Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS
6.1   List of excipients

Carmellose sodium
Hydrochloric acid (for pH adjustment)
Sodium hydroxide (for pH adjustment)
Purified water

6.2   Incompatibilities
Not applicable.

6.3   Shelf life

The expiry date of the product is indicated on the printing materials.
Opened cartridge: Use immediately. The product can be used for up to 24 hours once it is out of the refrigerator. The dosing pump with installed cartridge can be worn close to the body for up to 16 hours. During overnight treatment, the pump should not be worn next to the body but can, for example, be kept on the bedside table. Discard any unused portion.

6.4   Special precautions for storage

Store in a refrigerator (2°C–8°C). Do not freeze.
Store in the original package in order to protect from light.
For storage instructions after first opening of the medicinal product, see section 6.3.
6.5   Nature and contents of container

47 ml gel in polypropylene cartridge. The wide end is sealed with a plunger stopper made of polyisoprene rubber and the ENFit outlet connector opening is sealed with a cap made of polypropylene.

Carton of 7 cartridges.

6.6   Special precautions for disposal and other handling
The cartridges are intended for single use only. Do not reuse an opened cartridge. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
7.      REGISTRATION HOLDER

Truemed Ltd.,
10 Beni Gaon St., Poleg Industrial Park,
P.O.B 8105, Netanya 4250499