Pharmaceutical particulars : מידע רוקחי

6     PHARMACEUTICAL PARTICULARS

6.1   List of excipients
Hypromellose, sulfuric acid, DSPC (1,2-distearoyl-sn-glycero-3-phosphocholine), purified water, carrageenan (E407), calcium chloride, potassium chloride, carnauba wax, blue ink (shellac, indigo carmine aluminium lake (E132), N-butyl alcohol, titanium dioxide (E171), propylene glycol (E1520), isopropyl alcohol).

6.2    Incompatibilities

Not applicable
6.3    Shelf life

The expiry date of the product is indicated on the packaging materials.
Discard the Podhaler device and its case 1 week after first use.

6.4    Special precautions for storage
Store below 30°C. TOBI Podhaler capsules must always be stored in the original package in order to protect from moisture and only removed immediately before use. Store the inhaler in its tightly closed case when not in use.

6.5    Nature and contents of container

The hard capsules are supplied in PVC/PA/Alu/PVC- PET/Alu blisters.
TOBI Podhaler is supplied in monthly packs containing 4 weekly cartons and a reserve Podhaler device in its storage case. Each weekly carton contains 56 x 28 mg capsules (7 blisters with 8 capsules per blister), and a Podhaler device in its storage case.
Pack sizes
224 (4 x 56) capsules and 5 inhalers (monthly multipack)

6.6    Special precautions for disposal and other handling

Only TOBI Podhaler capsules are to be used in the Podhaler device. No other inhaler may be used.
TOBI Podhaler capsules must always be stored in the blister (capsule card), and only removed immediately before use. Each Podhaler device and its case are used for seven days and then discarded and replaced. Store the Podhaler device in its tightly closed case when not in use.
Basic instructions for use are given below, more detailed instructions are available from the patient leaflet.
1.    Wash and fully dry hands.
2.    Just before use, remove the Podhaler device from its case. Briefly inspect the inhaler to make sure it is not damaged or dirty.
3.    Holding the body of the inhaler, unscrew and remove the mouthpiece from the inhaler body.
Set the mouthpiece aside on a clean, dry surface.
4.    Separate the morning and evening doses from the capsule card.
5.    Peel back the foil from the capsule card to reveal one TOBI Podhaler capsule and remove it from the card.
6.    Immediately insert the capsule into the inhaler chamber. Replace the mouthpiece and screw it on firmly until it stops. Do not overtighten.
7.    To puncture capsule, hold the inhaler with the mouthpiece down, press the button firmly with your thumb as far as it will go, then release the button.

8.   Fully exhale away from the inhaler.
9.   Place mouth over the mouthpiece creating a tight seal. Inhale the powder deeply with a single continuous inhalation.
10. Remove inhaler from mouth, and hold breath for approximately 5 seconds, then exhale normally away from the inhaler.
11. After a few normal breaths away from the inhaler, perform a second inhalation from the same capsule.
12. Unscrew mouthpiece and remove the capsule from the chamber.
13. Inspect the used capsule. It should appear punctured and empty.
• If the capsule is punctured but still contains some powder, place it back into the inhaler and take another two inhalations from the capsule. Reinspect capsule.
• If the capsule appears to be unpunctured, place it back into the inhaler, press the button firmly as far as it goes and take another two inhalations from the capsule. After this if the capsule is still full and appears to be unpunctured, replace the inhaler with the reserve inhaler and try again.
14. Discard the empty capsule.
15. Repeat, starting at step 5, for the remaining three capsules of the dose.
16. Replace the mouthpiece and screw it on firmly until it stops. When the full dose (4 capsules) has been inhaled, wipe mouthpiece with a clean dry cloth.
17. Place inhaler back in storage case and close tightly. The inhaler should never be washed with water.
See also section 4.2.
Any unused product or waste material should be disposed of in accordance with local requirements.