Keep Ipratropiumbromide/Salbutamol Sandoz 0,5/2,5 mg per 2,5 ml out of the sight and reach of children.
Do not use Ipratropiumbromide/Salbutamol Sandoz 0,5/2,5 mg per 2,5 ml after the expiry date stated on the outer pack and label. The expiry date refers to the last day of that month.
Do not refrigerate or freeze. Do not store above 25°C.
For single use only. Use immediately after first opening the ampoule. Discard immediately after first use.
Partly used, opened or damaged ampoules should be disposed in accordance with local requirements.
Keep the nebuliser solution in the outer pouch or carton in order to protect from light.
Do not use this medicine if you notice the nebuliser solution is cloudy.
Do no throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6 Contents of the pack and other information
What Ipratropium bromide/Salbutamol contains
Each 2.5 ml Ipratropium bromide/Salbutamol contains:
- The active substances are 0.5 mg of ipratropium bromide as 525 micrograms ipratropium bromide monohydrate and salbutamol 2.5 mg as sulphate.
- The other ingredients are sodium chloride, water for injection and sulfuric acid.
What Ipratropium bromide/Salbutamol looks like and contents of the pack
The pack is a Plastic Form fill Seal (FFS) ampoule containing 2.5 ml of nebuliser solution, 5 of which are over wrapped in a triple laminated pouch and then packed into cardboard cartons containing 10, 20, 30, 40, 50, 60, 80, 100, 120 and 150 ampoules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sandoz B.V., Veluwezoom 22, Almere, Nederland
Correspondentie: Postbus 10332, 1301 AH Almere
Salutas Pharma GmbH
Otto-von-Guericke Allee 1
Lek Pharmaceuticals d.
Verovškova 57, 1526 Ljubljana
57 High Street, Odiham, Hampshire, RG29 1 LF
This medicinal product is authorised in the Member States of the EEA under the
Sweden Ipratropium/Salbutamol Sandoz Sandoz A/S
United kingdom Copralineb 0.5/2.5 mg per 2.5 ml Nebuliser Solution
This leaflet was last approved in mei 2013.