STRIVERDI RESPIMAT Inhalation solution (2023)
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Περιεχόμενα
Name of the medicinal product
Striverdi Respimat 2.5 microgram, 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: ...
Pharmaceutical form
Inhalation solution. Clear, colourless, inhalation solution.
Therapeutic indications
Striverdi Respimat is indicated as a maintenance bronchodilator treatment in patients with chronic obstructive pulmonary disease (COPD).
Posology and method of administration
Posology The medicinal product is intended for inhalation use only. The cartridge can only be inserted and used in the Respimat inhaler. Two actuations (puffs) from the Respimat inhaler comprise one medicinal ...
Contraindications
Striverdi Respimat is contraindicated in patients with hypersensitivity to olodaterol or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
Asthma Striverdi Respimat should not be used in asthma. The long-term efficacy and safety of olodaterol in asthma have not been studied. Acute bronchospasm Striverdi Respimat, as a once daily maintenance ...
Interaction with other medicinal products and other forms of interaction
Adrenergic agents Concomitant administration of other adrenergic agents (alone or as part of combination therapy) may potentiate the undesirable effects of Striverdi Respimat. Xanthine derivatives, Steroids ...
Fertility, pregnancy and lactation
Pregnancy There are no data from the use of Striverdi Respimat in pregnant women available. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity at clinically ...
Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed. However, patients should be advised that dizziness has been reported in clinical trials. Therefore, caution should ...
Undesirable effects
a. Summary of the safety profile The most common adverse reactions at the recommended dose were nasopharyngitis, dizziness, hypertension, rash and arthralgia. These were usually mild or moderate in intensity. ...
Overdose
Symptoms An overdose of olodaterol is likely to lead to exaggerated effects typical of beta<sub>2</sub>-adrenergic agonists, e.g. myocardial ischaemia, hypertension or hypotension, tachycardia, arrhythmias, ...
Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Drugs for obstructive airway diseases; Selective beta<sub>2</sub>-adrenoreceptor agonists <b>ATC code:</b> R03AC19 Mechanism of action Olodaterol has a high affinity and ...
Pharmacokinetic properties
a. General Introduction Information on the pharmacokinetics of olodaterol has been obtained from healthy subjects, COPD and asthma patients following oral inhalation of doses at and above the therapeutic ...
Preclinical safety data
Effects in non-clinical studies were observed only at exposures considered sufficiently in excess of the maximum human exposure indicating little relevance to clinical use. Studies on genotoxicity and ...
List of excipients
Benzalkonium chloride Disodium edetate Water, purified Citric acid (anhydrous)
Incompatibilities
Not applicable.
Shelf life
3 years. In-use shelf life cartridge: 3 months. In-use shelf-life inhaler: 1 year. Recommended use: 6 cartridges per inhaler. <u>Note:</u> The functioning of the RESPIMAT re-usable inhaler has been demonstrated ...
Special precautions for storage
Do not freeze.
Nature and contents of container
<u>Type and material of the container in contact with the medicinal product:</u> Solution filled into a polyethylene/polypropylene cartridge with a polypropylene cap with integrated silicone sealing ring. ...
Special precautions for disposal and other handling
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
Boehringer Ingelheim International GmbH, Binger Strasse 173, D-55216, Ingelheim am Rhein, Germany
Marketing authorization number(s)
PL 14598/0093
Date of first authorization / renewal of the authorization
07/06/2018
Date of revision of the text
February 2023
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