Tygacil 50mg powder for solution for infusion
- Name:
Tygacil 50mg powder 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: 12/04/19
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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 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 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 text – 10/2018 to align with the approved annex.
Updated on 8 August 2018 PIL
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 8 August 2018 SmPC
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:
Section 7 - MA transfer from Pfizer Limited Sandwich to Pfizer Europe MA EEIG Bruxelles.
Updated on 13 July 2016 PIL
Reasons for updating
- New PIL for new product
Updated on 13 July 2016 PIL
Reasons for updating
- Change of manufacturer
- Change to date of revision
Updated on 23 June 2016 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
Updated on 23 June 2016 SmPC
Reasons for updating
- New SmPC for new product
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 21 June 2016 PIL
Reasons for updating
- Change to date of revision
Updated on 25 April 2016 SmPC
Reasons for updating
- 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:
Section 4.8, see tracked changes, addition of AE: Hypofibrinogenaemia
Updated on 22 April 2016 PIL
Reasons for updating
- Change to side-effects
- Change to date of revision
Updated on 3 March 2016 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 4.6 - Pregnancy and lactation
- 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:
SPC: Renewal SmPC version has changes to the following:
Sections 4.2 and 4.4, see tracked changes, these are non-content related reordering of text and additional headings.
Section 4.6 change to pregnancy wording to preplace text with the following: “Tigecycline should not be used during pregnancy unless the clinical condition of the woman requires treatment with tigecycline.” Breast feeding section updated with text as follows: Available pharmacodynamic/toxicological data in animals have shown excretion of tigecycline/metabolites in milk (see section 5.3). A risk to the newborns/infants cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from tigecycline therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.”
Section 4.8 is reformatted into a table format from free text
Updated on 1 March 2016 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change of contraindications
- Change to side-effects
- Change to information about pregnancy or lactation
- Change to MA holder contact details
Updated on 1 October 2015 PIL
Reasons for updating
- Change to further information section
- Change to date of revision
Updated on 28 July 2015 SmPC
Reasons for updating
- 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:
to include updated information based on a recent review of the Core Data Sheet (CDS). This would enable prescribers to have the most up to date safety information.
Section 5.1 Pharmacodynamic Properties: Text was added to include information from a thorough QTc clinical trial in healthy subjects, which showed that no significant effect of a single intravenous dose of tigecycline 50 mg or 200 mg on QTc interval was detected.
Other minor administrative/ format changes have also been made to the product information.
Updated on 5 June 2015 SmPC
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - 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 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:
4.1 Therapeutic indications
Updated to include addition of indication in children from the age of eight years.
4.2 Posology and method of administration
Updated to include dosing in children and method of administration details
4.4 Special warnings and precautions for use
Updated to include details on use in children
4.8 Undesirable effects
Updated to include details in Paediatric population
5.1 Pharmacodynamic properties
Updated to include details in Paediatric population
5.2 Pharmacokinetic properties
Updated to include details in Paediatric population
10. DATE OF REVISION OF THE TEXT
Update to 05/2015Updated on 2 June 2015 PIL
Reasons for updating
- Change to, or new use for medicine
- Change to warnings or special precautions for use
- Change to storage instructions
- Change to date of revision
Updated on 8 January 2015 SmPC
Reasons for updating
- 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 4.8 - Undesirable effects
- 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
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The SPC has been updated as follows: Editorial updates to the SPC – sections – 4.4, 4.5, 4.6, 4.8 and 5.2 |
Updated on 1 September 2014 SmPC
Reasons for updating
- Change to Section 4.8 – Undesirable effects - how to report a side effect
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 26 August 2014 PIL
Reasons for updating
- Change to side-effects
- Change to further information section
- Change to date of revision
Updated on 12 May 2014 SmPC
Reasons for updating
- 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 4.8 - Undesirable effects
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 5.2 - Pharmacokinetic properties
- Change to 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
4.4 Special warnings and precautions for use
4.5 Interaction with other medicinal products and other forms of interaction
4.8 Undesirable effects
5.2 Pharmacokinetic properties
Updated on 1 May 2014 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to drug interactions
- Addition of information on reporting a side effect.
