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DYSPORT INJECTION 500 UNITS

Active substance(s): CLOSTRIDIUM BOTULINUM TYPE A TOXIN - HAEMAGGLUTININ COMPLEX

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11010101XX

Draft THREE - 11010101XX - TJ

PACKAGE LEAFLET: INFORMATION FOR THE USER
®
Clostridium botulinum type A
toxin-haemagglutinin complex
Read all of this leaflet carefully before you start
using this medicine.
• Keep this leaflet. You may need to read it again.
• If you have further questions, ask your doctor.
• This medicine has been prescribed for you. Do
not pass it on to others. It may harm them, even
if their symptoms are the same as yours.
• If any of the side effects become serious, or if
you notice any side effects not listed in this
leaflet, please tell your doctor.

2. BEFORE YOU USE DYSPORT
Do not use Dysport:
If you are allergic to botulinum toxin or any of the
ingredients (See section 6. for a list of ingredients).

Driving and using machines
Dysport may cause muscle weakness or problems
with your vision.
If you experience any of these effects, do not drive or
use any machines.

For treatment of muscle spasms in your arm:
The dose of Dysport will normally be 1000 units. The
doctor may divide the amount between the affected
arm muscles. Your muscle spasms should normally
improve within 2 weeks.
For treatment of muscle spasms in your neck and
shoulder:
The first dose of Dysport will normally be 500 units. The
doctor will divide this amount into a number of places
in the neck, probably into 2 or 3 of the neck muscles
most affected by the condition. A smaller amount may
be given to very underweight or elderly patients. Your
muscle spasms should improve within 1 week. Further
injections (250-1000 units) will be given about every
12 weeks depending on how long the effect lasts.
For treatment of muscle spasm around your eyes:
The first injection may be about 120 units per eye.
The medicine will be injected just under the skin at
various sites around the eye. If only one eye is
affected the doctor will only give injections of
Dysport around this eye. Injections will be given
about every 12 weeks depending on how long the
effects last. On the next visits the amount of Dysport
given may be reduced to 80 or 60 units per eye.
For treatment of muscle spasm in your face:
The doctor will give you injections on the side of your
face that is affected. The first injection may be about
120 units. Injections will be given about every 12 weeks
depending on how long the effects last. Your next
injections of Dysport may be reduced to 80 or 60 units.

Take special care with Dysport
There are increased risks of having Dysport
injections under any of these circumstances.
Tell your doctor if:
• you have problems swallowing.
• you have any history of bronchitis, pneumonia or
problems with breathing
• you have had an allergic reaction to a botulinum
toxin in the past
• you have other problems or diseases that affect
your muscles e.g. myasthenia gravis
• you bleed easily
• you have an infection where the injection will be
given or if that area is swollen

For treatment of a child with cerebral palsy with
muscle spasms in their legs:
The first dose of Dysport will be 20 units for each kg
of the child’s body weight. The doctor will divide the
amount between both lower leg muscles. If only one
leg is affected by spasms, the doctor will only give
injections of 10 units per kg in this leg. Injections will
be given about every 12 to 16 weeks. The dose your
doctor gives the child could change depending on
how they respond. The maximum dose is 1000 Units
per patient each time.

Important information about one of the ingredients of
Dysport
Dysport contains a small amount of albumin which
has been obtained from human blood. The risk of
passing on infections from blood cannot be
eliminated completely when using human blood or
products made from human blood.

If you are given more Dysport than you should
If you are given more Dysport than you need muscles
other than the ones that were injected may begin to
feel weak. This may not happen straightaway. If this
happens, speak to your doctor immediately. Seek
urgent medical help if you have difficulty breathing,
swallowing or speaking.

