Login

Targocid Powder and Solvent for Solution for Injection 400mg

*
Pharmacy Only: Prescription

  • Company:

    SANOFI

  • Status:

    No Recent Update

  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)

  • Active Ingredient(s):

    Teicoplanin

    *Additional information is available within the SPC or upon request to the company

Updated on 18 October 2022

File name

Targocid 200mg and 400mg PIL IES22 291 T1a IN Post PSUSA- PRAC recommendation _Clean.pdf

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect

Updated on 18 October 2022

File name

IE Targocid 400mg SmPC IES22 291 T1a IN Post PSUSA- PRAC recommendation _pancytopenia_clean.pdf

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • 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)

Updated on 05 January 2022

File name

IES21 280 Targocid 200mg and 400mg PIL CCDS 4.pdf

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - use in children and adolescents
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 2 - driving and using machines
  • Change to section 2 - excipient warnings
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect

Updated on 05 January 2022

File name

IE Targocid 400mg SmPC CCDS 4 IES21 280.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 4.8 – Undesirable effects - how to report a side effect

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 17 December 2021

File name

1.3.1 Targocid 400mg SmPC DEH3916001-003IB29G IE S21 152- CLEAN.pdf

Reasons for updating

  • Improved presentation of SPC

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 13 August 2021

File name

Targocid PIL text DE-H-3916-001-003-IB-29G S21 152.pdf

Reasons for updating

  • Change to Section 1 - what the product is
  • Change to section 1 - what the product is used for
  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - use in children and adolescents
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 2 - driving and using machines
  • 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 3 - overdose, missed or forgotten doses

Updated on 13 August 2021

File name

1.3.1 Targocid 400mg SmPC DEH3916001-003IB29G IE S21 152.pdf

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

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 06 May 2021

File name

targocid ie pl 790931.pdf

Reasons for updating

  • Change to improve clarity and readability

Updated on 14 October 2020

File name

1.3.1 Targocid 400mg IE1204 clean.pdf

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties
  • 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 14 October 2020

File name

Updated PIL 790931.pdf

Reasons for updating

  • Change to section 5 - how to store or dispose

Updated on 07 June 2019

File name

1.3.1 Targocid 400mg.pdf

Reasons for updating

  • Improved presentation of SPC

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 05 June 2018

File name

Targocid 200mg & 400mg Powder and Solvent for Solution PIL.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 3 - how to take/use
  • Change to section 6 - date of revision

Updated on 29 May 2018

File name

Targocid 400mg Powder and solvent for Solution SPC.docx

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • 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 4.2 amendments - Posology and method of administration

 Adults and elderly patients with normal renal function

  •  Changes to table

  Measured by FPI

The dose is to be adjusted on bodyweight whatever the weight of the patient.

 Adults and elderly patients with impaired renal function

Dose adjustment is not required until the fourth day of treatment, at which time dosing should be adjusted to maintain a serum trough concentration of at least 10 mg/L when measured by HPLC, or at least 15 mg/L when measured by FPIA method.

 Method of administration

Teicoplanin should be administered by the intravenous or intramuscular route. The intravenous injection may be administered either as a bolus over 3 to 5 minutes or as a 30‑minute infusion.

Only the infusion method should be used in neonates.

For Clostridium difficile infection-associated diarrhea and colitis, the oral route is to be used.

Section 4.8 Undesirable effects -typo corrected.

Section 5.1 Pharmacodynamic properties

  • Changes to table

Susceptibility testing breakpoints

The MICs breakpoints according to the European Committee on Antimicrobial Susceptibility Testing (EUCAST), version 3.1, February 11, 20137.1, March 10, 2017 are displayed in the following table

 

Non-susceptible isolates are rare or not yet reported. The identification and antimicrobial susceptibility test result on any such isolate must be confirmed and the isolate sent to a reference laboratory.Isolates with MIC values above the susceptible breakpoint are very rare or not yet reported. The identification and antimicrobial susceptibility tests on any such isolate must be repeated and if the result is confirmed the isolate must be sent to a reference laboratory. Until there is evidence regarding clinical response for confirmed isolates with MIC above the current resistant breakpoint they should be reported resistant.

 

Updated on 11 December 2017

File name

PIL_8415_95.pdf

Reasons for updating

  • New PIL for new product

Updated on 11 December 2017

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 14 July 2016

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 14 July 2016

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



Drug reaction with eosinophilia and systemic symptoms (DRESS), anaphylactic shock (see section 4.4)

Updated on 14 July 2016

Reasons for updating

  • Change to side-effects

Updated on 13 March 2015

Reasons for updating

  • Addition of information on reporting a side effect.
  • Addition of black triangle

Updated on 05 January 2015

Reasons for updating

  • Addition of black triangle
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • 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

Addition of Black Triangle.
Section 4.8 updated to include the new PV legislation wording on adverse event reporting.

Updated on 24 October 2014

Reasons for updating

  • Improved electronic presentation

Updated on 29 September 2014

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4 - Clinical particulars
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • 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 4.8 – Undesirable effects - how to report a side effect
  • 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 6.1 - List of excipients
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
  • 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

Full SmPC updated following a recent Union referral procedure. 

Updated on 25 September 2014

Reasons for updating

  • Change to packaging
  • Change to, or new use for medicine
  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to instructions about missed dose
  • Change to instructions about overdose
  • Change to storage instructions
  • Change to side-effects
  • Change to drug interactions
  • Change to information about drinking alcohol
  • Change to information about pregnancy or lactation
  • Change to information about driving or using machinery
  • Change to how the medicine works
  • Change to further information section
  • Change to date of revision

Updated on 20 September 2012

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 updated to include 'Sanofi' as a trading style

Updated on 07 September 2012

Reasons for updating

  • Addition of separate SPCs covering individual presentations

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

None provided

Updated on 03 September 2012

Reasons for updating

  • Improved electronic presentation

Updated on 18 May 2010

Reasons for updating

  • Improved electronic presentation

Updated on 23 October 2009

Reasons for updating

  • Change due to user-testing of patient information

Updated on 30 April 2007

Reasons for updating

  • Improved electronic presentation

Updated on 19 December 2006

Reasons for updating

  • Improved electronic presentation

Updated on 06 September 2006

Reasons for updating

  • Improved electronic presentation

Updated on 19 November 2004

Reasons for updating

  • Change to further information section

Updated on 19 August 2004

Reasons for updating

  • New PIL for medicines.ie