Updated on 3 January 2014 SmPC
Reasons for updating
- 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 4.8 - Undesirable effects
- 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
Updates to sections 4.4, 4.5, 4.8 &5.2
Updated on 23 December 2013 PIL
Reasons for updating
- Change to side-effects
- Change to date of revision
Updated on 4 December 2013 PIL
Reasons for updating
- Change to side-effects
Updated on 18 September 2013 SmPC
Reasons for updating
- Addition of black triangle
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to section 6.6 - Special precautions for disposal and other handling
- 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
- SPC updated to bring it in line with QRDv9 template, this includes the addition of the black triangle – additional monitoring statement at the beginning of the SPC.
- Section 4.8 also updated with reporting of suspected adverse reactions text as outlined in QRD v9.
- Minor changes to sections 4.3,4.4, 4.6, 6.6 to bring the text in line with QRD v9 and update to date of revision in section 10.
Updated on 5 September 2013 PIL
Reasons for updating
- Change to, or new use for medicine
- Change to date of revision
- Change to MA holder contact details
- Addition of black triangle
Updated on 20 February 2013 SmPC
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.8 - Undesirable effects
- Change to section 6.4 - Special precautions for storage
- Change to section 9 - Date of renewal of authorisation
- 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
Updated on 19 February 2013 PIL
Reasons for updating
- Change of manufacturer
- Change to warnings or special precautions for use
- Change to side-effects
- Change to date of revision
- Change to MA holder contact details
- Changes to therapeutic indications
Updated on 11 September 2012 SmPC
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
(1) include CHMP proposed wording on super infections in section 4.4
(2) add abnormal healing as a new ADR in section 4.8
(3) change frequency for thrombocytopenia from unknown to uncommon in section 4.8
(4) correct an acronym in section 4.8 (cSSSI to CSSTI)
(5) align with current QRD format.
Updated on 6 September 2012 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to date of revision
- Improved electronic presentation
Updated on 5 January 2012 SmPC
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
Updated on 16 December 2011 PIL
Reasons for updating
- Change to marketing authorisation holder
Updated on 17 November 2011 SmPC
Reasons for updating
- 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
Updated on 15 November 2011 PIL
Reasons for updating
- Addition of manufacturer
Updated on 16 September 2011 SmPC
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.8 - Undesirable effects
- 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
Section 4.8 Undesirable effects
Section 5.2 Pharmacokinetic properties
Updated on 8 July 2011 SmPC
Reasons for updating
- 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
Severe skin reactions has been added as an undesirable effect with unknown frequency in Section 4.8
Updated on 7 July 2011 PIL
Reasons for updating
- Change to side-effects
- Change to date of revision
Updated on 23 May 2011 SmPC
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to section 5.3 - Preclinical safety data
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Inclusion under section 4.4 Special Warnings and Precautions for Use and section 4.8 Undesirable Effects regarding details of Clinical Study outcomes, including numerically higher mortality rate among Tygacil treated patients compared to comparator treatments.
Inclusion under section 4.6 Fertility, Pregnancy and Lactation and section 5.3 Preclinical Safety Data regarding pre-clinical information on the mating and fertility of rats that have been exposed to tigecycline.
Updated on 23 May 2011 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change to storage instructions
- Change to date of revision
- Changes to therapeutic indications
Updated on 23 July 2010 SmPC
Reasons for updating
- 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
Updated on 21 July 2010 PIL
Reasons for updating
- Change to further information section
- Change to date of revision
Updated on 16 July 2010 SmPC
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.4 - Special warnings and precautions for use
- 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
-
Update of sections 4.1 & 4.4 of the SmPC and section 1 of the PIL with respect to data from the Diabetic Foot Infection (DFI) clinical trial.
