REVINTY ELLIPTA Inhalation powder, pre-dispensed (2021)
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Περιεχόμενα
1. Name of the medicinal product
Revinty Ellipta 92 micrograms/22 micrograms inhalation powder, pre-dispensed.
2. Qualitative and quantitative composition
Each single inhalation provides a delivered dose (the dose leaving the mouthpiece) of 92 micrograms of fluticasone furoate and 22 micrograms of vilanterol (as trifenatate). This corresponds to a pre-dispensed ...
3. Pharmaceutical form
Inhalation powder, pre-dispensed (Inhalation powder). White powder in a light grey inhaler with a yellow mouthpiece cover and a dose counter.
4.1. Therapeutic indications
Asthma Revinty Ellipta is indicated for the regular treatment of asthma in adults and adolescents aged 12 years and older where use of a combination medicinal product (long-acting beta2-agonist and inhaled ...
4.2. Posology and method of administration
Posology Asthma Patients with asthma should be given the strength of Revinty Ellipta containing the appropriate fluticasone furoate (FF) dosage for the severity of their disease. Prescribers should be ...
4.3. Contraindications
Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
4.4. Special warnings and precautions for use
Deterioration of disease Fluticasone furoate/vilanterol should not be used to treat acute asthma symptoms or an acute exacerbation in COPD, for which a short-acting bronchodilator is required. Increasing ...
4.5. Interaction with other medicinal products and other forms of interaction
Clinically significant drug interactions mediated by fluticasone furoate/vilanterol at clinical doses are considered unlikely due to the low plasma concentrations achieved after inhaled dosing. Interaction ...
4.6. Fertility, pregnancy and lactation
Pregnancy Studies in animals have shown reproductive toxicity at exposures which are not clinically relevant (see section 5.3). There are no or limited data from the use of fluticasone furoate and vilanterol ...
4.7. Effects on ability to drive and use machines
Fluticasone furoate or vilanterol has no or negligible influence on the ability to drive and use machines.
4.8. Undesirable effects
Summary of the safety profile Data from large asthma and COPD clinical trials were used to determine the frequency of adverse reactions associated with fluticasone furoate/vilanterol. In the asthma clinical ...
4.9. Overdose
Symptoms and signs An overdose of fluticasone furoate/vilanterol may produce signs and symptoms due to the individual components actions, including those seen with overdose of other beta2-agonists and ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Drugs for obstructive airways diseases, adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics <b>ATC code:</b> R03AK10 Mechanism of action ...
5.2. Pharmacokinetic properties
Absorption The absolute bioavailability for fluticasone furoate and vilanterol when administered by inhalation as fluticasone furoate/vilanterol was on average 15.2% and 27.3%, respectively. The oral bioavailability ...
5.3. Preclinical safety data
Pharmacological and toxicological effects seen with fluticasone furoate or vilanterol in nonclinical studies were those typically associated with either glucocorticoids or beta<sub>2</sub>-agonists. Administration ...
6.1. List of excipients
Lactose monohydrate Magnesium stearate
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
2 years. In-use shelf-life after opening the tray: 6 weeks.
6.4. Special precautions for storage
Do not store above 25°C. If stored in a refrigerator allow the inhaler to return to room temperature for at least an hour before use. Store in the original package in order to protect from moisture. Write ...
6.5. Nature and contents of container
The inhaler consists of a light grey body, a yellow 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 foil ...
6.6. Special precautions for disposal and other handling
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
7. Marketing authorization holder
GlaxoSmithKline (Ireland) Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland
8. Marketing authorization number(s)
EU/1/14/929/001 EU/1/14/929/002 EU/1/14/929/003
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 02 May 2014 Date of latest renewal: 26 July 2018
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