Ketalar 50mg/ml Solution for Injection/Infusion
*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
Updated on 22 February 2024
File name
Reg SPC KE 30_3 50mg perml IE.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
- Change to Section 4.8 – Undesirable effects - how to report a side effect
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 22 February 2024
File name
Reg SPC KE 30_3 50mg perml IE.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
- Change to Section 4.8 – Undesirable effects - how to report a side effect
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 22 February 2024
File name
Reg SPC KE 30_3 50mg perml IE.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
- Change to Section 4.8 – Undesirable effects - how to report a side effect
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 22 February 2024
File name
Reg SPC KE 30_3 50mg perml IE.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
- Change to Section 4.8 – Undesirable effects - how to report a side effect
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 22 February 2024
File name
Reg PIL KE 30_2 IE.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 3 - dose and frequency
- Change to section 6 - date of revision
- Change to information for healthcare professionals
Updated on 13 February 2023
File name
DEC202074561_Reg SPC KE 29_0 50mg per ml IE.pdf
Reasons for updating
- Document format updated
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 20 April 2021
File name
DEC202126186_Reg PIL KE 29_0 IE clean.pdf
Reasons for updating
- Change to section 2 - excipient warnings
- Change to section 4 - how to report a side effect
- Change to section 6 - what the product contains
- Change to section 6 - date of revision
Updated on 10 November 2020
File name
DEC202074561_Reg SPC KE 29_0 50mg per ml IE.pdf
Reasons for updating
- Change to section 6.4 - Special precautions for storage
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 6.4 Special precautions for storage as follows:
Addition of "This medicinal product does not require any special temperature storage conditions. Store in the original container".
Removal of "Do not store above 25 °C."
Updated on 10 November 2020
File name
DEC202074561_Reg PIL KE 26_0 IE.pdf
Reasons for updating
- Change to section 5 - how to store or dispose
- Change to section 6 - date of revision
- Change to information for healthcare professionals
Updated on 03 August 2020
File name
DEC202038215_Reg SPC KE 28_2 50mg per ml IE.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 5.2 - Pharmacokinetic properties
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:
- Section 4.4 Special warnings and precautions for use: Long-Term Use - addition of acute kidney injury, hydronephrosis, and ureteral disorders.
- Section 4.8 Undesirable effects – addition of *** Long term use (1 month to several years), especially in the setting of ketamine abuse.
- Section 5.2 Pharmacokinetic properties – μg/mL replaced with microg/mL
Updated on 10 June 2020
File name
DEC202038215_Reg SPC KE 28_2 10mg per ml IE.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 5.2 - Pharmacokinetic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 10 June 2020
File name
DEC202038215_Reg PIL KE 25_1 IE.pdf
Reasons for updating
- Change to section 6 - date of revision
Updated on 24 December 2019
File name
DEC201972910_Reg SPC KE 27_1 50mg per ml IE_clean.pdf
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
|
The SPC has been updated as follows: Addition of adverse drug reactions (ADRs); acute kidney injury, hydronephrosis and ureteral disorders to section 4.4 Special warnings and precautions - Long-Term Use.
