Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS

6.1 List of Excipients
Sodium phosphate monobasic, monohydrate
Sodium phosphate dibasic, anhydrous
Sodium chloride,
Polysorbate 80,
Water for injections.

6.2 Incompatibilities

In the absence of incompatibility studies, ARANESP® must not be mixed or administered as an infusion with other medicinal products.

6.3 Shelf Life

The expiry date of the product is indicated on the packaging materials 
6.4 Special Precautions for Storage

Store in a refrigerator at 2°C to 8°C.
Do not freeze.
Keep the container in the outer carton, in order to protect from light.
For the purpose of ambulatory use, ARANESP® may be removed from storage for a maximum period of seven days at room temperature (up to 25°C). Once removed from the refrigerator and has reached room temperature (up to 25°C) it must either be used within 7 days or disposed of.

6.5 Nature and Contents of Container

Package containing one or four pre-filled syringe(s) with or without an automatic needle guard of a 
10    mcg      ARANESP®         Solution     for    injection    in   0.4       mL       (25 mcg/mL) 20    mcg       ARANESP®        Solution     for    injection    in   0.5       mL       (40 mcg/mL)
30    mcg       ARANESP®        Solution     for    injection    in   0.3       mL       (100 mcg/mL) 40    mcg       ARANESP®        Solution     for    injection    in   0.4       mL       (100 mcg/mL)
50    mcg       ARANESP®        Solution     for    injection    in   0.5       mL       (100 mcg/mL) 60    mcg       ARANESP®        Solution     for    injection    in   0.3       mL       (200 mcg/mL) 80    mcg       ARANESP®        Solution     for    injection    in   0.4       mL       (200 mcg/mL) 100   mcg       ARANESP®        Solution     for    injection    in   0.5       mL       (200 mcg/mL) 150   mcg       ARANESP®        Solution     for    injection    in   0.3       mL       (500 mcg/mL) 300   mcg       ARANESP®        Solution     for    injection    in   0.6       mL       (500 mcg/mL) 500   mcg       ARANESP®        Solution     for    injection    in   1.0       mL       (500 mcg/mL) 
The pen will be presented as a single pack.

The pre-filled syringes and the syringes inside the pen are made from type 1 glass with stainless steel 27 gauge needles. The needle cap of the pre-filled syringe/pre-filled pen contains dry natural rubber (a derivative of latex). (see section 4.4).

Not all pack sizes may be marketed.

6.6 Special Precautions for Disposal
The carton contains a package leaflet with the full instructions for use and handling.

The ARANESP® (Sure-Click®) pre-filled pen delivers the complete dose of each presentation.

ARANESP® is a sterile but unpreserved product. Do not administer more than one dose.
Each pre-filled syringe/pre-filled pen may only be used once.

Any medicinal product remaining should be disposed of.

Before administration the ARANESP® solution should be inspected for visible particles. Only solutions, which are colorless, clear or slightly opalescent, should be injected. Do not shake. Allow the container to reach room temperature before injecting.

Rotate the injection sites to avoid discomfort at the site of injection.

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