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Atrovent 250 UDVs, 250 micrograms/1ml Nebuliser Solution

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Pharmacy Only: Prescription

Updated on 02 March 2023

File name

A9d;250-1-E-SPC-18 medicines.ie.pdf

Reasons for updating

  • Document format updated

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 26 January 2021

File name

250 PIL IE 65NOT1019-F 28.09.20 PIP012613-007 AMT 101623 cropped.pdf

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - what the product contains
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision

Updated on 25 January 2021

File name

A9d;250-1-E-SPC-18 medicines.ie.pdf

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic 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

The main changes were made to section 5.2:

  • Redundant information relating to intravenous administration was deleted
  • Some information within the section was reformatted

Additional editorial updates were also made to the following sections:

Section 4.2 – The statement that the UDVs must not be taken orally or administered parenterally was corrected, for clarification

Section 4.8 - The section was reformatted to align with the EU QRD template. Outdated adverse event (AE) reporting details were also corrected.

Sections 5.1 and 5.2 - A number of minor editorial corrections were made

Section 10,  Date of Revision, was updated to January 2021

Updated on 30 April 2019

File name

250 PIL IE 65NOT1019-E 12.11.18 PIP012613-006 AMT 89919 - cropped.pdf

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 29 April 2019

File name

A9d;250-1-E-SPC-17.pdf

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

Marketing Authorisation transfer to change the Irish Marketing Authorisation Holder (MAH) from Boehringer Ingelheim Ltd, UK to Boehringer Ingelheim International GmbH, Germany.  Marketing Authorisation numbers also changed.  Section 10, date of revision, has been updated.

Updated on 14 January 2016

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 14 January 2016

File name

PIL_8869_869.pdf

Reasons for updating

  • New PIL for new product

Updated on 14 January 2016

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.3 - Shelf life
  • Change to section 6.5 - Nature and contents of container
  • 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 4.3: updated to clarify the nature of Atrovent and define the circumstances under which it is contraindicated.

Section 4.4: Updated to include a paragraph on paradoxical bronchospasm.

Section 4.5: Updated with a statement relating to chronic co-administration of Atrovent.

Section 4.7: Deletion of repetitive text relating to driving or operating machinery.

Section 5.2: Updated with information that ipratropium does not cross the placental barrier and with information regarding the metabolites of Atrovent. A statement relating to the discontinued CFC-containing formulation was also deleted.

In addition a number of editorial updates were made to sections 4.2, 4.4, 4.5, 4.6, 5.1 and 5.2.

Section 10 has been revised to and minor typographical revisions have been made to the section 6.3 and 6.5 subheadings to align more fully with the schedule document.

Updated on 14 January 2016

Reasons for updating

  • Change to date of revision
  • Change to dosage and administration

Updated on 06 August 2014

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Adverse event reporting statements have been added to the end of section 4.8 (Undesirable effects) as follows:

 

4.8 Undesirable effects

 

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 HPRA Pharmacovigilance, Earlsfort Terrace, IRL – Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie.

 

 

In addition, minor typographical changes have been made to section 4.3 (Interactions) as indicated below:

 

4.5 Interaction with other medicinal products and other forms of interaction

 

There is evidence that the administration of ATROVENT with beta-adrenergic drugs and xanthine preparations may intensify the bronchodilator effect of ATROVENT.

 

The risk of acute glaucoma in patients with a history of narrow-angle glaucoma (see Special Wwarnings and Special Pprecautions for Uuse) may be increased when nebulised ipratropium bromide and beta2-agonists are administered simultaneously.

Section 10: date of revision updated to July 2014

Updated on 28 July 2014

Reasons for updating

  • Change to date of revision
  • Change to name of manufacturer
  • Addition of information on reporting a side effect.

Updated on 10 April 2012

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.5 - Nature and contents of container
  • 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 1 Name of Medicinal Product

Minor editorial changes have been made to this section.

 

Section 2 Qualitative and Quantitative Composition

Minor editorial changes have been made to this section.

 

Section 4.5 Interaction with Other Medicinal Products and Other Forms of Interaction

A minor editorial change has been made to the section header of this section.

 

Section 4.6 Fertility, Pregnancy and Lactation

A minor editorial change has been made to the section header of this section.

 

Section 5.1 Pharmacodynamic Properties

A new third paragraph regarding preclinical and clinical evidence has been added to this section.

 

The fourth paragraph has had text both added to and deleted from.

 

The fifth paragraph has had text deleted from.

 

A new final paragraph has been added to this section.

 

Section 6.5 Nature and Contents of Containers

Minor editorial changes have been made to this section.

 

Section 10 Date of Revision of the Text

The date has been amended from August 2010 to March 2012.

Updated on 06 October 2010

Reasons for updating

  • Change to side-effects
  • Change to information about driving or using machinery
  • Change to date of revision

Updated on 04 October 2010

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic 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

Section 4.4

Paragraph relating to ‘Immediate hypersensitivity reactions…’ has been moved to the beginning of the section to improve prominence of this important information.

 

Additional statement added relating to ‘pre-existing urinary outflow tract obstruction’

 

Section 4.6

Statement added to advise about the availability of data relating to the effects on human fertility


Section 4.7

Addition of information taking into account the listed side effects which may impair ability to drive and use machines

 

Section 4.8

Summary of safety profile added. List of adverse events mapped according to appropriate MedDRA preferred terms. Frequencies updated according to available data. Addition of side effect ‘stomatitis’ plus ‘dry throat’

 

Section 4.9

Change of ‘accommodation disturbances’ to ‘accommodation disorder’

 

Section 5.1

Mechanism of action corrected. Addition information on local nature of effect of ipratropium and other amendments to take into account available data.

 

Section 5.2

Section revised based on existing references, reworded and restructured according to ADME. Additional information included to provide more comprehensive information.


Section 10

Revision date changed to August 2010

Updated on 11 May 2010

Reasons for updating

  • Change to section 6.3 - Shelf life

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 6.3 has been updated to comply with CMPP/QWP/159/96 ‘Note for guidance on maximum shelf-life for sterile products for human use after first opening or following reconstitution’ to include information on the use of the product when diluted.

 

The following statement has been added:

 

'Diluted product:

From a microbiological point of view, unless the method of dilution precludes the risk of microbiological contamination, the product should be used immediately.

                If not used immediately, in-use storage times and conditions are the responsibility of the user.'

Updated on 19 April 2010

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • 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



Section 4.2 Posology and method of administration

The information relating to the use with a nebuliser has been removed and instead a direct reference has been made to refer to the patient information leaflet for instructions

 

Section 6.3 Shelf life

Information on the shelf life following removal from the foil overwrap (relates to product manufactured at new manufacturing site) has been included.

 

Section 10 has been revised to April 2010

Updated on 04 March 2009

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 6.1 - List of excipients
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 2: Editorial Change

Section 6.3: Editorial Change

Section 6.1: Editorial Change

Section 6.2: Editorial Change

Section 6.3: Editorial Change

Section 6.4: Editorial Change

Section 6.5: Editorial Change

Section 6.6: Guidance on dilution

Updated on 26 September 2008

Reasons for updating

  • Improved electronic presentation

Updated on 24 May 2007

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 22 March 2007

Reasons for updating

  • Improved electronic presentation

Updated on 15 May 2006

Reasons for updating

  • Improved electronic presentation

Updated on 14 September 2004

Reasons for updating

  • New PIL for medicines.ie