Pharmaceutical particulars : מידע רוקחי

6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
- Histidine
- Albumin (human)
- Arginine
- Water for injections (solvent)

6.2 Incompatibilities
Fanhdi® should not be mixed with other medicinal products.
Only the provided infusion set should be used because treatment failure can occur as a consequence of factor VIII adsorption to the internal surfaces of some infusion equipment.

6.3 Shelf-life
The expiry date of the product is indicated on the packaging materials.
Chemical and physical in-use stability has been demonstrated for 12 hours at 25 °C. From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are responsibility of the user and would normally not be longer than 24 hours at 2 to 8 °C, unless reconstitution has taken place in controlled and validated aseptic conditions.

6.4 Special precautions for storage
Do not store above 30 ºC.
Do not freeze.
Do not use after expiry date.

6.5 Nature and contents of container
Fanhdi® is supplied in type II glass vials containing 250, 500, 1000 or 1500 I.U. of FVIII (lyophilised) and type I glass pre-filled syringes containing 10 ml for the presentations of 250, 500 and 1000 I.U. or 15 ml for the presentation of 1500 I.U. of water for injections (solvent).


6.6 Special precautions for disposal and other handling
Do not use after expiry date shown on the label.
Left-over product must never be kept for later use, nor stored in a refrigerator.
To prepare the solution:
1. Warm the vial and syringe but not above 30 ºC.
2. Attach plunger to syringe containing diluent.
3. Remove filter from packaging. Remove cap from syringe tip and attach syringe to filter.
4. Remove vial adaptor from packaging and attach to syringe and filter.
5. Remove cap from vial and wipe stopper with swabs provided.
6. Pierce vial stopper with adaptor needle.
7. Transfer all diluent from syringe to vial.
8. Gently shake vial until all product is dissolved. As with other parenteral solutions, do not use if product is not properly dissolved or particles are visible.
9. Briefly separate the syringe/filter from vial/adaptor, to release the vacuum.
10. Invert vial and aspirate solution into syringe.
11. Prepare injection site, separate syringe and inject product using the butterfly needle provided. Injection rate should be 3 ml/min into a vein and never more than 10 ml/min to avoid vasomotor reactions.
Do not re-use administration sets.
Any unused product or waste material should be disposed of in accordance with local requirements.
The solution should be clear or slightly opalescent. Do not use solutions that are cloudy or have deposits.
Reconstituted products should be inspected visually for particulate matter and discolouration prior to administration.



7. MANUFACTURER:
Instituto Grifols, S.A.
08150 Barcelona - Spain