Medicinal Products

DYSPORT 300 SPEYWOOD UNITS

Generic drug of the therapeutic class: Rheumatology
active ingredients: Botulinum toxin type A
laboratory: Ipsen Pharma

Powder for solution for injection
Box of 1 bottle of 300 U
All forms

Indication

adults

· Blepharospasm

· Hemifacial spasm.

· Spasmodic torticollis.

· Local symptomatic treatment of spasticity (muscular hyperactivity) of the upper and / or lower limbs.

Children from 2 years

Local symptomatic treatment of lower limb spasticity.

This drug treatment should be included in a multidisciplinary global management (associating neurologist, pediatrician, doctor of physical medicine and rehabilitation, orthopedic surgeon ...).

NB: DYSPORT 300 SPEYWOOD UNITS SHOULD BE ADMINISTERED BY DOCTORS WHO HAVE ALREADY EXPERIENCED THE USE OF TOXIN IN THESE INDICATIONS.

Dosage DYSPORT 300 UNITS SPEYWOOD Powder for solution for injection Box of 1 Bottle of 300 U

General recommendations

The recommended doses of Dysport 300 Speywood units are not interchangeable with other Botulinum toxin A preparations. They are expressed in SPEYWOOD units (see Warnings and Precautions section ).

Minimum interval between two injections:

The presence of antibodies to botulinum toxin type A may reduce the efficacy of treatment with DYSPORT 300 UNITES SPEYWOOD. Therefore, as a precautionary measure, a minimum interval of time between 2 injection sessions should be respected:

· 2 months in blepharospasm, hemifacial spasm and spasmodic torticollis in adults,

· 3 months in the local symptomatic treatment of spasticity (muscle hyperactivity) of the upper and / or lower limbs in adults,

· 3 months in the local symptomatic treatment of lower limb spasticity in children from 2 years old.

· If there is a history of neurogenic involvement of the face, and in people over 70 years of age, it is recommended to reduce the dosage at the first injection (see Warnings and Precautions ).

Injection technique

Subcutaneous or intramuscular route.

After disinfection of the skin, the diluted DYSPORT dose is injected using a sterile needle of a caliber adapted to the muscle to be injected.

After reconstitution, DYSPORT should only be used for one injection session for one patient.

blepharospasm

1 °) Preparation of the product

Using a sterile needle, introduce 1.5 ml of 0.9% sodium chloride solution for injection into the vial (see section Instructions for use, handling and disposal ). There is thus obtained a clear solution containing 200 SPEYWOOD UNITS / ml of active substance.

2 °) Dosage and method of administration

The recommended loading dose for the treatment of bilateral blepharospasm is 120 units per eye (ie 0.6 ml, for the dilution of 1 vial of 300 units in 1.5 ml).

Subcutaneous way.

Electromyographic guidance is not necessary.

Use a 1 ml syringe and a 23 or 25 gauge needle.

Inject a dose of 0.1 ml (20 units) into the inner portion and a dose of 0.2 ml (40 units) into the outer portion of the junction between the pre-orbital and orbital areas of the upper and lower orbicular muscles of each eye .

When injecting into the upper eyelid, the needle should be oriented so that the center of the eyelid is avoided, where the levator muscle of the eyelid is inserted.

FOR YOUR INDICATIVE REFERENCE, SEE THE DIAGRAM BELOW:

In subsequent administrations, the total dose per eye may be reduced to 80 units (0.4 ml), that is to say 20 units per injection site (ie 0.1 ml).

Hemifacial spasm

1 °) Preparation of the product

Using a sterile needle, introduce 1.5 ml of 0.9% sodium chloride solution for injection into the vial (see section Instructions for use, handling and disposal ). There is thus obtained a clear solution containing 200 SPEYWOOD UNITS / ml of active substance.

2 °) Dosage and method of administration

The injections are made in the orbicularis muscle of the eye and sometimes in the muscles of the lower part of the face. The initial recommended doses are 20 units (or 0.1 ml) per site.

Spasmodic torticollis

1 °) Preparation of the product

Using a sterile needle, add 0.6 ml of 0.9% sodium chloride solution for injection to the vial (see section Instructions for use, handling and disposal ). A clear solution containing 500 SPEYWOOD UNITS / ml of active substance is thus obtained.

2 °) Dosage and method of administration

The recommended starting dose is 500 units per patient (ie 1 ml, for the dilution of 1 vial of 300 units in 0.6 ml).

This dose should never exceed 1000 units per patient and per injection session.

The total dose should be divided between the 2 or 3 most active cervical muscles (most often: sternocleidomastoid, splenius, trapezius or angular).

To minimize the risk of dysphagia, the sternocleidomastoid muscle should not be injected bilaterally and the initial dose for this muscle should not exceed 150 units (0.3 ml).

The clinician is free to determine with or without EMG, the most active muscles, and the number of sites to be injected per muscle.

For each muscle, the dose will be divided into 2 or 3 sites.

