription Only Medicine
NeisVac-C Vaccine is indicated for active immunisation of children from 8 weeks of age, adolescents and adults, for the prevention of invasive disease caused by Neisseria meningitidis serogroup C.
Visual Identification: HOMOGENEOUS, SEMI-OPAQUE, WHITE TO OFF-WHITE SUSPENSION; Container Type: Syringe; Container Life Time: 42 Months; Container Temperature: Store at 2 to 8 degrees Celsius
Licence status A
2002-08-22
NEISVAC-C ® _Meningococcal group C polysaccharide conjugate vaccine (tetanus toxoid protein conjugate)_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about NeisVac-C. 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 NeisVac-C against the benefits it is expected to provide. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS VACCINATION, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET You may need to read it again. WHAT NEISVAC-C IS USED FOR NeisVac-C is a vaccine, a type of medicine used to protect against infectious diseases. NeisVac-C is used to prevent invasive disease caused by bacteria called Neisseria meningitidis group C. The Neisseria meningitidis bacteria can cause serious and sometimes life- threatening infections such as meningitis and septicaemia (blood poisoning). NeisVac-C will only protect against invasive disease caused by the meningococci group C bacteria. It will not protect against other groups of meningococci or other organisms that cause meningitis and blood poisoning. When a person is given NeisVac-C, 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. NeisVac-C will not give you or your child meningococcal disease. The chance of a severe reaction from NeisVac-C is very small, but the risks from not being vaccinated against invasive meningococcal disease may be very serious. NeisVac-C is given to children from 8 weeks of age, adolescents and adults. BEFORE YOU ARE GIVEN NEISVAC-C _WHEN YOU OR YOUR CHILD_ _SHOULD NOT BE GIVEN_ _NEISV সম্পূর্ণ নথি পড়ুন
Version: pfpneisi10219 Supersedes: pfpneisi10915 Page 1 of 13 AUSTRALIAN PRODUCT INFORMATION - NEISVAC-C ® MENINGOCOCCAL GROUP C POLYSACCHARIDE CONJUGATE VACCINE (TETANUS TOXOID PROTEIN CONJUGATE) SUSPENSION FOR INTRAMUSCULAR INJECTION 1. NAME OF THE MEDICINE Meningococcal group C polysaccharide conjugate vaccine (tetanus toxoid protein conjugate). 2. QUALITATIVE AND QUANTITATIVE COMPOSITION _Active ingredient_ : each 0.5 mL dose contains 10 micrograms of meningococcal polysaccharide group C conjugated with 10 to 20 micrograms of tetanus toxoid protein, adsorbed to aluminium hydroxide hydrate (adjuvant). For the full list of excipients, see Section 6.1 List of Excipients. The manufacturer of this product includes exposure to bovine derived materials. No evidence exists that any case of vCJD (considered to be a human form of bovine spongiform encephalitis) has resulted from the administration of any vaccine product. 3. PHARMACEUTICAL FORM NeisVac-C vaccine is a sterile suspension in water for injection; thus upon storage, a white deposit and clear supernatant can be observed. After shaking, the vaccine should be a homogenous semi-opaque white to off-white suspension filled in single dose syringes. It is supplied in a 1.0 mL pre-filled syringe (without an integrated needle), containing one deliverable 0.5 mL dose. Contains no antibacterial agent. Product is for single use in one patient only. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS NeisVac-C vaccine is indicated for active immunisation of children from 8 weeks of age, adolescents and adults, for the prevention of invasive disease caused by _Neisseria meningitidis_ serogroup C. 4.2 DOSE AND METHOD OF ADMINISTRATION GENERAL The vaccine should be shaken thoroughly in order to obtain a homogenous suspension. After shaking, the vaccine should be a homogeneous semi-opaque white to off-white suspension . It should be inspected visually for particulate matter and discolouration prior to administration whenever solution and container permit. In the event of eit সম্পূর্ণ নথি পড়ুন