Dalacin C Phosphate 150mg/ml Concentrate for Solution for infusion or Solution for Injection, 2ml *

  • Company:

    Pfizer Healthcare Ireland
  • Status:

    Updated
  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)
  • Active Ingredient(s):

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

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 04 October 2021

File name

DEC202163915_Reg HCP Leaflet DA 21_2 & PIL DA 26_0 Inj IE cl_1633347629.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 04 October 2021

File name

DEC202163915_Reg SPC DA 23_0 inj 2ml IE cl_1633347545.pdf

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

The SPC has been updated as follows:

Updates to SmPC Sections 4.4 and 4.8 for safety signal of acute renal failure.

Updated on 15 September 2020

File name

Reg HCP Leaflet DA 21_2 PIL DA 24_0 Inj IE cl_1600164473.pdf

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 26 November 2019

File name

DEC201966314_Reg SPC DA 21_4 inj 2ml IE cl_1574789292.pdf

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 4.2 - 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 5.3 - Preclinical safety data
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 9 - Date of first authorisation/renewal of the authorisation

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

Updated on 26 November 2019

File name

DEC201966314_Reg HCP Leaflet DA 21_2 & PIL DA 22_4 Inj IE cl_1574789210.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 - pregnancy, breast feeding and fertility
  • Change to section 2 - excipient warnings
  • Change to section 3 - use in children/adolescents
  • Change to section 5 - how to store or dispose
  • Change to section 6 - what the product contains
  • Change to section 6 - date of revision
  • Change to name of medicinal product
  • Change to information for healthcare professionals
  • Correction of spelling/typing errors

Updated on 16 January 2018

File name

PIL_11700_114.pdf

Reasons for updating

  • New PIL for new product

Updated on 12 January 2018

Reasons for updating

  • New SPC for new product

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

Updated on 12 January 2018

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use

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 4.3 – removal of contraindication regarding concomitant use of erythromycin.

Section 4.4 – addition of warning regarding possibility of cross resistance to macrolides and lincosamides for some individual bacterial strains.

Section 5.1 – update to add new data, as per CDS update.

Updated on 12 January 2018

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows:

Section 4.3 – removal of contraindication regarding concomitant use of erythromycin.

Section 4.4 – addition of warning regarding possibility of cross resistance to macrolides and lincosamides for some individual bacterial strains.

Section 5.1 – update to add new data, as per CDS update.

Updated on 19 April 2017

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

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 19 April 2017

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

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 March 2017

Reasons for updating

  • Product/presentation re-marketed

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 03 March 2017

Reasons for updating

  • Product/presentation re-marketed

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 May 2016

Reasons for 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

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 19 May 2016

Reasons for 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

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 November 2014

Reasons for 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

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 18 November 2014

Reasons for 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

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 July 2014

Reasons for 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

Free text change information supplied by the pharmaceutical company

Update to sections 4.5 and 4.8 of SPC

Updated on 09 July 2014

Reasons for 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

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

Free text change information supplied by the pharmaceutical company

Update to sections 4.5 and 4.8 of SPC

Updated on 02 June 2014

Reasons for 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

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 02 June 2014

Reasons for 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

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

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 December 2013

Reasons for 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

Free text change information supplied by the pharmaceutical company

Updates to section 4.2, 4.6, 4.8

Updated on 23 December 2013

Reasons for 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

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

Free text change information supplied by the pharmaceutical company

Updates to section 4.2, 4.6, 4.8

Updated on 16 November 2012

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

Free text change information supplied by the pharmaceutical company



Section 7. MARKETING AUTHORISATION HOLDER

 

Updated on 16 November 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. MARKETING AUTHORISATION HOLDER

 

Updated on 10 July 2012

Reasons for updating

  • Correction of spelling/typing errors

Free text change information supplied by the pharmaceutical company

Correction of typo

Updated on 10 July 2012

Reasons for updating

  • Correction of spelling/typing errors

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

Free text change information supplied by the pharmaceutical company

Correction of typo

Updated on 12 June 2012

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

Update to section 4.8   Undesirable effects

Updated on 12 June 2012

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Free text change information supplied by the pharmaceutical company

Update to section 4.8   Undesirable effects

Updated on 15 May 2012

Reasons for 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

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

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 15 May 2012

Reasons for 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

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 October 2011

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • 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

SmPC changes to section 7 -  MA Holder’s name change and Section 10 – revision date.

Updated on 21 October 2011

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

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 May 2009

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use

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

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 18 May 2009

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use

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 January 2008

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 4.2 - 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

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

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 30 January 2008

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 4.2 - 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

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 December 2006

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • 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 7:  Updated to reflect updated MAH address
 
Section 10:  Updated revision date

Updated on 07 December 2006

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

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 July 2003

Reasons for updating

  • New SPC for medicines.ie

Updated on 02 July 2003

Reasons for updating

  • New SPC for medicines.ie

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