Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS

6.1   List of excipient(s) powder vial: alpha cyclodextrine lactose monohydrate sodium citrate
 hydrochloric acid for pH adjustment sodium hydroxide for pH adjustment

Diluent: benzyl alcohol (8.4 mg not including 5% overage) water for injection
6.2   Incompatibilities

Caverject is not intended to be mixed or coadministered with any other products.

6.3   Shelf-life

The expiry date of the product is indicated on the packaging materials.. Reconstituted solutions should be used immediately and not stored.

6.4   Special precautions for storage

Store below 25oC. Reconstituted solutions are intended for single use only, they should be used immediately and not stored.

6.5   Nature and contents of container

Single pack containing a 5 ml clear, colourless, glass vial of Caverject 10 micrograms or Caverject 20 micrograms powder with a bromobutyl rubber stopper and an aluminium overseal with polypropylene flip-off cap.

Packs also each contain a syringe of solvent, a sterile 22G and a 30G needle plus pre-injection swab.

6.6   Special precautions for disposal

The presence of benzyl alcohol in the reconstitution vehicle decreases the degree of binding to package surfaces. Therefore, a more consistent product delivery is produced when Bacteriostatic Water for Injection containing benzyl alcohol is used.

Use immediately after reconstitution.