Drug Class Description
Bacterial toxins.

Generic Name
Botulinum toxin Type A- haemagglutinin complex

Drug Description
Per Vial Active ConstituentClostridium botulinum type A toxin-haemagglutinin complex 500U *Other ConstituentsAlbumin solution 125 MCG Lactose 2.5 MG * One unit (U) is defined as the median lethal intraperitoneal dose in mice.

Presentation
Injection.

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

Adult Dosage
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 spasticityPosologyAdults:The recommended dose is 1000 units in total, distributed amongst the following five muscles:Biceps brachii(BB)Flexor digitorum profundus(FDP)Flexor digitorum superficialis(FDS)Flexor carpi ulnaris(FCU)Flexor carpi radialis(FCR)Total Dose300-400 units(0.6-0.8mL)150 units(0.3mL)150-250 units(0.3-0.5mL)150 units(0.3mL)150 units(0.3mL)1000 units(2.0mL)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 maximum dose administered must not exceed 1000 units.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 administrationWhen 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 spasticityPosologyThe 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 body weight 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 eva luation 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 administrationWhen treating paediatric cerebral palsy 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 calf muscles when treating spasticity.Spasmodic torticollisPosologyAdults 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. The maximum dose administered must not exceed 1000 units.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 administrationWhen treating spasmodic torticollis 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 as above when treating spasmodic torticollis.Blepharospasm and hemifacial spasmPosologyAdults 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.Injection of 10 units (0.05mL) should be made medially and of 10 units (0.05mL) 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 (0.05mL) medially and 20 units (0.1mL) laterally, 80 units: 20 units (0.1mL) medially and 20 units (0.1mL) laterally or up to 120 units: 20 units (0.1mL) medially and 40 units (0.2mL) 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.Children:The safety and effectiveness of Dysport in the treatment of blepharospasm and hemifacial spasm in children have not been demonstrated.Method of administrationWhen treating blepharospasm and hemifacial spasm, Dysport is reconstituted with 2.5mL 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.

Child Dosage
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 spasticityPosologyAdults:The recommended dose is 1000 units in total, distributed amongst the following five muscles:Biceps brachii(BB)Flexor digitorum profundus(FDP)Flexor digitorum superficialis(FDS)Flexor carpi ulnaris(FCU)Flexor carpi radialis(FCR)Total Dose300-400 units(0.6-0.8mL)150 units(0.3mL)150-250 units(0.3-0.5mL)150 units(0.3mL)150 units(0.3mL)1000 units(2.0mL)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 maximum dose administered must not exceed 1000 units.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 administrationWhen 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 spasticityPosologyThe 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 body weight 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 eva luation 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 administrationWhen treating paediatric cerebral palsy 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 calf muscles when treating spasticity.Spasmodic torticollisPosologyAdults 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. The maximum dose administered must not exceed 1000 units.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 administrationWhen treating spasmodic torticollis 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 as above when treating spasmodic torticollis.Blepharospasm and hemifacial spasmPosologyAdults 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.Injection of 10 units (0.05mL) should be made medially and of 10 units (0.05mL) 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 (0.05mL) medially and 20 units (0.1mL) laterally, 80 units: 20 units (0.1mL) medially and 20 units (0.1mL) laterally or up to 120 units: 20 units (0.1mL) medially and 40 units (0.2mL) 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.Children:The safety and effectiveness of Dysport in the treatment of blepharospasm and hemifacial spasm in children have not been demonstrated.Method of administrationWhen treating blepharospasm and hemifacial spasm, Dysport is reconstituted with 2.5mL 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.