Dimensions:
Specification ref:
ICN:
Draft No.:
Artwork Amend Date:

402 x 296 mm Component code:
Leaflet-04 PS
Presentation:
00548D Component:
THREE Territory:
09/04/09 Language:

Colours:

Black, P 361U Print supplier:

Barcode type:

11010101XX RE-PROOF
Dysport 500U
Preliminary PDF Approved
Pack insert
UK Final SET A artwork Approved
English
M.Y. Newmarket

Release ready

TICK RELEVANT BOX AND SIGN

N/A

Front
Perforation:
3 mm x 1 mm parallel to 296
measurement

Ipsen Biopharm Ltd,
Ash Road, Wrexham Ind. Est.,
Wrexham, LL13 9UF, UK.
Tel: +44 (0) 1978 661181
Fax: +44 (0) 1978 667569

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Dysport.

2 QUALITATIVE AND QUANTITATIVE
COMPOSITION

Use in children
Dysport should not be used in children younger than
2 years of age.

Your doctor will give you your injection and decide
how often you need treatment. This will depend on
what you are being treated for.
A vial of Dysport should be used only for you and only
for a single treatment session.

Dysport is a toxin produced by Clostridium botulinum
bacteria. The toxin works by stopping muscles
contracting. It does this by preventing the release of
a chemical in between the nerves and muscles which
would normally make the muscles contract. This
helps to reduce some of the abnormal muscle
contractions known as spasms.
Dysport is used in adults to treat muscle spasms
• around the eyes
• in the face
• in the neck and shoulders
• in the arm
Dysport is also used to treat spasms in legs of
children (aged two years or older) with cerebral
palsy, to improve their walking.
You may also have physiotherapy

Clostridium botulinum type A
toxin-haemagglutinin complex

Pregnancy and Breast-feeding
If you are pregnant or breast-feeding you should ask
your doctor for advice before taking any medicine.
Dysport should not normally be used.

3. HOW DYSPORT IS GIVEN

1. WHAT DYSPORT IS AND WHAT IT IS
USED FOR

®

Signature:

Date:

DETACH HERE AND GIVE INFORMATION TO PATIENT

In this leaflet:
1. What Dysport is and what it is used for
2. Before you use Dysport
3. How Dysport is given
4. Possible side effects
5. How to store Dysport
6. Further information

Taking other medicines:
Please tell your doctor if you are taking any
antibiotics for an infection (e.g. aminoglycosides such
as gentamicin or amikacin) or muscle relaxant drugs.
Please tell your doctor or pharmacist if you are taking
or have recently taken any other medicines, including
medicines obtained without a prescription.

Per Vial
Active Constituent
Clostridium botulinum type A toxinhaemagglutinin complex
500U *
Other Constituents
Albumin solution
125 MCG
Lactose
2.5 MG
* One unit (U) is defined as the median lethal intraperitoneal
dose in mice.

3 PHARMACEUTICAL FORM
Injection.

4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Dysport is indicated for focal spasticity, including the
treatment of:
• arm symptoms associated with focal spasticity in
conjunction with physiotherapy; and
• dynamic equinus foot deformity due to spasticity in
ambulant paediatric cerebral palsy patients, two years of
age or older, only in hospital specialist centres with
appropriately trained personnel.
Dysport is also indicated for the following treatments:
• Spasmodic torticollis in adults
• Blepharospasm in adults
• Hemifacial spasm in adults

4.2 Posology and method of administration
The units of Dysport are specific to the preparation and are
not interchangeable with other preparations of botulinum
toxin.
Training: Dysport should only be administered by
appropriately trained physicians.
Ipsen can facilitate training in administration of Dysport
injections.
The exposed central portion of the rubber stopper should
be cleaned with alcohol immediately prior to piercing the
septum. A sterile 23 or 25 gauge needle should be used.
Arm spasticity:
Posology
Adults: The recommended dose is 1000 units in total,
distributed amongst the following five muscles:
Biceps
brachii
(BB)
300-400
units
(0.6-0.8 ml)

Flexor
Flexor
digitorum
digitorum
profundus superficialis
(FDP)
(FDS)
150
150-250
units
units
(0.3 ml)
(0.3-0.5 ml)

Flexor
carpi
ulnaris
(FCU)
150
units
(0.3 ml)

Flexor
carpi
radialis
(FCR)
150
units
(0.3 ml)

Total
Dose
1,000
units
(2.0 ml)

