DYSPORT

Dysport
300 units; 500 units of neurotoxin complex of Clostridium botulinum type A,
powder for solution for injection
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.
Keep this leaflet, as you may need to read it again.

• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform the doctor or pharmacist. See section 4.

Leaflet contents:

1. What Dysport is and what it is used for
2. Important information before using Dysport
3. How to use Dysport
4. Possible side effects
5. How to store Dysport
6. Contents of the pack and other information

1. What Dysport is and what it is used for

Dysport contains neurotoxin complex of Clostridium botulinum type A (commonly known as botulinum toxin) produced by the bacterium Clostridium botulinum (botulinum bacillus). Its action consists of inhibiting muscle contraction by preventing the release of a chemical substance in the muscles that causes normal muscle contraction. This helps reduce abnormal muscle tension known as muscle spasm.

Indications

• Symptomatic treatment of focal lower limb spasticity in children with cerebral palsy aged 2 years and older
• Symptomatic treatment of focal upper limb spasticity in children with cerebral palsy aged 2 years and older
• Urinary incontinence due to detrusor overactivity associated with neurogenic bladder in patients with spinal cord injury or multiple sclerosis who perform regular clean intermittent catheterization
• Cervical dystonia in adults
• Blepharospasm in adults
• Hemifacial spasm in adults
• Upper limb spasticity in adults
• Lower limb spasticity in adults
• Severe primary axillary hyperhidrosis (excessive underarm sweating)

2. Important information before using Dysport

When not to use Dysport

• if the patient is allergic (hypersensitive) to botulinum toxin or to any of the other ingredients of Dysport (listed in section 6)
• if the patient has a urinary tract infection at the time of treatment for urinary incontinence.

Warnings and precautions
Before starting treatment with Dysport, discuss the following with your doctor:

• if the patient has muscle-related disorders or diseases, e.g. myasthenia gravis (a chronic condition characterized by rapid fatigue and weakness of skeletal muscles)
• if muscles at the proposed injection site show signs of atrophy
• if swallowing or breathing difficulties have previously been diagnosed
• if there is significant muscle weakness
• if chronic respiratory disorders are present
• if there is a tendency to bleed
• if there is inflammation or infection at the proposed injection site

Particular caution should be exercised when using this medicine to treat lower limb spasticity due to an increased risk of falls in adults, especially in elderly patients.
When Dysport is administered into muscles around the eyes, dry eye may occur, which could lead to damage of the eye surface (see section 4). To prevent this, protective eye drops, ointment, or an eye shield covering the eye may be necessary. Your doctor will inform you whether this is required.
During injections into the urinary bladder for the treatment of urinary incontinence, an uncontrolled autonomic reflex reaction (autonomic dysreflexia, e.g. excessive sweating, throbbing headache, increased blood pressure, or increased heart rate) may occur due to the nature of the procedure.

Special warnings

• Very rarely, botulinum toxin may cause muscle weakness in areas distant from the injection site.
• In a small number of patients treated with Dysport, antibodies against botulinum toxin have developed. This has been manifested by a marked decrease in response to treatment and the need for continuously increasing doses.

Dysport and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Some medicines affecting neuromuscular function may enhance the effect of Dysport.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.
Dysport is not recommended for use during pregnancy unless clearly necessary.
Dysport is not recommended for use in breastfeeding women.

Children and adolescents
In the treatment of spasticity associated with cerebral palsy, Dysport should be used in children aged 2 years and older.

Driving and operating machinery
After injection of Dysport, temporary muscle weakness and visual disturbances may occur.
In such cases, driving and operating machinery should be avoided.

This medicine contains albumin (a type of protein) derived from human blood.
The possibility of transmitting infectious agents is highly unlikely, but cannot be completely ruled out.

3. How to use Dysport

The injection will be administered by a physician who will decide how often the medicine should be given. This will depend on the type of condition diagnosed in the patient.
Dysport must be used for only one patient and only during a single therapeutic session.

In the symptomatic treatment of focal spasticity of the lower limbs in children:
Children aged 2 years or older: the dose will be determined by the physician. Dysport is injected into the muscles of the lower limbs affected by spasticity.
The total Dysport dose for a single therapeutic session must not exceed 1000 units or 30 units/kg, whichever is lower. Injections will be performed approximately every 16–22 weeks or as needed, but no more frequently than every 12 weeks.