Elderly Dosage
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 spasticityPosologyAdults:The recommended dose is 1000 units in total, distributed amongst the following five muscles:Biceps brachii(BB)Flexor digitorum profundus(FDP)Flexor digitorum superficialis(FDS)Flexor carpi ulnaris(FCU)Flexor carpi radialis(FCR)Total Dose300-400 units(0.6-0.8mL)150 units(0.3mL)150-250 units(0.3-0.5mL)150 units(0.3mL)150 units(0.3mL)1000 units(2.0mL)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 maximum dose administered must not exceed 1000 units.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 administrationWhen 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 spasticityPosologyThe 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 body weight 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 eva luation 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 administrationWhen treating paediatric cerebral palsy 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 calf muscles when treating spasticity.Spasmodic torticollisPosologyAdults 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. The maximum dose administered must not exceed 1000 units.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 administrationWhen treating spasmodic torticollis 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 as above when treating spasmodic torticollis.Blepharospasm and hemifacial spasmPosologyAdults 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.Injection of 10 units (0.05mL) should be made medially and of 10 units (0.05mL) 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 (0.05mL) medially and 20 units (0.1mL) laterally, 80 units: 20 units (0.1mL) medially and 20 units (0.1mL) laterally or up to 120 units: 20 units (0.1mL) medially and 40 units (0.2mL) 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.Children:The safety and effectiveness of Dysport in the treatment of blepharospasm and hemifacial spasm in children have not been demonstrated.Method of administrationWhen treating blepharospasm and hemifacial spasm, Dysport is reconstituted with 2.5mL 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.

Contra Indications
Dysport is contraindicated in individuals with known hypersensitivity to any components of Dysport.

Special Precautions
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.Dysport should only be used with caution under close supervision in patients with subclinical or clinical evidence of marked defective neuro-muscular transmission (eg myasthenia gravis). Such patients may have an increased sensitivity to agents such as Dysport which may result in excessive muscle weakness.There are no reports of any immune response after the local administration of Clostridium botulinum type A toxin-haemagglutinin complex in accordance with the doses recommended when treating hemifacial spasm. Antibody formation to botulinum toxin has been noted rarely in patients (approximately 1 in 10, 000 cases) receiving Dysport.Clinically, neutralizing antibodies have been detected by substantial deterioration in response to therapy 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.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.Side effects related to spread of toxin distant from the site of administration have been reported, 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.

Interactions
Drugs which affect neuromuscular transmission, such as aminoglycoside antibiotics, should be used with caution.

Adverse Reactions
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).GeneralA total of approximately 7500 patients were treated with Dysport during a series of clinical trials in patients suffering blepharospasm, hemifacial spasm, torticollis or spasticity associated with cerebral palsy or stroke.Approximately 2200 patients included in these trials experienced an adverse event.Nervous system disordersRare: Neuralgic amyotrophySkin and subcutaneous tissue disordersUncommon: ItchingRare: Skin rashesGeneral disorders and administration site conditionsCommon: Generalised weakness, fatigue, flu-like syndrome, pain / bruising at injection site.Arm spasticityIn 5 clinical trials involving 141 patients treated with Dysport the following adverse reactions were reported.Gastrointestinal disordersCommon: DysphagiaMusculoskeletal and connective tissue disordersCommon: Arm muscle weaknessInjury, poisoning and procedural complicationsCommon: Accidental injury/fallsPaediatric cerebral palsy spasticityIn 14 clinical trials involving approximately 900 patients treated with Dysport, the following adverse reactions were reported:Gastrointestinal disordersCommon: Diarrhoea, vomitingMusculoskeletal and connective tissue disordersCommon: Leg muscle weaknessRenal and urinary disordersCommon: Urinary incontinenceGeneral disorders and administration site conditionsCommon: Abnormal gaitInjury, poisoning and procedural complicationsCommon: Accidental injury due to fallingAccidental 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 torticollisIn 21 clinical trials involving approximately 4100 patients the following adverse reactions were reported:Nervous system disordersCommon: DysphoniaUncommon: HeadacheEye disordersUncommon: Diplopia, blurred visionRespiratory, thoracic and mediastinal disordersRare: Respiratory disordersGastrointestinal disordersVery common: DysphagiaUncommon: Dry mouthMusculoskeletal and connective tissue disordersCommon: Neck muscle weaknessDysphagia 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 spasmIn 13 clinical trials involving approximately 1400 patients treated with Dysport, the following adverse reactions were reported:Nervous system disordersCommon: Facial muscle weaknessUncommon: Facial nerve paresisEye disordersVery common: PtosisCommon: Diplopia, dry eyes, tearingRare: OphthalmoplegiaSkin and subcutaneous tissue disordersCommon: Eyelid oedemaRare: EntropionSide effects may occur due to deep or misplaced injections of Dysport temporarily paralysing other nearby muscle groups.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.

Manufacturer
Ipsen Ltd

Drug Availability
(POM)

Updated
22 November 2011