The sites of injection should be guided by standard locations
used for electromyography, although actual location of the
injection site will be determined by palpation. All muscles
except the biceps brachii (BB) should be injected at one
site, whilst the biceps should be injected at two sites.
The dose should be lowered if there is evidence to suggest
that this dose may result in excessive weakness of the
target muscles, such as for patients whose target muscles
are small, where the BB muscle is not to be injected or
patients who are to be administered multi-level injections.
Clinical improvement may be expected within two weeks
after injection. Data on repeated and long term treatment
are limited.
Children: The safety and effectiveness of Dysport in the
treatment of arm spasticity in children have not been
demonstrated.
Method of administration
When treating arm spasticity, Dysport is reconstituted with
1.0ml of sodium chloride injection B.P. (0.9%) to yield a
solution containing 500 units per ml of botulinum toxin type A.
Dysport is administered by intramuscular injection into the
five muscles detailed above when treating arm spasticity.

Paediatric cerebral palsy spasticity:
Posology
The initial recommended dose is 20 units/kg body weight
given as a divided dose between both calf muscles. If only
one calf is affected, a dose of 10 units/kg bodyweight
should be used. Consideration should be given to lowering
this starting dose if there is evidence to suggest that this
dose may result in excessive weakness of the target
muscles, such as for patients whose target muscles are
small or patients who require concomitant injections to
other muscle groups. Following evaluation of response to
the starting dose subsequent treatment may be titrated
within the range 10 units/kg and 30 units/kg divided
between both legs. The maximum dose administered must
not exceed 1000 units/patient.
Administration should primarily be targeted to the
gastrocnemius, although injections of the soleus and
injection of the tibialis posterior should also be considered.
The use of electromyography (EMG) is not routine clinical
practice but may assist in identifying the most active muscles.
Clinical improvement may be expected within two weeks
after injection. Injections may be repeated approximately
every 16 weeks or as required to maintain response, but not
more frequently than every 12 weeks.
Method of administration
When treating paediatric cerebral palsy spasticity, Dysport
is reconstituted with 1.0 ml of sodium chloride injection B.P.
(0.9%) to yield a solution containing 500 units per ml of
botulinum toxin type A.
Dysport is administered by intramuscular injection into the
calf muscles when treating spasticity.
Spasmodic torticollis
Posology
Adults and elderly: The doses recommended for torticollis
are applicable to adults of all ages providing the adults are
of normal weight with no evidence of low neck muscle
mass. A reduced dose may be appropriate if the patient is
markedly underweight or in the elderly, where reduced
muscle mass may exist.
The initial recommended dose for the treatment of
spasmodic torticollis is 500 units per patient given as a
divided dose and administered to the two or three most
active neck muscles.
• For rotational torticollis distribute the 500 units by
administering 350 units into the splenius capitis muscle,
ipsilateral to the direction of the chin/head rotation and
150 units into the sternomastoid muscle, contralateral to
the rotation.
• For laterocollis, distribute the 500 units by administering
350 units into the ipsilateral splenius capitis muscle and
150 units into the ipsilateral sternomastoid muscle. In
cases associated with shoulder elevation the ipsilateral
trapezoid or levator scapulae muscles may also require
treatment, according to visible hypertrophy of the muscle
or electromyographic (EMG) findings. Where injections
of three muscles are required, distribute the 500 units as
follows, 300 units splenius capitis, 100 units
sternomastoid and 100 units to the third muscle.
• For retrocollis distribute the 500 units by administering
250 units into each of the splenius capitis muscles. This
may be followed by bilateral trapezius injections (up to
250 units per muscle) after 6 weeks, if there is
insufficient response. Bilateral splenii injections may
increase the risk of neck muscle weakness.
• All other forms of torticollis are highly dependent on
specialist knowledge and EMG to identify and treat the
most active muscles. EMG should be used diagnostically
for all complex forms of torticollis, for reassessment after
unsuccessful injections in non complex cases, and for
guiding injections into deep muscles or in overweight
patients with poorly palpable neck muscles.
On subsequent administration, the doses may be adjusted
according to the clinical response and side effects
observed. Doses within the range of 250-1000 units are
recommended, although the higher doses may be
accompanied by an increase in side effects, particularly
dysphagia. Doses above 1000 units are not recommended.
The relief of symptoms of torticollis may be expected within
a week after the injection. Injections should be repeated
approximately every 12 weeks or as required to prevent
recurrence of symptoms.
Children: The safety and effectiveness of Dysport in the
treatment of spasmodic torticollis in children have not been
demonstrated.

