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Updated on 16 August 2022

File name

220815A ie-pl-clean-225.1_DYS500_IE.pdf

Reasons for updating

  • 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 3 - dose and frequency
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company


Addition of new indication Neurogenic Detrusor Overactivity (NDO)

Updated on 16 August 2022

File name

220815A ie-spc-clean-224_DYS500_IE.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 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.6 - Special precautions for disposal and other handling
  • 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


Addition of new indication Neurogenic Detrusor Overactivity (NDO)

Updated on 10 March 2022

File name

220308A ie-spc-clean-222_DYS500.pdf

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • 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

The following changes have been to the SmPC: 

  • Section 4.2 - addition of the the description of the product after reconstitution.
  • Section 4.4 - addition of warning on dry eye, warning related to muscle atrophy and addition of statement on traceability.
  • Section 4.8 - addition of muscle atrophy to ADR  frequency Not known and update of reporting details. 

Updated on 10 March 2022

File name

220308A ie-pl-clean-223_DYS500.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 4 - how to report a side effect
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

The following PIL sections have been updated: 

  • Section 2: Addition of dry eye warning and a warning related to muscle wasting. 
  • Section 4: Addition of muscle wasting to ADR with frequency Not Known and update to reporting details.

Updated on 03 March 2022

File name

220225A ie-pl-clean-219.1_DYS500.pdf

Reasons for updating

  • Change to information for healthcare professionals

Free text change information supplied by the pharmaceutical company

Addition of instructions for HCP to section 6 of the PIL.

Updated on 09 February 2022

File name

211216A ie-pl-clean-218_DYS500.pdf

Reasons for updating

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

Free text change information supplied by the pharmaceutical company

The following sections of the PIL have been amended: 

Section 6 Contents of the pack and other information

Manufactures

Removal of UK manufacturer

 

Updated on 14 December 2020

File name

201202A ie-pl-clean-203_DYS500.pdf

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

The following changes were made:

Section 4 of the PIL - ADR hypoesthesia, frequency unknown addes in the 'Possible side effects' section.

Updated on 14 December 2020

File name

201202A ie-spc-clean-202_DYS500.pdf

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • 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

The following changes were made:

Section 4.8 of the SmPC - ADR hypoesthesia, frequency unknown. 

Updated on 15 July 2020

File name

200713A ie-spc-clean-192_DYS500.pdf

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.1 - List of excipients
  • 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

The following changes were made to the SmPC:

- In section 4.1, the indication for use in symptomatic treatment of focal spasticity affecting the upper limbs in paediatric cerebral palsy patients, two years of age or older was added

- In section 4.2, information on the posology and method of administration for the symptomatic treatment of focal spasticity in the upper limbs of children was added

- In section 4.8, adverse reactions related to the use in children for the treatment of focal spasticity affecting the upper limbs were added

- In section 5.1, information on the efficacy and safety of the product for use in the treatment of focal spasticity affecting the upper limbs in paediatric cerebral palsy patients was added

- In section 6.1, information on the components of Human Albumin solution was removed

Updated on 15 July 2020

File name

200713A ie-pl-clean-193_DYS500.pdf

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 3 - use in children/adolescents
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

The following changes have been made in the PIL:

- In section 1, the indication for use in children with with cerebral palsy (aged two years or older) for treatment of muscle spasms in arms was added

- In section 3, information on dose and frequency for the treatment of muscle spasms in the arms of children with cerebral palsy was added

- In section 4, adverse reactions associated with treatment of muscle spasms in the arms of children with cerebral palsy were added

Updated on 14 January 2020

File name

200106A ie-spc-clean-182_DYS500.pdf

Reasons for updating

  • Change to section 4.9 - Overdose
  • 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

Type 1A Update to section 4.9 overdose following PSUR review

Updated on 02 May 2019

File name

190430A ie-pl-cl-164_DYS500_IE.pdf

Reasons for updating

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

Updated on 04 March 2019

File name

190225A ie-pl-cl-159_DYS500_IE.pdf

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 04 March 2019

File name

190225A ie-spc-cl-158_DYS500_IE.pdf

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • 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

Change in frequency category of 'pain in extremity' for Adult Upper Limb.

