Zinforo 600 mg powder for concentrate for solution for infusion

  • Name:

    Zinforo 600 mg powder for concentrate for solution for infusion

  • Company:
    info
  • Active Ingredients:

    Ceftaroline Fosamil

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 06/12/19

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Summary of Product Characteristics last updated on medicines.ie: 29/7/2019

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Pfizer Healthcare Ireland

Pfizer Healthcare Ireland

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51 - 75 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 6 December 2019 PIL

Reasons for updating

  • Change to section 6 - date of revision

Updated on 31 July 2019 PIL

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 6 - date of revision

Updated on 29 July 2019 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 5.1 - Pharmacodynamic properties
  • 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 Therapeutic Indications -  Indication updated to include neonates, infants, children and adolescents.

Section 4.2 Posology and method of administration - Tables 2 and 4 updated to include dosage in paediatric patients. Section also updated to include neonates and infants. Statement on paediatric population removed.

New statememnt added; "The recommended dosage of Zinforo shown in Table 2 for paediatric patients < 2 months of age are based on pharmacokinetic-pharmacodynamic modelling and simulation".

Section 4.8 Undesirable Effects - CDAD expanded to read; Clostridium difficile-associated disease. Sub-section on paediatric population updated with additional safety statement.

Section 5.1 Pharmacodynamic properties - Mechanism of action updated.

Section 5.2 Pharmacokinetic properties - Sub-section, special populations updated to paesriatic patients. Sub-section, paediatric patients updated with neonates, infants, children and adolescents. 

Updated on 28 June 2019 PIL

Reasons for updating

  • Change to section 3 - how to take/use
  • Change to section 6 - date of revision
  • Change to information for healthcare professionals

Updated on 27 June 2019 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
  • 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)

Updated on 23 May 2019 PIL

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 23 May 2019 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects

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

Updated on 12 April 2019 PIL

Reasons for updating

  • Change to section 6 - date of revision

Updated on 12 April 2019 SmPC

Reasons for updating

  • 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 7 March 2019 PIL

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 7 March 2019 SmPC

Reasons for updating

  • 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 30 October 2018 PIL

Reasons for updating

  • Change to section 6 - date of revision

Updated on 29 October 2018 SmPC

Reasons for updating

  • 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

The SPC has been updated as follows:

Section 10.

DATE OF REVISION OF THE TEXT – 10/2018

Updated on 14 December 2017 SmPC

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • 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

The SPC has been updated as follows:

4.8   Undesirable effects

Updated Reporting of suspected adverse reactions for MHRA.

7.   MARKETING AUTHORISATION HOLDER

Updated to: Pfizer Ireland Pharmaceuticals
Operations Support Group
Ringaskiddy
County Cork
Ireland

Updated on 14 December 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 12 December 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 12 December 2017 PIL

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 21 July 2017 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • 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

The SPC has been updated as follows:

4.8   Undesirable effects

Reporting of suspected adverse reactions. MHRA and HPRA details added.

7.   MARKETING AUTHORISATION HOLDER

Updated to Pfizer Ireland Pharmaceuticals

Updated on 20 July 2017 PIL

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - marketing authorisation number
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 2 May 2017 SmPC

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - 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 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 9 - Date of first authorisation/renewal of the authorisation
  • Change to section 10 - Date of revision of the text
  • Removal of black triangle

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

Free text change information supplied by the pharmaceutical company

 

Removal of black triangle

Section 3 – addition of text ‘powder for concentrate’

Section 4.2 – editorial changes

Section 4.2 – addition of text ‘no data available’ to paediatric population subheading

Section 4.2 – addition of text ‘intravenous use’ to method of administration subheading

Section 4.4 – amendment of text related to contraindications : hypersensitivity to cephalosporins and to any other type of beta-lactam antibacterial agents

Section 4.4 – amednment of text to the following: ‘The incidence of DAGT seroconversion in patients receiving ceftaroline fosamil was 11.2% in the five pooled pivotal studies..’

Section 4.5 – addition of text related to paediatric population : ‘As with adults, the interaction potential is expected to be low in paediatrics.’

Section 4.6 – editorial changes and breast-feeding – addition of text related to risk to newborns/infants and the benefit of breast-feeding versus benefit of zinforo therapy for the woman

Section 4.7 – editorial changes

Section 4.8 – editorial changes and amendment of text related to phase III studies and adverse events

Section 4.9- editorial changes

Section 5.1 – editorial changes and addition of text ‘and penems’. Removal of text ‘information from clinical studies’

Section 5.2 – editorial changes, removal of text under gender subheading

Section 5.3 – editorial changes

Section 6.3 – amendment of text to read: ‘The reconstituted vial should be diluted immediately.’

