Zavedos 5mg Powder for Solution for Injection

  • Name:

    Zavedos 5mg Powder for Solution for Injection

  • Company:
    info
  • Active Ingredients:

    Idarubicin Hydrochloride

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 12/10/18

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Summary of Product Characteristics last updated on medicines.ie: 12/10/2018

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Pfizer Healthcare Ireland

Pfizer Healthcare Ireland

Company Products

Medicine NameActive Ingredients
Medicine Name Zyvox 2 mg/ml Solution for Infusion Active Ingredients Linezolid
Medicine Name Zyvox 600 mg Film-Coated Tablets Active Ingredients Linezolid
226 - 227 of 227 items.Total: 10 pages

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 12 October 2018 PIL

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 2 - what you need to know - contraindications
  • Change to section 6 - date of revision
  • Change to information for healthcare professionals

Updated on 12 October 2018 SmPC

Reasons for updating

  • 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 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 following SPC sections have been updated to reflect name change from Idarubicin to idarubicin hydrochloride:

4.1   Therapeutic indications

4.3   Contraindications

4.4   Special warnings and precautions for use

5.2   Pharmacokinetic properties

Updated on 10 December 2014 PIL

Reasons for updating

  • New PIL for new product

Updated on 4 December 2014 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 4 December 2014 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • 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)

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows

Section 4.1 – inclusion of

Children

For first line treatment of acute non-lymphoblastic leukaemia (ANLL), in combination with cytarabine, for remission induction.

 

Section 4.2 was updated to reflect section 4.1

Children

10-12 mg/m2  i.v. daily for 3 days, in combination with cytarabine.

[…………]

NOTE: These are general guidelines. Refer to individual protocols for exact dosage.

 

Section 4.8 was updated to include:

Paediatric population

Undesirable effects are similar in adults and children except a greater susceptibility to anthracycline-induced cardiac toxicity of children (see section 4.4).

 

Section 5.2 was updated to reflect the information concerning paediatric population

Updated on 4 December 2014 PIL

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.2 - Pharmacokinetic properties

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows

Section 4.1 – inclusion of

Children

For first line treatment of acute non-lymphoblastic leukaemia (ANLL), in combination with cytarabine, for remission induction.

 

Section 4.2 was updated to reflect section 4.1

Children

10-12 mg/m2  i.v. daily for 3 days, in combination with cytarabine.

[…………]

NOTE: These are general guidelines. Refer to individual protocols for exact dosage.

 

Section 4.8 was updated to include:

Paediatric population

Undesirable effects are similar in adults and children except a greater susceptibility to anthracycline-induced cardiac toxicity of children (see section 4.4).

 

Section 5.2 was updated to reflect the information concerning paediatric population

Updated on 11 August 2014 SmPC

Reasons for updating

  • 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)

Free text change information supplied by the pharmaceutical company

Updates to sections 4.4 & 4.8

Updated on 11 August 2014 PIL

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to Section 4.8 – Undesirable effects - how to report a side effect

Free text change information supplied by the pharmaceutical company

Updates to sections 4.4 & 4.8

Updated on 13 January 2014 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number
  • 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

Update to section 7 & 8

Updated on 13 January 2014 PIL

Reasons for updating

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

Free text change information supplied by the pharmaceutical company

Update to section 7 & 8

Updated on 17 December 2012 PIL

Reasons for updating

  • 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 4.8 - Undesirable effects

Free text change information supplied by the pharmaceutical company

Section 4.1 Therapeutic indication – definition of ‘AML’ acute myelogenous leukaemia added

Section 4.3 Contraindications - severe cardiomyopathy added
Section 4.4 Special Warnings and Precautions for Use -
During the phase of severe myelosuppression, deaths due to infections and/or haemorrhages have been reported added

Section 4.4 Special Warnings and Precautions for Use - If febrile neutropenia occurs, treatment with an IV antibiotic is recommended added

Section 4.4 Special Warnings and Precautions for Use - live-attenuated vaccines (like yellow fever) added
Section 4.4 Special Warnings and Precautions for Use - The product may cause a red colouration of the urine for 1 - 2 days after administration and patients should be advised of this fact added
Section 4.4 Special Warnings and Precautions for Use – Extravasation: In cases of extravasation dexrazoxane can be used to prevent or reduce tissue injury added
Section 4.5 Special Warnings and Precautions for Use - Concomitant use of live attenuated vaccines added
Section 4.5 Special Warnings and Precautions for Use - At combination of oral anticoagulants and anticancer chemotherapy, increased frequency of the INR added
Section 4.5 Special Warnings and Precautions for Use - Cyclosporin A added
Section 4.6 Fertility, pregnancy and lactation – updated for the use of contraceptives up to 3 months after treatment
Section 4.8 Undesirable Effects – Updated in line with CDS

