STRIVERDI RESPIMAT Inhalation solution Ref.[8473] Active ingredients: Olodaterol

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2023  Publisher: Boehringer Ingelheim International GmbH, Binger Strasse 173, D-55216, Ingelheim am Rhein, Germany

Product name and form

Striverdi Respimat 2.5 microgram, inhalation solution.

Pharmaceutical Form

Inhalation solution.

Clear, colourless, inhalation solution.

Qualitative and quantitative composition

The delivered dose is 2.5 microgram Olodaterol (as hydrochloride) per actuation.

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
Olodaterol

Olodaterol has a high affinity and high selectivity to the human beta2-adrenoceptor. The compound exerts its pharmacological effects by binding and activation of beta2-adrenoceptors after topical administration by inhalation. Activation of these receptors in the airways results in a stimulation of intracellular adenyl cyclase, an enzyme that mediates the synthesis of cyclic-3',5' adenosine monophosphate (cAMP). Elevated levels of cAMP induce bronchodilation by relaxation of airway smooth muscle cells.

List of Excipients

Benzalkonium chloride
Disodium edetate
Water, purified
Citric acid (anhydrous)

Pack sizes and marketing

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 actuations (puffs) (30 medicinal doses).

Triple pack: 1 Respimat re-usable inhaler and 3 cartridges, providing 60 actuations (puffs) (30 medicinal doses) each.

Single refill pack: 1 cartridge, providing 60 actuations (puffs) (30 medicinal doses).

Triple refill pack: 3 cartridges, providing 60 actuations (puffs) (30 medicinal doses) each.

Not all pack sizes may be marketed.

Marketing authorization holder

Boehringer Ingelheim International GmbH, Binger Strasse 173, D-55216, Ingelheim am Rhein, Germany

Marketing authorization dates and numbers

PL 14598/0093

07/06/2018

Drugs

Drug Countries
STRIVERDI RESPIMAT Austria, Brazil, Cyprus, Germany, Estonia, Spain, Finland, France, Hong Kong, Ireland, Lithuania, Malta, Netherlands, Poland, Romania, Singapore, United Kingdom, United States

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