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Pfizer Healthcare Ireland

9 Riverwalk, National Digital Park, Citywest Business Campus, Dublin 24,
Telephone: +353 1 467 6500
Fax: +353 1 467 6501
Medical Information Direct Line: 1 800 633 363
Medical Information Website: http://www.pfizermedicalinformation.ie
Summary of Product Characteristics last updated on medicines.ie: 19/04/2017
SPC Dalacin C Phosphate 150 mg/ml Concentrate for Solution for Infusion or Solution for Injection 4ml

When a pharmaceutical company changes an SPC or PIL, 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 19/04/2017 and displayed until Current
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-Apr-2017
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

s4.5 and 5.2 - addition of text related to the drug interaction between clindamycin and cytochrome P450 (CYP) 3A4 inducers including rifampicin.
Updated on 03/03/2017 and displayed until 19/04/2017
Reasons for adding or updating:
  • Product/presentation re-marketed
Date of revision of text on the SPC:   01-Feb-2017
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company



SPC

Ireland brand marketing

Please implement in line with REG08-WI-IRL02 Generation and update of promotional material with regulatory license change

Updated on 19/05/2016 and displayed until 03/03/2017
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • 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
Date of revision of text on the SPC:   01-May-2016
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company



CDS update to sections 4.2 (addition of Adult and Paediatric sub-headers), 5.1 (addition of ATC code) and 5.3 of SmPC (addition of oral embryo-foetal data in rats & rabbits).

QRD v9 updates to sections 2, 4.2, 4.9, 5.1, 5.2 and 5.3

Updated on 18/11/2014 and displayed until 19/05/2016
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.1 - Therapeutic indications
  • 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
Date of revision of text on the SPC:   01-Nov-2014
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company



Section 2: QUALITATIVE AND QUANTITATIVE COMPOSITION - QRD update to this section

 

Section 4.1: Posology and method of administration – Addition of reference to section 4.4

 

Section 4.3: Contra-indications – deletion of warning concerning benzyl alcohol”  

 

Section 4.4:Special warnings and precautions for use- Update to include a warning concerning benzyl alcohol, in line with the guidance laid out in “Excipients in the Label and Package leaflet of Medicinal Products for Human Use” and Notice to Applicants.

 

Section 4.6:Fertility, pregnancy and lactation - Update to include a warning concerning benzyl alcohol

Updated on 09/07/2014 and displayed until 18/11/2014
Reasons for adding or updating:
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
Date of revision of text on the SPC:   01-Jun-2014
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company



Update to sections 4.5 and 4.8 of SPC

Updated on 30/05/2014 and displayed until 09/07/2014
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 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
Date of revision of text on the SPC:   01-May-2014
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company



Updates to:

Section 4.3: Contra-indications
– Update to include a warning concerning benzyl alcohol, in line with the guidance laid out in “Excipients in the Label and Package leaflet of Medicinal Products for Human Use” and Notice to Applicants – A Guideline on Summary of Product Characteristics (SmPC) September 2009”  and update in line with QRD version 9 on excipients.

 

Section 4.4:Special warnings and precautions for use- Update to include a warning concerning benzyl alcohol, in line with the guidance laid out in “Excipients in the Label and Package leaflet of Medicinal Products for Human Use” and Notice to Applicants – A Guideline on Summary of Product Characteristics (SmPC) September 2009”. Addition of warning concerning “pseudomembraneous colitis”

 

Section 4.5: Interaction with other medicinal products and other forms of interactionAddition of text “administered by injection”

 

Section 4.6:Fertility, pregnancy and lactation - Update to include a warning concerning benzyl alcohol and update the SPC in line with the Core safety profile.

 

Section 4.7:Effects on ability to drive and use machines – Update in line with CSP. The  following text has been includedClindamycin has no or negligible influence on the ability to drive and use machines”

 

Section 4.8:Undesirable effects – Revision of the  ADRs and frequencies to be in line with the CSP. Addition of the adverse event “pseudomembraneous colitis” to section 4.8.

 

Section 4.9 Overdosage -  Update to section by including text in line with CSP

Updated on 23/12/2013 and displayed until 30/05/2014
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   01-Dec-2013
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company

Updates to sections 4.2, 4.6, 4.8
Updated on 14/11/2012 and displayed until 23/12/2013
Reasons for adding or updating:
  • New individual SPC (was previously included in combined SPC)
Date of revision of text on the SPC:  
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company

None provided

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Active Ingredients

 
   Clindamycin Phosphate