Updated on 17 December 2012 SmPC

Reasons for updating

  • 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 4.8 - 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 4.1 Therapeutic indication – definition of ‘AML’ acute myelogenous leukaemia added

Section 4.3 Contraindications - severe cardiomyopathy added
Section 4.4 Special Warnings and Precautions for Use -
During the phase of severe myelosuppression, deaths due to infections and/or haemorrhages have been reported added

Section 4.4 Special Warnings and Precautions for Use - If febrile neutropenia occurs, treatment with an IV antibiotic is recommended added

Section 4.4 Special Warnings and Precautions for Use - live-attenuated vaccines (like yellow fever) added
Section 4.4 Special Warnings and Precautions for Use - The product may cause a red colouration of the urine for 1 - 2 days after administration and patients should be advised of this fact added
Section 4.4 Special Warnings and Precautions for Use – Extravasation: In cases of extravasation dexrazoxane can be used to prevent or reduce tissue injury added
Section 4.5 Special Warnings and Precautions for Use - Concomitant use of live attenuated vaccines added
Section 4.5 Special Warnings and Precautions for Use - At combination of oral anticoagulants and anticancer chemotherapy, increased frequency of the INR added
Section 4.5 Special Warnings and Precautions for Use - Cyclosporin A added
Section 4.6 Fertility, pregnancy and lactation – updated for the use of contraceptives up to 3 months after treatment
Section 4.8 Undesirable Effects – Updated in line with CDS

Updated on 3 April 2009 SmPC

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

Section 4.4 - Additional information on  Anthracyclines

Updated on 3 April 2009 PIL

Reasons for updating

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

Free text change information supplied by the pharmaceutical company

Section 4.4 - Additional information on  Anthracyclines

Updated on 11 January 2008 PIL

Reasons for updating

  • Correction of spelling/typing errors

Updated on 11 January 2008 SmPC

Reasons for updating

  • Correction of spelling/typing errors

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

Updated on 9 January 2008 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 4.2 - 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 5.1 - Pharmacodynamic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.2 - Incompatibilities
  • 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)

Free text change information supplied by the pharmaceutical company

1 - Product name reformatted to Zavedos 5mg or 10mg Powder for Solution for Injection in line with Notice to Applicants, Guideline on Summary of Product Characteristics (October 2005).

2 – Reformatted in line with QRD template

3 – Reformatted

4.2 – Inclusion of statement concerning administration in patients with severe mucositis

4.3 – Added contraindications: hypersensitivity, cardiac events (myocardial insufficiency, infarction, arrthythmias), persistent myelosuppression, previous treatment with maximum cumulative doses

4.4 – Added cumulative IV dose range, Inclusion of statement regarding neutrophil and platelet counts, more detailed descriptions included on cardiotoxicity  by manifestation of early (ie.acute) and late (i.e delayed) events, addition of secondary leukaemia, inclusion of gastrointestinal effects, addition of statement regarding thrombophlebitis and thromboembolic phenomena,

4.5 –Additional interactions -  Hepatic function changes induced by concomitant therapies  may affect Zavedos metabolism, pharmacokinetics and therapeutic efficacy and/or toxicity and necessity for cardiac monitoring when used with combination chemotherapy and potentially cardiotoxic drugs

4.6 Inclusion of use of contraceptive measures by males undergoing treatment due to toxicological studies on rats and dogs. * (this statement will need to be moved to section 5.3 by way of a subsequent variation).

4.8 – Addition of the following adverse effects:

Blood: leucopenia, neutropenia, anaemia, thrombocytopenia, haemorrhage

Cardiovascular: sinus tachycardia, ECG abnormalities, tachyarrhythmias, atrio-ventricular and bundle branch block, asymptomatic reductions in left ventricular ejection fraction, congestive heart failure, pericarditis, myocarditis

Gastrointestinal: anorexia, dehydration, abdominal pain or burning sensation, erosions/ulceration, gastrointestinal tract bleeding, diarrhoea, colitis, including severe enterocolitis/neutropenic enterocolitis with perforation

Endocrine: hot flashes.