Text addition “Adverse effects have also been reported: see “Long-Term Use”. to section 4.4 Special warnings and precautions - Drug Abuse and Dependence. the term ‘micro’ is utilised instead of the symbol μ to denote terms of strength or dosing. |
Updated on 12 March 2019
File name
DEC201912384_clean Reg SPC KE 26_2 50mg per ml IE.pdf
Reasons for updating
- Change to section 4.6 - Pregnancy and lactation
- Change to section 5.3 - Preclinical safety data
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 30 July 2018
File name
Reg PIL KE 23_1 IE clean.pdf
Reasons for updating
- Change to section 6 - date of revision
- Change to information for healthcare professionals
Updated on 20 March 2018
File name
PIL_8710_356.pdf
Reasons for updating
- New PIL for new product
Updated on 19 March 2018
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 19 March 2018
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
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 s4.5 in line with CDS update (regarding concurrent use of ketamine with diazepam). |
Updated on 19 March 2018
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
Free text change information supplied by the pharmaceutical company
|
The SPC has been updated as follows: Update to s4.5 in line with CDS update (regarding concurrent use of ketamine with diazepam). |
Updated on 06 December 2017
Reasons for updating
- Change to section 4.1 - Therapeutic indications
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:
Addition of “Ketamine is indicated in children and in adults” in section 4.1.Updated on 06 December 2017
Reasons for updating
- Change to section 4.1 - Therapeutic indications
Free text change information supplied by the pharmaceutical company
The SPC has been updated as follows:
Addition of “Ketamine is indicated in children and in adults” in section 4.1.Updated on 17 January 2017
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 6.3 - Shelf life
- Change to section 6.6 - Special precautions for disposal and other handling
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:
Section 2 (10 mg/ml only) – correction to amount of sodium
Section 4.4 – text regarding use with caution in the chronic alcoholic and the alcohol-intoxicated patient reinstated
Section 6.3 – updated with text regarding use immediately unless method of opening precludes risk of microbial contamination
Section 6.6 – updated with text regarding use immediately unless method of opening precludes risk of microbial contamination; parenteral drugs should be inspected visually for particulate matter and discolorationUpdated on 17 January 2017
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 6.3 - Shelf life
- Change to section 6.6 - Special precautions for disposal and other handling
Free text change information supplied by the pharmaceutical company
The SPC has been updated as follows:
Section 2 (10 mg/ml only) – correction to amount of sodium
Section 4.4 – text regarding use with caution in the chronic alcoholic and the alcohol-intoxicated patient reinstated
Section 6.3 – updated with text regarding use immediately unless method of opening precludes risk of microbial contamination
Section 6.6 – updated with text regarding use immediately unless method of opening precludes risk of microbial contamination; parenteral drugs should be inspected visually for particulate matter and discolorationUpdated on 05 December 2016
Reasons for updating
- Change to section 5.3 - Preclinical safety data
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:
Section 5.3 – addition of findings from animal researchUpdated on 05 December 2016
Reasons for updating
- Change to section 5.3 - Preclinical safety data
Free text change information supplied by the pharmaceutical company
The SPC has been updated as follows:
Section 5.3 – addition of findings from animal researchUpdated on 31 October 2016
Reasons for updating
- Change to section 6.4 - Special precautions for storage
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: Sec 6.4 Special precautions for storage was updated with the temperature storage conditions. |
|
The PIL has been updated to reflect the SmPC changes. Section 5 of the PIL was updated with temperature storage conditions. Corresponding SmPC section of the HCP part was also updated. See PIL tick list for sections updated. |
Updated on 31 October 2016
Reasons for updating
- Change to section 6.4 - Special precautions for storage
Free text change information supplied by the pharmaceutical company
|
The SPC has been updated as follows: Sec 6.4 Special precautions for storage was updated with the temperature storage conditions. |
|
The PIL has been updated to reflect the SmPC changes. Section 5 of the PIL was updated with temperature storage conditions. Corresponding SmPC section of the HCP part was also updated. See PIL tick list for sections updated. |
Updated on 28 October 2016
Reasons for updating
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.2 - Posology and method of administration
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:
Sec 4.2 Dosage in Obstetrics and Maintenance of anaesthesia- to provide information that there is no substantive clinical information available on the optimal dose of ketamine when used intramuscularly or as a maintenance IV infusion during labour and delivery
Sec 4.6 Pregnancy - to provide information that there is no substantive clinical information available on the optimal dose of ketamine when used intramuscularly or as a maintenance IV infusion during labour and delivery and section
