Alvesco 80 micrograms pressurised inhalation,solution
- Name:
Alvesco 80 micrograms pressurised inhalation,solution
- Company:
AstraZeneca Pharmaceuticals (Ireland) DAC
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may be renewed (B)
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AstraZeneca Pharmaceuticals (Ireland) DAC
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When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.
Updated on 9 January 2019 PIL
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - marketing authorisation number
- Change to section 6 - date of revision
Updated on 8 January 2019
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - Marketing authorisation number(s)
- Change to section 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
MA Holder updated
MA Number updated
Date of last revision of text updated
Updated on 7 June 2017
Reasons for updating
- New SmPC for new product
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 7 June 2017 SPC
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - Marketing authorisation number(s)
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 8 – Change to licence number
Section 10 – Date of revision of text
Updated on 7 June 2017 PIL
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - Marketing authorisation number(s)
- Change to section 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
Section 8 – Change to licence number
Section 10 – Date of revision of text
Updated on 6 June 2017 PIL
Reasons for updating
- New PIL for new product
Updated on 5 May 2017 PIL
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
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Change to section |
Details of section |
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4.2 Posology and method of administration |
Updated text:
The recommended dose of Alvesco is 160 micrograms once daily, which leads to asthma control in the majority of patients. In patients with severe asthma and while reducing or discontinuing oral corticosteroids, a higher dose of up to 640mcg/day (given as 320mcg twice daily) may be used (see sec 5.1). Patients should be given a dose of inhaled ciclesonide which is appropriate to the severity of their disease. Symptoms start to improve with Alvesco within 24 hours of treatment. Once control is achieved, the dose of Alvesco should be individualised and titrated to the minimum dose needed to maintain good asthma control. Dose reduction to 80 micrograms once daily may be an effective maintenance dose for some patients.
Alvesco should preferably be administered in the evening although morning dosing of Alvesco has also been shown to be effective. The final decision on evening or morning dosing should be left to the discretion of the physician.
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5.1 Pharmacodynamic properties |
Deleted and updated text:
A further 52 week trial involving 367 patients with mild to moderate asthma, was unable to demonstrate a significant difference in the effect of higher doses of Ciclesonide (320 or 640 mcg per day) as compared to a lower dose (160 mcg per day) on asthma control.
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10. DATE OF REVISION OF THE TEXT
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25 April 2017
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Updated on 5 May 2017 SPC
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
|
Change to section |
Details of section |
|
4.2 Posology and method of administration |
Updated text:
The recommended dose of Alvesco is 160 micrograms once daily, which leads to asthma control in the majority of patients. In patients with severe asthma and while reducing or discontinuing oral corticosteroids, a higher dose of up to 640mcg/day (given as 320mcg twice daily) may be used (see sec 5.1). Patients should be given a dose of inhaled ciclesonide which is appropriate to the severity of their disease. Symptoms start to improve with Alvesco within 24 hours of treatment. Once control is achieved, the dose of Alvesco should be individualised and titrated to the minimum dose needed to maintain good asthma control. Dose reduction to 80 micrograms once daily may be an effective maintenance dose for some patients.
Alvesco should preferably be administered in the evening although morning dosing of Alvesco has also been shown to be effective. The final decision on evening or morning dosing should be left to the discretion of the physician.
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5.1 Pharmacodynamic properties |
Deleted and updated text:
A further 52 week trial involving 367 patients with mild to moderate asthma, was unable to demonstrate a significant difference in the effect of higher doses of Ciclesonide (320 or 640 mcg per day) as compared to a lower dose (160 mcg per day) on asthma control.
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10. DATE OF REVISION OF THE TEXT
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25 April 2017
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Updated on 15 April 2015 SPC
Reasons for updating
- Change to section 10 - Date of revision of the text
- Change to Section 4.8 – Undesirable effects - how to report a side effect
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Changed from:
IMB Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.imb.ie; e-mail: imbpharmacovigilance@imb.ie.
To:
HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie.
Updated on 15 April 2015 PIL
Reasons for updating
- Change to section 10 - Date of revision of the text
- Change to Section 4.8 – Undesirable effects - how to report a side effect
Free text change information supplied by the pharmaceutical company
Changed from:
IMB Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.imb.ie; e-mail: imbpharmacovigilance@imb.ie.
To:
HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie.
Updated on 16 May 2014 PIL
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- Change to section 4.6 - Pregnancy and lactation
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
- addition of the subheading Posology
- addtion of the subheading Elderly and patients with renal or hepatic impairment
- removal of the subheading
- removal of the subheading Instructions for use/handling
- addition of the subheading Method of administration and sub subheadingPrecautions to be taken before handling or administering the medicinal product
In section 4.3
- Addition of the wording listed in section 6.1 to the following sentence:
Hypersensitivity to ciclesonide or any of the excipients listed in section 6.1
In section 4.6
- addition of the heading Fertility, pregnancy and lactation
- removal of the subheading Pregnancy and Lactation
- addition of the subheading Fertility and Pregnancy
- addition of the subheading Breast-feeding
In section 4.8
- Addition of the following wording :
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via IMB Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.imb.ie; e-mail: imbpharmacovigilance@imb.ie.