Injection sessions should be repeated depending on the duration of the clinical effect. They will always be spaced at least 2 months apart.

Local symptomatic treatment of upper and / or lower limb spasticity in adults

1 °) Preparation of the product

Using a sterile needle, add 0.6 ml or 1.5 ml (based on target muscle volume) of 0.9% sodium chloride solution for injection (see section for use, handling and disposal ). A clear solution containing 500 or 200 SPEYWOOD UNITS / ml of active substance is thus obtained.

2 °) Dosage and method of administration

Dosage

The exact dosage, the volume of dilution and the number of injection sites should be tailored to each individual based on the size, number and location of the muscles involved, the severity of spasticity, the presence of weakness localized muscle and the patient's response to the previous treatment.

The recommended starting dose is 1000 units per patient.

This dose should never exceed 1, 500 units per patient and per injection session.

The total dose should be divided into the different muscles to be injected, in general: Flexor digitorum profundus (deep flexor of the fingers), Flexor digitorum superficialis (superficial flexor of the fingers), Flexor carpi ulnaris (anterior cubital), Flexor carpi radialis (large palmar ), Biceps brachii (brachial biceps), Gastrocnemius (gastrocnemius), Soleus (soleus), Tibialis posterior (posterior leg), Flexor digitorum longus (common flexor of the toes), Adductor (adductors).

By respecting a total dose of 1500 units: the recommended distribution of the dose per muscle is given in the following table:

Muscular

Dose 1 per muscle (SPEYWOOD unit): Number of injection sites 2 per muscle

Biceps brachii (brachial biceps)

300-400: 2 sites

Flexor digitorum profundus (deep flexor of the fingers)

150: 1 site

Flexor digitorum superficialis (superficial flexor of the fingers)

150-250: 1 site

Flexor carpi ulnaris (anterior cubital)

150: 1 site

Flexor carpi radialis (large palmar)

150: 1 site

Gastrocnemius (gastrocnemius)

250-750: 1 to 2 sites

Soleus (soleus)

250-750: 1 to 2 sites

Tibialis posterior (hindleg)

200-350: 1 to 2 sites

Flexor digitorum longus (common flexor of the toes)

150-300: 1 to 2 sites

Adductor (adductors)

500-1500: 1 to 2 sites

1. A lower initial dose should be used to avoid the occurrence of excessive muscle weakness in the muscles involved, for example in patients with weakly developed muscles or patients requiring concomitant injection another muscle group.

2. The number of sites depends on the volume of the injected muscle.

Administration mode

Use a 1 ml or 5 ml syringe depending on the total volume to be injected (23-25 ​​gauge needle).

The site of injection will be determined either by electromyographic guidance (especially for the deep muscles), or thanks to a detection by muscular stimulation-detection.

However, because of the technical difficulty of electromyographic guidance, the injection of the posterior tibialis requires training and special skill of the physician injector.

Clinical improvement generally occurs within two weeks after the injection session.

Injection sessions may be repeated if necessary but will always be spaced at least 3 months apart.

During a new injection session, the intensity and type of muscle spasticity may lead to a change in the dose of DYSPORT 300 UNITES SPEYWOOD and the choice of muscles to be injected.

LOCAL SYMPTOMATIC TREATMENT OF THE SPASTICITY OF LOWER LIMBS (IN CHILDREN FROM 2 YEARS

1 °) Preparation of the product

Using a sterile needle, add 0.6 ml of 0.9% sodium chloride solution for injection to the vial (see section Instructions for use, handling and disposal ). A clear solution containing 500 SPEYWOOD UNITS / ml of active substance is thus obtained.

2 °) Dosage and method of administration

Dosage

The treatment must be adapted according to the clinical state of each patient.

In children receiving an injection for the first time, care should be taken, the initial dose not to exceed 10 units / kg for unilateral injections, and 20 units / kg for bilateral injections ( without exceeding a total dose of 1000 units / patient). The dose should be divided among the different spastic muscles of the lower limb (for example, calf muscles, hamstrings or hip adductors).

In case of injection of only the twin muscles, the recommended starting dose is 5 Units / kg of weight, in each of the two gastrocnemius muscle (twins) muscle heads.

The exact dosage and number of injection sites should be tailored to each individual based on the size, number and location of the muscles involved, the severity of spasticity, and the presence of localized muscle weakness.

Dosage should be reduced in children:

· With associated comorbidities, especially those with pre-existing respiratory or swallowing disorders,

· Whose muscles to be treated are poorly developed,

· Which require a multisite injection,

· Who benefit from injections under general anesthesia.

In all cases, when choosing the dose, an individual assessment of the benefit / risk ratio should be considered, in order to reduce the risk of adverse effects, especially the risk of diffusion of the toxin away from the administration site (see Warnings and Precautions and Adverse Reactions sections).

