Last Updated on eMC 24-07-2017 View medicine  | Ipsen Ltd Contact details

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC.  For each version, we show the dates it was published on the eMC and the reasons for change.

Reasons for adding or 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 10 - Date of revision of the text

Date of revision of text on the SPC:11-07-2017

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Addition of new indication: Axillary hyperhidrosis

Reasons for adding or 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 10 - Date of revision of the text

Date of revision of text on the SPC:11-07-2017

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Addition of new indication: Axillary Hyperhidrosis

Reasons for adding or updating:

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.6 - Fertility, 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 6.1 - List of excipients
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.3 - Shelf life
  • 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 10 - Date of revision of the text
  • Correction of spelling/typing errors

Date of revision of text on the SPC:27-02-2017

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Clinical and non-clinical updates for Paediatric indication; and QRD updates

Reasons for adding or updating:

  • Change to section 4.8 - Undesirable effects
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:09-01-2017

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Update to ADRs in section 4.8

Reasons for adding or updating:

  • Change to section 1 - Name of the medicinal product
  • 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 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:06-12-2016

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 1 and 2: update to name in line with QRD template
Section 4.1: Inclusion of new indication for adult lower limb in spasticity
Section 4.2: Inclusion of new indication for adult lower limb in spasticity
Section 4.8: inlcusion of AEs relating to use in adult lower limb
Section 5.1: Inclusion of summary of clinical data related to adult lower limb use

Reasons for adding or updating:

  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:14-06-2016

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 4.8: addition of nausea as a side effect for spasmodic torticollis indication.
Rewording of some side-effects under the general, Dynamic equinus foot deformity due to focal spasticity, spasmodic torticollis and Blepharospasm and hemifacial spasm indications sections.

 

Reasons for adding or 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 - Fertility, 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 9 - Date of first authorisation/renewal of the authorisation
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:31-01-2016

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



In section 4.1 (Therapeutic indications): adult arm spasticity indication has been updated to symptomatic treatment of focal spasticity of upper limbs in adults and the requirement to treat paediatric patients in hospital specialist centres with appropriate trained personnel has been removed.

In section 4.2 (Posology and method of administration): A s
tatement has been added to capture that instructions on reconstitution can be found in section 6.6.   The indication ‘Arm spasticity’ has been updated to ‘Focal spasticity affecting the upper limb’, resulting in significant changes in this section for this indication.  The indication ‘Paediatric cerebral palsy spasticity’ has been updated to ‘Dynamic equines foot deformity due to focal spasticity’.


In section 4.4 (Special warnings and precautions for use):
The special warning on the risk of viral infection transmission due to the human serum albumin has been removed.

In section 4.6 (Pregnancy and lactation): Formatting changes.

In section 4.8 (Undesirable effects): The adverse event table for focal spasticity affecting the upper limbs has been updated. The frequency of dysphagia is changed from common to uncommon. Arm muscle weakness is changed to muscle weakness.  Accidental injury/falls was removed as a common effect. Asthenia was added as an uncommon effect.

In section 5.1 (Pharmacodynamic properties): Data from the latest clinical study for focal spasticity affecting he upper limbs has been added.

In section 6.6 (
Special precautions for disposal): Reconstitution information has been removed from section 4 and tabulated in section 6.6.

In section 9 (Date of first authorisation/renewal of the authorisation): Formatting changes.

In section 10 (Date of revision of text): 31 January 2016.

Reasons for adding or updating:

  • Change to section 4.8 - Undesirable effects
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:02-09-2015

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



In section 4.8 (Undesirable effects) – the following information has been added at the end of the section:

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

In section 6.3 (Shelf life) – the existing text has been replaced by the following information:

Unopened vial:

24 months

Reconstituted solution:

Chemical and physical in-use stability has been demonstrated for 24 hours at 2°C-8°C.

From a microbiological point of view, unless the method of reconstitution precludes the risk of microbial contamination, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.

In section 6.4 (Special precautions for storage) – the existing text has been replaced by the following information:

Unopened vial:

Store in a refrigerator (2°C - 8°C).

Do not freeze.

Reconstituted solution:

For storage conditions after reconstitution of the medicinal product, see section 6.3.

Reasons for adding or updating:

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

Date of revision of text on the SPC:11-12-2013

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

In section 4.4 Special warnings and precautions for use - The text in bold has been added in the first sentence of the third paragraph:
Very rare cases of death, occasionally in the context of dysphagia, pneumopathy (including but not limited to dyspnoea, respiratory failure, respiratory arrest) and/or in patients with significant asthenia have been reported following treatment with botulinum toxin A or B. 

Reasons for adding or updating:

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for Use
  • Individual SPC superseded by joint SPC covering several presentations
  • Change to section 4.8 - Undesirable Effects
  • Change to section 10 date of revision of the text

Date of revision of text on the SPC:12-06-2012

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

In section 4.2 Posology and method of administration: $0$0Clarification of the reinjection interval for all indications (except blepharospasm and hemifacial spasm - 12 weeks): Injections may be repeated approximately every 16 weeks or as required to maintain response, but not more frequently than every 12 weeks.$0$0$0$0$0$0$0Also in this section, under spasmodic torticollis, the dosing instructions for retrocollis have been amended with the removal of: …bilateral trapezius injections (up to 250U per muscle) after 6 weeks if there is insufficient response.$0$0$0$0$0$0In section 4.4 Special warnings and precautions for use:$0$0There has been a rewording of the dysphagia section: Very rare cases of death, occasionally in the context of dysphagia, pneumopathy and/or in patients with significant asthenia have been reported following treatment with botulinum toxin A or B. Patients with disorders resulting in defective neuromuscular transmission,$0$0difficulty 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. Dysport should be administered with caution to patients with pre-existing swallowing or breathing problems as these can worsen following the distribution of the effect of toxin into the relevant muscles. Aspiration has occurred in rare cases and is a risk when treating patients who have a chronic respiratory disorder.$0$0$0$0$0A comment has been added with regard to use in spasticity patients: Dysport should not be used to treat spasticity in patients who have developed a fixed contracture.$0$0$0$0$0In section 4.8 Undesirable effects:$0$0This section has changed considerably in some cases, please see SPC for all changes.$0

Reasons for adding or updating:

  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 10 date of revision of the text

Date of revision of text on the SPC:01-04-2011

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

In section 4.2 Psology and method of administration - the following text has replaced the existing text under Blepharospasm and hemifacial spasm:

Adults and elderly: In a dose ranging clinical trial on the use of Dysport for the treatment of benign essential blepharospasm, a dose of 40 units per eye was significantly effective.  Doses of 80 units and 120 units per eye resulted in a longer duration of effect.  However, the incidence of related adverse events, including eye adverse events particularly with regard to ptosis, showed a dose relationship by an increased incidence with increasing doses of Dysport.

In the treatment of blepharospasm and hemifacial spasm, the maximum dose used must not exceed a total dose of 120 units per eye. For further information see section 5.1.

    

Injection of 10 units (0.05mL) should be made medially and of 10 units (0.05 mL) should be made laterally into the junction between the preseptal and orbital parts of both the upper (3 and 4) and lower orbicularis oculi muscles (5 and 6) of each eye. In order to reduce the risk of ptosis, injections near the levator palpebrae superioris should be avoided.

For injections into the upper lid the needle should be directed away from its centre to avoid the levator muscle. A diagram to aid placement of these injections is provided. The relief of symptoms may be expected to begin within two to four days with maximal effect within two weeks.

 

Injections should be repeated approximately every twelve weeks or as required to prevent recurrence of symptoms but not more frequently than every twelve weeks. On such subsequent administrations, if the response from the initial treatment is considered insufficient, the dose per eye may need to be increased to 60 units: 10 units (0.05 mL) medially and 20 units (0.1 mL) laterally, 80 units: 20 units (0.1 mL) medially and 20 units (0.1 mL) laterally or up to 120 units: 20 units (0.1 mL) medially and 40 units (0.2 mL) laterally above and below each eye in the manner previously described. Additional sites in frontalis muscle above brow (1 and 2) may also be injected if spasms here interfere with vision.

 

In cases of unilateral blepharospasm the injections should be confined to the affected eye. Patients with hemifacial spasm should be treated as for unilateral blepharospasm. The doses recommended are applicable to adults of all ages including the elderly.


In section 5.1 Pharmacodynamic properties - additional information and a table has been added.

In section 5.1 Pharmacodynamic properties - additional information and a table has been added.

