INCRUSE ELLIPTA Inhalation powder, pre-dispensed (2022)
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
Incruse Ellipta 55 micrograms inhalation powder, pre-dispensed.
Qualitative and quantitative composition
Each single inhalation provides a delivered dose (the dose leaving the mouthpiece of the inhaler) of 55 micrograms umeclidinium (equivalent to 65 micrograms of umeclidinium bromide) This corresponds to ...
Pharmaceutical form
Inhalation powder, pre-dispensed (inhalation powder). White powder in a grey inhaler (Ellipta) with a light green mouthpiece cover and a dose counter.
Therapeutic indications
Incruse Ellipta 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 Adults The recommended dose is one inhalation of umeclidinium bromide once daily. It should be administered each day at the same time of the day to maintain bronchodilation. The maximum dose is ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
Asthma Umeclidinium bromide should not be used in patients with asthma since it has not been studied in this patient population. Paradoxical bronchospasm Administration of umeclidinium bromide may produce ...
Interaction with other medicinal products and other forms of interaction
Clinically significant interactions mediated by umeclidinium bromide at clinical doses are considered unlikely due to the low plasma concentrations achieved after inhaled dosing. Other antimuscarinics ...
Fertility, pregnancy and lactation
Pregnancy There are no data from the use of umeclidinium bromide in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section ...
Effects on ability to drive and use machines
Umeclidinium bromide has no or negligible influence on the ability to drive and use machines.
Undesirable effects
Summary of the safety profile The most frequently reported adverse reactions are nasopharyngitis (6%) and upper respiratory tract infection (5%). Tabulated list of adverse reactions The safety profile ...
Overdose
An overdose of umeclidinium bromide will likely produce signs and symptoms consistent with the known inhaled muscarinic antagonist adverse reactions (e.g. dry mouth, visual accommodation disturbances and ...
Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Drugs for obstructive airway diseases, anticholinergics <b>ATC code:</b> R03BB07 Mechanism of action Umeclidinium bromide is a long acting muscarinic receptor antagonist ...
Pharmacokinetic properties
Absorption Following inhaled administration of umeclidinium bromide in healthy volunteers, C<sub>max</sub> occurred at 5 to 15 minutes. The absolute bioavailability of inhaled umeclidinium bromide was ...
Preclinical safety data
Non clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and carcinogenic potential. In nonclinical studies with ...
List of excipients
Lactose monohydrate Magnesium stearate
Incompatibilities
Not applicable.
Shelf life
2 years. In-use shelf-life after opening the tray: 6 weeks.
Special precautions for storage
Do not store above 30°C. If stored in the refrigerator, allow the inhaler to return to room temperature for at least an hour before use. Keep the inhaler inside the sealed tray in order to protect from ...
Nature and contents of container
The Ellipta inhaler consists of a grey body, light green mouthpiece cover and a dose counter, packed into a foil laminate tray containing a silica gel desiccant sachet. The tray is sealed with a peelable ...
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
GlaxoSmithKline (Ireland) Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland
Marketing authorization number(s)
EU/1/14/922/001 EU/1/14/922/002 EU/1/14/922/003
Date of first authorization / renewal of the authorization
Date of first authorisation: 28 April 2014 Date of latest renewal: 11 January 2019
Πηγαίο έγγραφο
Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:
