Cerubidin 20mg Powder for Solution for Injection

  • Name:

    Cerubidin 20mg Powder for Solution for Injection

  • Company:
    info
  • Active Ingredients:

    daunorubicin 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: 09/07/19

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XPIL

Summary of Product Characteristics last updated on medicines.ie: 9/7/2019

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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 9 July 2019 PIL

Reasons for updating

  • Change to section 4 - how to report a side effect

Updated on 9 July 2019 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • 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

Section 4.4

Posterior reversible encephalopathy syndrome (PRES):

Cases of PRES have been reported with daunorubicin used in combination chemotherapy. PRES is a neurological disorder which can present with headache, seizure, lethargy, confusion, blindness and other visual and neurologic disturbances. Mild to severe hypertension may be present. Magnetic resonance imaging is necessary to confirm the diagnosis of PRES. In patients with PRES, the discontinuation of daunorubicin treatment should be considered.

 

 

Section 4.8

Infections and Infestations

Very common:  serious infections (including sepsis, septic shock and pneumonia), which sometimes can be fatal.

 

Updated on 28 June 2019 PIL

Reasons for updating

  • Improved presentation of PIL

Updated on 9 November 2018 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - use in children and adolescents
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect

Updated on 9 November 2018 SmPC

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 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

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

Free text change information supplied by the pharmaceutical company

The dosage should be reduced in patients with impaired hepatic or renal function.  A 25% reduction is recommended in patients with serum bilirubin concentrations of 1.2-3mg/100ml and a 50% reduction in cases with serum bilirubin or creatinine concentrations above 3 mg/100ml.

Daunorubicin should be administered with caution when the neutrophil count is <1,500/mm3. Daunorubicin dose reduction should be considered in case of severe neutropenia.

The number of infusions required varies widely from patient to patient and must be determined in each case according to response and tolerance.

Infections should be treated before the start of daunorubicin therapy.  If during daunorubicin treatment a patient becomes febrile (regardless of the neutrophil count), treatment with broad spectrum antibiotics should be initiated.

Daunorubicin produces bone marrow depression. Daunorubicin should be administered with caution when the neutrophil count is < 1,500/mm3. Febrile neutropenia has been reported when daunorubicin is given in combination with other antineoplastic treatments.   

Monitoring of blood counts prior to and during daunorubicin treatment is recommended, and hematological abnormalities should be treated promptly (see sections 4.2 and 4.8).

Cases of colitis, entercolitis and neutropenic entercolitis (typhlitis) have been reported in patients treatment with daunorubicin.  Treatment discontinuation and prompt appropriate medical management are recommended.

PRES, a neurologic disorder, has been reported in patients receiving daunorubicin combination chemotherapy. PRES may present with headache, visual disturbances, altered mental status, confusion, status epilepticus, seizures, nausea and vomiting, usually associated with hypertension. The diagnosis of PRES requires confirmation by brain Magnetic Resonance Imaging (MRI). Discontinuation of daunorubicin therapy is recommended in patients developing PRES. Symptoms, including uncontrolled hypertension, should be treated promptly. Clinical symptoms and MRI changes usually improve within a few weeks after treatment discontinuation. Following resolution of PRES, daunorubicin treatment may be resumed at the discretion of the prescriber. Cases of neurologic sequelae and fatal outcomes have been reported (see section 4.8).

Secondary malignancies have been reported when daunorubicin was given in combination with other antineoplastic treatments known to be associated with secondary malignancies. Secondary malignancies (including leukemia) may occur during daunorubicin-containing therapy, or several months or years after the end of therapy. Patients should be monitored for secondary malignancies (see section 4.8).

Care should be taken to avoid extravasation during intravenous administration. 

4.7       Effects on ability to drive and use machines

Not applicable

. No studies on the effects on the ability to drive and use machines have been performed. However, confusion, seizures and visual disturbances have been observed in patients treated with daunorubicin combination therapy (see section 4.4). Therefore, patients should be warned of the possible impact of the side effects on their ability to drive or use machines, and be advised not to drive or use machines if they experience these side effects during treatment.

