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BOTOX 50 Units

*
Pharmacy Only: Prescription

  • Company:

    AbbVie Limited

  • Status:

    No Recent Update

  • Legal Category:

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

  • Active Ingredient(s):

    Botulinum Toxin Type A

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

Updated on 09 July 2024

File name

ie-spc-en50u.pdf

Reasons for updating

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

Updated on 09 July 2024

File name

ie-pl-en50u-100u-200u.pdf

Reasons for updating

  • Change to section 3 - how to take/use
  • Change to date of revision

Updated on 08 May 2024

File name

ie_mt_PL_Botox_10 vial pack_clean.pdf

Reasons for updating

  • Introduction of new pack/pack size

Updated on 09 March 2023

File name

ie_SmPC_Botox_50U_Type IB_PRAC Mephisto Sign_clean.pdf

Reasons for updating

  • Change to section 4.8 - Undesirable effects

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

Updated on 09 March 2023

File name

ie_mt_PL_Botox_Type IB_PRAC Mephisto Sign_clean.pdf

Reasons for updating

  • Change to section 4 - possible side effects

Updated on 21 November 2022

File name

ie_SmPC_Botox_50U_Type II_aULS_Nov22-clean.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
  • 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 21 November 2022

File name

ie_mt_PL_Botox_Type II_aULS_Nov22-clean.pdf

Reasons for updating

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

Updated on 07 October 2022

File name

BOTOX IE & MT 50U 100U 200U PIL_Clean.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Updated on 08 April 2022

File name

BOTOX 50U SPC.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)

Updated on 08 April 2022

File name

BOTOX IE & MT 50U 100U 200U PIL.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 08 February 2022

File name

ie-mt-botox-50U 100U 200U-pil-clean.pdf

Reasons for updating

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

Updated on 02 February 2022

File name

ie-botox-50U-spc_v15.pdf

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • 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 26 October 2021

File name

ie-botox-50U-spc v14.pdf

Reasons for updating

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

In section 4.4 (special warnings and precautions for use), following information was added.  This medicinal product contains less than 1 mmol sodium (23 mg) per vial, i.e. essentially “sodium free”.  In addition, in order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.

In section 4.8 (undesirable effects), side effect worsening of migraine was added.

In section 10 (date of revision of the text), the revised date was updated to 25/08/2021.

 

Updated on 26 October 2021

File name

ie-mt-botox-50U-100U-200U-pil-clean - v13.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 11 February 2021

File name

IE-PIL-BOTOX-MRP-WS110-v12.pdf

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 2 - use in children and adolescents
  • Change to section 3 - use in children/adolescents
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision
  • Change to information for healthcare professionals

Updated on 11 February 2021

File name

IE-SmPC-BOTOX-50U-MRP-WS110-v13.pdf

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - 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

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

Free text change information supplied by the pharmaceutical company

In section 4.1 (therapeutic indications, neurological disorders), indication updated to:

Focal spasticity of the ankle and foot in ambulant paediatric cerebral palsy patients, two years of age or older as an adjunct to rehabilitative therapy.

 

In section 4.2 (posology, paediatric population), no recommendation on posology can be made for indications other than paediatric focal spasticity associated with cerebral palsy.  BOTOX should only be administered by physicians who are experienced in the assessment and treatment of paediatric focal spasticity and as part of a structured program of rehabilitation. For Focal spasticity of the lower limb in paediatric patients administration guidance, recommended needle size, recommended dose and diagram indicating the injection sites were added.

 In section 4.8 (undesirable effects, general), clinical trial data was updated.  For focal spasticity of the lower limb in paediatric patients, ligament sprain, skin abrasion were added.  The frequency of muscular weakness was changed from common to uncommon. Viral infection, ear infection, somnolence, paraesthesia, myalgia, pain in extremity, asthenia, malaise, urinary incontinence and fall were removed.

In section 5.1 (pharmacodynamic properties), clinical data for focal spasticity of the upper limb in paediatric patients was added (section 5.1 only).  Study data for lower limb spasticity patients was added.

In section 5.3 (preclinical safety data), study data was added.

In section 10 (date of revision of text), the revised date was updated to 21/12/202

Updated on 27 July 2020

File name

botox50u100u200u-pil-clean-ie-mt.pdf

Reasons for updating

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

Updated on 27 July 2020

File name

botox50u-spc-clean-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

In section 4.8 (undesirable effects), the adverse drug reaction eyelid oedema was added in additional information.

In section 10 (date of revision of the text), the revision date was updated to 13/07/2020.

