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1,2,3,6 X 50 U
1,2,3,6 X 100 U
For blepharospasm, spasmodic torticollis and post-stroke spasticity of the upper limb, the optimum dose, frequency and number of injection sites in the treated muscle should be determined by the physician individually for each patient. A titration of the dose should be performed.
Blepharospasm: The initial recommended dose is 1.25 to 2.5 units per injection site. The initial dose should not exceed 25 units per eye. Total dosing should not exceed 100 units every 12 weeks. Treatment intervals should be determined based on the actual clinical need of the individual patient.
The median time to first onset of effect is observed within four days after injection. The effect of the treatment with this drug generally lasts approximately 3-4 months, however, it may last significantly longer or shorter. The treatment can be repeated if required.
At repeat treatment sessions, the dose may be increased up to two-fold if the response to the initial treatment is considered insufficient. However, there appears to be no additional benefit obtainable from injecting more than 5.0 units per site.
Spasmodic torticollis: In the management of spasmodic torticollis, this drug dosing must be tailored to the individual patient, based on the patient’s head and neck position, location of possible pain, muscle hypertrophy, patient’s body weight, and response to the injection.
No more than 200 units should be injected for the first course of therapy, with adjustments made in the subsequent courses depending on the response. A total dose of 300 units at any one session should not be exceeded. No more than 50 units should be administered at any one injection site.
The median first onset of effect is observed within seven days after injection. The effect of a this drug treatment generally lasts approximately 3-4 months, however, it may last significantly longer or shorter. Treatment intervals of less than 10 weeks are not recommended. Treatment intervals should be determined based on the actual clinical need of the individual patient.
Post-stroke Spasticity of the upper limb presenting with flexed wrist and clenched fist in adults: The exact dose and number of injection sites should be tailored to the individual patient based on the size, number and location of muscles involved, the severity of spasticity, and the presence of local muscle weakness.
Recommended initial doses:
Flexed Wrist: Flexor carpi radialis -50UN; Flexor carpi ulnaris -40UN.
Clenched Fist: Flexor digitorum superficialis –40UN; Flexor digitorum profundus –40UN.
Flexed Elbow: Brachioradialis-60 UN; Biceps -80 UN; Brachialis -50 UN.
Pronated Forearm: Pronator quadratus 25 UN; Pronator teres 40 UN.
Thumb-in-Palm: Flexor pollicis longus- 20 UN; Adductor pollicis -10 UN; Flexor pollicis brevis/ Opponens pollicis- 10 UN.
For recommended treatment doses for repeated treatment per muscle: See prescribing information for full details.
Symptomatic treatment of blepharospasm, cervical dystonia of a predominantly rotational form (spasmodic torticollis) and of post-stroke spasticity of the upper limb presenting with flexed wrist and clenched fist in adults.
Indicated for the temporary improvement in the appearance of moderate to severe vertical lines between eyebrows seen at frown (glabellar frown lines) in adults below 65 years when the severity of these lines has an important psychological impact for the patient.
Hypersensitivity to the active substance or to any of the excipients.
Generalised disorders of muscle activity (e.g. myasthenia gravis, Lambert-Eaton syndrome).
Infection or inflammation at the proposed injection site.
General: Prior to administering Botulinum Toxin Type A, the physician must familiarise himself/herself with the patient’s anatomy and any alterations to the anatomy due to prior surgical procedures.
Care should be taken to ensure that Botulinum Toxin Type A is not injected into a blood vessel. For the treatment of cervical dystonia and post-stroke-spasticity, Botulinum toxin type A should be injected carefully when injecting at sites close to sensitive structures such as the carotid artery lung apices and oesophagus.
The drug should be used with caution:
Bleeding disorders of any type exist.
Patients receiving anticoagulant therapy or other substances that could have an anticoagulant effect.
The recommended single doses of Botulinum toxin type A should not be exceeded.
Previously akinetic or sedentary patients treated for Blepharospasm, Spasmodic torticollis and Post-stroke spasticity of the upper limb, should be reminded to gradually resume activities following the injection of Botulinum Toxin Type A.
The clinical effects of Botulinum neurotoxin type A may increase or decrease by repeated injections. The possible reasons for changes in clinical effects are different techniques of reconstitution, the chosen injection intervals, the injected muscles and marginally varying toxin activity resulting from the biological testing procedure employed or secondary non-response.
Local and distant spread of toxin effect: Undesirable effects may occur from misplaced injections of Botulinum neurotoxin type A that temporarily paralyse nearby muscle groups. Patients treated with therapeutic doses may experience excessive muscle weakness. Large doses may cause paralysis in muscles distant from the injection site.
There have been reports of undesirable effects that might be related to the spread of Botulinum toxin typeA to sites distant from the injection site. Some of these can be life threatening and there have been reports of death, which in some cases was associated with dysphagia, pneumonia and/or significant debility.
