Vaborem 1 g/1 g powder for concentrate for solution for infusion
*Company:
A. Menarini Pharmaceuticals Ireland LtdStatus:
No Recent UpdateLegal 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 27 July 2023
File name
IE Vaborem SmpC Clean Approved Renewal July 23.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 27 July 2023
File name
IE Vaborem SmpC Clean Approved Renewal July 23.pdf
Reasons for updating
- Change to improve clarity and readability
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Minor typo amends.
Updated on 27 July 2023
File name
UKNI and IE Combined PIL Clean Renewal July 23.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - pregnancy, breast feeding and fertility
- Removal of Black Inverted Triangle
Free text change information supplied by the pharmaceutical company
Black Triangle Removed
Contraceptives warnings relocated
Warnings for taking other medicines updated
Warning not to be given the medicine during pregnancy
Updated on 09 June 2022
File name
ie-smpc Vaborem NI IE DDI Phototox Clean May 22.pdf
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- 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 4.5 - Updated In Vitro data added along with Vaboractam details added - Contraception warnings also added
Section 5.2 - Effect of vaborbactam/meropenem on enzymes and transporters added
Section 10 - Date of revision updated
Updated on 09 June 2022
File name
UKNI_IE_pil Vaborem NI IE DDI Phototox Clean May 22.pdf
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 6 - date of revision
Free text change information supplied by the pharmaceutical company
Section 2 - New section on contraception warnings added
Section 2 - Interactions with oral contraceptive warnings added and section further updated with text deletions for other medications
Section 6 - Date of Revision updated
Updated on 26 November 2021
File name
ie-smpc Vaborem clean Nov 21.pdf
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 - Shelf life updated from 3 to 4 years
Section 10 - Date of revision updated
Updated on 05 November 2020
File name
uk-ie-pil Vaborem 26-7-19 clean.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Sections 2 and 4 of the PL are updated to include the safety information already approved in meropenem single component texts but missing in Vaborem PIL:
- In particular, the addition concerns severe cutaneous adverse reactions (SCAR), such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), erythema multiforme (EM) and acute generalised exanthematous pustulosis (AGEP).
- Delirium is also added as a Side-Effect in section 4
- The wording of the sodium excipient is also updated in line with the European Commission guidelines and Pharmaprim has been approved as new local representative for Sweden
- The date of revision is also updated to 15 Oct 2020.
Updated on 05 November 2020
File name
ie-smpc Vaborem clean 15-10-20.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- 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
Sections 4.4 and 4.8 of the SmPC are updated to include the safety information already approved in meropenem single component texts but missing in Vaborem SmPC/PIL:
- In particular, the addition concerns severe cutaneous adverse reactions (SCAR), such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), erythema multiforme (EM) and acute generalised exanthematous pustulosis (AGEP).
- Delirium is also added as Adverse Reaction in 4.8.
- The wording of the sodium excipient is also updated in line with the European Commission guidelines
Updated on 20 November 2019
File name
ie-smpc Vaborem clean 30-9-19.pdf
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
This change is to correct the spelling errors in the Vaborem SmPC:
- MRSA (section 4.4)
- haemodialysis (section 4.9).
The date of revision is also updated to 30 September 2019.
Updated on 24 October 2019
File name
uk-ie-pil Vaborem 26-7-19 clean.pdf
Reasons for updating
- New PIL for new product
Updated on 24 October 2019
File name
ie-smpc Vaborem clean 17-4-19.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)