In the symptomatic treatment of focal spasticity of the upper limbs in children:
Children aged 2 years or older: the dose will be determined by the physician. Dysport is injected into the muscles of the upper limb affected by spasticity.
When administered into one upper limb, the dose during a single therapeutic session must not exceed 640 units or 16 units/kg, whichever is lower.
When administered into both upper limbs during a single therapeutic session, the dose must not exceed 840 units or 21 units/kg, whichever is lower.
Usually, muscle spasms should improve within a few weeks after treatment, and the therapeutic effect typically lasts up to 34 weeks. The physician will repeat the treatment approximately every 16–28 weeks or as needed, but no more frequently than every 16 weeks.

In the simultaneous treatment of focal spasticity of upper and lower limbs in children:
If during the same therapeutic session treatment of both upper and lower limbs is required, the physician should determine the Dysport dose to be injected into each limb, without exceeding the total dose for a single therapeutic session of 1000 units or 30 units/kg, whichever is lower.
Repeat simultaneous treatment of upper and lower limbs should not be considered earlier than 12–16 weeks after the previous therapeutic session.

In the treatment of urinary incontinence:
The initial dose administered into the detrusor muscle is 600 units; however, for subsequent injections, the physician may decide to increase the dose up to 800 units.
Dysport will be administered during cystoscopy. A cystoscope, equipped with a light source at its tip, will be inserted into the bladder through the urethral opening (the opening through which urine is passed). This allows the physician performing the procedure to visualize the inside of the bladder, enabling injection of Dysport into the bladder wall.
Dysport will be administered only in patients undergoing clean intermittent catheterization (CIC). CIC is a procedure in which a catheter (a soft, hollow tube inserted into the urethra to facilitate urine removal from the bladder) is temporarily introduced into the bladder and removed after bladder emptying. For further details about the procedure, please consult your physician.
To prevent urinary tract infections, antibiotic therapy will be necessary. If the patient is taking anticoagulant medication, the physician will appropriately adjust the treatment before and after Dysport injection. Prior to injection, the patient may receive local or general anesthesia or a sedative. The patient will be observed for at least 30 minutes after the injection. Symptoms usually resolve within 2 weeks, and improvement may last up to 48 weeks. The physician will decide whether to repeat treatment as needed, but no more frequently than every 12 weeks.

In the treatment of cervical dystonia:
The usual initial dose of Dysport is 500 units. The physician may divide this dose, injecting it at several sites in the neck, typically into 2 or 3 of the most active muscles.
A lower dose may be administered to patients with significant underweight or elderly patients.
Muscle spasm relief usually occurs within 1 week. Depending on the duration of the therapeutic effect, additional doses (250–1000 units) may be administered approximately every 12–16 weeks.

In the treatment of blepharospasm and hemifacial spasm:
The physician will administer injections into the affected areas of the face. The initial dose is 40 units per eye. Depending on the duration of the therapeutic effect, injections may be repeated approximately every 12 weeks. If a longer duration of effect is required, the Dysport dose may be increased up to 80 units per eye.
The maximum administered dose must not exceed a total of 120 units per eye.

In the treatment of upper limb spasticity in adults:
Depending on the physician's decision, Dysport will be injected at a dose ranging from 500 to 1000 units. The physician may divide this dose and inject it into individual muscles of the hand and arm.
Muscle spasm relief usually occurs within one week. Injections will be performed approximately every 12–16 weeks.

In the treatment of lower limb spasticity in adults:
Dysport is usually administered at a dose of 1500 units. The physician may divide this dose and inject it into individual muscles of the lower limb. Injections will be performed approximately every 12–16 weeks.

In the treatment of spasticity of upper and lower limbs in adults:
If during a single treatment session there is a need to administer the drug into both upper and lower limb muscles, the physician may divide the dose between the muscles of these two body parts. In this case, the total dose of the drug must not exceed 1500 units.

In the treatment of axillary hyperhidrosis:
Dysport is usually administered at a dose of 100 units per axilla. The physician will divide this dose and inject it into 10 sites within the axilla. Maximum effect should be visible around the second week after administration. The maximum administered dose must not exceed 200 units per axilla.

