ATIVAN INJECTION *
Company:
Pfizer Healthcare IrelandStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
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 17 February 2021
File name
DEC202110565_Reg SPC AT 13_0 Inj IE _1613553473.pdf
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 5.2 - Pharmacokinetic properties
- Updated inline with QRD template and/or excipient guideline
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 17 February 2021
File name
DEC202110565_Reg PIL AT Inj 11_0 IE_1613553156.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 3 - use in children/adolescents
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
- Improved presentation of PIL
Updated on 25 January 2019
File name
DEC201903413_clean Reg SPC AT 11_1 Inj IE_1548425073.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
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 to section 4.2 and 4.4 of SPC with information regarding a risk of falls for the elderly. |
Updated on 03 January 2019
File name
DEC201900220_Reg PIL AT Inj 7_2 IE clean_1546518553.pdf
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
- Change to information for healthcare professionals
Updated on 12 September 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 12 September 2017
Reasons for 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
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 11 September 2017
File name
PIL_7715_225.pdf
Reasons for updating
- New PIL for new product
Updated on 11 September 2017
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 3 - overdose, missed or forgotten doses
- Change to section 4 - possible side effects
- Change to section 6 - what the product looks like and pack contents
- Change of distributor details
Updated on 23 June 2016
Reasons for updating
- Change to section 6.3 - Shelf life
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 dilutionUpdated on 22 June 2016
Reasons for updating
- Change to storage instructions
- Change to date of revision
Updated on 25 June 2015
Reasons for 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
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 23 June 2015
Reasons for updating
- Change to side-effects
- Change to information about drinking alcohol
- Change to information about pregnancy or lactation
- Change to date of revision
- Change to improve clarity and readability
Updated on 25 June 2014
Reasons for updating
- Change to section 6.3 - Shelf life
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 24 June 2014
Reasons for updating
- Change to side-effects
- Change to date of revision
Updated on 08 April 2014
Reasons for 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
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 03 April 2014
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to date of revision
- Change to dosage and administration
Updated on 27 June 2013
Reasons for updating
- Change to date of revision
Updated on 12 October 2012
Reasons for updating
- Change to section 6.5 - Nature and contents of container
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 October 2012
Reasons for updating
- Change of manufacturer
- Change to date of revision
- Change to dosage and administration
- Change to name of manufacturer
Updated on 21 December 2011
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to information about pregnancy or lactation
- Change to date of revision
- Change to dosage and administration
- Change to improve clarity and readability
- Change due to user-testing of patient information
Updated on 10 June 2011
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - MA number
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 10 June 2011
Reasons for updating
- Change to date of revision
- Change to marketing authorisation holder
Updated on 30 November 2010
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 12 May 2009
Reasons for updating
- Change to storage instructions
Updated on 12 May 2009
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 not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 10 - date of revision updated to March 2009
Updated on 16 October 2008
Reasons for updating
- Change to warnings or special precautions for use
- Change to date of revision
Updated on 16 October 2008
Reasons for 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
Legal category:Product subject to medical prescription which may not be renewed (A)
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’
Updated on 15 September 2008
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 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
Legal category:Product subject to medical prescription which may not be renewed (A)
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 15 September 2008
Reasons for updating
- Change of trade or active ingredient name
- Change to date of revision
- Change to storage instructions
Updated on 14 February 2008
Reasons for updating
- Correction of spelling/typing errors
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Change to section 3
update
Updated on 26 August 2004
Reasons for updating
- New PIL for medicines.ie
Updated on 03 June 2004
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 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
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 17 June 2003
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may not be renewed (A)