TOVANOR Inhalation powder, hard capsule (2021)
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
Tovanor Breezhaler 44 micrograms inhalation powder, hard capsules.
Qualitative and quantitative composition
Each capsule contains 63 micrograms of glycopyrronium bromide equivalent to 50 micrograms of glycopyrronium. Each delivered dose (the dose that leaves the mouthpiece of the inhaler) contains 55 micrograms ...
Pharmaceutical form
Inhalation powder, hard capsule (inhalation powder). Transparent orange capsules containing a white powder, with the product code “GPL50” printed in black above and the company logo ( ) printed in black ...
Therapeutic indications
Tovanor Breezhaler is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).
Posology and method of administration
Posology The recommended dose is the inhalation of the content of one capsule once daily using the Tovanor Breezhaler inhaler. Tovanor Breezhaler is recommended to be administered, at the same time of ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
Not for acute use Tovanor Breezhaler is a once-daily, long-term maintenance treatment and is not indicated for the initial treatment of acute episodes of bronchospasm, i.e. as a rescue therapy. Hypersensitivity ...
Interaction with other medicinal products and other forms of interaction
The co-administration of Tovanor Breezhaler with other anticholinergic-containing medicinal products has not been studied and is therefore not recommended. Although no formal drug interaction studies have ...
Fertility, pregnancy and lactation
Pregnancy There are no data from the use of Tovanor Breezhaler in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3). ...
Effects on ability to drive and use machines
Glycopyrronium has no or negligible influence on the ability to drive and use machines.
Undesirable effects
Summary of the safety profile The most common anticholinergic adverse reaction was dry mouth (2.4%). The majority of the reports of dry mouth were suspected to be related to the medicinal product and were ...
Overdose
High doses of glycopyrronium may lead to anticholinergic signs and symptoms for which symptomatic treatment may be indicated. Acute intoxication by inadvertent oral ingestion of Tovanor Breezhaler capsules ...
Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Drugs for obstructive airway diseases, anticholinergics <b>ATC code:</b> R03BB06 Mechanism of action Glycopyrronium is an inhaled long-acting muscarinic receptor antagonist ...
Pharmacokinetic properties
Absorption Following oral inhalation using the Tovanor Breezhaler inhaler, glycopyrronium was rapidly absorbed and reached peak plasma levels at 5 minutes post dose. The absolute bioavailability of glycopyrromium ...
Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction and development. ...
List of excipients
<u>Capsule content:</u> Lactose monohydrate Magnesium stearate
Incompatibilities
Not applicable.
Shelf life
2 years. Each inhaler should be disposed of after all capsules have been used.
Special precautions for storage
Do not store above 25°C. The capsules must always be stored in the original blister in order to protect from moisture. The capsules must only be removed immediately before use.
Nature and contents of container
Tovanor Breezhaler is a single-dose inhaler. Inhaler body and cap are made from acrylonitrile butadiene styrene, push buttons are made from methyl metacrylate acrylonitrile butadiene styrene. Needles and ...
Special precautions for disposal and other handling
The inhaler provided with each new prescription should be used. Each inhaler should be disposed of after all capsules have been used. Instructions for handling and use Please read the full Instructions ...
Marketing authorization holder
Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
Marketing authorization number(s)
EU/1/12/790/001-008
Date of first authorization / renewal of the authorization
Date of first authorisation: 28 September 2012 Date of latest renewal: 26 July 2017
Πηγαίο έγγραφο
Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:
