Zavicefta 2g/0.5g 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 19 February 2025
File name
clean Adv SPC ZV 12_0 IE.pdf
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)
Updated on 19 February 2025
File name
clean Adv PIL ZV 15_0 IE.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 24 October 2024
File name
Adv SPC ZV 11_0 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 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 6.3 - Shelf life
- 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
The SPC has been updated as follows: necessary additional information for the use of Zavicefta in paediatric patients from birth to less than 3-months of age is added in Sections 4.1, 4.2 (with new Table 3 providing recommended dose for paediatric patients less than 3 months of age), 4.4, 4.8, 5.1, 5.2, 6.3 & 6.6 (with new instructions for preparing doses for paediatric patients from birth, including new Table 12).
Updated on 24 October 2024
File name
Adv PIL ZV 14_0 IE & NI CLEAN.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 2 - use in children and adolescents
- Change to section 3 - use in children/adolescents
- Change to section 6 - date of revision
- Change to other sources of information section
- Change to information for healthcare professionals
Updated on 20 February 2024
File name
AdvSPCZV100IECLEAN.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 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
The SPC has been updated as follows:
Update of Section 4.8 to add ‘Kounis syndrome’ to the list of ADRs, with a warning about this syndrome also added to Section 4.4.
Editorial updates to Section 4.2 (to embolden the ceftazidime information for clarity to the prescriber in Tables 2, 3, 4 & 5) and Section 5.1 (to remove the table describing Susceptibility testing breakpoints and replace it with a link to a EMA website)
Updated on 20 February 2024
File name
AdvSPCZV100IECLEAN.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 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
The SPC has been updated as follows:
Update of Section 4.8 to add ‘Kounis syndrome’ to the list of ADRs, with a warning about this syndrome also added to Section 4.4.
Editorial updates to Section 4.2 (to embolden the ceftazidime information for clarity to the prescriber in Tables 2, 3, 4 & 5) and Section 5.1 (to remove the table describing Susceptibility testing breakpoints and replace it with a link to a EMA website)
Updated on 20 February 2024
File name
AdvPILZV130IENICLEAN.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 14 February 2023
File name
AdvSPCZV90IECLEAN.pdf
Reasons for updating
- Document format updated
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 27 April 2022
File name
AdvSPCZV90IECLEAN.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 6.3 - Shelf life
- 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
In Section 4.2 footnote added to Tables 2-5 (p3-5): regarding the 4:1 ratio of the active ingredients and in Table 4 (p4): Dose of avibactam corrected from 4.75mg TO 4.7mg
In Sections 6.3 and 6.6 in-use Shelf Life after dilution reduced to “12 hours at 2 ‑ 8°C, followed by up to 4 hours”
Updated on 27 April 2022
File name
AdvPILZV120IENICLEAN.pdf
Reasons for updating
- Change to section 6 - date of revision
- Change to information for healthcare professionals
Updated on 11 October 2021
File name
CLEAN Adv PIL ZV 11_0 IV IE & NI.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
- Change to other sources of information section
Updated on 18 February 2021
File name
DEC202111240_Adv SPC ZV 8_1 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 5.1 - Pharmacodynamic properties
- Removal of Black Inverted Triangle
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 18 February 2021
File name
DEC202111240_Adv PIL ZV 10_1 IV IE_clean.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 6 - date of revision
- Change to information for healthcare professionals
- Removal of Black Inverted Triangle
Updated on 16 February 2021
File name
DEC202110249_Adv SPC ZV 8_0 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 5.1 - Pharmacodynamic properties
- Removal of Black Inverted Triangle
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 16 February 2021
File name
DEC202110249_Adv PIL ZV 10_0 IV IE_clean.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 6 - date of revision
- Change to information for healthcare professionals
- Removal of Black Inverted Triangle
Updated on 16 February 2021
File name
DEC202083142_Adv PIL ZV 10_0 IV UK_clean.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 6 - date of revision
- Change to information for healthcare professionals
- Removal of Black Inverted Triangle
Updated on 05 November 2020
File name
DEC202073079_Adv SPC ZV 7_0 IE_clean.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- Change to section 4.1 - Therapeutic indications
- 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 - how to report a side effect
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 6.2 - Incompatibilities
- Change to section 6.3 - Shelf life
- 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
IE:
- Update to sodium statement in section 2 and section 4.4.
- To extend the use of Zavicefta in paediatric patients from aged 3 months and older to section 4.1, 4.2, 5.1, 5.2
- Update to dosage for adults and paediatric patients in section 4.2.
- Separate IE SPC created - Update to reporting of adverse reactions - to remove UK details in section 4.8. IE AE reporting details updated in line with abbreviated HPRA wording.
- Change to section 3 - recommended dose for adults and paediatric patients
- Update to incompatabilities in section 6.2
- Update to section 6.3 shelf life - on infusion syringes
Update to section 6.6 special precautions for disposal and other handling.
Updated on 05 November 2020
File name
DEC202073079_Adv PIL ZV 9_0 IV IE_clean.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 2 - use in children and adolescents
- Change to section 2 - excipient warnings
- Change to section 3 - dose and frequency
- Change to section 3 - use in children/adolescents
- Change to section 3 - how to take/use
- Change to section 3 - duration of treatment
- Change to section 4 - how to report a side effect
- Change to section 6 - what the product contains
- Change to section 6 - date of revision
- Change to other sources of information section
- Change to information for healthcare professionals
Updated on 14 August 2020
File name
DEC202053876_Adv SPC ZV 6_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
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 14 August 2020
File name
DEC202053876_Adv PIL ZV 8_0 UK IE_clean.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 6 - date of revision
Updated on 19 February 2020
File name
DEC202010542_Adv PIL ZV 7_0 UK IE_clean.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 06 December 2019
File name
DEC201968139_Adv PIL ZV 6_0 UK IE clean.pdf
Reasons for updating
- Change to section 6 - date of revision
Updated on 15 April 2019
File name
DEC201919329_Adv PIL ZV 5_0 UK IE_clean.pdf
Reasons for updating
- Change to section 6 - date of revision
Updated on 12 April 2019
File name
DEC201919329_Adv SPC ZV 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 31 October 2018
File name
Adv PIL ZV 4_0 UK IE-clean.pdf
Reasons for updating
- Change to section 6 - date of revision
Updated on 31 October 2018
File name
Adv SPC ZV 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)
Free text change information supplied by the pharmaceutical company
The SPC has been updated as follows:
Section 10: DATE OF REVISION OF THE TEXT has been updated – (10/2018)
Updated on 25 July 2018
File name
Adv PIL ZV 3_0 UK IE_clean.pdf
Reasons for updating
- Change to section 2 - excipient warnings
- Improved presentation of PIL
Updated on 25 July 2018
File name
Adv SPC ZV 3_1 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
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Sections 4.2 (Posology and method of administration) and 4.8 (Undesirable effects) updated following completion of the paediatric study C3591004.
Section 4.4 sodium statement updated to align with the Annex to the EU Commission guideline on ‘Excipients in the labelling and package leaflet of medicinal products for human use’.
Updated on 06 February 2018
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 06 February 2018
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
Section 7 - MA Holder address "Operations Services Group" corrected to "Operations Support Group".
Updated on 05 February 2018
File name
PIL_17387_394.pdf
Reasons for updating
- New PIL for new product
Updated on 05 February 2018
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 08 January 2018
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 08 January 2018
Reasons for updating
- New PIL for new product
Pfizer Healthcare Ireland Unlimited Company
Address:
The Watermarque Building, Ringsend Road, Dublin 4, D04 K7N3, IrelandTelephone:
+353 1 467 6500Fax:
+353 1 467 6501Website:
https://www.pfizermedicalinformation.ie/Medical Information Direct Line:
1 800 633 363