Dalacin C Phosphate 150mg/ml Concentrate for Solution for infusion or Solution for Injection, 2ml
*Company:
Pfizer Healthcare Ireland Unlimited CompanyStatus:
UpdatedLegal 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
Updated on 16 October 2024
File name
Reg SPC DA 27_0 inj 2ml IE clean.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 16 October 2024
File name
Reg PIL DA 31_0 Inj IE clean.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
- Change to MA holder contact details
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 13 February 2023
File name
RegSPCDA262inj2mlIEclean.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
RegSPCDA262inj2mlIEclean.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 SPC DA 25_0 inj 2ml 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 - how to report a side effect
- Change to section 6.1 - List of excipients
Legal category:Product subject to medical prescription which may not be renewed (A)
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 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 04 October 2021
File name
DEC202163915_Reg SPC DA 23_0 inj 2ml 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 15 September 2020
File name
Reg HCP Leaflet DA 21_2 PIL DA 24_0 Inj IE cl.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.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.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
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 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 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 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 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 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 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 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 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 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 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 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 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 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 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
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
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 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 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
Updated on 10 July 2012
Reasons for updating
- Correction of spelling/typing errors
Free text change information supplied by the pharmaceutical company
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
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
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
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
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
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
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
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
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)
Updated on 02 July 2003
Reasons for updating
- New SPC for medicines.ie