Ketalar 50mg/ml Solution for Injection/Infusion

  • Name:

    Ketalar 50mg/ml Solution for Injection/Infusion

  • Company:
    info
  • Active Ingredients:

    Ketamine Hydrochloride

  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 10/06/20

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Summary of Product Characteristics last updated on medicines.ie: 3/8/2020

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Pfizer Healthcare Ireland

Pfizer Healthcare Ireland

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1 - 0 of 231 items.Total: Infinity pages

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 3 August 2020 SmPC

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:

  1. Section 4.4 Special warnings and precautions for use: Long-Term Use - addition of acute kidney injury, hydronephrosis, and ureteral disorders.
  2. Section 4.8 Undesirable effects – addition of *** Long term use (1 month to several years), especially in the setting of ketamine abuse.
  3. Section 5.2 Pharmacokinetic properties – μg/mL replaced with microg/mL

Updated on 10 June 2020 SmPC

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 SmPC

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 SmPC

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 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 19 March 2018 SmPC

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 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 SmPC

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 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 17 January 2017 SmPC

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 discoloration

Updated 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 discoloration

Updated 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 research

Updated on 5 December 2016 SmPC

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 research

Updated on 31 October 2016 SmPC

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 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.

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 population

Updated on 28 October 2016 SmPC

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 population

Updated on 17 June 2016 SmPC

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 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 1 April 2015 SmPC

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 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 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 9

Updated on 9 September 2014 SmPC

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 9

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

Updated on 16 August 2013 SmPC

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