Method of administration
When treating spasmodic torticollis Dysport is reconstituted
with 1.0 ml of sodium chloride injection B.P. (0.9%) to yield a
solution containing 500 units per ml of botulinum toxin type A.
Dysport is administered by intramuscular injection as above
when treating spasmodic torticollis.
Blepharospasm and hemifacial spasm
Posology
Adults and elderly: In the treatment of bilateral blepharospasm
the recommended initial dose is 120 units per eye.
Injection of 0.1 ml (20 units) should be made medially and
of 0.2 ml (40 units) should be made laterally into the junction
between the preseptal and orbital parts of both the upper
and lower orbicularis oculi muscles of each eye.
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 12 weeks
or as required to prevent recurrence of symptoms. On such
subsequent administrations the dose may need to be reduced
to 80 units per eye - viz -: 0.1 ml (20 units) medially and 0.1 ml
(20 units) laterally above and below each eye in the manner
previously described. The dose may be further reduced to
60 units per eye by omitting the medial lower lid injection.
0.1 ml

0.2 ml

0.1 ml

0.2 ml

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.
Children: The safety and effectiveness of Dysport in the
treatment of blepharospasm and hemifacial spasm in
children have not been demonstrated.
Method of administration
When treating blepharospasm and hemifacial spasm
Dysport is reconstituted with 2.5 ml of sodium chloride
injection B.P. (0.9%) to yield a solution containing
200 units per ml of botulinum toxin type A.
Dysport is administered by subcutaneous injection medially
and laterally into the junction between the preseptal and
orbital parts of both the upper and lower orbicularis oculi
muscles of the eyes.

4.3 Contraindications
Dysport is contraindicated in individuals with known
hypersensitivity to any components of Dysport.

4.4 Special warnings and precautions for use
Dysport should be administered with caution to patients
with existing problems in swallowing or breathing as these
problems 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.
Patients with a history of dysphagia and aspiration should
be treated with extreme caution.
Dysport should only be used with caution and under close
supervision in patients with subclinical or clinical evidence
of marked defective neuro-muscular transmission
(e.g.myasthenia gravis). Such patients may have an
increased sensitivity to agents such as Dysport which may
result in excessive muscle weakness.
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.

Draft THREE - 11010101XX - TJ

4.5 Interaction with other medicinal products and
other forms of interaction
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.

4.6 Pregnancy and lactation
Teratological and other reproductive studies have not been
performed with Dysport. The safety of its use in pregnant or
lactating women has not been demonstrated.
Dysport should not be used in pregnant or lactating women,
unless clearly necessary.

4.7 Effects on ability to drive and use machines
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).

4.8 Undesirable effects
Very common >1/10: Common >1/100, <1/10:
Uncommon >1/1000, <1/100:
Rare >1/10 000, < 1/1000: Very rare <1/10 000.
Side effects related to 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).

General
In the clinical trial programme, approximately 28% of the
patients treated with Dysport experienced an adverse
event.
The following adverse reactions were seen in patients
treated across variety of indications including
blepharospasm, hemifacial spasm, torticollis and spasticity
associated with either cerebral palsy or stroke.
Nervous system disorders
Rare: Neuralgic amyotrophy
Skin and subcutaneous tissue disorders
Uncommon: Itching
Rare: Skin rashes
General disorders and administration site conditions
Common: Generalised weakness, fatigue, flu-like syndrome,
pain / bruising at injection site.
In addition, the following adverse reactions specific to
individual indications were reported.

