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Instructions for use and handling: Sandimmun Neoral: Capsules: The capsules should not be removed from the blisters until immediately before use. When a blister is opened, a characteristic smell is noticeable. This is normal and does not mean that there is anything wrong with the capsules.
The capsules should be swallowed whole.
Oral solution: Sandimmun Neoral oral solution is provided with two syringes for measuring doses. The 1 ml syringe is used to measure out doses ≤ 1 ml (each graduation of 0.05 ml corresponds to 5 mg ciclosporin). The 4 ml syringe is used to measure out doses > 1 ml and ≤ 4 ml (each graduation of 0.1 ml corresponds to 10 mg ciclosporin).
Instructions for first-time use: 1. Open the plastic cap.
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 volumes ≤ 1 ml, use the 1 ml syringe. For volumes > 1 ml, use the 4 ml syringe. Insert the syringe into the white stopper.
6. Draw up the prescribed volume of solution (position the lower edge of the plunger at the graduation mark 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 volume of solution from the bottle. The presence of a few small bubbles is of no importance and will not affect the dose in any way.
8. Push the solution out of the syringe into a small glass of liquid (not grapefruit juice). Avoid any contact between the syringe and the liquid in the glass. The solution should be mixed immediately before drinking. Stir and drink the entire mixture right away. The mixture must 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. Do not rinse it with water, alcohol, or any other liquid. The white stopper and tube should remain in the bottle. Close the bottle using the screw cap provided.
Subsequent use: Repeat from point 5 onwards.
The solution must be diluted in a glass immediately before use. Orange or apple juice are the most suitable diluents. Other non-alcoholic drinks may also be used, depending on individual taste. Grapefruit juice should not be used, however, due to the risk of local interactions involving the intestinal P450-dependent enzyme system. The syringe must not come into contact with the diluent.
Stir well and drink immediately.
In order to ensure that the whole dose is taken, pour a little more of the diluent into the glass, swirl round, then drink. The same liquid should always be used as the diluent.
For practical recommendations regarding correct use of the capsules/oral solution, see Dosage & Administration.
Incompatibilities: Sandimmun: The polyoxyethylated castor oil contained in the concentrate for infusion can cause phthalate stripping from PVC. If available, therefore, glass bottles should be used. Plastic bottles should be used only if they do not contain PVC with phthalates and if they meet the requirements of the currently valid edition of the European Pharmacopoeia for "Sterile plastic containers for human blood and blood components"/"Empty sterile containers of plasticised poly(vinyl chloride) for human blood and blood components". The same applies to transfusion devices.
Containers and their stoppers should be free from silicone oil and fatty substances.
