Mitoxantrone 2 mg/ml Concentrate for Solution for Infusion
- Name:
Mitoxantrone 2 mg/ml Concentrate for Solution for Infusion
- Company:
Pfizer Healthcare Ireland
- 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: 25/02/19
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Pfizer Healthcare Ireland
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 25 February 2019 PIL
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 1 October 2018 PIL
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 1 October 2018 SmPC
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - Marketing authorisation number(s)
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 7 has been updated from Current MAH to Pfizer Healthcare Ireland, 9 Riverwalk, National Digital Park, Citywest Business Campus, Dublin 24, Ireland. Subsequently section 8 has also been updated with the HPRA newly appointed Marketing Authorisation number.
Updated on 30 August 2018 SmPC
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- Change to section 4.1 - Therapeutic indications
- 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 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 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
Please update eMC
1,2,3, 4.9, 6.5, 6.6 – administrative updates
4.1 – indications updated to remove use in palliation of non-resectable primary hepatocellular carcinoma and add use in combination regimens in the remission-induction treatment of blast crisis in chronic myeloid leukaemia, in combination with corticosteroids for palliation (e.g. pain relief) related to advanced castrate resistant prostate cancer, in treatment of patients with highly active relapsing multiple sclerosis associated with rapidly evolving disability where no alternative therapeutic options exist
4.3 – administer under supervision of a physician experienced in the use of cytotoxic chemotherapy agents. References to Hepatoma deleted, combination therapy text updated, information added regarding Treatment of blast crisis in (chronic) myeloid leukaemia, Advanced castrate-resistant prostate cancer and Multiple Sclerosis. Special Populations section expanded and method of administration updated
4.4 – substantial updates
4.5 – interactions added
4.6 – addition of contraception in males and females, use in pregnancy advise updated
4.7 –has minor influence on the ability to drive and use machines. Confusion and fatigue may occur following administration
4.8 – adverse reactions tabulated and updated, including indication specific information
4.9 – administrative update
5.1-5.3 – additional data added
Updated on 20 June 2018 SmPC
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- Change to section 4.1 - Therapeutic indications
- 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 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 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
Please update eMC
1,2,3, 4.9, 6.5, 6.6 – administrative updates
4.1 – indications updated to remove use in palliation of non-resectable primary hepatocellular carcinoma and add use in combination regimens in the remission-induction treatment of blast crisis in chronic myeloid leukaemia, in combination with corticosteroids for palliation (e.g. pain relief) related to advanced castrate resistant prostate cancer, in treatment of patients with highly active relapsing multiple sclerosis associated with rapidly evolving disability where no alternative therapeutic options exist
4.3 – administer under supervision of a physician experienced in the use of cytotoxic chemotherapy agents. References to Hepatoma deleted, combination therapy text updated, information added regarding Treatment of blast crisis in (chronic) myeloid leukaemia, Advanced castrate-resistant prostate cancer and Multiple Sclerosis. Special Populations section expanded and method of administration updated
4.4 – substantial updates
4.5 – interactions added
4.6 – addition of contraception in males and females, use in pregnancy advise updated
4.7 –has minor influence on the ability to drive and use machines. Confusion and fatigue may occur following administration
4.8 – adverse reactions tabulated and updated, including indication specific information
4.9 – administrative update
5.1-5.3 – additional data added
Updated on 20 June 2018 PIL
Reasons for updating
- Change to Section 1 - what the product is
- Change to section 1 - what the product is used for
- 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 - use in children and adolescents
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 2 - driving and using machines
- Change to section 2 - excipient warnings
- Change to section 3 - dose and frequency
- Change to section 3 - use in children/adolescents
- Change to section 3 - how to take/use
- Change to section 3 - duration of treatment
- Change to section 3 - overdose, missed or forgotten doses
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
- Change to section 5 - how to store or dispose
- Change to section 6 - what the product contains
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - marketing authorisation holder
- Change to section 6 - marketing authorisation number
- Change to section 6 - date of revision
Updated on 8 March 2017 SmPC
Reasons for updating
- New SmPC for new product
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 6 March 2017 PIL
Reasons for updating
- New PIL for new product