In section 5.2
- removal of subheading Renal or hepatic insufficiency, elderly
- addition of subheading Elderly
- addition of subheading Renal or hepatic impairment
In section 6.6
- Change of heading to Special precautions for disposal of a used medicinal product or waste materials derived from such medicinal product and other handling of the product
- Addition of the following wording:
No special requirements for disposal. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
In section 10
- Date of Revision amended to 2 May 2014 (previously 30th November 2012)
Updated on 16 May 2014 SPC
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- Change to section 4.6 - Pregnancy and lactation
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
- addition of the subheading Posology
- addtion of the subheading Elderly and patients with renal or hepatic impairment
- removal of the subheading
- removal of the subheading Instructions for use/handling
- addition of the subheading Method of administration and sub subheadingPrecautions to be taken before handling or administering the medicinal product
In section 4.3
- Addition of the wording listed in section 6.1 to the following sentence:
Hypersensitivity to ciclesonide or any of the excipients listed in section 6.1
In section 4.6
- addition of the heading Fertility, pregnancy and lactation
- removal of the subheading Pregnancy and Lactation
- addition of the subheading Fertility and Pregnancy
- addition of the subheading Breast-feeding
In section 4.8
- Addition of the following wording :
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via IMB Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.imb.ie; e-mail: imbpharmacovigilance@imb.ie.
In section 5.2
- removal of subheading Renal or hepatic insufficiency, elderly
- addition of subheading Elderly
- addition of subheading Renal or hepatic impairment
In section 6.6
- Change of heading to Special precautions for disposal of a used medicinal product or waste materials derived from such medicinal product and other handling of the product
- Addition of the following wording:
No special requirements for disposal. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
In section 10
- Date of Revision amended to 2 May 2014 (previously 30th November 2012)
Updated on 18 December 2012 PIL
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
Section 10: Change to Date of Revision of the Text to 30/11/12
Updated on 18 December 2012 SPC
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 10: Change to Date of Revision of the Text to 30/11/12
Updated on 22 September 2011 PIL
Reasons for updating
- Change to section 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
Updated on 22 September 2011 SPC
Reasons for updating
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 8 July 2011 PIL
Reasons for updating
- Change to section 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
Updated on 8 July 2011 SPC
Reasons for updating
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 1 March 2010 PIL
Reasons for updating
- Change to section 9 - Date of renewal of authorisation
- Change to section 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
18 February 2005/24 February 2009
10. DATE OF REVISION OF THE TEXT
5th February 2010
Updated on 1 March 2010 SPC
Reasons for updating
- Change to section 9 - Date of renewal of authorisation
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
18 February 2005/24 February 2009
10. DATE OF REVISION OF THE TEXT
5th February 2010
Updated on 20 April 2009 PIL
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
Updated on 20 April 2009 SPC
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 18 February 2009 PIL
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
4.2 Posology and method of administration
The recommended dose of Alvesco is 160 micrograms once daily, which leads to asthma control in the majority of patients. However in severe asthmatics, a 12 week study has shown that a dose of 640 micrograms/day (given 320 micrograms twice daily) has demonstrated a reduction in the frequency of exacerbations but without an improvement in lung function (see section 5.1).
5.1 Pharmacodynamic properties
A controlled study compared 24-hour plasma cortisol AUC in 26 adult asthmatic patients following 7 days of treatment. Compared to placebo, treatment with ciclesonide 320, 640, and 1280 micrograms/day did not statistically significantly lower the 24-hour time averages of plasma cortisol (AUC(0-24)/24 hours) nor was a dose-dependent effect seen.
In a clinical trial involving 164 adult male and female asthmatic patients, ciclesonide was given at doses of 320 micrograms or 640 micrograms/day over 12 weeks. After stimulation with 1 and 250 micrograms cosyntropin, no significant changes in plasma cortisol levels were observed versus placebo.
Double-blind placebo-controlled trials of 12-weeks duration in adults and adolescents have shown that treatment with ciclesonide resulted in improved lung function as measured by FEV1 and peak expiratory flow, improved asthma symptom control, and decreased need for inhaled beta-2 agonist. In a 12-week study of 680 severe asthmatics, previously treated with 500 - 1000 micrograms fluticasone propionate per day or equivalent, 87.3% and 93.3% of patients remained exacerbation-free during treatment with 160 or 640 micrograms of ciclesonide, respectively. At the end of the 12 week study period, the results showed a statistically significant difference between the doses of 160 micrograms and 640 micrograms/day ciclesonide with regard to the occurrence of an exacerbation after the first day of the study: 43 patients/339 (= 12.7%) in the 160 micrograms/day group and 23 patients/341 (6.7%) in the 640 micrograms/day group (Hazard ratio=0.526; p= 0.0134). Both ciclesonide doses resulted in comparable FEV1 values at 12 weeks. Treatment-related adverse events were seen in 3.8% and 5% of patients treated with 160 or 640 micrograms per day of ciclesonide respectively. No study was performed to compare 160 micrograms, 320 micrograms and 640 micrgrams daily dose in patients with severe asthma.
