Pharmaceutical particulars : מידע רוקחי

6.      PHARMACEUTICAL PARTICULARS
6.1     List of excipients

L-proline
Polysorbate 80
Water for injections

6.2     Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

6.3     Shelf life

The expiry date of the product is indicated on the packaging materials.
Once a vial or the blistered pre-filled syringe has been opened, the solution should be used immediately.

6.4     Special precautions for storage

Do not store above 25 °C.
Do not freeze.
Keep the vial or the blistered pre-filled syringe in the outer carton in order to protect from light.
For storage conditions after first opening of the medicinal product, see section 6.3.

6.5     Nature and contents of container

Vials
10
5, 10 or 20 ml of solution in a vial (type I glass) and 50 ml of solution in a vial (type II glass), with a stopper (halobutyl), a cap (aluminium crimp) and a flip off disc (plastic).

Pack sizes of 1 vial:
1 g / 5 ml
2 g / 10 ml
4 g / 20 ml
10 g / 50 ml

Pre-filled syringes
5, or 10 ml of solution in a pre-filled syringe (cyclo-olefin-copolymer (COC)).
Pack sizes of 1 pre-filled syringe:
1 g / 5 ml
2 g / 10 ml

Alcohol swabs, needles and other supplies or equipment are not contained in the pack.

Not all pack sizes may be marketed.
6.6   Special precautions for disposal and other handling

Hizentra comes as a ready-to-use solution in single-use vials or single-use pre-filled syringes. Because the solution contains no preservative, Hizentra should be used/infused as soon as possible after opening the vial or blistered pre-filled syringe.

The medicinal product should be brought to room or body temperature before use.

The solution should be clear and pale-yellow or light-brown.
Solutions that are cloudy or have deposits should not be used.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.