4.8       Undesirable effects

Bone marrow depression (very common): in every patient bone marrow function will be depressed by treatment with daunorubicin and in a variable proportion of cases, severe aplasia will develop.  Risk of sepsis, severe opportunistic infections may occur with bone marrow depression.

Frequency not known: febrile neutropenia, including with fatal outcomes, has been reported.

Leucopenia is usually more significant than thrombocytopenia. 

Neoplasms benign, malignant and unspecified (including cysts and polyps)

Frequency not known:  secondary malignancies, including leukaemia has have been reported in association with daunorubicin when used in combination with other antineoplastics.treatments known to be associated with secondary malignancies.

Metabolism and nutrition disorders

Frequency not known:  Tumour lysis syndrome.

Nervous system disorders

Frequency not known: Posterior Reversible Encepahlopathy Syndrome (PRES, also known as Reversible Posterior Leukoencephalopathy Syndrome, RPLS), including with fatal outcomes, has been reported.

Other less serious adverse reactions that have been reported (in order of reducing frequency) are: stomatitis, alopecia, phlebitis, fever, anaemia, nausea, vomiting, mucositis, diarrhoea and rash.

Updated on 13 October 2016 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 13 October 2016 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • 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

Type II.C.1.4 Change(s) in the Summary of Product Characteristics, Labelling or Package Leaflet due to new quality, preclinical, clinical or pharmacovigilance data – Daunorubicin CCDSv2

Updated on 7 October 2016 PIL

Reasons for updating

  • New PIL for new product

Updated on 7 October 2016 PIL

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 11 August 2016 SmPC

Reasons for updating

  • 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

Gastrointestinal disorders:

Unknown: colitis.

 

Blood and lymphatic system disorders:

Very common:  Bone marrow failure.

Updated on 9 August 2016 PIL

Reasons for updating

  • Change to side-effects

Updated on 19 September 2013 PIL

Reasons for updating

  • Change to how the medicine works

Updated on 23 April 2013 PIL

Reasons for updating

  • Change to marketing authorisation holder

Updated on 20 September 2012 SmPC

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

Section 7 updated to include 'T/A SANOFI'

Updated on 20 September 2011 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.1 - Pharmacodynamic properties

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

Free text change information supplied by the pharmaceutical company

Update Section 4.1, 4.2, 5.1 CRN 2103080

Updated on 16 September 2011 PIL

Reasons for updating

  • Change to, or new use for medicine

Updated on 5 May 2011 SmPC

Reasons for updating

  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • 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

Approved changes to affect the following sections of the SPC

Section 6.3: Shelf life

Section 6.4: Special Precautions for storage

Section 6.6: Instructions for use/handling

Updated on 3 May 2011 PIL

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 1 April 2011 PIL

Reasons for updating

  • Correction of spelling/typing errors

Updated on 5 November 2010 SmPC

Reasons for updating

  • Correction of spelling/typing errors

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

Free text change information supplied by the pharmaceutical company

Changes made as a result of a renewal approval, administrative changes made.

Updated on 11 June 2010 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • 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 Section 2 Excipients

Updated on 4 June 2010 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 15 December 2009 PIL

Reasons for updating

  • Change due to user-testing of patient information

Updated on 20 August 2009 PIL

Reasons for updating

  • Change to improve clarity and readability

Updated on 21 March 2007 SmPC

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

Update
Section 7 - Change MAH to sanofi-aventis Ireland Ltd.
Section 10 - Date of Revision

Updated on 18 December 2006 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 19 October 2006 SmPC

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 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

Update to -
Section 4.2: Updated information regarding administration
Section 4.4: Updated information regarding dose repetition in the presence of bone marrow depression or buccal ulceration.
Addition information regarding infection.
Section 4.8: Information added : 'Risk of sepsis, severe opportunistic infections may occur with bone marrow depression.'

Updated on 25 November 2005 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 17 November 2005 SmPC

Reasons for updating

  • Improved electronic presentation

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

Updated on 11 July 2005 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • 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 13 December 2004 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)

Updated on 5 June 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

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