Arm spasticity
Gastrointestinal disorders
Common: Dysphagia
Musculoskeletal and connective tissue disorders
Common: Arm muscle weakness

Dimensions:
Specification ref:
ICN:
Draft No.:
Artwork Amend Date:

402 x 296 mm Component code:
Leaflet-04 PS
Presentation:
00548D Component:
THREE04 Territory:
09/04/09 Language:

Colours:

Black, P 361U Print supplier:

Barcode type:

Injury, poisoning and procedural complications
Common: Accidental injury/falls

Paediatric cerebral palsy spasticity
Gastrointestinal disorders
Common: Diarrhoea, vomiting
Musculoskeletal and connective tissue disorders
Common: Leg muscle weakness
Renal and urinary disorders
Common: Urinary incontinence
General disorders and administration site conditions
Common: Abnormal gait
Injury, poisoning and procedural complications
Common: Accidental injury due to falling
Accidental injury due to falling and abnormal gait may have
been due to the over-weakening of the target muscle and/or
the local spread of Dysport to other muscles involved in
ambulation and balance.

Spasmodic torticollis
Nervous system disorders
Common: Dysphonia
Uncommon: Headache
Eye disorders
Uncommon: Diplopia, blurred vision
Respiratory, thoracic and mediastinal disorders
Rare: Respiratory disorders
Gastrointestinal disorders
Very common: Dysphagia
Uncommon: Dry mouth
Musculoskeletal and connective tissue disorders
Common: Neck muscle weakness
Dysphagia appeared to be dose related and occurred most
frequently following injection into the sternomastoid
muscle. A soft diet may be required until symptoms resolve.
These side effects may be expected to resolve within two to
four weeks.

Blepharospasm and hemifacial spasm
Nervous system disorders
Common: Facial muscle weakness
Uncommon: Facial nerve paresis
Eye disorders
Very common: Ptosis
Common: Diplopia, dry eyes, tearing
Rare: Ophthalmoplegia
Skin and subcutaneous tissue disorders
Common: Eyelid oedema
Rare: Entropion
Side effects may occur due to deep or misplaced injections
of Dysport temporarily paralysing other nearby muscle
groups.
Post-marketing experience
The profile of adverse reactions reported to the company
during post-marketing use reflects the pharmacology of the
product and those seen during clinical trials. In addition,
hypersensitivity reactions have been reported.

4.9 Overdose
Excessive doses may produce distant and profound
neuromuscular paralysis. Respiratory support may be
required where excessive doses cause paralysis of
respiratory muscles. There is no specific antidote; antitoxin
should not be expected to be beneficial and general
supportive care is advised. Overdose could lead to an
increased risk of the neurotoxin entering the bloodstream
and may cause complications associated with the effects
of oral botulinum poisoning (e.g deglutition and dysphonia).
Symptomatic treatment should be instituted if necessary. In
the event of an overdose the patient should be medically
monitored for up to several weeks for symptoms of
systemic weakness or muscle paralysis.

5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Clostridium botulinum type A toxin-haemagglutinin
complex blocks peripheral cholinergic transmission at
the neuromuscular junction by a presynaptic action at a
site proximal to the release of acetylcholine. The toxin acts
within the nerve ending to antagonise those events that are
triggered by Ca2+ which culminate in transmitter release. It
does not affect postganglionic cholinergic transmission or
postganglionic sympathetic transmission.
The action of toxin involves an initial binding step whereby
the toxin attaches rapidly and avidly to the presynaptic
nerve membrane. Secondly, there is an internalisation step
in which toxin crosses the presynaptic membrane, without
causing onset of paralysis. Finally the toxin inhibits the
release of acetylcholine by disrupting the Ca2+ mediated

11010101XX RE-PROOF
Dysport 500U
Preliminary PDF Approved
Pack insert
UK Final SET A artwork Approved
English
M.Y. Newmarket

Release ready

TICK RELEVANT BOX AND SIGN

N/A

Back
Perforation:
See other side

Ipsen Biopharm Ltd,
Ash Road, Wrexham Ind. Est.,
Wrexham, LL13 9UF, UK.
Tel: +44 (0) 1978 661181
Fax: +44 (0) 1978 667569

Signature:

Date:

acetylcholine release mechanism, thereby diminishing the
endplate potential and causing paralysis.
Recovery of impulse transmission occurs gradually as new
nerve terminals sprout and contact is made with the post
synaptic motor endplate, a process which takes 6 - 8 weeks
in the experimental animal.

