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ProMED翻訳情報(229回) ~フィリピンにおける偽造ワクチンの流通~


狂犬病 – フィリピン(05) : (カリンガ州)、偽造ワクチン、警戒警報
Date: Fri 6 Dec 2013
Source: Tempo News [edited]

The Food and Drug Administration (FDA) has warned the public against a counterfeit rabies vaccine that is being sold in the country.

The FDA and Novartis Healthcare (Philippines) have “determined that there is an illegally imported and unregistered Purified Chick Embryo Cell (Rabipur) Rabies Vaccine being offered for sale in vaccination clinics, drug establishments and outlets, and internet websites.”
FDAと(フィリピンの)ノバルティスヘルスケアは、”予防接種クリニック、薬局、小売店、インターネットウェブサイトで販売のために提供されている、違法に輸入され未登録である精製ニワトリ杯細胞ワクチン(Rabipur)があることを” 突き止めた。

A complaint sample of the vaccine was collected at Tabuk City in Kalinga, and it was verified that the sample was counterfeit.

The rabies vaccine is administered to people who are at high risk of exposure to rabies or to someone who has been exposed to rabies, the FDA said. Vaccines are sensitive biological substances that can lose their potency and effectiveness if they are exposed to temperatures outside the temperature range of 2-8 C [35-46 F], the agency added.
“Proper handling and storage should be exercised to assure the product’s safety, efficacy, and quality. However, there is no assurance of safety, efficacy, and quality of counterfeit vaccines,” the FDA said.
“適切な取扱いと保管は、製品の安全、有効性と品質を保証するために行われなければなりません。しかしながら、偽造ワクチンの安全性、効力および品質の保証はありません。” FDAはそう言った。

All drug establishments and outlets have been warned against importing, distributing, and selling this unregistered drug product.

[Byline: Jonathan Hicap]

Communicated by:

[Tabuk is a city and the capital of the province of Kalinga in the Philippines. According to census figures obtained in 2007, it has a population of 87 912 people. Its location can be found in the maps at:
[ Tabukはフィリピン、Kalinga州の州都である。2007年の国勢調査によれば、87,912人の人口である。その位置は地図中で見つけることができる;

Canine rabies is widespread throughout the Philippines, and administration of rabies virus vaccine is a life-saving treatment for humans bitten or injured in encounters with rabid animals. It is not clear from this report whether the counterfeit vaccine is an unauthorised product or a genuine vaccine that has exceeded its expiry date. Whatever the reason, it should be avoided and destroyed if identified. Travellers to the Philippines as well as residents should be made aware of the hazard. – Mod.CP