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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 150mg/ml Concentrate for Solution for infusion or Solution for Injection, 2ml

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 02/06/2014 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 02/06/2014
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 section 4.2, 4.6, 4.8
Updated on 16/11/2012 and displayed until 23/12/2013
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
Date of revision of text on the SPC:   01-Nov-2012
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company



Section 7. MARKETING AUTHORISATION HOLDER

 

Updated on 10/07/2012 and displayed until 16/11/2012
Reasons for adding or updating:
  • Correction of spelling/typing errors
Date of revision of text on the SPC:   01-May-2012
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company

Correction of typo
Updated on 12/06/2012 and displayed until 10/07/2012
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   01-May-2012
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company



Update to section 4.8   Undesirable effects

Updated on 15/05/2012 and displayed until 12/06/2012
Reasons for adding or updating:
  • 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
Date of revision of text on the SPC:   01-May-2012
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company

SPC update to sections 4.1, 4.2, 4.3 and 4.4 of the SPC.

Updated on 21/10/2011 and displayed until 15/05/2012
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   06-Oct-2011
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company

SmPC changes to section 7 -  MA Holder’s name change and Section 10 – revision date.
Updated on 18/05/2009 and displayed until 21/10/2011
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
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

Section 4.4 - updated to include a warning for Clostridium difficile associated diarrhoea (CDAD)
Updated on 30/01/2008 and displayed until 18/05/2009
Reasons for adding or 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 4.2 - 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
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.3 - Preclinical safety data
Date of revision of text on the SPC:   11/2007
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

1.  – reformatting of name

2.  – addition of amount to excipient Benzyl alcohol 9mg/ml

3. – full pharmaceutical Form

4.2 – adjustment/modifications of dosing for Neonates, Dosage in Elderly and Renal & Hepatic impairment

4.4 – addition of warning for the treatment of meningitis and moving some of warnings under section 4.8 (see below)

4.6 – update of safety during pregnancy and lactation

 

4.8 – addition of Gastro-intestinal tract, Haemopoietic, skin and mucous membranes, Hypersensitivity reactions, Hepatic, Nervous system, cardiovascular & local reactions.

5.1 – Product has been shown to have in vitro activity against isolates various organisms (for full list refer to annotated SPC)

5.3 – update to Preclinical Safety Data for carcinogenesis, mutagenesis and Impairment of fertility

Updated on 07/12/2006 and displayed until 30/01/2008
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   12/2006
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

Section 7:  Updated to reflect updated MAH address
 
Section 10:  Updated revision date
Updated on 02/07/2003 and displayed until 07/12/2006
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
   Clindamycin Phosphate