Administration of a higher than recommended dose of Dysport
If a higher than recommended dose of Dysport is administered, the patient may experience muscle weakness in muscles other than those injected. Symptoms of overdose may not appear immediately after injection. If such symptoms occur, contact a physician immediately. In case of breathing difficulties, swallowing problems, or speech impairment, seek immediate medical attention at the nearest healthcare facility.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although they do not occur in everyone.
You should inform the doctor immediately if:

• the patient experiences difficulties with swallowing, breathing, or speaking
• the patient experiences breathing difficulties with or without swelling of the face, lips, tongue and (or) throat, skin redness or itchy, raised rash (urticaria). The appearance of such symptoms may indicate that the patient is allergic to Dysport.

The likelihood of occurrence of adverse reactions has been classified according to the following categories:

Some adverse reactions may occur in all patients treated with Dysport,
while the occurrence of other adverse reactions may depend on the type of condition
for which the treatment is administered. Please read the information related to the appropriate
condition.
The following adverse reactions have been reported (regardless of indication):
Common:

• Bruising and (or) pain at the injection site
• Generalized weakness
• Fatigue
• Influenza-like symptoms Uncommon:
• Itching Rare:
• Rash, neuralgia with muscle atrophy Unknown frequency (frequency cannot be estimated from the available data):
• Numbness
• Muscle atrophy

Other adverse reactions related to the spread of the drug beyond the injection site have also been reported (increased muscle weakness, swallowing disorders, or life-threatening aspiration in very rare cases).
Symptomatic treatment of focal spasticity of lower limbs in children with cerebral palsy
The following adverse reactions have been reported:
Common:

• Muscle pain
• Weakness of lower limb muscles
• Urinary incontinence
• Influenza-like symptoms
• Pain, redness, bruising at the injection site
• Gait disturbance
• Fatigue
• Fall Uncommon:
• Decreased muscle strength and weakness

Symptomatic treatment of focal spasticity of upper limbs in children with cerebral palsy
The following adverse reactions have been reported:
Common:

• Muscle weakness
• Muscle pain
• Influenza-like symptoms
• Fatigue
• Itching, bruising, pain, swelling, and rash at the injection site
• Rash Uncommon:
• Decreased muscle strength and weakness

Concomitant treatment of focal spasticity of upper and lower limbs in children with cerebral palsy
No additional adverse reactions were observed during concomitant treatment of upper and lower limbs within the same therapeutic session compared to administering the drug separately into the upper or lower limb.
Treatment of urinary incontinence due to overactive bladder detrusor muscle contractions
The following adverse reactions have been reported:
Common:

• Haematuria*
• Constipation
• Bacteria in urine*
• Erectile dysfunction, sometimes referred to as impotence
• Urinary tract infection*
• Headache
• Fever Uncommon:
• Numbness
• Muscle weakness
• Bladder pain*
• Uncontrolled reflex response of the body (autonomic dysreflexia)*
• Inability to empty the bladder (urinary retention)
• Bleeding from the bladder or from the tube that carries urine out of the bladder to the outside of the body (urethra) * This adverse reaction may be related to the procedure

Treatment of cervical dystonia
The following adverse reactions have been reported:
Very common:

• Difficulty swallowing (dysphagia)
• Dry mouth
• Muscle weakness Common:
• Headache
• Facial muscle weakness
• Dizziness
• Blurred vision
• Worsening of visual acuity
• Dyspnea
• Neck pain
• Musculoskeletal pain
• Muscle pain
• Pain in hands and fingers
• Muscle stiffness
• Change in voice quality (dysphonia) Uncommon:
• Double vision
• Drooping of the lower or upper eyelid
• Loss of muscle tissue
• Jaw muscle weakness
• Nausea Rare:
• Aspiration (choking)

Treatment of blepharospasm and hemifacial spasm
The following adverse reactions have been reported:
Very common:

• Drooping of the lower or upper eyelid Common:
• Dry eyes
• Double vision
• Excessive tearing
• Eyelid swelling
• Facial muscle weakness (paresis) Uncommon:
• Facial nerve paralysis Rare:
• Ocular muscle paralysis (limitation of eye movement)
• Eyelid inversion

