Ketalar 50mg/ml Solution for Injection/Infusion
- Name:
Ketalar 50mg/ml Solution for Injection/Infusion
- Company:
Pfizer Healthcare Ireland
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may not be renewed (A)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 10/11/20
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Pfizer Healthcare Ireland
Company Products
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 10 November 2020 SPC
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 PIL
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 3 August 2020 SPC
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 SPC
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 PIL
Reasons for updating
- Change to section 6 - date of revision
Updated on 24 December 2019 SPC
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
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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 SPC
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 PIL
Reasons for updating
- Change to section 6 - date of revision
- Change to information for healthcare professionals
Updated on 20 March 2018 PIL
Reasons for updating
- New PIL for new product
Updated on 19 March 2018 SPC
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
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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 SPC
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 PIL
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 6 December 2017 PIL
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 6 December 2017 SPC
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 17 January 2017 SPC
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 PIL
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 5 December 2016 PIL
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 5 December 2016 SPC
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 31 October 2016 SPC
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. |
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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 PIL
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. |
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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 PIL
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 28 October 2016 SPC
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 17 June 2016 PIL
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 17 June 2016 SPC
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 1 April 2015 PIL
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 1 April 2015 SPC
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 9 September 2014 PIL
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 9 September 2014 SPC
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 16 August 2013 SPC
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 PIL
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