Reasons for adding or updating:

  • Change to section 2 - Qualitative and quantitative composition
  • 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 4.7 - Effects on Ability to Drive and Use Machines
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 5.3 - Preclinical Safety Data
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
  • Change to section 10 date of revision of the text

Date of revision of text on the SPC:13-09-2010

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



  • In section 2, 500U changed to 500 units and list of other consitituents removed.
  • In section 4.2, the following statement added to the arm spasticity and spasmodic torticollis posology - "The maximum dose administered must not exceed 1000 units."
  • In section 4.4, the following wording added - "Antibody formation to botulinum toxin has been noted rarely in patients receiving Dysport. Clinically, neutralising antibodies might be detected by substantial deterioration in response to therapy and/or the need for consistent use of increased doses. Careful consideration should be given before the injection of patients who have experienced a previous allergic reaction to a product containing botulinum toxin type A. The risk of a further allergic reaction must be considered in relation to the benefit of treatment."
  • In section 4.6, the following wording has been added - "Pregnancy: There are limited data from the use of Clostridium botulinum type A toxin-haemagglutinin complex in pregnant women. Studies in animals have shown reproductive toxicity at doses causing maternal toxicity (see section 5.3).

    Dysport should be used during pregnancy only if the benefit justifies any potential risk to the fœtus. Caution should be exercised when prescribing to pregnant women.

    Lactation:
    It is not known whether Clostridium botulinum type A toxin-haemagglutinin complex is excreted in human milk. The excretion of Clostridium botulinum type A toxin-haemagglutinin complex in milk has not been studied in animals. The use of Clostridium botulinum type A toxin-haemagglutinin complex during lactation cannot be recommended.
  • In section 4.7, the following wording replaces existing tex - "There is a potential risk of muscle weakness or visual disturbances which, if experienced, may temporarily impair the ability to drive or operate machinery.
  • In section 4.9, the text has been re-arranged.
  • In section 5.1, the following wording has been added - "Pharmacotherapeutic Group: Other muscle relaxants, peripherally acting agents. ATC code: M03AX01"
  • In section 5.3, the following wording has been added - "Reproductive toxicity studies in pregnant rats and rabbits given Clostridium botulinum type A toxin-haemagglutinin complex by daily intramuscular injection, at doses of 6.6 units/kg (79 units/kg total cumulative dose) and 3.0 units/kg (42 units/kg total cumulative dose) in rats and rabbits respectively, did not result in embryo/foetal toxicity. Implantation losses at maternally toxic doses were observed at higher doses in both species. Clostridium botulinum type A toxin-haemagglutinin complex demonstrated no teratogenic activity in either rats or rabbits and no effects were observed in the pre- and postnatal study on the F1 generation in rats. Fertility of male and female rats was decreased due to reduced mating secondary to muscle paralysis at doses of 29.4 units/kg weekly in males and increased implantation loss at 20 units/kg weekly in females.
    In a chronic toxicity study performed in rats up to 12 units/animal, there was no indication of systemic toxicity. Effects in chronic toxicity non-clinical studies were limited to changes on injected muscles related to the mechanism of action of Clostridium botulinum type A toxin-haemagglutinin complex. There was no ocular irritation following administration of Clostridium botulinum type A toxin-haemagglutinin complex into the eyes of rabbits."
  • In section 6.5, 'chlorobutyl' has been chnaged to 'bromobutyl'
  • In section 8, the MA number has changed to PL 034926/0001
  • In section 9, the following dates have been added - Date of First Authorisation: 09 Dec 1990
    Date of Latest Renewal: 17 Dec 2002
  • In section 10, the date of revision of the text has been changed to 13 September 2010 

Reasons for adding or updating:

  • 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 4.4 - Special warnings and precautions for Use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction

Date of revision of text on the SPC:28-04-2009

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 4.4  - addition of the following paragraph: "Dysport should only be used to treat a single patient, during a single session. Specific precautions must be taken for the preparation and administration of the product (see section 4.2) and for the inactivation and disposal of any unused reconstituted solution (see section 6.6)".

Some other data in section 4.4 reworded slightly.

Section 4.5 previously stated: "Drugs which affect neuromuscular transmission, such as aminoglycoside antibiotics, should be used with caution". This section now states: "The effects of botulinum toxin may be enhanced by drugs interfering directly or indirectly with the neuromuscular function (e.g. aminoglycosides, curare-like non-depolarising blockers) and such drugs should be used with caution in patients treated with botulinum toxin".

