Pharmaceutical particulars : מידע רוקחי

6     PHARMACEUTICAL PARTICULARS

6.1   List of excipients
Capsules
Capsule content: macrogolglycerol hydroxystearate / polyoxyl 40 hydrogenated castor oil, corn oil– mono–di–triglycerides, ethanol anhydrous / alcohol dehydrated, propylene glycol, alpha–tocopherol.
Capsule shell: gelatin, propylene glycol, glycerol 85%, titanium dioxide (E 171), iron oxide black (E 172) (25- and 100-mg capsules)
Imprint: carminic acid (E 120), aluminium chloride hexahydrate, sodium hydroxide, propylene glycol, hypromellose / Hydroxypropyl methylcellulose 2910, isopropanol / Isopropyl alcohol, water, purified.

Oral solution polyoxyl 40 hydrogenated castor oil , corn oil-mono–di–triglycerides, propylene glycol, ethanol absolute, DL–alpha–tocopherol.

6.2   Incompatibilities

Not applicable.
6.3   Shelf life

The expiry date of the product is printed on the package materials

6.4    Special precautions for storage
Sandimmun Neoral Capsules may be stored at room temperature not exceeding 25°C. Sandimmun Neoral Capsules should be left in the blister pack until required for use in order to protect from moisture. When a blister is opened, a characteristic smell is noticeable. This is normal and does not mean that there is anything wrong with the capsule.

Sandimmun Neoral oral solution should be stored between 15 and 30°C. Do not store at the refrigerator. Below 20°C a jelly-like formation may occur as Sandimmun Neoral oral solution contains oily components of natural origin which tend to solidify at low temperatures. If a jelly-like appearance does not disappear after warming up, up to 30°C, Sandimmun Neoral oral solution should not be used.
Minor flakes or slight sediment may still be observed. These phenomena do not affect the efficacy and safety of the product and the dosing by means of the pipette remains accurate.
After opening, Sandimmun Neoral oral solution should be used within 2 months.

Sandimmun Neoral must be kept out of the reach and sight of children.

6.5    Nature and contents of container
Sandimmun Neoral Capsules are available in 10 x 5 and 2 x 25 blister packs of double-sided aluminium consisting of a polyamide/aluminium/polyvinyl chloride (PA/AL/PVC) bottom side and an aluminium foil on the upper side. Not all pack sizes may be marketed.

Sandimmun Neoral Oral Solution is available in 50 mL amber glass bottle closed with a rubber stopper and aluminium tear-off cap. The tear-off cap indicates if the bottle has been previously opened. A cap is provided for closure of the bottle during the in-use period.


6.6    Special precautions for disposal
Sandimmun Neoral capsules: No special requirements.

Sandimmun Neoral Oral Solution is provided with two syringes for measuring the doses.
The 1 ml syringe is used to measure doses less than or equal to 1 ml (each graduation of 0.05 ml corresponds to 5 mg of ciclosporin).
The 4 ml syringe is used to measure doses greater than 1 ml, and up to 4 ml (each graduation of 0.1 ml corresponds to 10 mg of ciclosporin).

Initial use of Sandimmun Neoral Oral Solution

1.     Raise the flap in the centre of the metal sealing ring.


2.   Tear off the sealing ring completely.



3.   Remove the grey stopper and throw it away.



4.   Push the tube unit with the white stopper firmly into the neck of the bottle.


5.   Choose the syringe depending on the prescribed volume. For volume less than 1 ml or equal to 1 ml, use the 1-ml syringe. For volume greater than 1 ml, use the 4-ml syringe. Insert the nozzle of the syringe into the white stopper.



6.   Draw up the prescribed volume of solution (position the lower part of the plunger ring in front of the graduation corresponding to the prescribed volume).



7.   Expel any large bubbles by depressing and withdrawing the plunger a few times before removing the syringe containing the prescribed dose from bottle. The presence of a few tiny bubbles is of no importance and will not affect the dose in any way.


8.    Push the medicine out of the syringe into a small glass with some liquid (not grapefruit juice). Avoid any contact between the syringe and the liquid in the glass. The medicine can be mixed just before it is taken. Stir and drink the entire mixture right away. Once mixed it should be taken immediately after preparation.



9.    After use, wipe the syringe on the outside only with a dry tissue and replace it in its cover. The white stopper and tube should remain in the bottle. Close the bottle with the separately provided black cap.



Subsequent use
Commence at point 5.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

7     REGISTRATION HOLDER and Importer
Novartis Israel Ltd
P.O.B 7126, Tel Aviv, Israel