ALVESCO 80 Pressurised inhalation, solution (2017)
Βιβλιογραφική αναφορά
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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 of excipients, see section 6.1.
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. Posology Dosing recommendation for adults and adolescents The recommended dose of Alvesco is 160 micrograms once daily, which leads to asthma control in ...
Contraindications
Hypersensitivity to ciclesonide or any of the excipients listed in section 6.1.
Special warnings and precautions for use
As with all inhaled corticosteroids, Alvesco should be administered with caution in patients with active or quiescent pulmonary tuberculosis, fungal, viral or bacterial infections, and only if these patients ...
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 of ciclesonide M1 in man. In a drug-drug interaction study at steady state with ciclesonide and ...
Fertility, pregnancy and lactation
Fertility and Pregnancy There are no adequate and well-controlled studies in pregnant women. In animal studies glucocorticoids have been shown to induce malformations (see section 5.3). This is not likely ...
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 dose range 40 to 1280 micrograms per day. In the majority of cases, these were mild and did not require ...
Overdose
Acute Inhalation by healthy volunteers of a single dose of 2880 micrograms of ciclesonide was well tolerated. The potential for acute toxic effects following overdose of inhaled ciclesonide is low. After ...
Pharmacodynamic properties
Pharmacotherapeutic group: Other drugs for obstructive airway diseases, Inhalants, Glucocorticoids ATC Code: R03BA08 Ciclesonide exhibits low binding affinity to the glucocorticoid-receptor. Once orally ...
Pharmacokinetic properties
Ciclesonide is presented in HFA-134a propellant and ethanol as a solution aerosol, which demonstrates a linear relationship between different doses, puff strengths and systemic exposure. Absorption Studies ...
Preclinical safety data
Preclinical data with ciclesonide reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, or carcinogenic potential. In animal studies ...
List of excipients
Norflurane (HFA-134a) Ethanol, anhydrous
Incompatibilities
Not applicable.
Shelf life
<u>30 metered actuations:</u> 1 year. <u>60 and 120 metered actuations:</u> 3 years.
Special precautions for storage
This medicinal product does not require any special storage conditions. The container contains a pressurised liquid. Do not expose to temperatures higher than 50°C. The container should not be punctured, ...
Nature and contents of container
The inhaler comprises a pressurised container made from aluminium and is sealed with a metering valve, mouthpiece, and cap. 30 metered actuations 60 metered actuations 120 metered actuations Not all pack ...
Special precautions for disposal and other handling
Patients should be carefully instructed in the proper use of their inhaler (see Patient Information Leaflet). As with most inhaled medicinal products in pressurised containers, the therapeutic effect of ...
Marketing authorization holder
AstraZeneca UK Ltd., 600 Capability Green, Luton, LU1 3LU, UK.
Marketing authorization number(s)
PL 17901/0297
Date of first authorization / renewal of the authorization
16 April 2004 / 24 February 2014
Date of revision of the text
30 May 2017
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