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Φάρμακα Δραστικές ουσίες Συμπληρώματα διατροφής Έλεγχος συγχορήγησης Νόσοι ICD-10
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Βιβλιογραφική αναφορά

Προτάσεις

SPC, UK: Alvesco 80 Inhaler (2011)

Εκδότης

Εκδότης Takeda UK Ltd
Διεύθυνση Takeda House, Mercury Park, Wycombe Lane, Wooburn Green, High Wycombe, Buckinghamshire, HP10 0HH
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Περιεχόμενα

Name of the medicinal product

Alvesco® 80 Inhaler.

Qualitative and quantitative composition

1 actuation (delivered dose from the mouthpiece) contains 80 micrograms of ciclesonide. For a full list ...

Pharmaceutical form

Pressurised inhalation, solution. Clear and colourless.

Therapeutic indications

Treatment to control persistent asthma in adults and adolescents (12 years and older).

Posology and method of administration

The medicinal product is for inhalation use only. Dosing recommendation for adults and adolescents The ...

Contraindications

Hypersensitivity to ciclesonide or any of the excipients.

Special warnings and precautions for use

As with all inhaled corticosteroids, Alvesco should be administered with caution in patients with active ...

Interaction with other medicinal products and other forms of interaction

In vitro data indicate that CYP3A4 is the major enzyme involved in the metabolism of the active metabolite ...

Pregnancy and lactation

There are no adequate and well-controlled studies in pregnant women. In animal studies glucocorticoids ...

Effects on ability to drive and use machines

Inhaled ciclesonide has no or negligible influence on the ability to drive and use machines.

Undesirable effects

Approximately 5% of patients experienced adverse reactions in clinical trials with Alvesco given in the ...

Overdose

Acute Inhalation by healthy volunteers of a single dose of 2880 micrograms of ciclesonide was well tolerated. ...

Pharmacodynamic properties

Pharmacotherapeutic group: Other drugs for obstructive airway diseases, Inhalants, Glucocorticoids ATC ...

Pharmacokinetic properties

Ciclesonide is presented in HFA-134a propellant and ethanol as a solution aerosol, which demonstrates ...

Preclinical safety data

Preclinical data with ciclesonide reveal no special hazard for humans based on conventional studies of ...

List of excipients

Norflurane (HFA-134a) Ethanol, anhydrous

Incompatibilities

Not applicable.

Shelf life

30 metered actuations: 1 year. 60 and 120 metered actuations: 3 years.

Special precautions for storage

This medicinal product does not require any special storage conditions. The container contains a pressurised ...

Nature and contents of container

The inhaler comprises a pressurised container made from aluminium and is sealed with a metering valve, ...

Special precautions for disposal and other handling

Patients should be carefully instructed in the proper use of their inhaler (see Patient Information Leaflet). ...

Marketing authorization holder

Nycomed GmbH Byk-Gulden-Str. 2 D-78467 Konstanz Germany

Marketing authorization number(s)

PL 31752/0005

Date of first authorization / renewal of the authorization

16 April 2004 / 28 September 2009

Date of revision of the text

18 May 2011
Απαγορεύεται η αναπαραγωγή και αναδιανομή. Το έργο επεξεργασίας των παραπάνω πληροφοριών αποτελεί πνευματική ιδιοκτησία της Ergobyte Πληροφορική Α.Ε. και προστατεύεται από τη νομοθεσία περί πνευματικών δικαιωμάτων.