Ancotil 2.5g/250ml Solution for Infusion
- Name:
Ancotil 2.5g/250ml Solution for Infusion
- Company:
Mylan IRE Healthcare Limited
- 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: 01/02/21
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Mylan IRE Healthcare Limited
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 1 February 2021 SPC
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 1 February 2021 PIL
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 PIL
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 SPC
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 8 November 2018 PIL
Reasons for updating
- New PIL for new product
Updated on 7 November 2018 SPC
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 SPC
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 SPC
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 PIL
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 PIL
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 SPC
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 SPC
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 PIL
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 7 March 2011 PIL
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 7 March 2011 SPC
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 7 January 2011 SPC
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 7 January 2011 PIL
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 3 September 2009 SPC
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 3 September 2009 PIL
Reasons for updating
- New SPC for medicines.ie