Treatment of upper limb spasticity in adults
The following adverse reactions have been reported:
Common:

• Muscle weakness
• Musculoskeletal pain
• Pain in hands and fingers
• Pain, redness, swelling at the injection site
• Fatigue, weakness
• Influenza-like symptoms Uncommon:
• Difficulty swallowing

Treatment of lower limb spasticity in adults
The following adverse reactions have been reported:
Common:

• Fall
• Muscle weakness
• Muscle pain
• Difficulty swallowing (dysphagia)
• Weakness
• Fatigue
• Influenza-like symptoms
• Bruising, pain, rash, itching at the injection site

Treatment of excessive underarm sweating (axillary hyperhidrosis)
The following adverse reactions have been reported:
Common:

• Dyspnea
• Compensatory sweating (increased sweating in areas other than the underarms)
• Back, shoulder, and neck pain
• Back and calf muscle pain Uncommon:
• Dizziness
• Headache
• Tingling or numbness in hands or feet
• Involuntary eyelid muscle contractions
• Facial flushing
• Epistaxis

If any of the adverse reactions worsen or if any adverse reactions not listed in this leaflet occur, consult your doctor or pharmacist.
Reporting of adverse reactions
If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder or its representative.
Reporting adverse reactions helps to provide more information on the safety of the medicinal product.

5. How to store Dysport

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the container.
Store Dysport in a refrigerator (2°C - 8°C). Do not freeze.
The solution should be used immediately after reconstitution. After reconstitution, the solution may be stored for up to 24 hours in a refrigerator (2°C – 8°C).
Expiry date (EXP)
Batch number (Lot)

6. Contents of the pack and other information

What Dysport contains

• The active substance is botulinum toxin type A, 300 or 500 units/vial
• The other ingredients are human albumin and monohydrate lactose. Neurotoxin complex of Clostridium botulinum type A

What Dysport looks like and contents of the pack
Dysport is a white powder for solution for injection. Packs containing 1 or 2 vials are available.
Marketing Authorisation Holder
IPSEN PHARMA
70 rue Balard
75015 Paris
France
Importer
Ipsen Manufacturing Ireland Limited, Blanchardstown Industrial Park
Blanchardstown, Dublin 15, Ireland
Additional information or the package leaflet in a format suitable for blind or partially sighted people is available upon request from:
Ipsen Poland Sp. z o.o.
ul. Chmielna 73
00-801 Warsaw
Tel: +48 22 653 68 00
Fax: +48 22 653 68 22
Marketing Authorisation Holder's logo
 --------------------------------------------------------------------------------------------------------------

Information intended exclusively for professional medical personnel:

To improve the traceability of biological medicinal products, the name and batch number of the administered product should be clearly recorded.
Units of the Dysport medicinal product are specific to this product and are not equivalent to units of other products containing botulinum toxin.
Dysport should be administered only by appropriately trained physicians.
The exposed rubber stopper should be wiped with alcohol immediately before piercing with a needle. Use sterile 23 or 25 gauge needles.
The following instructions describe the preparation of Dysport for injection. The solvent volumes indicated below yield concentrations intended for use in specific indications, except for the indication of urinary incontinence due to neurogenic detrusor overactivity, for which specific instructions apply (see below).

* 0.9% sodium chloride injection solution without preservatives
In children, where the dose is determined based on units per kg of body weight, further dilution may be necessary to achieve the appropriate injection volume.
Focal spasticity in children with cerebral palsy aged 2 years or older
Focal spasticity of lower limbs in children with cerebral palsy
The maximum total dose of Dysport medicinal product administered during a single therapeutic session must not exceed 15 IU/kg body weight when injected into one lower limb or 30 IU/kg body weight when administered into both lower limbs. The total dose of Dysport medicinal product during a single therapeutic session must not exceed 1000 units or 30 IU/kg body weight, whichever is lower. The total drug dose should be divided among the lower limb muscles affected by spasticity. If possible, the dose per muscle should be divided into more than one injection site. The maximum volume of drug administered intramuscularly at a single injection site must not exceed 0.5 ml. Recommended dosing is presented in the table below.

