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`Ventavis 10 microgram/ml nebuliser solution
`
`Last Updated on eMC 14-Dec-2016 View document | Bayer plc Contact details
`
`Versions
`14-Dec-2016 to Current
`
`21-Nov-2016 to 14-Dec-2016
`
`11-Dec-2014 to 21-Nov-2016
`
`05-Aug-2014 to 11-Dec-2014
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`09-Jan-2014 to 05-Aug-2014
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`10-Sep-2013 to 09-Jan-2014
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`25-Mar-2013 to 10-Sep-2013
`
`31-Aug-2011 to 25-Mar-2013
`
`08-Mar-2011 to 31-Aug-2011
`
`24-Jan-2011 to 08-Mar-2011
`
`12-Feb-2010 to 24-Jan-2011
`
`16-Dec-2009 to 12-Feb-2010
`
`22-Oct-2008 to 16-Dec-2009
`
`11-Feb-2008 to 22-Oct-2008
`
`18-Sep-2007 to 11-Feb-2008
`
`13-Aug-2007 to 18-Sep-2007
`
`05-Sep-2006 to 13-Aug-2007
`
`31-Jan-2006 to 05-Sep-2006
`
`22-Sep-2005 to 31-Jan-2006
`
`05-Aug-2004 to 22-Sep-2005
`
`15-Jan-2004 to 05-Aug-2004
`
`When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC. For each
`version, we show the dates it was published on the eMC and the reasons for change.
`
`Updated on 14-Dec-2016 and displayed until Current
`
`Reasons for adding or updating:
`Change to section 6.3 - Shelf life
`
`Date of revision of text on the SPC: 13-Oct-2016
`Legal Category:POM
`Black Triangle (CHM): NO
`Free-text change information supplied by the pharmaceutical company:
`
`An error was noted in section 6.3 “Shelf life” which currently states:
`Ventavis 20 microgram/ml nebuliser solution
`2 years.
`Ventavis 20 microgram/ml nebuliser solution
`5 years.
`
`This has now been corrected to state:
`Ventavis 10 microgram/ml nebuliser solution
`2 years.
`Ventavis 20 microgram/ml nebuliser solution
`5 years.
`
`Updated on 21-Nov-2016 and displayed until 14-Dec-2016
`
`Reasons for adding or updating:
`Change to section 1 - Name of the medicinal product
`
`Change to section 2 - Qualitative and quantitative composition
`
`Change to section 3 - Pharmaceutical form
`
`Change to section 4.2 - Posology and method of administration
`
`Change to section 4.4 - Special warnings and precautions for use
`This site uses cookies. By continuing to browse the site you are agreeing to our policy on the use of cookies. Continue
`Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
`
`Find out more here.
`
`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 5.3 - Preclinical safety data
`
`Change to section 6.3 - Shelf life
`
`Change to section 6.5 - Nature and contents of container
`
`Change to section 6.6 - Special precautions for disposal and other handling
`
`Change to section 8 - Marketing authorisation number(s)
`
`Change to section 10 - Date of revision of the text
`
`WATSON LABORATORIES, INC. , IPR2017-01622, Ex. 1045, p. 1 of 8
`
`

`

`Date of revision of text on the SPC: 13-Oct-2016
`Legal Category:POM
`Black Triangle (CHM): NO
`Free-text change information supplied by the pharmaceutical company:
`
`The key changes are:
`To add information on the Breelib Inhaler.
`New combined SmPC for 10 & 20 microgram/ml nebulizer solution.
`
`Updated on 11-Dec-2014 and displayed until 21-Nov-2016
`
`Reasons for adding or updating:
`Change to section 6.5 - Nature and contents of container
`
`Change to section 8 - Marketing authorisation number(s)
`
`Change to section 10 - Date of revision of the text
`
`Date of revision of text on the SPC: 07-Nov-2014
`Legal Category:POM
`Black Triangle (CHM): NO
`Free-text change information supplied by the pharmaceutical company:
`
`The key changes are:
`· Section 6.5: 1 ml nebuliser solution – packages containing 30, 42 or 168 ampoules
`· Section 8: new MA numbers added for the new pack size.
`
`Updated on 05-Aug-2014 and displayed until 11-Dec-2014
`
`Reasons for adding or updating:
`Change to section 2 - Qualitative and quantitative composition
`
`Change to section 4.4 - Special warnings and precautions for use
`
`Change to section 5.2 - Pharmacokinetic properties
`
`Change to section 10 - Date of revision of the text
`
`Date of revision of text on the SPC: 18-Jul-2014
`Legal Category:POM
`Black Triangle (CHM): NO
`Free-text change information supplied by the pharmaceutical company:
`The key changes are:
`· Clearer statement of ethanol content in section 2
`· In section 4.4 a heading has been added for Pulmonary veno-occlusive disease and an additional statement
`“Pulmonary vasodilators may significantly worsen the cardiovascular status of patients with pulmonary veno-occlusive
`disease.”
`The remainder of the paragraph (Should signs of pulmonary oedema occur………) has been included in the previous
`version of the SmPC but has now been relocated under this PVOD heading. The end of the paragraph states that Ventavis
`should be discontinued (rather than stopped as previous version).
`· In section 5.2 under the heading “Age and gender” there is now a statement that PK data are not available for the
`elderly.
`
`Updated on 09-Jan-2014 and displayed until 05-Aug-2014
`
`Reasons for adding or updating:
`Change to section 4.2 - Posology and method of administration
`
`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 4.8 - Undesirable effects
`
`Change to section 5.1 - Pharmacodynamic properties
`
`Change to section 5.2 - Pharmacokinetic properties
`
`Change to section 6.1 - List of excipients
`
`Change to section 10 - Date of revision of the text
`
`WATSON LABORATORIES, INC. , IPR2017-01622, Ex. 1045, p. 2 of 8
`
`

`

`Date of revision of text on the SPC: 21-Nov-2013
`Legal Category:POM
`Black Triangle (CHM): NO
`Free-text change information supplied by the pharmaceutical company:
`
`Updates to Sections 4.8 of the SmPC:
`· Addition of ‘Cardiac disorders’ to the ADR table including tachycardia and palpitations as common events
`· Addition of ‘General disorders and administration site conditions’ to the ADR table including peripheral oedema as
`a very common event
`· Deletion of nasal congestion from ‘Respiratory, thoracic and mediastinal disorders (frequency not known).
`
`
`In addition the following sentence was added to the ‘bleeding events’ subsection underneath the ADR table (below the
`heading ‘Description of selected adverse reactions’):
`‘The risk of bleeding may be increased in patients when potential inhibitors of platelet aggregation or anticoagulants are
`given concomitantly (see section 4.5).’
`
`The standard warning on reporting of suspected adverse reactions has also now been added to this section.
`
`Other changes are editorial and have been made to sections 4.2, 4.4, 5.1, 5.2 and 6.1.
`
`Updated on 10-Sep-2013 and displayed until 09-Jan-2014
`
`Reasons for adding or updating:
`Change to section 2 - Qualitative and quantitative composition
`
`Change to section 4.1 - Therapeutic indications
`
`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 - Fertility, 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
`
`Date of revision of text on the SPC: 26-Aug-2013
`Legal Category:POM
`Black Triangle (CHM): NO
`Free-text change information supplied by the pharmaceutical company:
`
`The key changes are:
`Approval of Renewal of the licence: updates to sections: 2 (Qualitative and Quantitative Composition), 4.1 (Therapeutic
`Indications), 4.2 (Posology and method of administration), 4.3 (Contraindications), 4.4 (Special warnings and
`precautions for use), 4.5 (Interaction with other medicinal products and other forms of interaction), 4.6 (Fertility,
`pregnancy and lactation), 4.7 (Effects on ability to drive and use machines), 4.8 (Undesirable effects), 4.9 (Overdose),
`5.1 (Pharmacodynamic properties), 5.2 (Pharmacokinetic properties), 10 (Date of revision of the text).
`
`Updated on 25-Mar-2013 and displayed until 10-Sep-2013
`
`Reasons for adding or updating:
`Change to section 4.3 - Contraindications
`
`Change to section 4.6 - Fertility, pregnancy and lactation
`
`Change to section 4.8 - Undesirable effects
`
`Change to section 10 - Date of revision of the text
`
`Date of revision of text on the SPC: 01-Apr-2012
`Legal Category:POM
`
`WATSON LABORATORIES, INC. , IPR2017-01622, Ex. 1045, p. 3 of 8
`
`

`

`Black Triangle (CHM): NO
`Free-text change information supplied by the pharmaceutical company:
`
`The key changes are:
`· Section 4.3 where ‘pregnancy & lactation’ have been removed as a CI
`
`· Section 4.6 where a section on ‘fertility’ has been added.
`
`· Section 4.8 a sentence on serious ARs has been added in the introduction and ‘thrombocytopenia’ has been added to the
`ADR table.
`· Other editorial type changes have also been made to other sections of the SmPC.
`
`Updated on 31-Aug-2011 and displayed until 25-Mar-2013
`
`Reasons for adding or updating:
`Change to section 7 - Marketing Authorisation Holder
`
`Change to section 10 date of revision of the text
`
`Date of revision of text on the SPC: 01-Jul-2011
`Legal Category:POM
`Black Triangle (CHM): NO
`Free-text change information supplied by the pharmaceutical company:
`
`The key changes are:
`
`The name of the Marketing Authorisation Holder and manufacturers have changed from Bayer Schering Pharma AG
`to Bayer Pharma AG.
`
`Updated on 08-Mar-2011 and displayed until 31-Aug-2011
`
`Reasons for adding or updating:
`Change to section 4.2 - Posology and method of administration
`
`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 4.8 - 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 5.3 - Preclinical Safety Data
`
`Date of revision of text on the SPC: 21-Feb-2011
`Legal Category:POM
`Black Triangle (CHM): NO
`Free-text change information supplied by the pharmaceutical company:
`
`The SmPC has been updated as follows:
`
`minor editorial changes have been made throughout
`4.2 amended to include concomitant therapy and additional info on renally impaired patients.
`4.4 amended to include additional info on blood pressure.
`4.5 amended to include hypotension.
`4.8 all side effects are now incorporated into the MedDRA table - some frequencies have changed.
`4.9 symptoms expanded.
`5.1 STEP trial added.
`5.2 & 5.3 minor amendments.
`
`WATSON LABORATORIES, INC. , IPR2017-01622, Ex. 1045, p. 4 of 8
`
`

`

`Updated on 24-Jan-2011 and displayed until 08-Mar-2011
`
`Reasons for adding or updating:
`Change to section 4.2 - Posology and method of administration
`
`Change to section 4.6 - Pregnancy and Lactation
`
`Change to section 4.8 - Undesirable Effects
`
`Change to section 10 date of revision of the text
`
`Date of revision of text on the SPC: 01-Dec-2010
`Legal Category:POM
`Black Triangle (CHM): NO
`Free-text change information supplied by the pharmaceutical company:
`
`The SmPC has been updated as follows:
`minor change to section 4.2: 'children and adolescents' - heading amended to 'Paediatric Population'
`minor change to section 4.6: title changed to Fertility, pregnancy and lactation and separate section created for women
`of child bearing potential
`changes to section 4.8: additional common side effects included in the MedDRA table (rash, mouth and tongue
`irritation, pharyngolaryngeal pain and throat irritation) and a new column has also been added for side effects of
`unknown frequency (dysgeusia, hypersensitivity).
`
`Updated on 12-Feb-2010 and displayed until 24-Jan-2011
`
`Reasons for adding or updating:
`Removal of Black Triangle
`
`Date of revision of text on the SPC: 01-Nov-2009
`Legal Category:POM
`Black Triangle (CHM): YES
`Free-text change information supplied by the pharmaceutical company:
`Removal of black triangle with effect from 03.02.2010
`
`Updated on 16-Dec-2009 and displayed until 12-Feb-2010
`
`Reasons for adding or updating:
`Change to section 4.2 - Posology and method of administration
`
`Change to section 6. 5 - Nature and Contents of Container
`
`Change to section 10 date of revision of the text
`
`Date of revision of text on the SPC: 17-Nov-2009
`Legal Category:POM
`Black Triangle (CHM): YES
`Free-text change information supplied by the pharmaceutical company:
`
`The key changes to the SmPC are:
`To change the 1 mL ampoule ring code from three coloured rings (pink-red-red) to two coloured
`rings (white-yellow). This affects Section 4.2 (Posology and method of administration) and Section
`6.5 (Nature and contents of container).
` Section 10 (Date of revision of the text) has been updated to 11/2009.
`
`Updated on 22-Oct-2008 and displayed until 16-Dec-2009
`
`Reasons for adding or updating:
`Change to section 2 - Qualitative and quantitative composition
`
`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 4.6 - Pregnancy and Lactation
`
`Change to section 4.8 - Undesirable Effects
`
`Change to section 5.2 - Pharmacokinetic Properties
`
`Change to section 9 - Date of first Authorisation/renewal of the Authorisation
`
`WATSON LABORATORIES, INC. , IPR2017-01622, Ex. 1045, p. 5 of 8
`
`

`

`Change to section 10 date of revision of the text
`
`Date of revision of text on the SPC: 01-Sep-2008
`Legal Category:POM
`Black Triangle (CHM): YES
`Free-text change information supplied by the pharmaceutical company:
`Section 2 (Qualitative and Quantitative composition) - mention that Ventavis contains excipient ethanol.
`Section 4.2 ( Posology) - updated to state that I-Neb nebuliser has been shown to produce a faster delivery of solution.
`Section 4.3 ( Contraindications) - cross reference to Section 6.6 included for pregnancy/lactation.
`Section 4.4 ( Special Warnings) - now includes risk of inducing bronchospasm and risk benfit of Ventavis not established in
`patients with concomitant Chronic Obstructive Pulmonay Disease (COPD).
`Section 4.6 ( Pregnancy & lactation) - cross reference to Section 4.3 added.
`Section 4.8 ( Undesirable effects) - updated to include additional side effects in association with Ventavis
`inhalation.Additional text above AE table.
`Section 5.2 ( Pharmacokinetic properties) - Additional study results have been incorporated.
`Section 9 ( Date of Renewal) - last renewal date ie 16/09/08 has been added.
`Section 10 (Revision Date) - now 09/2008.
`
`Updated on 11-Feb-2008 and displayed until 22-Oct-2008
`
`Reasons for adding or updating:
`Change to section 10 date of revision of the text
`
`Date of revision of text on the SPC: 01-Oct-2007
`Legal Category:POM
`Black Triangle (CHM): NO
`Free-text change information supplied by the pharmaceutical company:
`Section 10: revision date has been amended from May 2007 to October 2007
`
`Updated on 18-Sep-2007 and displayed until 11-Feb-2008
`
`Reasons for adding or updating:
`Addition of Black Triangle
`
`Date of revision of text on the SPC: 01-May-2007
`Legal Category:POM
`Black Triangle (CHM): NO
`Free-text change information supplied by the pharmaceutical company:
`Addition of the black triangle in the header.
`
`Updated on 13-Aug-2007 and displayed until 18-Sep-2007
`
`Reasons for adding or updating:
`Change to section 4.2 - Posology and method of administration
`
`Change to section 4.8 - Undesirable Effects
`
`Change to section 5.1 - Pharmacodynamic Properties
`
`Change to section 6. 6 - Instructions for use, handling and disposal
`
`Change to section 10 date of revision of the text
`
`Date of revision of text on the SPC: 01-May-2007
`Legal Category:POM
`Black Triangle (CHM): NO
`Free-text change information supplied by the pharmaceutical company:
`Section 4.2: Additional text re method of administration and doseage - instructions on poor tolerability have been added
`Section 4.8: Information on common adverse reactions and frequencies seen in clinical trials has been inserted,
`presentation of data has been tabulated and a new paragraph on adverse events in health volunteers has been included.
`Section 5.1: Confirmation that this medicine has been authorised under exceptional circumstance has been added
`Section 6.6: Extra information on disposal of unused material has been included
`Section 10 : Revision date has been amended to 30 May 2007
`
`Updated on 05-Sep-2006 and displayed until 13-Aug-2007
`
`Reasons for adding or updating:
`Change to section 2 - qualitative and quantitative composition
`
`Change to section 4.2 - Posology and Method of Administration
`
`Change to section 4.8 - Undesirable Effects
`
`WATSON LABORATORIES, INC. , IPR2017-01622, Ex. 1045, p. 6 of 8
`
`

`

`Change to section 6. 5 - Nature and Contents of Container
`
`Change to section 8 - MA number
`
`Change to section 10 (date of (partial) revision of the text
`
`Date of revision of text on the SPC: 01-Jun-2006
`Legal Category:POM
`Black Triangle (CHM): NO
`Free-text change information supplied by the pharmaceutical company:
`
`Section 2: Addition of new size - 1ml ampoule containing 10 micrograms of iloprost
`Section 4.2: Change in description of ampoule ie from one 2-ml ampoule of Ventavis to one ampoule
`containing 2ml of Ventavis.
`Addition of coloured rings to one ampoule size.
`Insertion of text re I-Neb AAD System as follows - The I-Neb System is a portable, hand-held, vibrating mesh
`technology nebuliser system. This system generates droplets by ultrasound, which is forcing the solution
`through a mesh. The I-Neb AAD nebluliser has also been shown to be suitable for the administration
`of Ventavis. The measured MMAD of the aerosol droplets was 2.1µm. This nebuliser monitors the breathing
`pattern to determine the aerosol pulse time required to deliver the pre-set dose of 2.5 or 5µg iloprost. The pre-
`set dose provided by the I-Neb AAD system is controlled by the medication chamber in combination with a
`control disc. There are two different colour coded medication chambers. For each medication chamber there
`is a corresponding colour coded control disc: For the 2.5µg dose the medication chamber (350µl) with the red
`latch is used together with the red control disc. For the 5µg dose the medication chamber (650µl) with the
`purple coloured latch is used together with the purple control disc. For each inhalation session with the I-Neb
`AAD, the content of one 1-ml ampoule of Ventavis, showing three coloured rings (pink - red - red), will be
`transferred into the appropriate nebuliser medication chamber immediately before use.
`(Table inserted). Since the I-Neb nebuliser has been shown to produce an aerosol with slightly different
`physical characteristics to those of HaloLite, Prodose and VentaNeb devices, patients stabilized on one
`nebuliser should not switch to another nebuliser without supervision by the treating physician.
`
`Section 4.8: Additional undesirable effect under cardiovascular disorders - dizziness related to hypotension
`and under musculoskeletal disorders - pain in jaw.
`Insertion of new paragraph - Adverse events in healthy volunteers - In a randomized placebo-controlled study
`in 160 healthy volunteers, inhaled doses of iloprost solution were given either with a fixed dose of 2.5mcg
`iloprost 6 times daily (total daily dose of 15mcg), or beginning with 5.0mcg and increasing up to 20mcg or the
`highest tolerated dose for a total of 6 dose inhalations (total daily dose of 70mcg). In the fixed dose group of
`2.5mcg per inhalation chest pain or chest discomfort (32.5%), pharyngolaryngeal pain, or throat irritation
`(22.5%) and nausea (7.5%) (all non-serious and mild in intensity) occurred more frequently in comparison
`with the adverse events obtained from the placebo controlled phase II and III studies in patients with doses of
`2.5mcg or 5mcg per inhalation. Five volunteers were unable to increase the dose up to 20mcg per inhalation
`because of mild to moderate transient chest pain or chest discomfort, usually accompanied by headache,
`dizziness and nausea.
`Section 6.5: Nature & contents of container -Addition of new text: 1-ml ampoules, colourless, glass type I,
`containing 1ml nebuliser solution , ring coded with three coloured rings (pink-red-red).
`Addition of ring coding to 3-ml ampoules - ring coded with two coloured rings (white-pink). 1ml nebuliser
`solution - packages containg 30 or 168 ampoules. 2ml nebuliser solution - packages containing 30, 100 or 300
`ampoules. Not all pack sizes may be marketed.
`Section 8: Addition of 2 MA numbers - EU/1/03/255/004 & 005
`Section 10: Revision date amended from 5 September 2005 to 8 June 2006
`
`Updated on 31-Jan-2006 and displayed until 05-Sep-2006
`
`Reasons for adding or updating:
`Change to section 6. 5 - Nature and Contents of Container
`
`Updated on 22-Sep-2005 and displayed until 31-Jan-2006
`
`Reasons for adding or updating:
`Change to section 4.2 - Posology and Method of Administration
`
`WATSON LABORATORIES, INC. , IPR2017-01622, Ex. 1045, p. 7 of 8
`
`

`

`Change to section 10 (date of (partial) revision of the text
`
`Updated on 05-Aug-2004 and displayed until 22-Sep-2005
`
`Reasons for adding or updating:
`Correction of spelling/typing errors
`
`Updated on 15-Jan-2004 and displayed until 05-Aug-2004
`
`Reasons for adding or updating:
`New SPC for new product
`
`Company contact details
`
`Bayer plc
`http://www.bayer.co.uk
`
`Address
`Bayer House, Strawberry Hill, Newbury, Berkshire,
`RG14 1JA
`Fax
`+44 (0)1635 563 393
`
`Telephone
`+44 (0)1635 563 000
`
`Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this
`is the correct company before contacting them. Why?
`
`Active ingredients
`
`iloprost trometamol
`
`Legal categories
`
`POM - Prescription Only Medicine
`
`Contact us | Mobile Site | Useful links | Accessibility | Legal and privacy policy | Glossary | Site map
`
`© 2017 Datapharm Ltd
`
`WATSON LABORATORIES, INC. , IPR2017-01622, Ex. 1045, p. 8 of 8
`
`