looks like something afoot with rotacap...

looks like something afoot with rotacap labeling

http://apps.who.int/prequal/WHOPAR/WHOPARPRODUCTS/IN008Part5v1.pdRelenza Rotacaps/Rotahaler WHOPAR part 5 01/2010, version 1.0
(GlaxoSmithKline), IN008
LABELLING*
* This Labelling has been confirmed by the marketing authorisation holder to represent the authorised English translation of the text as approved in Sweden.
Relenza Rotacaps/Rotahaler WHOPAR part 5 01/2010, version 1.0
(GlaxoSmithKline), IN008
PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
OUTER CARTON
1. NAME OF THE MEDICINAL PRODUCT
Relenza Rotacaps 5 mg/capsule, inhalation powder, pre-dispensed
Zanamivir
2. STATEMENT OF ACTIVE SUBSTANCE(S)
Each capsule contains zanamivir 5 mg.
3. LIST OF EXCIPIENTS
Contains lactose, see leaflet for further information
4. PHARMACEUTICAL FORM AND CONTENTS
144 Rotahalers
144 bottles, each containing 20 Rotacaps
5. METHOD AND ROUTE(S) OF ADMINISTRATION
For Inhalation Use only
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN
Keep out of the reach and sight of children.
7. OTHER SPECIAL WARNING(S), IF NECESSARY
One Rotahaler MUST be provided with each bottle of capsules
8. EXPIRY DATE
9. SPECIAL STORAGE CONDITIONS
Trade names are not prequalified by WHO. This is under local DRA responsibility. Throughout this WHOPAR the proprietary name is given as an example only.
Relenza Rotacaps/Rotahaler WHOPAR part 5 01/2010, version 1.0
(GlaxoSmithKline), IN008
Do not store above 30oC.
Protect from moisture.
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
GlaxoSmithKline AB
Box 516
169 29 Solna
Sweden
12. MARKETING AUTHORISATION NUMBER(S)
Not applicable The MPA has not issued a Marketing Authorisation Number for Relenza Rotacaps as it is only authorised for temporary distribution under article 5(2) of directive 2001/83/E.
13. BATCH NUMBER
14. GENERAL CLASSIFICATION FOR SUPPLY
15. INSTRUCTIONS ON USE
16. INFORMATION IN BRAILLE
Justification for not including Braille acceptef