Updated on 16 November 2018

File name

181115A ie-pl-clean-148_DYS500_IE.pdf

Reasons for updating

  • Change to section 3 - dose and frequency
  • Change to section 3 - use in children/adolescents

Updated on 09 November 2018

File name

181106A ie-spc-clean-147_DYS500_IE.pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 10 - Date of revision of the text

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

Updated on 07 August 2018

File name

180803A ie-pl-clean-145_DYS500_IE.pdf

Reasons for updating

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

Updated on 07 August 2018

File name

180803A ie-spc-clean-144_DYS500_IE.pdf

Reasons for updating

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

Transfer of ownership from Ipsen Biopharm Limited to Ipsen Pharma

Updated on 12 May 2018

Reasons for updating

  • New SPC for new product

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

Updated on 07 August 2017

Reasons for updating

  • New SPC for new product

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

Updated on 07 August 2017

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • 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 - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text
  • 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

Update of Adult Upper Limb indication and addition of Adult Lower Limb indication

Updated on 31 July 2017

File name

PIL_13628_58.pdf

Reasons for updating

  • New PIL for new product

Updated on 31 July 2017

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 3 - how to take/use
  • Change to section 4 - possible side effects
  • Change to section 5 - how to store or dispose
  • Change to section 6 - what the product contains
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision
  • Correction of spelling/typing errors

Updated on 08 May 2017

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 10 - Date of revision of the text
  • 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

Clinical and non-clinical update for existing Paediatric Lower Limb indication.

Updated on 02 May 2017

Reasons for updating

  • Change to section 3 - use in children/adolescents
  • Change to section 3 - how to take/use
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision
  • Correction of spelling/typing errors
  • Change to section 2 - what you need to know - warnings and precautions

Updated on 07 February 2017

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • 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

Update to ADR section 4.8

Updated on 02 February 2017

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 14 April 2016

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 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.6 - Special precautions for disposal and other handling
  • 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

Type II Clinical Variation Relating to Adult Upper Limb (AUL) Spasticity Indication and CCSI update.

 

Changes to sections of the SmPC:

(main change - 4.1 detailed below addition of AUL)

 

4.1          Therapeutic indications

Dysport is indicated for focal spasticity including  the:

-              Symptomatic treatment of focal spasticity affecting the upper limbs (fingers, wrist and elbow) in adults

-              Treatment of dynamic equinus foot deformity due to spasticity in ambulant paediatric cerebral palsy patients, two years of age or older.

 

Dysport is also indicated for the following treatments:

-              Spasmodic torticollis.

-              Blepharospasm.

-              Hemifacial spasm.

-              Persistent severe primary hyperhidrosis of the axillae, which interferes with the activities of daily living and is resistant to topical treatment.

Updated on 14 April 2016

Reasons for updating

  • Change to, or new use for medicine
  • Change to warnings or special precautions for use
  • Change to storage instructions
  • Change to side-effects
  • Change to drug interactions
  • Change to information about pregnancy or lactation
  • Change to how the medicine works
  • Change to further information section
  • Change to date of revision
  • Change to dosage and administration
  • Changes to therapeutic indications
  • Correction of spelling/typing errors

Updated on 17 February 2016

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • 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 4.8: 
General: rewording of AEs under skin and subcutaneous tissue disorders, general disorders
Paediatric leg spasicity due to cerebral palsy: rewording of AEs in injury and poisoning sections
Spasmodic torticollis: rewording of AEs under eye disorders and addition of nausea as uncommon AE under GI disorders
Blepharospasm and hemifacial spasm: rewording of AEs under nervous system and eye disorders

Addition of reporting side effects wording to section 4.8.

Updated on 17 February 2016

Reasons for updating

  • Change to side-effects
  • Addition of information on reporting a side effect.