Section 6.4 – editorial changes

Section 6.6 – editorial changes

Section 9 – addition of date of latest renewal: 24th April 2017

Section 10 – updated date of revision

Updated on 27 April 2017 PIL

Reasons for updating

  • 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 2 - pregnancy, breast feeding and fertility
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision
  • Removal of black triangle
  • Correction of spelling/typing errors
  • Improved presentation of PIL

Updated on 9 March 2017 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 5.1 - Pharmacodynamic properties
  • 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)

Free text change information supplied by the pharmaceutical company

Section 4.2: addition of text in dosing table (s) footnote (s) related to dose recommendations for treatment of cSSTI due to S.aureus

Section 4.2: addition of text on durations of treatment for renal impairment

Section 4.4: addition of text on limited clinical trial data related to the use of ceftaroline to treat cSSTI caused by S. aureus

Section 5.1: deletion of non species related breakpoints and addition of footnotes related to dosing for S. aureus

Section 5.2 amendment of text – amendment of text to read: ‘No appreciable accumulation of ceftaroline is observed following multiple intravenous infusions of 600 mg every 8 or 12 hours in healthy adults with CrCL > 50 mL/min’

Section 10: updated date of revision

Updated on 6 March 2017 PIL

Reasons for updating

  • Change to section 3 - dose and frequency
  • Change to section 6 - date of revision
  • Correction of spelling/typing errors

Updated on 6 July 2016 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
  • 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



Section

Change

4.1 Indications

Added indication for children from the age of 2 months

4.2 Posology

Added dosing for children with normal renal function and for children with renal impairment from 2 years.

4.8 Undesirable effects

Added text on the paediatric population

5.2 Pharmacokinetic properties

Revised text on special populations, renal impairment and paediatric population

5.3 Pre-clinical

Added section on juvenile toxicity

10 Date of Revision

1 June 2016

 

 

Updated on 1 July 2016 PIL

Reasons for updating

  • Change to, or new use for medicine
  • Change to warnings or special precautions for use
  • Change to date of revision
  • Change to dosage and administration

Updated on 21 March 2016 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects
  • 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



4.2 Minor editorial/formatting changes.

4.8 Addition of Agranulocytosis as a rare adverse reaction. Minor formatting  changes and change ceftaroline fosamil to Zinforo in the rash section.

10 change to revision date.

Updated on 18 March 2016 PIL

Reasons for updating

  • Change to side-effects
  • Change to date of revision
  • Correction of spelling/typing errors

Updated on 8 December 2015 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • 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 4.8 – editorial changes

- section 4.8 – addition of side effect – addition of ‘eosinophilia’ as frequency ‘not known’ side effect in table

-section 10 – updated date of revision

Updated on 7 December 2015 PIL

Reasons for updating

  • Change to side-effects
  • Change to date of revision

Updated on 2 October 2015 PIL

Reasons for updating

  • Addition of information on reporting a side effect.

Updated on 1 October 2015 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
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • 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)

Free text change information supplied by the pharmaceutical company



-section 4.2 – editorial changes

-section 4.4 – more detail added on dosages correlated with the incidence of DAGT seroconversion in patients receiving ceftaroline fosamil

- section 4.8 - Addition of information on a study in adult patients with cSSTI - most common adverse reactions occurring in ≥ 3% of patients treated with Zinforo were nausea, headache, and rash. The safety profile of Zinforo was similar to that observed in previous pooled Phase III studies with the exception of both a greater incidence of rash in Asian patients and a greater incidence of DAGT seroconversion.

-section 4.8 - More detail added on the above adverse event (rash) – dosages and incidence

-section 4.8 – amendment of ADR reporting details for Malta

-section 5.2 – editorial changes

-section 10 – updated date of revision

Updated on 24 November 2014 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • 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 5.2 - Pharmacokinetic properties
  • 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 4.2 – Add dosing for patients with renal impairment

Section 4.3 – Remove information about renal impairment

Section 4.5 – Editorial change for clarification (P450 changed to CYP450)

Section 4.8 – Addition of information from study Community-acquired pneumonia and addition of side effect – neutropenia. Amendment of AE reporting address in line with QRD.

Section 4.9 – Clarity provided around removal of ceftaroline by haemodialysis.

Section 5.2 – Editorial change for clarification (P450 changed to CYP450). Addition of further information around patients with renal impairment.

Section 7 – Update to MAH postcode.

Section 10 – Update to date of revision.

Updated on 20 November 2014 PIL

Reasons for updating

  • Change to date of revision
  • Change to dosage and administration
  • Change to MA holder contact details
  • Change to improve clarity and readability
  • Addition of information on reporting a side effect.
  • Change to warnings or special precautions for use
  • Change to side-effects
  • Correction of spelling/typing errors

Updated on 18 July 2014 SmPC

Reasons for updating

  • Change to section 6.3 - Shelf life
  • 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 6.3 Update shelf life from 2 years to 3 years.

Section 10 Update to date of revision

Updated on 29 November 2013 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
  • Improved electronic presentation

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

Free text change information supplied by the pharmaceutical company

“Additional monitoring” wording added to SmPC preceding section 1.

Section 1 – Black triangle moved to area preceding section 1.

Section 4.2 – Editorial change to “older people” section heading. Lower infusion volumes added to “Method of administration” section. Cross reference to section 6.6 added.

Section 4.8 – Adverse event reporting details added.

Section 5.1 – “Mode of action” updated to “Mechanism of action”.

Section 6.6 – Additional detail regarding lower infusion volumes added.

Section 9 – Editorial amendment in line with the QRD.

Section 10 – Update to "Date of Revision"

Updated on 27 November 2013 PIL

Reasons for updating

  • Change to date of revision
  • Addition of information on reporting a side effect.
  • Improved electronic presentation

Updated on 2 January 2013 SmPC

Reasons for updating

  • New SPC for new product

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

Free text change information supplied by the pharmaceutical company

None provided

Updated on 18 December 2012 PIL

Reasons for updating

  • New PIL for new product