Sandimmun/Sandimmun Neoral Caution For Usage

Instructions for Use and Handling: Instructions for use and handling of Sandimmun concentrate for solution for infusion: Sandimmun concentrate for solution for infusion contains polyoxyl castor oil, which can cause phthalate stripping from PVC. If available, glass containers should be used for infusion. Plastic bottles should be used only if they conform to the requirements for 'Sterile plastic containers for human blood and blood components' respectively to 'Empty sterile containers of plasticized poly(vinyl chloride) for human blood and blood components' of the current European Pharmacopoeia. Containers and stoppers should be free of silicone oil and fatty substances.
Instructions for use and handling of Sandimmun Neoral solution: 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 flap in center 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 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 plunger a few times before removing syringe containing 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, but no 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 syringe on outside only with a dry tissue and replace in its cover. White stopper and tube should remain in bottle. Close bottle with cap provided.
Subsequent use: Commence at point 5.
Special precautions for disposal: Any unused product or waste material should be disposed of in accordance with local requirements.