Sec 5.2 Distribution and Biotransformation - to provide updated information on ketamine distribution and additional information regarding the distribution of ketamine in the parturient populationUpdated on 28 October 2016
Reasons for updating
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.2 - Posology and method of administration
Free text change information supplied by the pharmaceutical company
The SPC has been updated as follows:
Sec 4.2 Dosage in Obstetrics and Maintenance of anaesthesia- to provide information that there is no substantive clinical information available on the optimal dose of ketamine when used intramuscularly or as a maintenance IV infusion during labour and delivery
Sec 4.6 Pregnancy - to provide information that there is no substantive clinical information available on the optimal dose of ketamine when used intramuscularly or as a maintenance IV infusion during labour and delivery and section
Sec 5.2 Distribution and Biotransformation - to provide updated information on ketamine distribution and additional information regarding the distribution of ketamine in the parturient populationUpdated on 17 June 2016
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 is updated to reflect a change in vial size
Updated on 17 June 2016
Reasons for updating
- Change to section 6.5 - Nature and contents of container
Free text change information supplied by the pharmaceutical company
section 6.5 is updated to reflect a change in vial size
Updated on 01 April 2015
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.6 - Pregnancy and lactation
- Change to section 5.2 - Pharmacokinetic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 4.2 – Section added with Dosage in obstetrics
Section 4.6 – Addition of Pregnancy wording and Lactation
Section 5.2 – Distribution details for peak plasma level
Updated on 01 April 2015
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.6 - Pregnancy and lactation
- Change to section 5.2 - Pharmacokinetic properties
Free text change information supplied by the pharmaceutical company
Section 4.2 – Section added with Dosage in obstetrics
Section 4.6 – Addition of Pregnancy wording and Lactation
Section 5.2 – Distribution details for peak plasma level
Updated on 09 September 2014
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- 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 5.2 - Pharmacokinetic properties
- Change to section 5.3 - Preclinical safety data
- Change to section 6.1 - List of excipients
- 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
- 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
Section 2- 4.3 Updated in line with QRD version 9
Section 4.4 Special Warnings and precautions for use- addition of hepatotoxicity language under the subheadings of ‘Long-term Use’ and ‘Drug Abuse and Dependence’.
Section 4.5 Interaction with other medicinal products and other forms of interaction- addition of Drug Drug Interactions
Section 4.6 and 4.7- Updated in line with QRD version 9
Section 4.8 Undesirable effects- addition of new ADR term ‘Drug-induced liver injury’ under MedDRA SOC ‘Hepatobiliary disorders’ accompanied with a footnote indicating an association with ‘extended period use (>3 days) or drug abuse.
Section 5.2 Pharmacokinetic properties- addition additional information regarding interactions with CYP P450 enzymes.
Section 5.3,6.1, 6..3, 6.4, 6.5, 6.6, 8-Updated in line with QRD version 9Updated on 09 September 2014
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- 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 5.2 - Pharmacokinetic properties
- Change to section 5.3 - Preclinical safety data
- Change to section 6.1 - List of excipients
- 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
- Change to section 8 - MA number
Free text change information supplied by the pharmaceutical company
Section 2- 4.3 Updated in line with QRD version 9
Section 4.4 Special Warnings and precautions for use- addition of hepatotoxicity language under the subheadings of ‘Long-term Use’ and ‘Drug Abuse and Dependence’.
Section 4.5 Interaction with other medicinal products and other forms of interaction- addition of Drug Drug Interactions
Section 4.6 and 4.7- Updated in line with QRD version 9
Section 4.8 Undesirable effects- addition of new ADR term ‘Drug-induced liver injury’ under MedDRA SOC ‘Hepatobiliary disorders’ accompanied with a footnote indicating an association with ‘extended period use (>3 days) or drug abuse.
Section 5.2 Pharmacokinetic properties- addition additional information regarding interactions with CYP P450 enzymes.
Section 5.3,6.1, 6..3, 6.4, 6.5, 6.6, 8-Updated in line with QRD version 9Updated on 16 August 2013
Reasons for updating
- New individual SPC (was previously included in combined SPC)
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 2 Qualitative and Quantitative Composition: updated for consistency
Section 4.4 Special Warnings and Precautions for Use: addition of abnormal liver function tests
Section 4.8 Undesirable effects: addition of hepatic effects
Section 6.5 Nature and Contents of Containers: updated for consistency
Updated on 16 August 2013
Reasons for updating
- New individual SPC (was previously included in combined SPC)
Free text change information supplied by the pharmaceutical company
Section 2 Qualitative and Quantitative Composition: updated for consistency
Section 4.4 Special Warnings and Precautions for Use: addition of abnormal liver function tests
Section 4.8 Undesirable effects: addition of hepatic effects
Section 6.5 Nature and Contents of Containers: updated for consistency