Pharmaceutical particulars : מידע רוקחי

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients
Sodium phosphate, monobasic,
monohydrate Sodium phosphate, dibasic,
heptahydrate Sodium chloride
Polysorbate 80 (E 433)
Water for injections

6.2   Incompatibilities

Tysabri 300 mg concentrate for solution for infusion must not be mixed with other medicinal products except those mentioned in section 6.6.

6.3   Shelf life

Unopened vial
The expiry date of the product is indicated on the packaging materials.

Diluted solution

After dilution with sodium chloride 9 mg/mL (0.9%) solution for injection, immediate use is recommended. If not used immediately, the diluted solution must be stored at 2˚C to 8˚C and infused within 8 hours of dilution. In-use storage times and conditions prior to use are the responsibility of the user.

6.4 Special precautions for storage

Store in a refrigerator (2˚C to 8˚C).
Do not freeze.
Keep the vial in the outer carton in order to protect from light.
For storage conditions after dilution of the medicinal product see section 6.3.
6.5   Nature and contents of container

15 mL concentrate in a vial (type I glass) with a stopper (chlorobutyl rubber) and a seal (aluminium) with a flip-off cap.

Pack size of one vial per carton.

6.6   Special precautions for disposal and other handling
Instructions for use:
• Inspect the vial for particles prior to dilution and administration. If particles are observed and/or the liquid in the vial is not colourless, clear to slightly opalescent, the vial must not be used.

• Use aseptic technique when preparing the solution for intravenous (IV) infusion.
Remove flip-off cap from the vial. Insert the syringe needle into the vial through the centre of the rubber stopper and remove 15 mL concentrate for solution for infusion.

• Add the 15 mL concentrate for solution for infusion to 100 mL sodium chloride 9 mg/mL (0.9 %) solution for injection. Gently invert the solution to mix completely.
Do not shake.

• This medicinal product must not be mixed with other medicinal products or diluents.

• Visually inspect the diluted medicinal product for particles or discolouration prior to administration. Do not use if it is discoloured or if foreign particles are seen.

• The diluted medicinal product is to be used as soon as possible and within 8 hours of dilution.
If the diluted medicinal product is stored at 2˚C to 8˚C (do not freeze), allow the solution to warm to room temperature prior to infusion.

• The diluted solution is to be infused intravenously over 1 hour at a rate of approximately 2 mL per minute.

• After the infusion is complete, flush the intravenous line with sodium chloride 9 mg/mL (0.9%) solution for injection.

• Each vial is for single–use only.

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