Ancotil 2.5g/250ml Solution for Infusion *

  • Company:

    Mylan IRE Healthcare Limited
  • Status:

    Updated
  • Legal 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 08 September 2021

File name

ie-pl-ancotil-pr2216916-clean-rtq2_1631094667.pdf

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - excipient warnings
  • Change to information for healthcare professionals

Updated on 08 September 2021

File name

ie-spc-ancotil-pr2216916-clean-rtq2_1631094345.pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • 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 4.8 - Undesirable effects
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.2 - Incompatibilities

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

Updated on 01 February 2021

File name

ie-spc-ancotil-pr2176181rtq2-clean_1612195217.pdf

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 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 10 - Date of revision of the text

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

Updated on 01 February 2021

File name

ie-pl-ancotil-pr2176181rtq2-clean_1612195100.pdf

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Updated on 20 May 2019

File name

ie-PIL-ancotil-20May2019_TIBart45CRN00916J_clean_1558362123.pdf

Reasons for updating

  • Change to section 3 - use in children/adolescents
  • Change to section 6 - date of revision
  • Change to information for healthcare professionals

Updated on 20 May 2019

File name

IE-SPC-ancotil-20May2019_TIB_CRN00916J_clean_1558360115.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 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text

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

Updated on 08 November 2018

File name

ie-pl-ancotil-mahtransfer-clean_1541610622.pdf

Reasons for updating

  • New PIL for new product

Updated on 07 November 2018

File name

ie-spc-ancotil-mahtransfer-clean_1541610677.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)
  • Change to section 10 - Date of revision of the text

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

Updated on 17 February 2016

Reasons for updating

  • 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 5.3 - Preclinical safety data
  • 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

In section 4.3: Addition to contraindication regarding pregnancy

In section 4.4: Information regarding contraception in males and females added

In section 4.6:  Detailed text added regarding contraception, pregnancy and breast-feeding

In section 5.3: Preclinical safety data added

In section 10: The date of revision has been changed.

 

Updated on 17 February 2016

Reasons for updating

  • New SPC for new product

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

Updated on 17 February 2016

Reasons for updating

  • 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 5.3 - Preclinical safety data
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

In section 4.3: Addition to contraindication regarding pregnancy

In section 4.4: Information regarding contraception in males and females added

In section 4.6:  Detailed text added regarding contraception, pregnancy and breast-feeding

In section 5.3: Preclinical safety data added

In section 10: The date of revision has been changed.

 

Updated on 21 October 2015

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 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

In section 4.2: Sub-heading for adults and children has been added. New information for duration of treatment, liver impairment and older people has been added.

In section 4.3: Information regarding co-administration of Ancotil with antiviral nucleoside drugs has been added

In section 4.4: Information has been removed and information regarding haematological status and liver function, flucytosin serum levels and dihydropyrimidine dehydrogenase enzyme deficiency has been added.

In section 4.5: Additional information has been added

In section 4.8: Undesirable effects has been reformatted and new information has been added. Adverse reaction statement has been added.

In section 4.9: New information regarding signs, symptoms and management in overdose has been added.

In section 5.1: Pharmacotherapeutic group and ATC code added. Additional information added including antimycotic activity

In section 5.2: Information regarding absorption, distribution and elimination has been added.

In section 5.3: Preclinical safety data has been added

In section 10: The date of revision has been changed.

Updated on 21 October 2015

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 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • 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

In section 4.2: Sub-heading for adults and children has been added. New information for duration of treatment, liver impairment and older people has been added.

In section 4.3: Information regarding co-administration of Ancotil with antiviral nucleoside drugs has been added

In section 4.4: Information has been removed and information regarding haematological status and liver function, flucytosin serum levels and dihydropyrimidine dehydrogenase enzyme deficiency has been added.

In section 4.5: Additional information has been added

In section 4.8: Undesirable effects has been reformatted and new information has been added. Adverse reaction statement has been added.

In section 4.9: New information regarding signs, symptoms and management in overdose has been added.

In section 5.1: Pharmacotherapeutic group and ATC code added. Additional information added including antimycotic activity

In section 5.2: Information regarding absorption, distribution and elimination has been added.

In section 5.3: Preclinical safety data has been added

In section 10: The date of revision has been changed.

Updated on 11 May 2011

Reasons for updating

  • 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

in section 6.4; the storage conditions have changed. the statement 'which should be  redissolved by heating to 80 degress C for not more than 30 minutes' has been removed.
In section10; teh date of revision has changed to May 2011

Updated on 11 May 2011

Reasons for updating

  • Change to section 6.4 - Special precautions for storage
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

in section 6.4; the storage conditions have changed. the statement 'which should be  redissolved by heating to 80 degress C for not more than 30 minutes' has been removed.
In section10; teh date of revision has changed to May 2011

Updated on 07 March 2011

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • 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

In section 7: the address of the MAH has changed
In section 10: The date of revision has changed to Feb 2011

Updated on 07 March 2011

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

In section 7: the address of the MAH has changed
In section 10: The date of revision has changed to Feb 2011

Updated on 07 January 2011

Reasons for updating

  • Change to section 10 - Date of revision of the text
  • 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

Free text change information supplied by the pharmaceutical company

In Section 4.3; Addition of text stating that co-administration of Ancotil with antilviral nucleoside drugs is contraindicated.
In section 4.4; Warning added that severe drug toxcity is increased when Ancotil is used in individuals with deficiency in DPD
In Section 4.5: Warning that brivudine, sorivudine and analogues are ptent inhibitors of DPD
In section 10: Date of revision has changed 

Updated on 07 January 2011

Reasons for updating

  • Change to section 10 - Date of revision of the text
  • 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

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

Free text change information supplied by the pharmaceutical company

In Section 4.3; Addition of text stating that co-administration of Ancotil with antilviral nucleoside drugs is contraindicated.
In section 4.4; Warning added that severe drug toxcity is increased when Ancotil is used in individuals with deficiency in DPD
In Section 4.5: Warning that brivudine, sorivudine and analogues are ptent inhibitors of DPD
In section 10: Date of revision has changed 

Updated on 03 September 2009

Reasons for updating

  • New SPC for medicines.ie

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

Free text change information supplied by the pharmaceutical company

None provided

Updated on 03 September 2009

Reasons for updating

  • New SPC for medicines.ie

Free text change information supplied by the pharmaceutical company

None provided