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Tygacil 50mg powder for solution for infusion

Last Updated on eMC 14-May-2014 View document  | Pfizer Limited Contact details

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC.  For each version, we show the dates it was published on the eMC and the reasons for change.

Updated on 14-May-2014 and displayed until Current

Reasons for adding or 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
  • Improved presentation of SPC

Date of revision of text on the SPC: 01-Nov-2013

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:

To update sections 4.4 and 4.8 to include the most current pooled safety data in the approved indications
update section 5.2 of the SmPC with the revised pharmacokinetic results of paediatric study
section 5.2 of the SmPC with new information from an in vitro study conducted to assess whether tigecycline is an inhibitor or a substrate of P-Glycoprotein.

Updated on 03-Jan-2014 and displayed until 14-May-2014

Reasons for adding or 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

Date of revision of text on the SPC: 01-Dec-2013

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:



Updates to sections 4.4, 4.5, 4.8 &5.2.

Updated on 11-Sep-2013 and displayed until 03-Jan-2014

Reasons for adding or updating:

  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Fertility, 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
  • Addition of black triangle

Date of revision of text on the SPC: 01-Aug-2013

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:

addition of the black triangle
Update to Section 4.8
Update to sections 4.3,4.4, 4.6, 6.6
& 10

Updated on 20-Feb-2013 and displayed until 11-Sep-2013

Reasons for adding or updating:

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 6.4 - Special precautions for storage
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC: 12-Feb-2013

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Updates to bring the SPC in line with the latest QRD template version 8.2

Updated on 10-Sep-2012 and displayed until 20-Feb-2013

Reasons for adding or updating:

  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.8 - Undesirable Effects

Date of revision of text on the SPC: 28-Aug-2012

Legal Category:POM

Black Triangle (CHM): NO

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 21-Dec-2011 and displayed until 10-Sep-2012

Reasons for adding or updating:

  • Change to section 7 - Marketing Authorisation Holder

Date of revision of text on the SPC: 21-Nov-2011

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:

Section 7 Marketing Authorisation Holder: From Wyeth to Pfizer

Updated on 16-Nov-2011 and displayed until 21-Dec-2011

Reasons for adding or updating:

  • Change to section 4.8 - Undesirable Effects

Date of revision of text on the SPC: 27-Oct-2011

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:

Section 4.8: Update to the mortality figures

Updated on 16-Sep-2011 and displayed until 16-Nov-2011

Reasons for adding or 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

Date of revision of text on the SPC: 24-Aug-2011

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:

Section 4.2 Posology and method of administration: Minor update to Paediatric Population.
Section 4.8 Undesirable effects: Addition regarding Paediatric Population.
Section 5.2 Pharmacokinetic properties: Addition of paediatric population study data.

Updated on 14-Jul-2011 and displayed until 16-Sep-2011

Reasons for adding or updating:

  • Change to section 4.8 - Undesirable Effects

Date of revision of text on the SPC: 17-Jun-2011

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:



Pneumonia and hypoglycaemia have been added as common undesirable effects in Section 4.8
Severe skin reactions has been added as an undesirable effect with unknown frequency in Section 4.8

Updated on 25-May-2011 and displayed until 14-Jul-2011

Reasons for adding or updating:

  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.3 - Preclinical Safety Data
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.1 - Therapeutic indications

Date of revision of text on the SPC: 06-May-2011

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:

Inclusion of the following under section 4.1 Therapeutic Indications: Tygacil should be used only in situations where it is known or suspected that other alternatives are not suitable (see sections 4.4 and 4.8).
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 16-Sep-2010 and displayed until 25-May-2011

Reasons for adding or updating:

  • Correction of spelling/typing errors

Date of revision of text on the SPC: 01-Jul-2010

Legal Category:POM

Black Triangle (CHM): YES

Updated on 19-Jul-2010 and displayed until 16-Sep-2010

Reasons for adding or updating:

  • Correction of spelling/typing errors

Date of revision of text on the SPC: 01-Jul-2010

Legal Category:POM

Black Triangle (CHM): YES

Updated on 09-Jul-2010 and displayed until 19-Jul-2010

Reasons for adding or updating:

  • Change to section 6. 6 - Instructions for use, handling and disposal

Date of revision of text on the SPC: 01-Jul-2010

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:

Section 6.6 - Additional Text

The lyophilised powder should be reconstituted with 5.3 ml of sodium chloride 9 mg/ml (0.9 %) solution for injection, or dextrose 50 mg/ml (5 %) solution for injection, or Lactated Ringer’s solution for injection to achieve a concentration of 10 mg/ml of tigecycline.

.............................................................................................................................................

Compatible intravenous solutions include: sodium chloride 9 mg/ml (0.9 %) solution for injection, and dextrose 50 mg/ml (5 %) solution for injection.  and Lactated Ringer’s solution for injection.

Updated on 28-May-2010 and displayed until 09-Jul-2010

Reasons for adding or updating:

  • Change to section 6. 3 - Shelf Life

Date of revision of text on the SPC: 06-May-2010

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:

Section 6.3 - Shelf Life
Updated from 18 months to 24 months

Updated on 25-May-2010 and displayed until 28-May-2010

Reasons for adding or updating:

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.4 - Special warnings and precautions for Use

Date of revision of text on the SPC: 29-Apr-2010

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:

Section 4.1: Additional text -

· Complicated skin and soft tissue infections, excluding diabetic foot infections (see section 4.4)


Section 4.4:Additional terxt -

 The results in a large study in patients with diabetic foot infection, showed that tigecycline was less effective than comparator, therefore, tigecycline is not recommended for use in these patients (see section 4.1)

Updated on 15-Apr-2010 and displayed until 25-May-2010

Reasons for adding or updating:

  • Change to section 4.8 - Undesirable Effects

Date of revision of text on the SPC: 26-Mar-2010

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:

Update of section 4.8 of the SmPC Undesirable effects with respect to Phase 3 and 4 mortality data from cIAI and cSSSI studies.

Updated on 22-Jul-2009 and displayed until 15-Apr-2010

Reasons for adding or 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
  • Change to section 6.2 - Incompatibilities
  • Change to section 6. 6 - Instructions for use, handling and disposal
  • Change to section 10 date of revision of the text

Date of revision of text on the SPC: 07-Jul-2009

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:

In section 4.4 the following has been added

Cases of liver injury with a predominantly cholestatic pattern have been reported in patients receiving tigecycline treatment, including some cases of hepatic failure with a fatal outcome. Although hepatic failure may occur in patients treated with tigecycline due to the underlying conditions or concomitant medications, a possible contribution of tigecycline should be considered. (see section 4.8)

 
In section 4.8

Hepato-biliary disorders:

the following has been added
Not known: Hepatic failure(see section 4.4)

Section 5.1 Mechanism of resistance
has been amended and Gran-negative Aerobes has been added to Commonly Susceptible Species

In section 6.2 the following has been added

esomeprazole, omeprazole and intravenous solutions that could result in an increase of pH above 7.



Updated on 27-Jan-2009 and displayed until 22-Jul-2009

Reasons for adding or updating:

  • Correction of spelling/typing errors

Date of revision of text on the SPC: 30-Oct-2008

Legal Category:POM

Black Triangle (CHM): YES

Updated on 14-Jan-2009 and displayed until 27-Jan-2009

Reasons for adding or updating:

  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 4.8 - Undesirable Effects

Date of revision of text on the SPC: 30-Oct-2008

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:



Section 4.8 SPC

- Inclusion of Jaundice and liver injury, mostly cholestatic as adverse reactions.

 

Section 5.1 SPC

- The mechanism of tigecycline resistance in Acinetobacter baumannii is described. In addition, the Bacteroides fragilis group has been moved to category 2.

Updated on 29-Aug-2008 and displayed until 14-Jan-2009

Reasons for adding or updating:

  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 6. 6 - Instructions for use, handling and disposal
  • Change to section 10 date of revision of the text
  • Change to section 6.1 - List of Excipients
  • Change to section 6.2 - Incompatibilities

Date of revision of text on the SPC: 27-Mar-2008

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:



Section 6.1
Excipients have been added-lactose monohydrate, sodium hydroxide and hydrochloric acid.

Section 6.2
Incompatibilies have been updated to: Amphotericin B, amphotericin B lipid complex, and diazepam.

Section 6.4
The storage statement was rephrased from “Do not store above 25ºC” to “Store at or below 25ºC

Section 6.6
Final paragraph in this section updated as follows:
'When administered through a Y-site, compatibility of Tygacil diluted in sodium chloride 0.9 % for injection is demonstrated with the following medicinal products or diluents: amikacin, dobutamine, dopamine HCl, gentamicin, haloperidal, Lactated Ringer’s, lidocaine HCl, morphine, norepinephrine, piperacillin/tazobactam (EDTA formulation), potassium chloride, propofol, ranitidine HCl, theophylline and tobramycin.'

Section 10
Updated with most recent approval date.

Updated on 01-Feb-2008 and displayed until 29-Aug-2008

Reasons for adding or updating:

  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.8 - Undesirable Effects

Date of revision of text on the SPC: 01-Dec-2007

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 4.4 SPC
- Inclusion of a statement  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
- Inclusion of Thrombocytopenia and anaphylaxis/anaphylactoid reactions as adverse reactions.
- Inclusion of class effects listed in section 4.4.

Updated on 06-Dec-2007 and displayed until 01-Feb-2008

Reasons for adding or updating:

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 5.2 - Pharmacokinetic Properties

Date of revision of text on the SPC: 01-Oct-2007

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Update of sections 4.5 and 5.2 of the SPC with information on the action of tigecycline on Cytochrome P (CYP) isoenzymes

Updated on 13-Aug-2007 and displayed until 06-Dec-2007

Reasons for adding or 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

Date of revision of text on the SPC: 01-Jun-2007

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 4.4
- 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 and displayed until 13-Aug-2007

Reasons for adding or updating:

  • Correction of spelling/typing errors

Updated on 12-May-2006 and displayed until 26-May-2006

Reasons for adding or updating:

  • New SPC for new product

Company contact details

Pfizer Limited

Company image
Address

Ramsgate Road, Sandwich, Kent, CT13 9NJ

Fax

+44 (0)1304 656 221

Telephone

+44 (0)1304 616 161

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?

Active ingredients

tigecycline

Legal categories

POM - Prescription Only Medicine

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