Ketalar 10mg/ml Injection/Infusion

Product Information *

  • Company:

    Pfizer Healthcare Ireland
  • Status:

    No Recent Update
  • Active Ingredients :

    *Additional information is available upon request

  • Legal Category:

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

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 20 April 2021

File name

DEC202126186_Reg SPC KE 31_0 10mg per ml IE clean_1618920157.pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • 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 20 April 2021

File name

DEC202126186_Reg PIL KE 29_0 IE clean_1618920095.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 10mg per ml IE_1604994477.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_1604994425.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 10 June 2020

File name

DEC202038215_Reg SPC KE 28_2 10mg per ml IE_1591782582.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_1591782522.pdf

Reasons for updating

  • Change to section 6 - date of revision

Updated on 24 December 2019

File name

DEC201972910_Reg SPC KE 27_1 10mg per ml IE_clean_1577173408.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 10mg per ml IE_1_1552401164.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_1532963103.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 2 - Qualitative and quantitative composition
  • 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 17 January 2017

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • 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 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 research

Updated 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 research

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 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 28 October 2016

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

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

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

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

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

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

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 23 October 2014

Reasons for updating

  • Change to section 8 - MA number
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4 - Clinical particulars
  • Change to section 4.1 - Therapeutic indications
  • 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 - how to report a side effect
  • 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

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- 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 23 October 2014

Reasons for updating

  • Change to section 8 - MA number
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4 - Clinical particulars
  • Change to section 4.1 - Therapeutic indications
  • 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 - how to report a side effect
  • 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

Free text change information supplied by the pharmaceutical company



The SPC has been updated as follows

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 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 9

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

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

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • 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 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

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 6.5 - Nature and contents of container

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 24 April 2012

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • 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

SPC update to section 4.4 and 4.8

Updated on 24 April 2012

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

Free text change information supplied by the pharmaceutical company

SPC update to section 4.4 and 4.8

Updated on 10 August 2010

Reasons for updating

  • Change to section 4.3 - Contraindications
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage

Free text change information supplied by the pharmaceutical company

Sections 4.3 (Contra-indications) and 5.2 (Pharmacokinetic Properties): typographical/minor corrections

Section 6.3 (Shelf Life): substantial change

Section 6.4 (Special Precautions for Storage): substantial changes

Updated on 10 August 2010

Reasons for updating

  • Change to section 4.3 - Contraindications
  • Change to section 6.3 - Shelf life
  • 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

Sections 4.3 (Contra-indications) and 5.2 (Pharmacokinetic Properties): typographical/minor corrections

Section 6.3 (Shelf Life): substantial change

Section 6.4 (Special Precautions for Storage): substantial changes

Updated on 21 May 2010

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.1 - List of excipients
  • 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 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number
  • 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

re-positioning/re-formatting of text in-line with current EU regulatory guidance have been made to the following sections:

1, 2, 4.2, 4.4, 4.5, 4.8, 5.1, 6.1, 6.2, 6.3, 6.4, 6.5, 6.6, 7, 8, 9 and (as a consequence) 10.

Updated on 21 May 2010

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.1 - List of excipients
  • 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 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

re-positioning/re-formatting of text in-line with current EU regulatory guidance have been made to the following sections:

1, 2, 4.2, 4.4, 4.5, 4.8, 5.1, 6.1, 6.2, 6.3, 6.4, 6.5, 6.6, 7, 8, 9 and (as a consequence) 10.

Updated on 15 May 2009

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 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • 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

Section 4.3 - Text amendment: "See Adverse Reactions section" changed to "See section 4.8 Undesirable effects".

Section 4.4 - Information added regarding psychological manifestations, warnings for patients with respiratory problems and warnings for patients with liver problems.

Section 4.5 - Information added regarding bradycardia, hypotension, decreased cardiac output, respiratory depression, tachycardia and seizures.

Section 4.8 - Information added regarding immune system disorders, increased salivation, eye disorders and cardiac & vascular disorders.

Section 5.1 - Information added regarding 'Mechanism of Action'.

Section 5.2 - Information added regarding distribution and metabolism.

Updated on 15 May 2009

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 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 4.8 - Undesirable effects

Free text change information supplied by the pharmaceutical company

Section 4.3 - Text amendment: "See Adverse Reactions section" changed to "See section 4.8 Undesirable effects".

Section 4.4 - Information added regarding psychological manifestations, warnings for patients with respiratory problems and warnings for patients with liver problems.

Section 4.5 - Information added regarding bradycardia, hypotension, decreased cardiac output, respiratory depression, tachycardia and seizures.

Section 4.8 - Information added regarding immune system disorders, increased salivation, eye disorders and cardiac & vascular disorders.

Section 5.1 - Information added regarding 'Mechanism of Action'.

Section 5.2 - Information added regarding distribution and metabolism.

Updated on 09 January 2006

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.4 - Special warnings and precautions for use
  • 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 7 - Marketing authorisation holder

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

Updated on 09 January 2006

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.4 - Special warnings and precautions for use
  • 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 7 - Marketing authorisation holder

Updated on 17 February 2004

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

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

Updated on 17 February 2004

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

Updated on 26 June 2003

Reasons for updating

  • New SPC for medicines.ie

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

Updated on 26 June 2003

Reasons for updating

  • New SPC for medicines.ie