Focal spasticity of upper limbs in children with cerebral palsy aged 2 years or older
The maximum dose of Dysport medicinal product administered during a single therapeutic session
with unilateral injection must not exceed 16 IU/kg body weight or 640 IU, whichever is lower.
For bilateral injection, the maximum dose of Dysport medicinal product administered during a single
therapeutic session must not exceed 21 IU/kg body weight or 840 IU, whichever is lower.
The total administered dose should be divided among the muscles affected by spasticity of the upper
limb(s). No more than 0.5 mL of Dysport medicinal product should be injected at any single site.
Recommended dosing is shown in the table below:
Dysport dosing by muscle in children with upper limb spasticity

Focal spasticity of lower and upper limbs in children with cerebral palsy aged 2 years or older
Dosing
When treating spasticity of both the upper and lower limbs simultaneously in children, refer to the dosing recommendations for the respective indication—treatment of focal spasticity of upper limbs or treatment of focal spasticity of lower limbs in children. When treating both indications simultaneously, the total dose of Dysport should not exceed 30 units/kg body weight or 1000 units, whichever is lower, administered in a single therapeutic session.
Re-treatment of upper and lower limbs should be considered when the effect of the previous injection diminishes, with re-administration no sooner than 12–16 weeks after the prior therapeutic session. The optimal timing for re-treatment should be determined based on disease progression and response to therapy.
Administration method
For the treatment of spasticity in lower or upper limbs associated with cerebral palsy, or both indications, the Dysport medicinal product solution is used, reconstituted with 0.9% (w/v) sodium chloride solution and administered intramuscularly as described above.

Urinary incontinence due to neurogenic detrusor overactivity
Dosing
The recommended dose is 600 units. In cases of inadequate response to treatment or in patients with severe disease (e.g., depending on the severity of objective and subjective symptoms and/or urodynamic parameters), a dose of 800 units may be used.
The Dysport medicinal product should be administered to patients who regularly perform clean intermittent catheterization.
The total dose should be divided into 30 injections evenly distributed throughout the detrusor muscle, avoiding the trigone area. Dysport is injected using a flexible or rigid cystoscope, with each injection administered to a depth of approximately 2 mm, delivering 0.5 ml at each site. To ensure the full dose is administered, approximately 0.5 ml of sterile saline solution should be injected with the final injection.
Administration method
Dysport is administered via intravesical injections into the detrusor muscle as described above. For the treatment of urinary incontinence due to neurogenic detrusor overactivity, a Dysport medicinal product solution containing 600 or 800 units in 15 ml is used, obtained by reconstituting the medicinal product with 0.9% (9 mg/ml) sodium chloride solution.

Instructions for preparing the solution for the indication urinary incontinence due to neurogenic detrusor overactivity:
The goal is to obtain the required volume of 15 ml of reconstituted Dysport medicinal product, equally divided between two 10 ml syringes, each containing 7.5 ml of reconstituted product at the same concentration.
After reconstitution, the product should be used immediately.

Instructions for preparing the solution using 500-unit vials:

• For a 600-unit dose: Reconstitute each of the two vials containing 500 units with 2.5 ml of 0.9% (9 mg/ml) sodium chloride injection solution without preservatives per vial. Draw 1.5 ml from the first vial into the first 10 ml syringe and 1.5 ml from the second vial into the second 10 ml syringe. Complete reconstitution by adding 6 ml of 0.9% (9 mg/ml) sodium chloride solution without preservatives to each syringe and gently mix. This results in a total of 600 units of reconstituted Dysport medicinal product, distributed in two 10 ml syringes, each containing 7.5 ml of solution.
• For an 800-unit dose: Reconstitute each of the two vials containing 500 units with 2.5 ml of 0.9% (9 mg/ml) sodium chloride injection solution without preservatives per vial. Draw 2 ml from the first vial into the first 10 ml syringe and 2 ml from the second vial into the second 10 ml syringe. Complete reconstitution by adding 5.5 ml of 0.9% (9 mg/ml) sodium chloride solution without preservatives to each syringe and gently mix. This results in a total of 800 units of reconstituted Dysport medicinal product, distributed in two 10 ml syringes, each containing 7.5 ml of solution.

