Xeomin, lyophilizate 50 units

-idiopathic cervical dystonia (spastic torticollis) of predominantly rotatory form;
– spasticity of the upper extremity after the stroke in adults;
– spasticity of the upper extremity after stroke in adults. –
– spastic equinus and equinovarus foot deformity in children with cerebral palsy in children from 2 to 18 years old;
– Chronic sialorrhea in adults;
– Chronic sialorrhea in children from 2 to 18 years old;
– Hyperkinetic wrinkles (facial mimicry).

Active ingredient

Composition

How to take, the dosage

Volume of solvent per vial containing 100 units (ml)

./p>

Solvent volume per vial containing 50 units (ml)

Ed/0.1 ml

0.25

0.5

1.0

1.25

2.0

/p>

2.5

4.0

5.0

not applicable

0.125

0.25

0.5

0.625

1.0

1.25

2.0

2.5

4.0

/td>

40

20

10

8

5

4

2.5

p> 2

1.25

Clinical pattern

ED (range)

Number of injection points per muscle

Hand bent at wrist

Multiple hand flexor

10-50

5-30

5-30

1

1

1

Interaction

Special Instructions

Contraindications

Side effects

Indesirable reactions are usually observed in the first week after administration of the drug and are temporary. Unwanted reactions may be related to the active substance and/or to the administration procedure. The expected pharmacological effect of botulinum toxin administration is localized muscle weakness.

The unwanted reactions are classified by frequency of occurrence: very frequently (≥1/10), frequently (≥1/100 to < 1/10), infrequently (≥1/1,000 to ≤1/100), rarely (≥1/10,000 to ≤1/1,000), very rarely (≤1/10,000), frequency not determined (cannot be estimated from available data).

Blepharospasm:

Classification of adverse reactions according to organ and organ system involvement (MedDRA)

./p>

Frequency of adverse reaction

Unwanted reaction

Nervous system disorders

Infrequent

Headache

Facial nerve palsy

Visual disturbances

very often

Ptosis of eyelid

Often

Dry eyes Decreased visual clarity

/p>

Visual disturbances

Infrequent

Diplopia

Tearfulness

Gastrointestinal tract disorders

Dyslopia/p>

Often

Dry mouth

Infrequently

Dysphagia

Musculoskeletal and connective tissue disorders

/p>

Infrequent

Muscle weakness

General disorders and disorders at the site of administration

Often

Pain at injection site

injection

Infrequent

Fatigue

Skin and subcutaneous tissue disorders

/p>

Infrequent

Skin rashes

Classification of adverse reactions according to organ and organ system involvement (MedDRA)

The frequency of adverse reactions

Unwanted reaction

Nervous system disorders

Often

Headache

Predizure

Headache

Headache

Infrequent

Speech disorders

Respiratory system, thoracic and mediastinal disorders

Infrequent

Dysphonia

/p>

Shortness of breath

Infectious and parasitic diseases

Often

/p>

Upper respiratory tract infection

Gastrointestinal tract disorders

Infections with gastrointestinal tract/p>

Very often

Dysphagia

often

/p>

Mouth dryness

Nausea

Skin and subcutaneous tissue disorders

/p>

Often

Increased sweating

Infrequent

Skin rashes

Musculoskeletal and connective disorders

/p>

connective tissue

Often

Neck pain

p> Muscle weakness

Myalgia

Muscle stiffness

p> Muscle spasms

General disorders and disorders at the site of administration

Often

Pain at injection site

Asthenia

Classification of adverse reactions according to organ and organ system involvement (MedDRA)

Frequency of adverse reaction

Unwanted reaction

Often

Dry mouth

Infrequent

Dysphagia

Nausea

/p>

Musculoskeletal and connective disorders

/p>

connective tissue

Infrequent

Muscular

weakness

Pain in limb

Myalgia

/p>

General disorders and disorders at the site of administration

/p>

Infrequent

Asthenia

Frequency not established

Pain at injection site

/p>

Classification of adverse reactions according to organ and organ system involvement

(MedDRA)

Frequency of developing an adverse reaction

Unwanted reaction

Infectious and parasitic diseases

Very common

Viral infections of the upper respiratory tract Nasopharyngitis Infectious otitis media

/p>

Nervous system disorders

Often

Somnolence Gait disturbances Paresthesias

Skin and subcutaneous tissue disorders

Often

Skin rashes

Musculoskeletal and connective tissue disorders

Often

Myalgia Muscle weakness

Pain in limb

Infrequent

Myofascial pain syndrome

Renal and urinary tract disorders

Often

Tension urinary incontinence

Injuries, intoxications, and complications of manipulation

/td>

Often

Falls

General disorders and disorders at the injection site

Often

Malaise Pain at the injection site Asthenia

Infrequent

Redness at injection site

Flu-like symptoms

Classification of adverse reactions according to organ and organ system involvement (MedDRA)

The frequency of an adverse reaction

Adverse reaction

Gastrointestinal disorders

Often

Dryness

In the mouth

Dysphagia

Infrequent

changing (thickening) of saliva

/p>

Dysgeusia

Nervous system disorders

Often

Paresthesia

Infrequent

Speech impairment

Classification of adverse reactions according to organ and organ system involvement (MedDRA)

The frequency of adverse reactions

Unwanted reaction

Gastrointestinal disorders

Infrequent

Dryness

In the mouth Dysphagia

Alteration (thickening) of saliva

Classification of adverse reactions according to organ and organ system involvement (MedDRA)

Frequency of adverse reaction

Unwanted reaction

/p>

Nervous system disorders

Very often

Headache

Often

Hypoesthesia

Visual disturbances

/p>

Often

Eyelid edema

/p>

Dry eyes

Ptosis of the eyelid

Infrequent

Decreased visual clarity

Skin and subcutaneous tissue disorders

Often

Brow ptosis

Infrequent

Itching

Musculoskeletal and connective tissue disorders

Often

/p>

Infrequent

Muscle spasms in the brow area

Gastrointestinal disorders

Often

Nausea

General disorders and disorders at the point of administration

Often

bruise at the injection site

Pain at the injection site

Browning at the injection site

Discomfort (heavy feeling in the forehead)

Infrequent

Hemorrhage at the injection site

Hypopod-like symptoms

Local soreness in the area between the eyebrows and in the brow bone area

Tiredness

Discomfort (feeling of heaviness in the eyelid and brow area)

Vascular disorders

Infrequent

Hematoma

Overdose

Pregnancy use