Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS

6.1   List of excipients
Purified water
6.2   Incompatibilities
Chlorhexidine is incompatible with soap, hypochlorite bleach and other anionic agents.
Hypochlorite bleaches may cause brown stains to develop in fabrics, which have previously been in contact with preparations containing chlorhexidine.

6.3   Shelf life
The expiry date of the product is indicated on the packaging materials.

6.4   Special precautions for storage
Flammable. This medicinal product does not require any special temperature storage conditions.
Store in the original packaging; applicator is sterile unless seal is broken.
Avoid exposure of the container and contents to naked flames during use, storage and disposal.

6.5   Nature and contents of container
The applicators consist of a latex-free sponge attached to a plastic handle/barrel which holds a latex-free pledget and glass ampoule containing the sterile antiseptic solution.
The Frepp 1.5 ml applicator consists of a latex-free rectangular foam sponge attached to a plastic barrel which holds a glass ampoule containing the antiseptic solution. The 1 ml, 1.5 ml, 3 ml and 10.5 ml applicators consist of a latex-free round foam sponge attached to a plastic barrel which holds a glass ampoule containing the antiseptic solution. The 26 ml applicator consists of a latex-free square foam sponge attached to a plastic barrel which holds two glass ampoules containing the antiseptic solution. The sterile applicators are individually packaged in a transparent film.

The medicinal product is available as 1 ml, 1.5 ml, 3 ml, 10.5 ml and 26 ml fill volumes.

Pack Size:
1 ml:                   60 applicators
1.5 ml (Frepp):         20 applicators
1.5 ml and 3 ml:        1 applicator or 25 applicators
10.5 ml:                1 applicator or 25 applicators
26 ml:                  1 applicator
Not all pack sizes may be marketed.

6.6   Special precautions for disposal
This product is for single use only.

Any unused product or waste material should be discarded in accordance with local requirements. No additional environmental precautions for disposal are necessary.

7.    REGISTRATION HOLDER
Becton Dickinson (BD) Israel Ltd., 14 Hashita St., Caesarea, Israel