Instructions for preparing the solution using 300-unit vials:

• For a 600-unit dose: Reconstitute each of the two vials containing 300 units with 1.5 ml of 0.9% (9 mg/ml) sodium chloride injection solution without preservatives per vial. Draw the full 1.5 ml from the first vial into the first 10 ml syringe and the full 1.5 ml from the second vial into the second 10 ml syringe. Complete reconstitution by adding 6.0 ml of 0.9% (9 mg/ml) sodium chloride solution without preservatives to each syringe and gently mix. This results in a total of 600 units of reconstituted Dysport medicinal product, distributed in two 10 ml syringes, each containing 7.5 ml of solution.
• For an 800-unit dose: Reconstitute each of the three vials containing 300 units with 1.5 ml of 0.9% (9 mg/ml) sodium chloride injection solution without preservatives per vial. Draw the full 1.5 ml from the first vial and 0.5 ml from the second vial into the first 10 ml syringe. Draw 0.5 ml from the second vial and the full 1.5 ml from the third vial into the second 10 ml syringe. Complete reconstitution by adding 5.5 ml of 0.9% (9 mg/ml) sodium chloride solution without preservatives to each syringe and gently mix. This results in a total of 800 units of reconstituted Dysport medicinal product, distributed in two 10 ml syringes, each containing 7.5 ml of solution.

Instructions for preparing the solution using a combination of 500-unit and 300-unit vials (applies exclusively to the 800-unit dose):

• For an 800-unit dose: Reconstitute the vial containing 500 units with 2.5 ml of 0.9% (9 mg/ml) sodium chloride injection solution without preservatives; reconstitute the vial containing 300 units with 1.5 ml of 0.9% (9 mg/ml) sodium chloride injection solution without preservatives. Draw 2 ml from the 500-unit vial into the first 10 ml syringe. Draw the remaining 0.5 ml from the 500-unit vial and the full 1.5 ml from the 300-unit vial into the second 10 ml syringe. Complete reconstitution by adding 5.5 ml of 0.9% (9 mg/ml) sodium chloride solution without preservatives to each syringe and gently mix. This results in a total of 800 units of reconstituted Dysport medicinal product, distributed in two 10 ml syringes, each containing 7.5 ml of solution.

Cervical dystonia
Dosing
Recommended doses for the treatment of cervical dystonia apply to adults of all ages with normal body weight and without reduced muscle mass in the neck muscles. In individuals with reduced neck muscle mass, e.g., due to significant underweight, or in elderly patients, the dose may be reduced.
The recommended initial dose for the treatment of cervical dystonia is 500 units, administered in divided doses into two or three of the most active neck muscles.
During continued treatment, doses may be adjusted according to therapeutic response and observed adverse effects. A dose range of 250 to 1000 units is recommended, although higher doses within this range may be associated with an increased frequency and severity of adverse effects, particularly dysphagia. The maximum administered dose must not exceed 1000 units. Symptomatic relief from cervical dystonia should be noticeable within one week of the first injection. Injections should be repeated approximately every 16 weeks or as needed to maintain treatment, but no more frequently than every 12 weeks.
For cervical dystonia with head rotation, a total dose of 500 units is recommended: 350 units injected into the head splenius muscle on the side to which the chin/head is turned, and 150 units into the contralateral sternocleidomastoid muscle.
For cervical dystonia with lateral head tilt, a total dose of 500 units is recommended: 350 units injected into the head splenius muscle on the side to which the head is tilted, and 150 units into the sternocleidomastoid muscle on the same side.
If shoulder elevation is additionally present, treatment of the trapezius and levator scapulae muscles on the affected side may also be required if EMG examination reveals noticeable signs of hypertrophy in these muscles. If injection into three muscles is needed, the 500 units of product should be divided as follows: 300 units into the head splenius muscle, 100 units into the sternocleidomastoid muscle, and 100 units into the third muscle.
For cervical dystonia with head extension, administer a total of 500 units: 250 units into each of the head splenius muscles. Injections into both head splenius muscles may increase the risk of neck muscle weakness.
For all other forms of cervical dystonia, identification and treatment of the most active muscles depend on the specialist physician’s expertise and EMG findings. EMG should be used in the diagnosis of all complex forms of cervical dystonia, for re-evaluation after ineffective injections in uncomplicated cases, and to guide injections into deep-seated muscles or in overweight patients where palpation of neck muscles is difficult.
Administration method
For the treatment of cervical dystonia, a solution containing 500 units in 1 ml is used, obtained by reconstituting Dysport 300 units with 0.6 ml or Dysport 500 units with 1 ml of 0.9% (w/v) sodium chloride injection solution. Dysport is administered intramuscularly as described above.