Updated on 14 June 2019

File name

IE_BOTOX_PIL_50U-100U-200U-v10.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 6 - date of revision
  • Change to information for healthcare professionals

Updated on 13 June 2019

File name

IE_SPC_BOTOX_50U_v11.pdf

Reasons for updating

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

In section 4.2 (posology and method of administration), further information is provided regarding the safety and efficacy of BOTOX in the paediatric population.

In section 10 (date of the revision of the text), the revised date was updated to 07/03/2019

Updated on 22 February 2019

File name

BOTOX IE PIL 50U 100U 200U - V9.pdf

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 5 - how to store or dispose
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision

Updated on 22 February 2019

File name

IE-SmPC-BOTOX-50U-V10.pdf

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects
  • Change to section 6.4 - Special precautions for storage

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

Free text change information supplied by the pharmaceutical company

In section 3 (pharmaceutical form), the pharmaceutical form was expanded.

In section 4.2 (posology and method of administration), clarification was provided to reconstitute BOTOX with sterile unpreserved normal saline solution (0.9% sodium chloride solution for injection).

In section 4.8 (undesirable effects), adverse reactions listed for urinary incontinence due to neurogenic detrusor overactivity, also occured in Phase 2 clinical trials.  In additional information, dry eye (associated with periocular injections) and localised muscle twitching/involuntary muscle contractions were added.

In section 6.4 (special precautions for storage), freezer temperature was updated to -5°C to -20°C.

In section 6.6 (special precautions for disposal and other handling), clarification was provided to reconstitute BOTOX with sterile unpreserved normal saline solution (0.9% sodium chloride solution for injection).

Updated on 27 December 2018

File name

pil-50u-100u-200u-proposed-clean-IE-v8.pdf

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 - dose and frequency
  • Change to section 4 - possible side effects
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision
  • Change to information for healthcare professionals

Updated on 21 December 2018

File name

spc-50u-proposed-clean-IE-v9.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 10 - Date of revision of the text

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

Updated on 21 December 2018

File name

spc-50u-proposed-clean-IE-v9.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 10 - Date of revision of the text

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

Updated on 28 February 2017

Reasons for updating

  • New SPC for new product

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

Updated on 28 February 2017

Reasons for updating

  • 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 6.6 - 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

In section 4.2 (Posology and method of administration):
-  BLADDER DISORDERS, Overactive Bladder  - duration of response updated (based on clinical data from completion of urology studies)
-  BLADDER DISORDERS, Urinary incontinence due to NDO  - duration of response updated (based on clinical data from completion of urology studies)
-  harmonisation of the terminology for saline diluent - term "sterile unpreserved normal saline (0.9% sodium chloride for injection) used

In section 4.8 (Undesirable effects)
-BLADDER DISORDERS, Overactive Bladder - correction of the system organ class for the preferred term "residual urine volume" (editorial change, no change to the actual ADR profile)
- BLADDER DISORDERS, Urinary incontinence due to NDO - clinical safety data for Botox 100 U dose in the treatment of NDO for non-catheterising MS patients with NDO with regard to adverse reactions, MS exacerbation annualised rate

In section 5.1 (Pharmacodynamic Properties)
-  Pharmacodynamic effect - additional information regarding sensory mechanism of action
- BLADDER DISORDERS, Overactive Bladder - duration of response updated (based on clinical data from completion of urology studies)
- BLADDER DISORDERS, Overactive Bladder - incidence of neutralising anti-drug antibody (based on clinical data from completion of urology studies)
- BLADDER DISORDERS, Overactive Bladder, Urinary incontinence due to NDO - duration of response updated (based on clinical data from completion of urology studies)
- BLADDER DISORDERS, Overactive Bladder, Urinary incontinence due to NDO - incidence of neutralising anti-drug antibody (based on clinical data from completion of urology studies)
- BLADDER DISORDERS, Overactive Bladder, Urinary incontinence due to NDO - efficacy of Botox 100 U dose in the treatment of NDO for non-catheterising (based on clinical data from completion of urology studies)

In section 6.6 (Special precautions for disposal and other handling) - harmonisation of the terminology for saline diluent - term "sterile unpreserved normal saline (0.9% sodium chloride for injection) used

In section 10 (Date of revision of the text) - date of revision of the text is February 2017.

Updated on 27 February 2017

File name

PIL_15206_956.pdf

Reasons for updating

  • New PIL for new product

Updated on 27 February 2017

Reasons for updating

  • Change to section 3 - duration of treatment
  • Change to section 6 - date of revision

Updated on 15 February 2016

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 6.3 - Shelf life
  • 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

In section 4.2 (Posology and method of administration) - elevation of the text  that limits chronic migraine diagnosis, and administration of BOTOX for chronic migraine, to neurologist, from the chronic migraine administration guidance (page 8 of the SmPC ) to the beginning of section 4.2 (page 2), to emphasize the importance of this message.

