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Aciclovir 25 mg/ml Concentrate for Solution for Infusion. *
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):

    Aciclovir Sodium

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

Updated on 03 December 2021

File name

DEC202162710_Reg PIL gxAC 10_2 25mg_ml IE Clean_1638515917.pdf

Reasons for updating

  • Change to Section 1 - what the product is
  • Change to section 1 - what the product is used for
  • 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 - use in children and adolescents
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 2 - driving and using machines
  • Change to section 3 - dose and frequency
  • Change to section 3 - use in children/adolescents
  • Change to section 3 - how to take/use
  • Change to section 3 - duration of treatment
  • Change to section 3 - overdose, missed or forgotten doses
  • Change to section 4 - possible side effects
  • Change to section 5 - how to store or dispose
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision
  • Change to information for healthcare professionals

Updated on 23 September 2021

File name

DEC202162710_Reg SPC AC 6_2 25mg_ml IE Clean_1632393345.pdf

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
  • 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 - how to report a side effect
  • 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
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling

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 4.1:  Section has been revised to provide a tabulated presentation of the therapeutic indications.

Section 4.2: Updated the dosage information.

Section 4.3: Editorial update

Section 4.4: Updated warnings and precautions in patents with renal impairment and elderly patients.

Section 4.5: Editorial update

Section 4.6: Updated Fertility, pregnancy and lactation information

Section 4.7: Editorial update

Section 4.8: Updated ADRs

Section 4.9: Editorial update

Section 5.1: Updated Mechanism of action

Section 5.2: Added ‘absorption’ text

Section 5.3: Editorial update

Section 6.5: Editorial update

Section 6.6: Editorial update

Updated on 23 September 2021

File name

DEC202162824_Reg PIL gxDM 13_1 IE - Clean _1632393047.pdf

Reasons for updating

  • Change to Section 1 - what the product is
  • Change to section 1 - what the product is used for
  • 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 - use in children and adolescents
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 2 - driving and using machines
  • Change to section 3 - dose and frequency
  • Change to section 3 - use in children/adolescents
  • Change to section 3 - how to take/use
  • Change to section 3 - duration of treatment
  • Change to section 3 - overdose, missed or forgotten doses
  • Change to section 4 - possible side effects
  • Change to section 5 - how to store or dispose
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision
  • Change to information for healthcare professionals

Updated on 12 January 2021

File name

DEC202070660_Reg SPC AC 5_1 25mg_ml IE-clean_1610475092.pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for use

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

Updated on 12 January 2021

File name

DEC202070660_Reg PIL gxAC 8_1 25mg_ml IE-clean_1610475015.pdf

Reasons for updating

  • 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 September 2019

File name

DEC201951624_Reg SPC AC 3_0 25mg_ml IE_clean_1569826975.pdf

Reasons for updating

  • 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

 

The SPC has been updated as follows:

 

Section 4.6: QRD alignment ( relocate fertility section )

The entire SmPC has been re-formatted following QRD convention.

 

Updated on 30 September 2019

File name

DEC201951624_Reg PIL gxAC 5_0 25mg_ml IE_clean_1569826908.pdf

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 5 - how to store or dispose
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

The PIL has been updated to relocate statement on Aciclovir used to treat Herpes simplex infections

statement and update in line with QRD.

Updated on 18 December 2018

File name

Reg PIL gxAC 4_1 25mg_ml IE_clean_1545131485.pdf

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 31 October 2018

File name

Reg PIL gxAC 4_0 25mg_ml IE_clean_1540969838.pdf

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 30 October 2018

File name

Reg PIL gxAC 3_1 25mg_ml IE_clean_1540888472.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 25 September 2018

File name

Reg SPC AC 2_0 25mg_ml IE_clean_1537860686.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)

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

Free text change information supplied by the pharmaceutical company

Please update medicines.ie

 

The SPC has been updated as follows: Section 7 has been updated from Current MAH to Pfizer Healthcare Ireland, 9 Riverwalk, National Digital Park, Citywest Business Campus, Dublin 24, Ireland. Subsequently section 8 has also been updated with the HPRA newly appointed Marketing Authorisation number.

Updated on 24 September 2018

File name

Reg PIL gxAC 3_1 25mg_ml IE_clean_1537801094.pdf

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 24 September 2018

File name

Reg SPC AC 2_0 25mg_ml IE_clean_1537801328.pdf

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

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

Packaging components: The changes to the packaging components should be implemented in line with the requirements of REG25-WI-GBR0 Implementation of Changes to Packaging Components.

Updated on 10 May 2017

File name

PIL_17021_560.pdf

Reasons for updating

  • New PIL for new product

Updated on 27 March 2017

Reasons for updating

  • New SPC for new product

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

Updated on 27 March 2017

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • 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
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
  • 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

The reason for the SPC update was to bring it in line with the innovator product.  I’ve attached the annotated FYI, but it has affected the following sections:

 

2

4.1

4.2

4.3

4.4

4.5

4.8

4.9

5.1

5.2

5.3

Updated on 27 March 2017

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • 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
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
  • 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

The reason for the SPC update was to bring it in line with the innovator product.  I’ve attached the annotated FYI, but it has affected the following sections:

 

2

4.1

4.2

4.3

4.4

4.5

4.8

4.9

5.1

5.2

5.3

Updated on 04 January 2017

Reasons for updating

  • New SPC for medicines.ie

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 04 January 2017

Reasons for updating

  • New SPC for medicines.ie

Free text change information supplied by the pharmaceutical company

None provided