Zinforo 600 mg powder for concentrate for solution for infusion
- Name:
Zinforo 600 mg powder for 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: 06/12/19
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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 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 PharmaceuticalsOperations 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 PharmaceuticalsUpdated 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
Updated on 18 December 2012 PIL
Reasons for updating
- New PIL for new product