Updated on 25 July 2014

Reasons for updating

  • Change to section 6.3 - Shelf life

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

Free text change information supplied by the pharmaceutical company

shelf-life reconstitution change variation rapp 9746. 

Updated on 23 July 2014

Reasons for updating

  • Change to storage instructions

Updated on 07 May 2014

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

Changes have been made to a paragraph of section 4.4 of the SmPC as follows: 

 

Very rare cases of death, occasionally in a context of dysphagia, pneumopathy (including but not limited to dyspnoea, respiratory failure, respiratory arrest) and/or in patients with significant asthenia have been reported after treatment with botulinum toxin A or B. Patients with disorders resulting in defective neuro-muscular transmission, difficulty in swallowing or breathing are more at risk of experiencing these effects. In these patients, treatment must be administered under the control of a specialist and only if the benefit of treatment outweighs the risk.

Updated on 22 April 2014

Reasons for updating

  • Addition of information on reporting a side effect.

Updated on 27 February 2014

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number

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

Free text change information supplied by the pharmaceutical company

The change to the SPC is change in Marketing Authorisation Holder and Number. 

Updated on 09 October 2013

Reasons for updating

  • Change due to user-testing of patient information

Updated on 22 August 2013

Reasons for updating

  • Change to improve clarity and readability

Updated on 29 July 2013

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - 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
  • 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

$0CRN 2091872  C.I.4. Changes to 4.2, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.3 and 6.5 of SPC$0$0$0$0CRN 2092132  C.I.4 To update the Summary of Product Characteristics in accordance with the Company Core Safety Information version 5$0$0CRN 2113934 C.I.3.A Changes to the SPC sections 4.2, 4.3, 4.4, 4.6, 4.8 & 6.6Incorporation of change in MAH address and contact details. Addition of PA no to the vial.$0

Updated on 09 March 2012

Reasons for updating

  • 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 6.1 - List of excipients

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

Free text change information supplied by the pharmaceutical company

Minor changes to format section 4.2, 4.8$0Minor change to wording: section 4.4, 4.6 (heading title)$0$0Major change to section 6.1$0

Updated on 22 September 2011

Reasons for updating

  • Change to section 1 - Name of medicinal product

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

Free text change information supplied by the pharmaceutical company

Changed to read Dysport 500 units powder for solution for injection

Updated on 27 May 2010

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 26 May 2010

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 16 July 2009

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 10 - Date of revision of the text
  • Change to section 4 - Clinical particulars
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration

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

Free text change information supplied by the pharmaceutical company

4.1 New indication - Persistent sever primary hyperhidrosis of the axillae, which interferes with the activities of daily living and is resistant to topical treatment

4.2 Axillary Hyperhidrosis - Posology and method of administration

4.4 Special Warnings and precautions for use - Primary Axillary Hyperhidrosis

4.8 Undesirable effects - Axillary Hyperhidrosis

10. Date of approval / revision of SPC

Updated on 08 July 2009

Reasons for updating

  • Change to, or new use for medicine
  • Change to dosage and administration
  • Changes to therapeutic indications
  • Change to date of revision

Updated on 27 August 2008

Reasons for updating

  • New PIL for new product

Updated on 21 February 2008

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

Changes to Undesirable Effects, approved by IMB January 2008.

Updated on 21 February 2008

Reasons for updating

  • Correction of spelling/typing errors

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

Updated on 13 September 2007

Reasons for updating

  • Change to section 6.3 - Shelf life

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

Free text change information supplied by the pharmaceutical company

Change to Shelf Life from 15 to 24 months

Updated on 23 August 2006

Reasons for updating

  • 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

Change to Date of Partial Revision of Text
Correction of Spelling/Typing Errors

Updated on 19 May 2005

Reasons for updating

  • Change to section 10 - Date of revision of the text

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

Updated on 16 August 2003

Reasons for updating

  • New SPC for medicines.ie

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

Updated on 30 June 2003

Reasons for updating

  • New SPC for medicines.ie

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