Blepharospasm and hemifacial spasm
Dosing
Inject 10 units (0.05 ml) of medicinal product medially and 10 units (0.05 ml) laterally relative to the junction of the palpebral and orbital portions, into both the upper (3 and 4) and lower (5 and 6) parts of the orbicularis oculi muscle of each eye.
To minimize the risk of eyelid ptosis, injections should avoid the area near the levator palpebrae superioris muscle.

When injecting into the upper eyelid, the needle should be directed away from the center of the eyelid to avoid injecting into the levator palpebrae superioris muscle. The diagram above is intended to assist in proper placement of the injection. Clinical improvement is expected within 2 to 4 days after injection, with maximal effect typically observed after two weeks.
Injections should be repeated approximately every 12 weeks or as frequently as necessary to prevent symptom recurrence, but no more frequently than every 12 weeks.
If the initial treatment response is considered inadequate, subsequent visits may require dose escalation up to 60 units as follows: 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, using the injection technique described above. Dysport may also be additionally injected into the frontalis muscle above the eyebrow (1 and 2) if spasm in this area causes visual disturbances.
In cases of unilateral blepharospasm, injections should be limited to the affected eye. Patients with hemifacial spasm should be treated in the same manner as those with unilateral blepharospasm. Recommended doses apply to adults of all ages, including the elderly.
Children: Efficacy and safety of this medicinal product for the treatment of blepharospasm and hemifacial spasm in children have not been established.
Administration method
For the treatment of blepharospasm and hemifacial spasm, a solution containing 200 units in 1 ml is used, obtained by reconstituting Dysport 300 units with 1.5 ml or Dysport 500 units with 2.5 ml of 0.9% (w/v) sodium chloride injection solution. Dysport is administered via intradermal injections medially and laterally relative to the junction of the palpebral and orbital portions, into both the upper and lower parts of the orbicularis oculi muscle of each eye.

Focal spasticity of upper and lower limbs in adults
Upper limb
Dosing
In clinical studies, doses of 500 and 1000 units were divided among selected muscles during specific treatment sessions according to the scheme outlined below.
No more than 1 ml of solution should be injected into a single site.

Lower limb
Dosage
The total dose of the medicinal product must not exceed 1500 units. No more than 1 ml of solution should be injected at a single site.

The degree and pattern of muscle spasticity at the time of re-injection may
require adjustment of the dose and injection sites of Dysport.
Upper and lower limbs
If during a single therapeutic session there is a need to administer Dysport into muscles of both the
upper and lower limbs, the dose of Dysport should be appropriately adjusted according to the patient's
needs, keeping in mind that the total dose should not exceed 1500 units.
Method of administration
For the treatment of focal spasticity of upper and lower limbs, a solution containing 100, 200 or 500 units
per 1 ml is used, obtained by reconstituting Dysport with 0.9% (w/v) sodium chloride solution for
injection. Dysport is administered by intramuscular injections into the specific muscles mentioned above.
Excessive underarm sweating
Dosing
The recommended initial dose for the treatment of excessive underarm sweating is 100 units per
axilla. If the desired effect is not achieved, this dose may be increased up to 200 units per axilla in the
next administration. The maximum administered dose must not exceed 200 units per axilla.
The area to be injected should first be assessed using the iodine-starch test. Both axillae must be
thoroughly cleaned and disinfected. Ten intradermal injections should be administered at ten sites.
Each injection site should receive 10 units, totaling 100 units per axilla. The maximum effect should
be evident approximately two weeks after injection.
Method of administration
For the treatment of excessive underarm sweating, a solution containing 200 units per 1 ml is used,
prepared by reconstituting the medicinal product Dysport 300 units with 1.5 ml or Dysport 500 units
with 2.5 ml of 0.9% (w/v) sodium chloride solution for injection. Dysport is administered by
intradermal injections as described above.
Detailed information on dosing and method of administration is provided in the Summary of Product
Characteristics.