During the following sessions, the dose used should be adjusted with extreme caution, depending on the response to the previous treatment, without exceeding 15 units / kg in the case of unilateral injections, and up to a maximum total dose of 30 units / kg. in case of bilateral injections (not exceeding 1000 units per patient).

The total dose administered during an injection session should never exceed 1000 units or 30 units / kg (the lowest of these 2 doses).

The table below provides guidelines for injecting DYSPORT in the treatment of spasticity in children 2 years of age and older:

Muscular

Dose per muscle (SPEYWOOD unit)

Maximum dose per session

Gastrocnemius (gastrocnemius), soleus (soleus) and tibialis posterior (hindleg)

3 to 15 U / kg

1st session:

· Unilateral injection: 10 U / kg.

· Bilateral injection: 20 U / kg.

Following sessions:

· Unilateral injection: 15 U / kg

· Bilateral injection: 30 U / kg or 1000 units per patient or 250 units per injection site

Biceps femoris, semitendinosus, semimembranosus, sartorius (hamstrings and sartorius)

3 to 15 U / kg

adductor magnus / longus / brevis (adductors)

3 to 15 U / kg

Rectus femoris, vastus medialis, vastus inermedius, vastus lateris (quadriceps)

3 to 15 U / kg

Administration mode

The administration is carried out intramuscularly at 1 or 2 injection points per muscle of the spastic lower limb.

Electromyographic guidance should be used to identify the most active muscles.

Clinical improvement generally occurs within two weeks after the injection session.

Injection sessions should be repeated depending on the duration of the clinical effect. They will always be spaced at least 3 months apart.

Against indications

· Hypersensitivity to the active substance or to any of the excipients

· Myasthenia,

· Breastfeeding (see section on Pregnancy and breastfeeding ).

Dysport side effects

Undesirable effects independent of the injection site or the indication:

· Adverse reactions related to the spread of the toxin, far from the injection site have been reported very rarely (excessive muscle weakness, dysphagia, inhalation pneumopathy, which can be fatal) (see Warnings and precautions section). employment ).

· Rare general allergic reactions (rash, erythema, pruritus).

· Pain / burns at the injection site, whatever the injected site or indication.

In the treatment of blepharospasm and hemifacial spasm

· Diffusion to the levator muscle of the eyelid may result in partial or complete ptosis, transient, lasting 6 to 8 weeks.

· Diffusion to oculomotor muscles may lead to transient diplopia.

· Other possible short-term local side effects: dry eye, watery eyes, swollen eyelids, photophobia, keratitis (see Warnings and Precautions section ).

· Risk of onset of facial paralysis.

In the treatment of hemifacial spasm

When patients receive an injection into the labialis levator muscle in addition to the injections made around the palpebral fissure, a fall of the labial commissure is possible.

In the treatment of spasmodic torticollis, particularly in the case of sternocleidomastoid injection, may appear:

· Dysphagia, sometimes severe, with possibility of false roads during 2 to 4 weeks, and risk of inhalation pneumopathy,

· Dysphonia,

· A decrease in the strength of the neck muscles.

In the local symptomatic treatment of spasticity (muscle hyperactivity) of the upper and / or lower limbs in adults

In clinical studies, the intensity of treatment-related adverse events is low to moderate. Adverse effects are transient and occur mainly in the first few weeks after injection.

Apart from a painful local reaction, the most frequently reported adverse effect in clinical trials is loco-regional muscle weakness and, more rarely, distance from the injection site, corresponding to a locoregional or systemic diffusion of botulinum toxin. This diffusion seems all the more frequent as the total dose injected is important.

Localized muscle weakness corresponds to the pharmacological action expected after injection of botulinum toxin.

Flu-like symptoms, fatigue and drowsiness have also been reported, as well as pain at the injection site.

These effects usually disappear in less than two weeks.

In the local symptomatic treatment of lower limb spasticity in children from 2 years

In clinical studies, most treatment-related adverse events were mild to moderate in intensity.

Adverse reactions are classified by System Organ Class and by frequency using the following categories: very common (≥ 1/10), common (≥ 1/100 to <1/10), uncommon (≥ 1/1000 to < 1/100), rare (≥ 1/10 000 to <1/1000), very rare (<1 / 10, 000), frequency not known (can not be estimated from the available data).

Class Organ System

Frequency: adverse effect.

Gastrointestinal disorders

Common: diarrhea

Musculoskeletal and systemic disorders

Frequent: muscle weakness.

Renal and urinary disorders

Common: urinary incontinence

General disorders and administration site conditions

Common: abnormal gait, asthenia, flu syndrome, pain at the injection site.

Injury, poisoning and procedural complications

Frequency: fall.

Accidental injury due to a fall and abnormal gait may be due to excessive weakness of the treated muscle and / or local spread of Dysport to other muscles involved in walking and balance.

Since being marketed, possible cases of toxin diffusion have been reported in children with cerebral palsy disorders. Generally, the dose used in these cases was above that recommended (see Dosage and Method of Administration section ).

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