-
Update of sections 6.3 of the SmPC (change in shelf life from 18 to 24 months)
- Update to the detailed description of the Pharmacovigilance system
Updated on 6 July 2010 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change to date of revision
Updated on 21 June 2010 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 10 – date of revision updated
Updated on 4 August 2009 PIL
Reasons for updating
- Change to MA holder contact details
- Change to side-effects
- Change to dosage and administration
Updated on 4 August 2009 SmPC
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 6.2 - Incompatibilities
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 5.1 - Pharmacodynamic properties
- Change to MA holder contact details
- 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
1) Update of sections 6.2 and 6.6 of the SPC to include information on incompatibility of Tygacil solution with esmoprazole and omeprazole, and compatibility with metoclopramide. The Package Leaflet has been updated accordingly.
2) Update of the pathogens table in section 5.1 "Pharmacodynamic properties" of the SPC further to the assessment of the PSUR covering the period from 15.12.2007 to 14.06.2008 and the data presented from the Tygecycline Evaluation Surveillance Trial (T.E.S.T).
3) Update of the Sections 4.4 Special Warnings and 4.8 Undesirable effects of the Summary of Product Characteristics (SPC) to include precautionary language regarding isolated cases of significant hepatic dysfunction and hepatic failure following the assessment of the PSUR covering the period from 15.12.2007 to 14.06.2008. The Package leaflet has been updated accordingly.
4) Update of the Detailed Description of the Pharmacovigilance System (DDPS) [Module 1.8.1] to reflect a change in the Qualified Person in the EEA for Pharmacovigilance (QPPV). Other administrative and editorial changed are incorporated in this revised DDPS (version 2.1).
5) Change in Maltese local repUpdated on 20 November 2008 SmPC
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic 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 4.8 addition of Jaundice to uncommon Hepato-biliary disorders:
Section 5.1 addition of Bacteroides fragilis group to Species for which acquired resistance may be a problem
Section 5.1 - Rewording of Mechanism of resistance paragraph to include - Decreased susceptibility in Acinetobacter baumannii has been attributed to the overexpression of the AdeABC efflux pump.
Updated on 20 November 2008 PIL
Reasons for updating
- Change to storage instructions
- Change to side-effects
- Addition of marketing authorisation holder
Updated on 8 October 2008 PIL
Reasons for updating
- Change to storage instructions
- Change of inactive ingredient
- Change to drug interactions
- Change to date of revision
Updated on 8 October 2008 SmPC
Reasons for updating
- Change to section 6.1 - List of excipients
- Change to section 6.2 - Incompatibilities
- Change to section 6.4 - Special precautions for storage
- Change to section 6.6 - Special precautions for disposal and other handling
- 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 6.1 - Addition of excipients -
Lactose monohydrate
Hydrochloric acid, sodium hydroxide (for pH adjustment)
Section 6.2 - Addition of 'amphotericin B lipid complex, e and diazepam' to list
Section 6.4 - rewording of storage conditions
Section 6.6 -
Updated on 12 February 2008 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
Updated on 1 February 2008 SmPC
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
- Inclusion of a statement on regarding anaphylaxis/anaphylactoid reactions.
- Inclusion of wording for the early detection of the onset or worsening of acute pancreatitis, and the need for specific clinical and laboratory monitoring.
Section 4 .8 SPC
Updated on 6 December 2007 SmPC
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
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 10 August 2007 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to further information section
Updated on 8 August 2007 SmPC
Reasons for updating
- 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
- Inclusion of statement on pancreatitis to reflect the Undesirable Effects section.
- Correction of medical terminology (i.e., hyperphosphataemia) to reflect class labelling for tetracyclines.
Section 4.8
Correction of the frequency categories based on QRD Appendix II version 01-2007.
Section 5.1
-Inclusion of Pharmacotherapeutic & ATC code assigned by the WHO.
-Correction of EUCAST breakpoints.
Updated on 26 May 2006 SmPC
Reasons for updating
- Correction of spelling/typing errors
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 12 May 2006 PIL
Reasons for updating
- New PIL for new product
Updated on 9 May 2006 SmPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may not be renewed (A)