SPIRIVA Inhalation powder, hard capsule (2023)
Βιβλιογραφική αναφορά
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Περιεχόμενα
Name of the medicinal product
Spiriva 18 microgram, inhalation powder, hard capsule.
Qualitative and quantitative composition
Each capsule contains 22.5 microgram tiotropium bromide monohydrate equivalent to 18 microgram tiotropium. The delivered dose (the dose that leaves the mouthpiece of the HandiHaler device) is 10 microgram ...
Pharmaceutical form
Inhalation powder, hard capsule. Light green hard capsules containing the inhalation powder with the product code TI 01 and company logo printed on the capsule.
Therapeutic indications
Spiriva is indicated as a maintenance bronchodilator treatment to relieve symptoms of patients with chronic obstructive pulmonary disease (COPD).
Posology and method of administration
Posology The medicinal product is intended for inhalation use only. The recommended dosage of tiotropium bromide is inhalation of the contents of one capsule once daily with the HandiHaler device at the ...
Contraindications
Hypersensitivity to the active substance or to the excipient listed in section 6.1 or to atropine or its derivatives, e.g. ipratropium or oxitropium.
Special warnings and precautions for use
Tiotropium bromide, as a once daily maintenance bronchodilator, should not be used for the initial treatment of acute episodes of bronchospasm, i.e. rescue therapy. Immediate hypersensitivity reactions ...
Interaction with other medicinal products and other forms of interaction
Although no formal drug interaction studies have been performed, tiotropium bromide inhalation powder has been used concomitantly with other drugs without clinical evidence of drug interactions. These ...
Fertility, pregnancy and lactation
Pregnancy There is a very limited amount of data from the use of tiotropium in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity at ...
Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed. The occurrence of dizziness, blurred vision, or headache may influence the ability to drive and use machinery.
Undesirable effects
Summary of the safety profile Many of the listed undesirable effects can be assigned to the anticholinergic properties of SPIRIVA. Tabulated summary of adverse reactions The frequencies assigned to the ...
Overdose
High doses of tiotropium bromide may lead to anticholinergic signs and symptoms. However, there were no systemic anticholinergic adverse effects following a single inhaled dose of up to 340 microgram tiotropium ...
Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Other drugs for obstructive airway diseases, inhalants, anticholinergics <b>ATC code:</b> R03BB04 Mechanism of action Tiotropium bromide is a long-acting, specific, muscarinic ...
Pharmacokinetic properties
a) General Introduction Tiotropium bromide is a non-chiral quaternary ammonium compound and is sparingly soluble in water. Tiotropium bromide is administered by dry powder inhalation. Generally with the ...
Preclinical safety data
Many effects observed in conventional studies of safety pharmacology, repeated dose toxicity, and reproductive toxicity could be explained by the anticholinergic properties of tiotropium bromide. Typically ...
List of excipients
Lactose monohydrate (which may contain small amounts of milk proteins)
Incompatibilities
Not applicable.
Shelf life
2 years. After first opening of the blister use within the next 9 days. Discard the HandiHaler device 12 months after first use.
Special precautions for storage
Do not store above 25°C. Do not freeze.
Nature and contents of container
Aluminium/PVC/Aluminium peel-off blister containing 10 capsules. The HandiHaler is a single dose inhalation device made from acrylonitrile butadiene styrene (ABS) plastic materials and stainless steel. ...
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 14598/0062
Date of first authorization / renewal of the authorization
09/10/2016
Date of revision of the text
March 2023
Πηγαίο έγγραφο
Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:
