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Pfizer Healthcare Ireland

9 Riverwalk, National Digital Park, Citywest Business Campus, Dublin 24,
Telephone: +353 1 467 6500
Fax: +353 1 467 6501
Medical Information Direct Line: 1 800 633 363
Medical Information Website: http://www.pfizermedicalinformation.ie
Summary of Product Characteristics last updated on medicines.ie: 12/09/2017
SPC ATIVAN INJECTION

When a pharmaceutical company changes an SPC or PIL, 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 12/09/2017 and displayed until Current
Reasons for adding or updating:
  • 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 4.8 - Undesirable effects
Date of revision of text on the SPC:   01-Sep-2017
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company

The SPC has been updated as follows: update as per CDS with concomitant use of venzodiazepines and opioids (section 4.3, 4.4, 4.5, 4.8) and QRD.
Updated on 23/06/2016 and displayed until 12/09/2017
Reasons for adding or updating:
  • Change to section 6.3 - Shelf life
Date of revision of text on the SPC:   01-Jun-2016
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company



6.3          Shelf life

 

Unopened: 15 21 months

After opening: Use immediately after opening

After dilution:  Use immediately after dilution
Updated on 25/06/2015 and displayed until 23/06/2016
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 4.7 - Effects on ability to drive and use machines
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 9 - Date of renewal of authorisation
Date of revision of text on the SPC:   01-Jun-2015
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company



Section 4.4: will include addition of warning relating to benzyl alcohol

Section 4.6: include wording on benzyl alcohol

Section 4.8: addition of Reporting of suspected adverse reactions

 

Please note the SPC and HCP/PIL has been updated in line with the current QRD template version

9 this includes revision of the text in section 2, 4.2, 4.3, 4.6, 4.7, 4.8, 5.1, 6.6 and 9 of the SPC

to ensure consistency.

Updated on 25/06/2014 and displayed until 25/06/2015
Reasons for adding or updating:
  • Change to section 6.3 - Shelf life
Date of revision of text on the SPC:   01-Jun-2014
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company

Update to section 6.3
Updated on 08/04/2014 and displayed until 25/06/2014
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 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text
  • Improved electronic presentation
Date of revision of text on the SPC:   01-Apr-2014
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company

Updates to sections, 4.2, 4.4, 4.8, 10
Updated on 12/10/2012 and displayed until 08/04/2014
Reasons for adding or updating:
  • Change to section 6.5 - Nature and contents of container
Date of revision of text on the SPC:   01-Oct-2012
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company



Section 6.5: Due to the introduction of a one point cut opening system on the vial for Ativan 4mg/ml solution for injection the wording in section 6.5 has been updated to reflect this.

Updated on 10/06/2011 and displayed until 12/10/2012
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number
Date of revision of text on the SPC:   01-Apr-2011
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company



MAH address change in section 7

PA number change section 8

Date of revision of text

Updated on 30/11/2010 and displayed until 10/06/2011
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
Date of revision of text on the SPC:   01-Nov-2010
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company

Section 4.4 of the SPC has been updated in regards to the paragraph on propylene glycol toxicity
Updated on 12/05/2009 and displayed until 30/11/2010
Reasons for adding or updating:
  • Change to section 6.3 - Shelf life
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   31-Mar-2009
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company

Section 6.3 - shelf life reduced from 24 months to 14 months
Section 10 - date of revision updated to March 2009
Updated on 16/10/2008 and displayed until 12/05/2009
Reasons for adding or updating:
  • Change to section 1 - Name of medicinal product
  • 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 4.9 - Overdose
  • Change to section 6.4 - Special precautions for storage
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   09/2008
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

Section 1 – update to trade name

 

Section 4.2 – rewording of text for withdrawal and rebound phemonemon

 

Section 4.4 – addition of text for severe anaphylactic/anaphylactoid reactions and angioedema.

 

Section 4.4 - Addition of text regarding withdrawal symptoms

 

Section 4.4 - Addition of text - Lorazepam may have abuse potential especially in patients with a history of drug and/or alcohol abuse.

 

Section 4.4 – Addition of text - There is evidence that tolerance develops to the sedative effects of benzodiazepines.

 

Section 4.5 – Addition of text - Not recommended:  Concomitant intake with alcohol

 

Section 4.5 – Addition of text - There have been reports of marked sedation, excessive salivation, and ataxia when lorazepam and clozapine have been given concomitantly.

 

Concurrent administration of lorazepam with sodium valproate may result in increased plasma concentrations and reduced clearance of lorazepam. Lorazepam dosage should be reduced to approximately 50% when coadministered with sodium valproate.

 

Concurrent administration of lorazepam with probenecid may result in a more rapid onset or prolonged effect of lorazepam due to increased half-life and decreased total clearance. Lorazepam dosage needs to be reduced by approximately 50% when coadministered with probenecid.

 

Administration of theophylline or aminophylline may reduce the sedative effects of benzodiazepines, including lorazepam.

 

Section 4.6 – Rewording of text in first paragraph

 

Section 4.6 – Addiation of information regarding breast feeding

 

 

Section 4.8 – Addition of full list of Adverse reactions divided into frequency

 

Section 4.9 –

 

Addition of text - In postmarketing experience, overdose with lorazepam has occurred predominantly in combination with alcohol and/or other drugs.

 

Addition of information on Lorazepam glucuronide, the inactive metabolite, may be highly dialysable.

 

Addition of text - The physician should be aware of a risk of seizure in association with flumenazil treatment, particularly in long-term benzodiazepine users and in cyclic antidepressant overdose.

 

Section 6.4 – Addition of ‘in order to protect from light’

 

Section 10 – updated
Updated on 15/09/2008 and displayed until 16/10/2008
Reasons for adding or 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 6.2 - Incompatibilities
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   08/2008
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

 

Section 1 - update to trade name

Section 2 - addition of excipient information

Section 4.5 - addition of 'Not recommended:  Concomitant intake with alcohol'

Section 6.2 - addition of text reffering to section 4.2

Section 6.3 - rewording of section

Section 6.4 - addition of text 'in order to protect from light'

Section 6.6 - addition of text reffering to section 4.2

Section 9 - addition of date of last renewal

Section 10 - update to date of last revision

Updated on 14/02/2008 and displayed until 15/09/2008
Reasons for adding or updating:
  • Correction of spelling/typing errors
Date of revision of text on the SPC:   10/2006
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

Change to section 3

update

Updated on 03/06/2004 and displayed until 14/02/2008
Reasons for adding or 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 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
Updated on 17/06/2003 and displayed until 03/06/2004
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
   Lorazepam