PARTICULARS TO APPEAR ON THE OUTER PACKAGE
CARTON BOX
1.
NAME OF THE MEDICINAL PRODUCT
[To be completed nationally]
Azithromycin
2.
STATEMENT OF ACTIVE SUBSTANCE(S)
5 ml suspension contains 200 mg azithromycin (as monohydrate)
3.
LIST OF EXCIPIENTS
Contains: sucrose, aspartame (E951) and titanium dioxide (E171)
4.
PHARMACEUTICAL FORM AND CONTENTS
Powder for Oral Suspension
15 ml (600 mg)
20 ml (800 mg)
22.5 ml (900 mg)
30 ml (1200 mg)
37.5 ml (1500 mg)
5.
METHOD AND ROUTE(S) OF ADMINISTRATION
Oral use
Shake well before use.
Read the package leaflet before use.
Preparation of the suspension:
Shake the dry powder loose. Add [the amount of water described below] to the powder.
For 15 ml (600 mg) bottle: add 7.5 ml water.
[For 20 ml (800 mg) bottle: add 10.0 ml water.]
[For 22.5 ml (900 mg) bottle: add 11.0 ml water.]
[For 30 ml (1200 mg) bottle: add 15.0 ml water.]
[For 37.5 ml (1500 mg) bottle: add 18.5 ml water.]
Shake well until a white to off white coloured, homogenous suspension is achieved.
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
8.
EXPIRY DATE
EXP
Reconstituted suspension can be stored for 5 days.
Do not use the oral suspension after: [DDMMYY]
9.
SPECIAL STORAGE CONDITIONS
Do not store above 30C.
Reconstituted suspension: do not store above 25C.
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
[To be completed nationally]
12.
MARKETING AUTHORISATION NUMBER(S)
[To be completed nationally]
13.
MANUFACTURER’S BATCH NUMBER
Lot
14.
GENERAL CLASSIFICATION FOR SUPPLY
[To be completed nationally]
15.
16.
INSTRUCTIONS ON USE
INFORMATION IN BRAILLE
[To be completed nationally]