Zinforo 600 mg powder for concentrate for solution for infusion
*Company:
Pfizer Healthcare Ireland Unlimited CompanyStatus:
UpdatedLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 23 January 2025
File name
Adv PIL ZI 16_0 IE clean.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
The PIL has been updated to reflect the SPC changes.
Updated on 23 January 2025
File name
Adv SPC ZI 14_0 IE clean.pdf
Reasons for updating
- 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:
7. MARKETING AUTHORISATION HOLDER
Pfizer Ireland Pharmaceuticals unlimited Company
Operations Support Group
Ringaskiddy, County Cork
Ireland
Updated on 20 February 2024
File name
AdvSPCZI130IEClean.pdf
Reasons for updating
- 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
The SPC has been updated as follows:
4.4 Special warnings and precautions for use
Updated to add a warning and a statement that Kounis syndrome has been reported with other beta lactam antibiotics.
4.8 Undesirable effects
Updated to add a warning and a statement that Kounis syndrome has been reported with other beta lactam antibiotics.
Updated on 20 February 2024
File name
AdvSPCZI130IEClean.pdf
Reasons for updating
- 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
The SPC has been updated as follows:
4.4 Special warnings and precautions for use
Updated to add a warning and a statement that Kounis syndrome has been reported with other beta lactam antibiotics.
4.8 Undesirable effects
Updated to add a warning and a statement that Kounis syndrome has been reported with other beta lactam antibiotics.
Updated on 20 February 2024
File name
AdvPILZI150IEClean.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 20 February 2024
File name
AdvPILZI150IEClean.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 20 February 2024
File name
AdvPILZI150IEClean.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 09 June 2022
File name
AdvSPCZI120IEClean.pdf
Reasons for updating
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 6.3 - Shelf life
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
The SPC NI and SPC IE has been updated as follows:
6.3 Shelf life – Reduction of the Shelf Life of the Finished Product - After Dilution or Reconstitution from 24 hours to 12 hours
4.8 Undesirable effects – ADR wording updated in line with EMA guidelines
Updated on 09 June 2022
File name
AdvPILZI140IEClean.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
- Change to information for healthcare professionals
Updated on 16 August 2021
File name
Adv PIL ZI 13_0 IE Clean.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 11 March 2021
File name
Adv SPC ZI 11_0 IE Clean.pdf
Reasons for updating
- 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)
Updated on 25 February 2021
File name
DEC202110791_Adv SPC ZI 11_0 IE Clean.pdf
Reasons for updating
- 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)
Updated on 25 February 2021
File name
DEC202110791_Adv PIL ZI 12_0 IE Clean.pdf
Reasons for updating
- Change to section 6 - date of revision
Updated on 13 October 2020
File name
DEC202067981_Adv SPC ZI 10_0 IE Clean.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- 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
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 13 October 2020
File name
DEC202067981_Adv PIL ZI 11_0 IE Clean.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
Updated on 27 February 2020
File name
DEC202010817_Adv SPC ZI 9_0 UK & IE CLEAN.pdf
Reasons for updating
- 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)
Updated on 27 February 2020
File name
DEC202010817_Adv PIL ZI 10_0 UK & IE CLEAN.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 6 - date of revision
Updated on 06 December 2019
File name
DEC201968283_Adv PIL ZI 9_0 UK & IE clean.pdf
Reasons for updating
- Change to section 6 - date of revision
Updated on 31 July 2019
File name
Adv PIL ZI 8_0 UK & IE CLEAN.pdf
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
File name
DEC201940512_Adv SPC ZI 8_0 UK & IE CLEAN.pdf
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
File name
DEC201933410_Adv PIL ZI 7_0 UK & IE clean.pdf
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
File name
DEC201933410_Adv SPC ZI 7_0 UK & IE clean.pdf
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
File name
DEC201927123_Adv PIL ZI 6_0 UK & IE clean.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 23 May 2019
File name
DEC201927123_Adv SPC ZI 6_0 UK & IE clean.pdf
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
File name
DEC201919234_Adv PIL ZI 5_0 UK & IE clean.pdf
Reasons for updating
- Change to section 6 - date of revision
Updated on 12 April 2019
File name
DEC201919234_Adv SPC ZI 5_0 UK & IE Clean.pdf
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 07 March 2019
File name
Adv PIL ZI 4_0 UK & IE CLEAN.pdf
Reasons for updating
- Change to section 6 - manufacturer
Updated on 07 March 2019
File name
Adv SPC ZI 4_0 UK & IE CLEAN.pdf
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
File name
Adv PIL ZI 3_0 UK IE clean.pdf
Reasons for updating
- Change to section 6 - date of revision
Updated on 29 October 2018
File name
Adv SPC ZI 3_0 UK IE clear.pdf
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
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 14 December 2017
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 12 December 2017
File name
PIL_15581_437.pdf
Reasons for updating
- New PIL for new product
Updated on 12 December 2017
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 21 July 2017
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
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 02 May 2017
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
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 09 March 2017
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 06 March 2017
Reasons for updating
- Change to section 3 - dose and frequency
- Change to section 6 - date of revision
- Correction of spelling/typing errors
Updated on 06 July 2016
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 01 July 2016
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
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
Reasons for updating
- Change to side-effects
- Change to date of revision
- Correction of spelling/typing errors
Updated on 08 December 2015
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 07 December 2015
Reasons for updating
- Change to side-effects
- Change to date of revision
Updated on 02 October 2015
Reasons for updating
- Addition of information on reporting a side effect.
Updated on 01 October 2015
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
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
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
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
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
Reasons for updating
- Change to date of revision
- Addition of information on reporting a side effect.
- Improved electronic presentation
Updated on 02 January 2013
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
Reasons for updating
- New PIL for new product