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Poliomyelitis (Live) Vaccine Type Ⅰ Type Ⅲ(Human Diploid Cell), Oral

Product Advantages:

Made from the attenuated strain which has been safely used for about 60 years.

Cultivated in human diploid cells.

Two dosage forms, oral liquid.

5 or 10 doses per pack.

Development and application of liquid dosage form OPVFrom 1992 to 2000, with exerting loan from World Bank, the IMBCAMS built up an OPV production facility in accordance with the European Good Manufacturing Practice (GMP) at Jiaoling Road Base. Since then, either the equipment or technology for OPV production achieved modernization which brought higher level of production output and quality.In 1999, IMBCAMS began to develop a new series of liquid form OPV. In 2004, the OPV in liquid form obtained the drug production approval and GMP certificate issued by National regulatory authority and then launched into market. IMBCAMS became the only liquid form OPV manufacturer in China at the time. The new liquid form OPV had been applied in immunization program for many years and was well received by users. Development of OPV (Human Diploid Cell) Series In addition of supplying OPV in China, IMBCAMS also optimized the cell substrate used for OPV production. A human diploid cell line named as ‘KMB17’ was used as the cell substrate in the production of OPV instead of monkey kidney cells. In 2016, the new drug registration of series products of trivalent OPV made from human diploid cells was successfully granted. In 2018, registration of the series of bOPV prdocuts made from human diploid cells was approved, of which the production capacity is 100-120 million doses per year. With the participation in the internationally promoting, bOPV becomes one of the significant export vaccine products. Characteristics of Type I Type II Poliomyelitis Live-attenuated Vaccine (Human Diploid Cell) Series (bOPV) The brand-new series of bOPV products of IMBCAMS are the vaccines upgraded based on its 60-year experience of OPV development and production. With application of human diploid cell line—KMB17 strain, which has been applied safely in vaccine production for more than 20 years, the upgraded vaccines are manufactured in accordance with the Chinese Pharmacopoeia (2015 Edition) and WHO standards and its excellent immunogenicity and safety of the product were verified. Liquid form OPV was packed in tidy volume using polyethylene plastic bottle, which is friendly to refrigerated transportation; Vaccination operation is quick and handy especially for infant application. The packages had two packaging specifications: 5 doses and 10 doses, providing different options for vaccination site, which can effectively reduce the cases of wastage.

<table cellspacing="0" width="553"><tbody><tr class="firstRow"><td width="553" valign="center" style="padding: 0 7px; border-color: rgba(0, 0, 0, 1)">Main Active Composition:</td></tr><tr><td width="553" valign="center" style="padding: 0 7px; border-color: initial rgba(0, 0, 0, 1) rgba(0, 0, 0, 1)">Type Ⅰ and Type Ⅲ live-attenuated Poliomyelitis viruses.</td></tr><tr><td width="553" valign="center" style="padding: 0 7px; border-color: initial rgba(0, 0, 0, 1) rgba(0, 0, 0, 1)">Description:  The oral liquid dosage form should be clear orange liquid.Storage: Stored below -20℃ and away from light. Cold-chain transportation is required.Period of Validity: 24 months.Packaging: Per pack contains 5 doses/10 doses of oral liquid.</td></tr><tr><td width="553" valign="center" style="padding: 0 7px; border-color: initial rgba(0, 0, 0, 1) rgba(0, 0, 0, 1)">Indication: The vaccine can stimulate immune response to prevent poliomyelitis caused by infection of poliovirus type Ⅰ and Ⅲ.</td></tr><tr><td width="553" valign="center" style="padding: 0 7px; border-color: initial rgba(0, 0, 0, 1) rgba(0, 0, 0, 1)">Usage: Mainly for the children over 2 months age.</td></tr><tr><td width="553" valign="center" style="padding: 0 7px; border-color: initial rgba(0, 0, 0, 1) rgba(0, 0, 0, 1)">Administration and Dosage:The primary immunization consists of three doses oral administration, starting from 2 months old with 4 to 6 weeks interval. A booster dose should be administered at 4 years old. Two drops (0.1ml) of oral liquid per person per time.Alternatively, the vaccine can be used following the national immunization program.The people in other age groups can use if necessary.  </td></tr></tbody></table>

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