Ancotil 2.5g/250ml Solution for Infusion *
Company:
Mylan IRE Healthcare LimitedStatus:
UpdatedLegal 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 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 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 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 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 4.4; 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 4.4; 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
Updated on 03 September 2009
Reasons for updating
- New SPC for medicines.ie