If you forget an injection of Dysport
Nothing will happen if an injection is missed other
than some of the spasm or muscle stiffness may
return. Tell your doctor and he will decide when the
next injection is needed.

5.2 Pharmacokinetic properties

If you stop taking Dysport
Your muscle movements will return to the way they
were before treatment.

Pharmacokinetic studies with botulinum toxin pose
problems in animals because of the high potency, the
minute doses involved, the large molecular weight of the
compound and the difficulty of labelling toxin to produce
sufficiently high specific activity. Studies using I125 labelled
toxin have shown that the receptor binding is specific and
saturable, and the high density of toxin receptors is a
contributory factor to the high potency. Dose and time
responses in monkeys showed that at low doses there was
a delay of 2 - 3 days with peak effect seen 5 - 6 days after
injection. The duration of action, measured by changes of
ocular alignment and muscle paralysis varied between 2
weeks and 8 months. This pattern is also seen in man, and
is attributed to the process of binding, internalisation and
changes at the neuromuscular junction.

4. POSSIBLE SIDE EFFECTS

5.3 Preclinical safety data
There is no further pre-clinical information relevant to the
prescribing physician that has not been included in other
sections of the Summary of Product Characteristics.

6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Albumin and Lactose.

6.2 Incompatibilities
None known.

6.3 Shelf life
The shelf life of the packaged product - 24 months at 2-8°C.
The product may be stored for up to 8 hours at 2-8°C
following reconstitution.
Since the product does not contain an anti-microbial agent,
from a microbiological point of view, it is recommended that
the product should be used immediately following
reconstitution.

6.4 Special precautions for storage
Unopened vials must be maintained at temperatures
between 2°C and 8°C. Dysport must be stored in a
refrigerator at the hospital where the injections are to be
carried out and should not be given to the patient to store.
Reconstituted Dysport may be stored in a refrigerator (2-8°C)
for up to 8 hours prior to use. Dysport should not be frozen.

6.5 Nature and contents of container
Nature of container/closure:
Type 1 glass vials 3 ml capacity. 13 mm chlorbutyl freezedrying closures oversealed by 13 mm aluminium overseals
with centre hole, crimped over.

Contents of container:
A white lyophilised powder for reconstitution.

6.6 Special precautions for disposal
Immediately after treatment of the patient, any residual
Dysport which may be present in either vial or syringe
should be inactivated with dilute hypochlorite solution (1%
available chlorine). Thereafter, all items should be disposed
of in accordance with standard hospital practice.
Spillage of Dysport should be wiped up with an absorbent
cloth soaked in dilute hypochlorite solution.

7 MARKETING AUTHORISATION HOLDER
Ipsen Limited, 190 Bath Road, Slough, Berkshire, SL1 3XE

8 MARKETING AUTHORISATION NUMBER(S)
PL 6958/0005

9 DATE OF FIRST AUTHORISATION/RENEWAL
OF THE AUTHORISATION
9th Dec 1990

10 DATE OF REVISION OF THE TEXT
March 2009

11 DOSIMETRY (IF APPLICABLE)
Not applicable.

12 INSTRUCTIONS FOR PREPARATION OF
RADIOPHARMACEUTICALS
(IF APPLICABLE)
Not applicable.

DETACH HERE AND GIVE INFORMATION TO PATIENT

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 and their care-givers must be warned of the
necessity of immediate medical treatment in case of
problems with swallowing, speech or respiratory disorders.
Careful consideration should be given before the injection
of patients who have experienced a previous allergic
reactions 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.
Antibody formation to botulinum toxin has been noted rarely
in patients receiving Dysport. Clinically, neutralizing
antibodies have been detected by substantial deterioration
in response to therapy and/or a need for consistently
increasing doses.
For the treatment of cerebral palsy in children, Dysport
should only be used in children over 2 years of age.
The recommended posology and frequency of
administration for Dysport must not be exceeded (see
section 4.2).
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).
As with any intramuscular injection, Dysport should be used
only where strictly necessary in patients with prolonged
bleeding times, infection or inflammation at the proposed
injection site.
This product contains a small amount of human albumin.
The risk of transmission of viral infection cannot be
excluded with absolute certainty following the use of
human blood or blood products.