Updated on 18 February 2009 SPC
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
4.2 Posology and method of administration
The recommended dose of Alvesco is 160 micrograms once daily, which leads to asthma control in the majority of patients. However in severe asthmatics, a 12 week study has shown that a dose of 640 micrograms/day (given 320 micrograms twice daily) has demonstrated a reduction in the frequency of exacerbations but without an improvement in lung function (see section 5.1).
5.1 Pharmacodynamic properties
A controlled study compared 24-hour plasma cortisol AUC in 26 adult asthmatic patients following 7 days of treatment. Compared to placebo, treatment with ciclesonide 320, 640, and 1280 micrograms/day did not statistically significantly lower the 24-hour time averages of plasma cortisol (AUC(0-24)/24 hours) nor was a dose-dependent effect seen.
In a clinical trial involving 164 adult male and female asthmatic patients, ciclesonide was given at doses of 320 micrograms or 640 micrograms/day over 12 weeks. After stimulation with 1 and 250 micrograms cosyntropin, no significant changes in plasma cortisol levels were observed versus placebo.
Double-blind placebo-controlled trials of 12-weeks duration in adults and adolescents have shown that treatment with ciclesonide resulted in improved lung function as measured by FEV1 and peak expiratory flow, improved asthma symptom control, and decreased need for inhaled beta-2 agonist. In a 12-week study of 680 severe asthmatics, previously treated with 500 - 1000 micrograms fluticasone propionate per day or equivalent, 87.3% and 93.3% of patients remained exacerbation-free during treatment with 160 or 640 micrograms of ciclesonide, respectively. At the end of the 12 week study period, the results showed a statistically significant difference between the doses of 160 micrograms and 640 micrograms/day ciclesonide with regard to the occurrence of an exacerbation after the first day of the study: 43 patients/339 (= 12.7%) in the 160 micrograms/day group and 23 patients/341 (6.7%) in the 640 micrograms/day group (Hazard ratio=0.526; p= 0.0134). Both ciclesonide doses resulted in comparable FEV1 values at 12 weeks. Treatment-related adverse events were seen in 3.8% and 5% of patients treated with 160 or 640 micrograms per day of ciclesonide respectively. No study was performed to compare 160 micrograms, 320 micrograms and 640 micrgrams daily dose in patients with severe asthma.
Updated on 20 February 2008 PIL
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - MA number
- Change to section 10 - Date of revision of the text
- Change to marketing authorisation holder
Free text change information supplied by the pharmaceutical company
Section 8: Change of company number reflecting change of name of MAH
Section 10: Updated date of text revision
Updated on 20 February 2008 SPC
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - MA number
- Change to section 10 - Date of revision of the text
- Change to marketing authorisation holder
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 8: Change of company number reflecting change of name of MAH
Section 10: Updated date of text revision
Updated on 29 May 2007 SPC
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 5.1 - Pharmacodynamic properties
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
In a 12-week study of 680 severe asthmatics, previously treated with 500 – 1000 micrograms fluticasone propionate per day or equivalent, 87.3% and 93.3% of patients remained exacerbation-free during treatment with 160 or 640 micrograms of ciclesonide, respectively. Both ciclesonide doses resulted in comparable FEV1 values at 12 weeks. Treatment-related adverse events were seen in 3.8% and 5% of patients treated with 160 or 640 micrograms per day of ciclesonide respectively.
Updated on 29 May 2007 PIL
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 5.1 - Pharmacodynamic properties
Free text change information supplied by the pharmaceutical company
In a 12-week study of 680 severe asthmatics, previously treated with 500 – 1000 micrograms fluticasone propionate per day or equivalent, 87.3% and 93.3% of patients remained exacerbation-free during treatment with 160 or 640 micrograms of ciclesonide, respectively. Both ciclesonide doses resulted in comparable FEV1 values at 12 weeks. Treatment-related adverse events were seen in 3.8% and 5% of patients treated with 160 or 640 micrograms per day of ciclesonide respectively.
Updated on 19 December 2006 SPC
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
(< 1/10,000, incl. isolated reports)
Updated on 19 December 2006 PIL
Reasons for updating
- Change to section 4.8 - Undesirable effects
Free text change information supplied by the pharmaceutical company
(< 1/10,000, incl. isolated reports)
Updated on 31 August 2006 PIL
Reasons for updating
- Change to section 6.3 - Shelf life
- Change to section 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
Updated on 31 August 2006 SPC
Reasons for updating
- Change to section 6.3 - Shelf life
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 24 April 2006 PIL
Reasons for updating
- Change to section 4.1 - Therapeutic indications
Updated on 24 April 2006 SPC
Reasons for updating
- Change to section 4.1 - Therapeutic indications
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 9 May 2005 SPC
Reasons for updating
- Change to section 6.5 - Nature and contents of container
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 9 May 2005 PIL
Reasons for updating
- Change to section 6.5 - Nature and contents of container
Updated on 28 April 2005 SPC
Reasons for updating
- New SPC for medicines.ie
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 28 April 2005 PIL
Reasons for updating
- New SPC for medicines.ie