Skin: rash/itch, skin changes, hypersensitivity of irradiated skin (‘radiation recall reaction’)

Vascular: phlebitis, thrombophlebitis,

Other: infection, sepsis/septicemia, shock, hyperuricemia

5.1 – Additional information on pharmacodynamics

5.3 – Replacement of name of active ingredient with product name

6.2 - Replacement of name of active ingredient with product name

6.4 – Replacement of ‘Not applicable’ with ‘No special storage conditions’

6.5 – Inclusion of full pharmaceutical form , ‘Powder for Solution for Injection’

6.6 – Additional precautions for safe handling and update section heading in line with QRD template

7 – Marketing authorisation holder address change

Updated on 9 January 2008 PIL

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 4.2 - 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 5.1 - Pharmacodynamic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.2 - Incompatibilities
  • 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

Free text change information supplied by the pharmaceutical company

1 - Product name reformatted to Zavedos 5mg or 10mg Powder for Solution for Injection in line with Notice to Applicants, Guideline on Summary of Product Characteristics (October 2005).

2 – Reformatted in line with QRD template

3 – Reformatted

4.2 – Inclusion of statement concerning administration in patients with severe mucositis

4.3 – Added contraindications: hypersensitivity, cardiac events (myocardial insufficiency, infarction, arrthythmias), persistent myelosuppression, previous treatment with maximum cumulative doses

4.4 – Added cumulative IV dose range, Inclusion of statement regarding neutrophil and platelet counts, more detailed descriptions included on cardiotoxicity  by manifestation of early (ie.acute) and late (i.e delayed) events, addition of secondary leukaemia, inclusion of gastrointestinal effects, addition of statement regarding thrombophlebitis and thromboembolic phenomena,

4.5 –Additional interactions -  Hepatic function changes induced by concomitant therapies  may affect Zavedos metabolism, pharmacokinetics and therapeutic efficacy and/or toxicity and necessity for cardiac monitoring when used with combination chemotherapy and potentially cardiotoxic drugs

4.6 Inclusion of use of contraceptive measures by males undergoing treatment due to toxicological studies on rats and dogs. * (this statement will need to be moved to section 5.3 by way of a subsequent variation).

4.8 – Addition of the following adverse effects:

Blood: leucopenia, neutropenia, anaemia, thrombocytopenia, haemorrhage

Cardiovascular: sinus tachycardia, ECG abnormalities, tachyarrhythmias, atrio-ventricular and bundle branch block, asymptomatic reductions in left ventricular ejection fraction, congestive heart failure, pericarditis, myocarditis

Gastrointestinal: anorexia, dehydration, abdominal pain or burning sensation, erosions/ulceration, gastrointestinal tract bleeding, diarrhoea, colitis, including severe enterocolitis/neutropenic enterocolitis with perforation

Endocrine: hot flashes.

Skin: rash/itch, skin changes, hypersensitivity of irradiated skin (‘radiation recall reaction’)

Vascular: phlebitis, thrombophlebitis,

Other: infection, sepsis/septicemia, shock, hyperuricemia

5.1 – Additional information on pharmacodynamics

5.3 – Replacement of name of active ingredient with product name

6.2 - Replacement of name of active ingredient with product name

6.4 – Replacement of ‘Not applicable’ with ‘No special storage conditions’

6.5 – Inclusion of full pharmaceutical form , ‘Powder for Solution for Injection’

6.6 – Additional precautions for safe handling and update section heading in line with QRD template

7 – Marketing authorisation holder address change

Updated on 26 July 2007 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 4.2 - 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 5.1 - Pharmacodynamic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.2 - Incompatibilities
  • 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)

Free text change information supplied by the pharmaceutical company


Section 1 Product name reformatted to Zavedos 5mg or 10mg Powder for Solution for Injection in line with Notice to Applicants, Guideline on Summary of Product Characteristics (October 2005).

Section 2 Reformatted in line with QRD template

Section 3 Reformatted

Section 4.2 Inclusion of statement concerning administration in patients with severe mucositis

Section 4.3 Added contraindications: hypersensitivity, cardiac events (myocardial insufficiency, infarction, arrthythmias), persistent myelosuppression, previous treatment with maximum cumulative doses

Section 4.4 Added cumulative IV dose range, Inclusion of statement regarding neutrophil and platelet counts, more detailed descriptions included on cardiotoxicity  by manifestation of early (ie.acute) and late (i.e delayed) events, addition of secondary leukaemia, inclusion of gastrointestinal effects, addition of statement regarding thrombophlebitis and thromboembolic phenomena,

Section 4.5 Additional interactions -  Hepatic function changes induced by concomitant therapies  may affect Zavedos metabolism, pharmacokinetics and therapeutic efficacy and/or toxicity and necessity for cardiac monitoring when used with combination chemotherapy and potentially cardiotoxic drugs

Section 4.6 Inclusion of use of contraceptive measures by males undergoing treatment due to chromosomal damage which idrarubicin can induce in human spermatozoa.