Section 4.7 previously stated: "None known".  This section now states: "Dysport may impair the ability to drive or operate machinery in case of adverse reactions such as muscle weakness and eye disorders (diplopia, blurred vision, eyelid ptosis)".

Section 4.8 - minor updates to style of section

Section 4.9 addition of the following paragraph: "Symptomatic treatment should be instituted if necessary. In the event of an overdose the patient should be medically monitored for several weeks for symptoms of systemic weakness or muscle paralysis".

Reasons for adding or updating:

  • Correction of spelling/typing errors

Reasons for adding or updating:

  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.8 - Undesirable Effects

Date of revision of text on the SPC:01-06-2007

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 4.4 The following wording has been deleted:

Dysport should be administered with caution to patients with existing problems in swallowing or breathing as these problems can worsen if toxin spreads to the relevant muscles. Aspiration has occurred in rare cases, and is a risk when treating patients with spasmodic torticollis who have a chronic respiratory disorder.

 

Section 4.4 The following wording has been added:

Side effects related to spread of toxin distant from the site of administration have been reported (See section 4.8), which in some cases was associated with dysphagia, pneumonia and / or significant debility resulting in death very rarely.

 

Patients treated with therapeutic doses may experience exaggerated muscle weakness. Patients with underlying neurological disorders including swallowing difficulties are at increased risk of these side effects. The botulinum toxin product should be used under specialist supervision in these patients and should only be used if the benefit of treatment is considered to outweigh the risk.

 

Patients with a history of dysphagia and aspiration should be treated with extreme caution.

 

Patients and their care-givers must be warned of the necessity of immediate medical treatment in case of problems with swallowing, speech or respiratory disorders.

 

Section 4.8 The following wording has been added:

Side effects related to the spread of toxin distant from the site of administration have been reported (exaggerated muscle weakness, dysphagia, aspiration/aspiration pneumonia, with fatal outcome in some very rare cases). (See section 4.4). 

 

Reasons for adding or updating:

  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.8 - Undesirable Effects

Date of revision of text on the SPC:01-06-2007

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 4.4 The following wording has been deleted:
Dysport should be administered with caution to patients with existing problems in swallowing or breathing as these problems can worsen if toxin spreads to the relevant muscles. Aspiration has occurred in rare cases, and is a risk when treating patients with spasmodic torticollis who have a chronic respiratory disorder.
 
Section 4.4 The following wording has been added:
Side effects related to spread of toxin distant from the site of administration have been reported (See section 4.8), which in some cases was associated with dysphagia, pneumonia and / or significant debility resulting in death very rarely.
 
Patients treated with therapeutic doses may experience exaggerated muscle weakness. Patients with underlying neurological disorders including swallowing difficulties are at increased risk of these side effects. The botulinum toxin product should  be used under specialist supervision in these patients and should only be used if the benefit of treatment is considered to outweigh the risk.
 
Patients with a history of dysphagia and aspiration should be treated with extreme caution.
 
Patients and their care-givers must be warned of the necessity of immediate medical treatment in case of problems with swallowing, speech or respiratory disorders.
 
Section 4.8 The following wording has been added:
Side effects related to the spread of toxin distant from the site of administration have been reported (exaggerated muscle weakness, dysphagia, aspiration/aspiration pneumonia, with fatal outcome in some very rare cases). (See section 4.4). 

Reasons for adding or updating:

  • Change to section 6. 3 - Shelf Life
  • Change to section 10 (date of (partial) revision of the text

Reasons for adding or updating:

  • Improved Electronic Presentation

Reasons for adding or updating:

  • Correction of spelling/typing errors
  • Change to section 4.1 - Therapeutic Indications
  • Change to section 4.2 - Posology and Method of Administration
  • Change to section 4.3 - Contra-indications
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 4.8 - Undesirable Effects
  • Change to section 4.9 - Overdose
  • Change to section 6. 3 - Shelf Life
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 10 (date of (partial) revision of the text

Reasons for adding or updating:

  • Change to section 7 - Marketing Authorisation Holder

Reasons for adding or updating:

  • Change to section 4.2 - Posology and Method of Administration

Reasons for adding or updating:

  • No reasons supplied

Reasons for adding or updating:

  • No reasons supplied