Like all medicines, Dysport can cause side effects,
although not everybody gets them.
Tell your doctor immediately if:
• you have any problems swallowing, breathing or
with your speech
• you develop difficulty in breathing with or without
swelling of the face, lips, tongue and /or throat,
redness of the skin or an itchy lumpy rash
(urticaria). This may mean you are having an
allergic reaction to Dysport.
The chance of having a side effect is described by
the following groups:
How often it occurs
Occurs in more than 1 in 10 patients
Very Common treated
Common
in less than 1 in 10 patients treated
Uncommon
in less than 1 in 100 patients treated
Rare
in less than 1 in 1000 patients treated
Some side effects may occur in any patient treated
with Dysport whilst other side effects may depend on
the condition treated. Make sure you read all the
sections that apply to you.
Treatment of any condition (all patients)
Side effects that have occurred include:
Common:
• Bruising, or pain around the site where the
injection was given or a burning sensation at the
time the injection is given
• Generalised weakness
• Tiredness
• Flu-like symptoms
Uncommon:
• Itching
Rare:
• Skin rashes and muscle weakness
Other side effects related to the spread of Dysport
away from the site of administration have also been
reported (worsened muscle weakness, difficulty with
swallowing or inhalation of foreign material which in
very rare cases have been fatal).
Treatment of muscle spasms in the arm:
Side effects that have occurred include:
Common:
• Arm muscle weakness
• Accidental injury/falls
• Difficulty in swallowing
Treatment of muscle spasms in the eyes or face
Side effects that have occurred include:
Very common:
• Drooping eyelids
Common:
• Dry eyes
• Double vision
• More tears than usual
• Swelling of the eyelid
• Facial muscle weakness
Uncommon:
• Facial nerves may become paralysed

Rare:
• Difficulty in moving the eye
• The edge of the eyelid may turn in towards the
eyeball and the eye muscles may become paralysed
Tell your doctor immediately if you notice very dry
eyes.
Treatment of muscle spasms in the neck or
shoulders:
Side effects that have occurred include:
Very common:
• Difficulty in swallowing. This side effect may be
expected to resolve within 2 to 4 weeks.
Common:
• Neck muscle weakness
• A change to the tone of the voice
Uncommon:
• Dry mouth
• Double or blurred vision
• Headache
Rare:
• Dysport may cause breathing difficulties
Treatment of children with muscle spasms in the leg:
Side effects that have occurred include:
Common:
• The muscles of the lower leg may be weakened
too much. This may change the way you walk or
make you fall over more
• Urinary incontinence
• Diarrhoea
• Vomiting
If any of the side effects becomes serious or if you
notice any side effects not listed in this leaflet,
please tell your doctor.

5. HOW TO STORE DYSPORT
Keep out of the reach and sight of children.
Do not use after the expiry date shown on the box.
Dysport will be stored in a refrigerator (2°C-8°C) at
the place where the injections are carried out. This
medicine should not be given to patients to store.

6. FURTHER INFORMATION
What Dysport contains
The active constituent of Dysport is Clostridium
botulinum complex (500 units). Dysport also contains
human albumin and lactose. Before it is injected
Dysport will be dissolved in sodium chloride for
injection (a solution of salt).
What Dysport looks like and contents of the pack
Dysport is a white powder in a glass container called
a vial. Each pack contains 2 vials of Dysport
Marketing Authorisation Holder and manufacturer
The marketing authorization holder is:
Ipsen Limited, 190 Bath Road, Slough, Berkshire,
SL1 3XE, UK.
Dysport is manufactured by:
Ipsen Biopharm Limited, Ash Road, Wrexham
Industrial Estate, Wrexham LL13 9UF.
This leaflet was last approved in
February 2009
Product licence number
PL 06958/0005

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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