Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS

6.1. List of excipients

Powder:
Glycine
Mannitol
Disodium phosphate anhydrous
Sodium dihydrogen phosphate monohydrate
Solvent:
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.
After reconstitution, the product should be used immediately.

6.4. Special precautions for storage

Store the powder vial(s) in a refrigerator (2°C – 8°C). Do not freeze. Keep the vial(s) in the outer carton in order to protect from light.

The powder vial(s) may be stored at room temperature up to a maximum of 25°C for a single period of up to 30 days. The vial(s) must be protected from light. Do not return this medicine to refrigerator.
The powder vial(s) must be discarded if not used within the 30 days of room temperature storage or the expiry date printed on the carton, whichever is earlier.
The Use by date should be written on the carton (up to 30 days from the date removed from the refrigerator).

The pre-filled syringe(s) may be stored below 25ºC or store in a refrigerator (2ºC - 8°C). Do not freeze.

After reconstitution:
For storage conditions after reconstitution of the medicinal product, see section 6.3.
6.5. Nature and contents of container

Vial (type I glass) with a stopper (chlorobutyl rubber). The colour of the protective plastic cap is specific to the strength of the product.

The powder vial of SOMAVERT® 10 mg contains 10 mg pegvisomant.
The powder vial of SOMAVERT® 15 mg contains 15 mg pegvisomant.
The powder vial of SOMAVERT® 20 mg contains 20 mg pegvisomant.
The powder vial of SOMAVERT® 25 mg contains 25 mg pegvisomant.
The powder vial of SOMAVERT® 30 mg contains 30 mg pegvisomant.

Solvent: 1 ml pre-filled syringe of water for injections.
Pack size of 30 vials of powder, pre-filled syringes and safety needles.

6.6. Special precautions for disposal and other handling

The syringe and safety needle used to administer the injection are provided with the medicinal product.


Before attaching the supplied safety needle the syringe cap will need to be removed from the pre-filled syringe. This is achieved by snapping it off. The syringe should be kept upright to avoid leakage and the end of the syringe should not be allowed to contact anything.


The powder should be reconstituted in 1 mL solvent. When adding the solvent from the syringe the vial and syringe should held at an angle as shown in the diagram below.



Add the solvent to the vial of powder. The solvent should be emptied into the vial slowly to avoid the possibility of a foam forming. This would make the medicine unusable. Gently dissolve the powder with a slow, swirling motion. Do not shake vigorously, as this might cause denaturation of the active substance.

After reconstitution, the reconstituted solution should be inspected visually for extraneous (or for any foreign) particulate matter or any variation in physical appearance prior to administration. In the event of either being observed, discard the medicinal product.


Before withdrawing the dissolved Somavert® invert the vial with the syringe still inserted into it and ensure the gap in the stopper can be seen as shown in the diagram below: 


Pull the needle down so that the needle tip is at its lowest point in the liquid. Slowly withdraw the plunger in the syringe to withdraw the medicine from the vial. If air is seen in the syringe, tap the barrel to float the bubbles to the top, and then gently push the bubbles out into the vial.

Before disposing of the syringe and needle fold the needle guard over the needle and ensure it clicks into place. The syringe and needle should never be reused.

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