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  • Dalacin C Phosphate 150 mg/ml Concentrate for Solution for Infusion or Solution for Injection 4ml

Dalacin C Phosphate 150 mg/ml Concentrate for Solution for Infusion or Solution for Injection 4ml

*
Pharmacy Only: Prescription

  • Company:

    Pfizer Healthcare Ireland

  • Status:

    No Recent Update

  • Legal Category:

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

  • Active Ingredient(s):

    Clindamycin Phosphate

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

Updated on 07 August 2023

File name

Reg PIL DA 30_1 Inj IE clean.pdf

Reasons for updating

  • Change to section 3 - use in children/adolescents
  • Change to section 6 - date of revision
  • Correction of spelling/typing errors

Updated on 07 August 2023

File name

Reg PIL DA 30_1 Inj IE clean.pdf

Reasons for updating

  • Change to section 2 - use in children and adolescents
  • Change to section 6 - date of revision
  • Correction of spelling/typing errors

Updated on 13 February 2023

File name

RegSPCDA272inj4mlIEclean.pdf

Reasons for updating

  • Document format updated

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

Updated on 21 March 2022

File name

RegSPCDA272inj4mlIEclean.pdf

Reasons for updating

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

Section 4.2 to add information re dosing in obese children.

Secion 5.2 to add new information regarding PK and PD data for clindamycin in obese children.

Also, minor typographical updates.

Updated on 21 March 2022

File name

RegPILDA291InjIEclean.pdf

Reasons for updating

  • Change to section 3 - use in children/adolescents
  • Change to section 6 - date of revision
  • Correction of spelling/typing errors

Updated on 30 November 2021

File name

Reg HCP Leaflet DA 21_2 & PIL DA 28_0 Inj IE clean.pdf

Reasons for updating

  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 2 - excipient warnings
  • Change to section 4 - how to report a side effect
  • Change to section 6 - what the product contains
  • Change to section 6 - date of revision

Updated on 30 November 2021

File name

Reg SPC DA 26_0 inj 4ml IE clean.pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 6.1 - List of excipients

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

Updated on 04 October 2021

File name

DEC202163915_Reg SPC DA 24_0 inj 4ml IE cl.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 04 October 2021

File name

DEC202163915_Reg HCP Leaflet DA 21_2 & PIL DA 26_0 Inj IE cl.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 21 September 2020

File name

Reg HCP Leaflet DA 21_2 PIL DA 24_0 Inj IE cl (002).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 HCP Leaflet DA 21_2 & PIL DA 22_4 Inj IE cl.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 26 November 2019

File name

DEC201966314_Reg SPC DA 22_4 inj 4ml IE cl.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 15 March 2018

Reasons for updating

  • New SPC for new product

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

Updated on 15 March 2018

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition

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

Free text change information supplied by the pharmaceutical company

Section 2: amount of clindamycin phosphate per 4 ml ampoule has been corrected from 300 mg to 600 mg.

Updated on 16 January 2018

File name

PIL_11700_114.pdf

Reasons for updating

  • New PIL for new product

Updated on 16 January 2018

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 - interactions with other medicines, food or drink
  • Change to section 6 - date of revision
  • Change to information for healthcare professionals

Updated on 12 January 2018

Reasons for updating

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

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 11 January 2018

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 6 - date of revision
  • Change to information for healthcare professionals

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 11 April 2017

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 6 - date of revision
  • Change to information for healthcare professionals

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 28 February 2017

Reasons for updating

  • Change to Section 1 - what the product is
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - excipient warnings
  • Change to section 3 - dose and frequency
  • Change to section 4 - possible side effects
  • Change to section 5 - how to store or dispose
  • Change to section 6 - date of revision
  • Change to information for healthcare professionals

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 17 May 2016

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to instructions about missed dose
  • Change to instructions about overdose
  • Change to storage instructions
  • Change to drug interactions
  • Change to information about pregnancy or lactation
  • Change to how the medicine works
  • Change to date of revision
  • Change to dosage and administration

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 14 November 2014

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to date of revision

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 07 July 2014

Reasons for updating

  • Change to side-effects
  • Change to drug interactions
  • Change to date of revision

Updated on 30 May 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 interaction – Addition 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 included “Clindamycin 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 27 May 2014

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to information about pregnancy or lactation
  • Change to date of revision

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 sections 4.2, 4.6, 4.8

Updated on 12 December 2013

Reasons for updating

  • Change to side-effects
  • Change to information about pregnancy or lactation
  • Change to date of revision

Updated on 14 November 2012

Reasons for updating

  • New individual SPC (was previously included in combined SPC)

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 08 November 2012

Reasons for updating

  • Change of licence holder
  • Change to marketing authorisation holder

Updated on 03 July 2012

Reasons for updating

  • Correction of spelling/typing errors

Updated on 08 June 2012

Reasons for updating

  • Change to side-effects
  • Change to date of revision

Updated on 18 May 2012

Reasons for updating

  • Change to, or new use for medicine
  • Change to date of revision

Updated on 20 October 2011

Reasons for updating

  • Change to date of revision
  • Change to marketing authorisation holder

Updated on 07 October 2011

Reasons for updating

  • Change due to user-testing of patient information

Updated on 13 August 2009

Reasons for updating

  • Improved electronic presentation

Updated on 13 May 2009

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 30 January 2008

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to storage instructions
  • Change to side-effects
  • Change to date of revision

Updated on 07 December 2006

Reasons for updating

  • New PIL for medicines.ie