In section 4.2 (Posology and method of administration) - inclusion of specific muscle (zygomaticus major, orbicularis oris) representing  lower facial muscles

In section 4.4 (Special warnings and precautions for use) - patients specified as: adult and paediatric patients; removal of word "report" to avoid using it twice in one sentence, unnecessarily.

In section 6.3 (Shelf Life) - update of the wording regarding in-use storage for the reconstitution of the product  in line with the standard wording from the note for guidance on maximum shelf-life for sterile products for human use after first opening or following reconstitution (CPMP/QWP/159/96corr).

In section 10 (Date of revision of the text) - the date of revision of text is January 2016.

Updated on 12 February 2016

Reasons for updating

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

Updated on 13 November 2014

Reasons for updating

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

Updated on 20 October 2014

Reasons for updating

  • 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 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 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

to update SmPC in line with CCDS 16.1 & CSP 5.0.

Updated on 24 September 2014

Reasons for updating

  • Change to side-effects
  • Change to date of revision
  • Addition of information on alternative format leaflets

Updated on 04 June 2014

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 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • 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

$0SPC changes relating to addition of new indication, Focal lower limb spasticity associated with stroke$0$0$0$0$0

Updated on 28 May 2014

Reasons for updating

  • Changes to therapeutic indications

Updated on 21 February 2014

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 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • 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 sections of the SPC have been mainly re-formatted and updated in line with current QRD version: sec. 4.1; 4.2; 4.3; 4.4; 4.5; 4.8 and 5.1.

Updated on 07 February 2014

Reasons for updating

  • Change to date of revision

Updated on 20 December 2013

Reasons for updating

  • Change to packaging
  • Change to date of revision

Updated on 27 June 2013

Reasons for updating

  • Addition of joint PIL covering all presentations

Updated on 29 January 2013

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 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; 
            Idiopathic overactive bladder with symptoms of urinary incontinence, urgency and frequency in adult patients who have an inadequate response to, or are intolerant of, anticholinergic medication.

With consequential updates to sections 4.2, 4.3, 4.4, 4.8, 5.1, 6.6 and 10.

Updated on 24 January 2013

Reasons for updating

  • Change to, or new use for medicine
  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to dosage and administration

Updated on 27 November 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 4.8 - 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

Section 4.2 added:

The safety and effectiveness of BOTOX in the treatment of upper limb spasticity associated with stroke has not been established in children and adolescents under 18 years of age.

Section 4.4 added:

Serious adverse events including fatal outcomes have been reported in patients who had received off-label injections of BOTOX directly into salivary glands, the oro-lingual-pharyngeal region, oesophagus and stomach.  Some patients had pre-existing dysphagia or significant debility.

and:

Pneumothorax associated with injection procedure has been reported following the administration of BOTOX near the thorax.  Caution is warranted when injecting in proximity to the lung, particularly the apices.

and:

Paediatric Use

The safety and efficacy of Botox in indications other than those described for the paediatric population in section 4.1 has not been established. Post-marketing reports of possible distant spread of toxin have been very rarely reported in paediatric patients with comorbidities, predominantly with cerebral palsy. In general the dose used in these cases was in excess of that recommended (see section 4.8).

There have been rare spontaneous reports of death sometimes associated with aspiration pneumonia in children with severe cerebral palsy after treatment with botulinum toxin, including following off-label use (e.g. neck area).  Extreme caution should be exercised when treating paediatric patients who have significant neurologic debility, dysphagia, or have a recent history of aspiration pneumonia or lung disease. Treatment in patients with poor underlying health status should be administered only if the potential benefit to the individual patient is considered to outweigh the risks.

Section 4.8 Additional Information updated to include:

constipation, denervation/ muscle atrophy; respiratory depression and/or respiratory failure; aspiration pneumonia; strabismus; peripheral neuropathy;

Section 4.9 added:

Excessive doses may produce local, or distant, generalised and profound neuromuscular paralysis.

If the respiratory muscles become paralysed or sufficiently weakened, intubation and assisted respiration will be required until recovery takes place and may involve the need for a tracheostomy and prolonged mechanical ventilation in addition to other general supportive care.

Updated on 21 November 2012

Reasons for updating

  • Change to side-effects
  • Change to dosage and administration

Updated on 06 January 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 21 December 2011

Reasons for updating

  • Change to, or new use for medicine
  • Change to side-effects
  • Change to information about pregnancy or lactation
  • Change to information about driving or using machinery
  • Change to date of revision
  • Change to dosage and administration
  • Changes to therapeutic indications

Updated on 30 November 2011

Reasons for updating

  • New PIL for medicines.ie
  • Individual presentations superseded by joint PIL