Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS
6.1   List of excipients

Powder
Sodium phosphate dibasic anhydrous, sodium phosphate monobasic dihydrate, sucrose and polysorbate 80.
Solvent
Water for injections.

Deliverable volume from pen = 0.5 ml. An overfill is also included for proper dispensing from the pen delivery system.

6.2   Incompatibilities

This medicinal product should only be reconstituted with the solvent provided (see section 6.6). In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

6.3   Shelf life

Before reconstitution
36 months.
After reconstitution
-      Chemical and physical in-use stability has been demonstrated for 24 hours at 2°C - 8ºC.
-      From a microbiological point of view, the product is to be used immediately. If not used immediately, in- use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C - 8°C.

6.4   Special precautions for storage

Store in a refrigerator (2°C - 8°C). Do not freeze.
For storage conditions of the reconstituted medicinal product, see section 6.3.
6.5   Nature and contents of container

The powder and solvent are both contained in a two-chamber cartridge (Type I flint glass) separated by a bromobutyl rubber plunger. The cartridge is sealed at one end with a polypropylene cap containing a bromobutyl rubber liner and at the other end by a bromobutyl rubber plunger.

PegIntron 80, 100, 120, 150 micrograms are supplied as:
-    1 pen containing powder and solvent for solution for injection, 1 injection needle and 2 cleansing swabs.

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

PegIntron pre-filled pen is to be removed from the refrigerator before administration to allow the solvent to reach room temperature (not more than 25°C).
Each pre-filled pen is reconstituted with the solvent provided in the two-chamber cartridge (water for injections) for administration of up to 0.5 ml of solution. A small volume is lost during preparation of PegIntron for injection when the dose is measured and injected. Therefore, each pre-filled pen contains an excess amount of solvent and PegIntron powder to ensure delivery of the labelled dose in 0.5 ml of PegIntron, solution for injection. The reconstituted solution has a concentration of 80, 100, 120, 150 micrograms in 0.5 ml.

PegIntron is injected subcutaneously after reconstituting the powder as instructed, attaching an injection needle and setting the prescribed dose. A complete and illustrated set of instructions is provided in the Annex to the Package Leaflet.

As for all parenteral medicinal products, the reconstituted solution is to be inspected visually prior to administration. The reconstituted solution should be clear and colourless. If discolouration or particulate matter is present, the reconstituted solution should not be used. After administering the dose, the PegIntron pre- filled pen and any unused solution contained in it is to be discarded..

7.    MANUFACTURER:

Schering-Plough Labo N.V., Heist- op-den-Berg, Belgium.