Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS
6.1   List of excipients
Spiolto Respimat                                       Approved prescribing information Inhalation solution                                    May 2019

Benzalkonium chloride
Disodium edetate
Water, purified
1M Hydrochloric acid (for pH adjustment)

6.2    Incompatibilities
Not applicable.

6.3    Shelf life

In-use shelf life: 3 months
The expiry date of the product is indicated on the packaging materials.

6.4    Special precautions for storage

Store below 25°C. Do not freeze.
6.5    Nature and contents of container

Type and material of the container in contact with the medicinal product: Solution filled into a polyethylene/polypropylene cartridge with a polypropylene cap with integrated silicone sealing ring. The cartridge is enclosed within an aluminium cylinder.
Each cartridge contains 4 ml inhalation solution.

Pack sizes and devices supplied:

1 Respimat inhaler and 1 cartridge, providing 60 puffs (30 medicinal doses) 
6.6    Special precautions for disposal and other handling

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

7.     MARKETING AUTHORISATION NUMBER(S)

155-58-34508-00