Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2022 Publisher: Boehringer Ingelheim International GmbH, Binger Strasse 173, 55216 Ingelheim am Rhein, Germany
Spiriva Respimat 2.5 microgram, inhalation solution.
| Pharmaceutical Form |
|---|
|
Inhalation solution. Clear, colourless, inhalation solution. |
The delivered dose is 2.5 microgram tiotropium per puff (2 puffs comprise one medicinal dose) and is equivalent to 3.124 microgram tiotropium bromide monohydrate.
The delivered dose is the dose which is available for the patient after passing the mouthpiece.
Excipient with known effect: This medicine contains 0.0011 mg benzalkonium chloride in each actuation.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Tiotropium |
Tiotropium is a long-acting, specific, muscarinic receptor antagonist, in clinical medicine often called an anticholinergic. By binding to the muscarinic receptors in the bronchial smooth musculature, tiotropium inhibits the cholinergic (bronchoconstrictive) effects of acetylcholine, released from parasympathetic nerve endings. |
| List of Excipients |
|---|
|
Benzalkonium chloride |
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:
Single pack: 1 Respimat re-usable inhaler and 1 cartridge, providing 60 puffs (30 medicinal doses)
Triple pack: 1 Respimat re-usable inhaler and 3 cartridges, providing 60 puffs (30 medicinal doses) each
Single refill pack: 1 cartridge, providing 60 puffs (30 medicinal doses)
Triple refill pack: 3 cartridges, providing 60 puffs (30 medicinal doses) each
Not all pack sizes may be marketed.
Boehringer Ingelheim International GmbH, Binger Strasse 173, 55216 Ingelheim am Rhein, Germany
PL 14598/0084
24/07/2017
| Drug | Countries | |
|---|---|---|
| SPIRIVA | Austria, Australia, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Malta, Mexico, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, United States, South Africa |
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