The product should be used once reconstituted and must be discarded if it is not used within one hour of reconstitution. use, any remaining vaccine and container must be disposed of safely, preferably by heat inactivation or incineration, according to locally agreed procedures. OVERDOSE No case of overdose has been reported. PRESENTATION AND STORAGE CONDITIONS One dose of freeze-dried vaccine and one dose of diluent in separate vials (type I glass), each equipped with a stopper (halo-butyl) and a flip off cap (aluminium/polypropylene), with one syringe (polypropylene) and two needles (stainless steel). Pack size of 1 powder vial and 1 diluent vial, 1 syringe and 2 needles. Store in a refrigerator (2C 8C). Do not freeze. – Keep the vials in the outer carton in order to protect from light. NAME AND ADDRESS OF THE SPONSOR sanofi-aventis pty ltd Talavera Corporate Centre Building D – Park NSW 2113 Tel: 1800 829 468 POISON SCHEDULE OF THE MEDICINE S4 Prescription Only Medicine DATE OF INCLUSION IN THE AUSTRALIAN REGISTER OF THERAPEUTIC GOODS (ARTG) 23 August 2010
The product should be used once reconstituted and must be discarded if it is not used within one hour of reconstitution. use, any remaining vaccine and container must be disposed of safely, preferably by heat inactivation or incineration, according to locally agreed procedures. OVERDOSE No case of overdose has been reported. PRESENTATION AND STORAGE CONDITIONS One dose of freeze-dried vaccine and one dose of diluent in separate vials (type I glass), each equipped with a stopper (halo-butyl) and a flip off cap (aluminium/polypropylene), with one syringe (polypropylene) and two needles (stainless steel). Pack size of 1 powder vial and 1 diluent vial, 1 syringe and 2 needles. Store in a refrigerator (2C – 8C). Do not freeze. Keep the vials in the outer carton in order to protect from light. NAME AND ADDRESS OF THE SPONSOR sanofi-aventis pty ltd Talavera Corporate Centre – Building D Park NSW 2113 Tel: 1800 829 468 POISON SCHEDULE OF THE MEDICINE S4 Prescription Only Medicine DATE OF INCLUSION IN THE AUSTRALIAN REGISTER OF THERAPEUTIC GOODS (ARTG) 23 August 2010
auspar-japanese-encephalitis-vaccine-140203-pi.docx