Atrovent 500 UDVs, 500 micrograms/2ml Nebuliser Solution

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 Outdated adverse event (AE) reporting details were also corrected.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

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.

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.

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 of text updated to July 2014

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.

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

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.'

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