Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Film-coated tablets
Tablet core
Microcrystalline cellulose
Lactose monohydrate
Hypromellose acetate succinate

KALY_50_75_150-SPC-0921-V1                              Page 17 of 19 Croscarmellose sodium
Magnesium stearate
Sodium lauryl sulfate
Colloidal silicon dioxide

Tablet film coat
Polyvinyl alcohol
Titanium dioxide
PEG 3350
Talc
FD&C Blue #2/Indigo carmine aluminum lake
Carnauba wax

Printing ink
Shellac
Isopropyl alcohol
Iron oxide black n-butyl alcohol
Propylene glycol
Ammonium hydroxide
Granules in sachet
Lactose monohydrate
Mannitol
Hypromellose acetate succinate
Croscarmellose sodium
Sucralose
Magnesium stearate
Colloidal silicon dioxide
Sodium lauryl sulfate

6.2 Incompatibilities
Not applicable.

6.3 Shelf life
Film-coated tablets
The expiry date of the product is indicated on the packaging materials.
Granules in sachet
The expiry date of the product is indicated on the packaging materials.

Once mixed with food, Kalydeco granules have been shown to be stable for one hour.

6.4 Special precautions for storage
Store below 30°C.
6.5 Nature and contents of container
Film-coated tablets
Kalydeco tablets are packaged in a thermoform (Aclar/foil) blister or a high-density polyethylene (HDPE) bottle with a polypropylene closure, foil-lined induction seal and molecular sieve desiccant.

The following pack sizes are available:
−  Blister pack containing 56 film-coated tablets
−  Bottle containing 56 film-coated tablets

KALY_50_75_150-SPC-0921-V1                    Page 18 of 19
Not all pack sizes may be marketed
Granules in sachet
Packaged in a Biaxially Oriented Polyethylene Terephthalate/Polyethylene/Foil/Polyethylene (BOPET/PE/Foil/PE) sachet.

Pack size of 56 sachets (contains 4 individual wallets with 14 sachets per wallet) 
6.6 Special precautions for disposal and other handling
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.