Section 4.8 Addition of the following adverse effects:

Blood: leucopenia, neutropenia, anaemia, thrombocytopenia, haemorrhage

Cardiovascular: sinus tachycardia, ECG abnormalities, tachyarrhythmias, atrio-ventricular and bundle branch block, asymptomatic reductions in left ventricular ejection fraction, congestive heart failure, pericarditis, myocarditis

Gastrointestinal: anorexia, dehydration, abdominal pain or burning sensation, erosions/ulceration, gastrointestinal tract bleeding, diarrhoea, colitis, including severe enterocolitis/neutropenic enterocolitis with perforation

Endocrine: hot flashes.

Skin: rash/itch, skin changes, hypersensitivity of irradiated skin (‘radiation recall reaction’)

Vascular: phlebitis, thrombophlebitis,

Other: infection, sepsis/septicemia, shock, hyperuricemia

Section 5.1 Additional information on pharmacodynamics

Section 5.3 Replacement of name of active ingredient with product name

Section 6.2 Replacement of name of active ingredient with product name

Section 6.4 Replacement of ‘Not applicable’ with ‘No special storage conditions’

Section 6.5 Inclusion of full pharmaceutical form , ‘Powder for Solution for Injection’

Section 6.6 Additional precautions for safe handling and update section heading in line with QRD template

Section 7 Marketing authorisation holder address change

Updated on 26 July 2007 PIL

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 4.2 - 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 5.1 - Pharmacodynamic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.2 - Incompatibilities
  • 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

Free text change information supplied by the pharmaceutical company


Section 1 Product name reformatted to Zavedos 5mg or 10mg Powder for Solution for Injection in line with Notice to Applicants, Guideline on Summary of Product Characteristics (October 2005).

Section 2 Reformatted in line with QRD template

Section 3 Reformatted

Section 4.2 Inclusion of statement concerning administration in patients with severe mucositis

Section 4.3 Added contraindications: hypersensitivity, cardiac events (myocardial insufficiency, infarction, arrthythmias), persistent myelosuppression, previous treatment with maximum cumulative doses

Section 4.4 Added cumulative IV dose range, Inclusion of statement regarding neutrophil and platelet counts, more detailed descriptions included on cardiotoxicity  by manifestation of early (ie.acute) and late (i.e delayed) events, addition of secondary leukaemia, inclusion of gastrointestinal effects, addition of statement regarding thrombophlebitis and thromboembolic phenomena,

Section 4.5 Additional interactions -  Hepatic function changes induced by concomitant therapies  may affect Zavedos metabolism, pharmacokinetics and therapeutic efficacy and/or toxicity and necessity for cardiac monitoring when used with combination chemotherapy and potentially cardiotoxic drugs

Section 4.6 Inclusion of use of contraceptive measures by males undergoing treatment due to chromosomal damage which idrarubicin can induce in human spermatozoa.

Section 4.8 Addition of the following adverse effects:

Blood: leucopenia, neutropenia, anaemia, thrombocytopenia, haemorrhage

Cardiovascular: sinus tachycardia, ECG abnormalities, tachyarrhythmias, atrio-ventricular and bundle branch block, asymptomatic reductions in left ventricular ejection fraction, congestive heart failure, pericarditis, myocarditis

Gastrointestinal: anorexia, dehydration, abdominal pain or burning sensation, erosions/ulceration, gastrointestinal tract bleeding, diarrhoea, colitis, including severe enterocolitis/neutropenic enterocolitis with perforation

Endocrine: hot flashes.

Skin: rash/itch, skin changes, hypersensitivity of irradiated skin (‘radiation recall reaction’)

Vascular: phlebitis, thrombophlebitis,

Other: infection, sepsis/septicemia, shock, hyperuricemia

Section 5.1 Additional information on pharmacodynamics

Section 5.3 Replacement of name of active ingredient with product name

Section 6.2 Replacement of name of active ingredient with product name

Section 6.4 Replacement of ‘Not applicable’ with ‘No special storage conditions’

Section 6.5 Inclusion of full pharmaceutical form , ‘Powder for Solution for Injection’

Section 6.6 Additional precautions for safe handling and update section heading in line with QRD template

Section 7 Marketing authorisation holder address change

Updated on 11 November 2005 SmPC

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties

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

Updated on 11 November 2005 PIL

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties

Updated on 2 July 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

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

Updated on 2 July 2003 PIL

Reasons for updating

  • New SPC for medicines.ie