Dysphagia has also been reported in patients treated for Blepharospasm, Spasmodic torticollis and Post-stroke spasticity of the upper limb, following injection to sites other than the cervical musculature.See prescribing information for full details.
Pre-existing neuromuscular disorders: Patients treated with therapeutic doses may experience excessive muscle weakness. Patients with neuromuscular disorders may be at increased risk of excessive muscle weakness. The Botulinum toxin typeA 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.
The injection of this drug is not recommended for patients treated for Glabellar frown lines with a history of dysphagia and aspiration.
Patients or caregivers should be advised to seek immediate medical care if swallowing, speech or respiratory disorders occur.
This drug should be used with caution:
Patients suffering from amyotrophic lateral sclerosis.
Patients with other diseases which result in peripheral neuromuscular dysfunction.
Targeted muscles which display pronounced weakness or atrophy.
Hypersensitivity reactions: Hypersensitivity reactions have been reported with Botulinum neurotoxin typeA products. If serious (e.g. anaphylactic reactions) and/or immediate hypersensitivity reactions occur, appropriate medical therapy should be instituted.
Antibody formation: Too frequent doses may increase the risk of antibody formation, which can result in treatment failure.
The potential for antibody formation may be minimised by injecting with the lowest effective dose at the longest intervals between injections as clinically indicated.
Blepharospasm: Injections near the levator palpebrae superioris should be avoided to reduce the occurrence of ptosis. Diplopia may develop as a result of Botulinum neurotoxin type A diffusion into the inferior oblique. Avoiding medial injections into the lower lid may reduce this adverse reaction.
Because of the anticholinergic effect of Botulinum neurotoxin type A, BOTULINUM TOXIN TYPE A should be used with caution in patients at risk of developing a narrow angle glaucoma.
In order to prevent ectropion, injections into the lower lid area should be avoided, and vigorous treatment of any epithelial defect is necessary. This may require protective drops, ointments, soft bandage contact lenses, or closure of the eye by patching or similar means.
Spasmodic torticollis: Patients should be informed that injections of this drug for the management of spasmodic torticollis may cause mild to severe dysphagia with the risk of aspiration and dyspnoea. Medical intervention may be necessary (e.g. in the form of a gastric feeding tube). Limiting the dose injected into the sternocleidomastoid muscle to less than 100 units may decrease the occurrence of dysphagia. Patients with smaller neck muscle mass, or patients who require bilateral injections into the sternocleidomastoid muscles are at greater risk. The occurrence of dysphagia is attributable to the spread of the pharmacological effect of Botulinum toxin type A as the result of the neurotoxin spread into the oesophageal musculature.
Post-stroke Spasticity of the upper limb: Botulinum toxin type A as a treatment for focal spasticity has been studied in association with usual standard care regimens, and is not intended as a replacement for these treatment modalities. This agent is not likely to be effective in improving range of motion at a joint affected by a fixed contracture.
New onset or recurrent seizures have been reported, typically in patients who are predisposed to experiencing these events. The exact relationship of these events to Botulinum toxin injection has not been established.
Headache, facial paresis, eyelid ptosis, dry eyes, vision blurred, visual impairment, diplopia, lacrimation increased, dry mouth, dysphagia, injection site pain, fatigue, musculoskeletal and connective tissue disorders, muscular weakness, headache, presyncope, dizziness, speech disorder.
See prescribing information for full details.
No drug interaction studies have been performed.
Theoretically, the effect of Botulinum neurotoxin may be potentiated by aminoglycoside antibiotics or other medicinal products that interfere with neuromuscular transmission, e.g. tubocurarine-type muscle relaxants.
Therefore, the concomitant use of this drug with aminoglycosides or spectinomycin requires special care. Peripheral muscle relaxants should be used with caution, if necessary reducing the starting dose of relaxant, or using an intermediate-acting substance such as vecuronium or atracurium rather than substances with longer lasting effects.
4-Aminoquinolines may reduce the effect of BOTULINUM TOXIN TYPE A.
See prescribing information for full details.
Pregnancy and Lactation
Pregnancy: There are no adequate data from the use of Botulinum neurotoxin typeA in pregnant women. The potential risk for humans is unknown. Therefore, XEOMIN should not be used during pregnancy unless clearly necessary and unless the potential benefit justifies the risk.
Lactation: It is unknown whether Botulinum neurotoxin type A is excreted into breast milk. Therefore, XEOMIN should not be used during breast-feeding.
See prescribing information for full details.
Symptoms of overdose: Increased doses of Botulinum neurotoxin type A may result in pronounced neuromuscular paralysis distant from the injection site with a variety of symptoms. Symptoms may include general weakness, ptosis, diplopia, breathing difficulties, speech difficulties, paralysis of the respiratory muscles or swallowing difficulties which may result in aspiration pneumonia.
Measures in cases of overdose: In the event of overdose the patient should be medically monitored for symptoms of excessive muscle weakness or muscle paralysis. Symptomatic treatment may be necessary. Respiratory support may be required if paralysis of the respiratory muscles occurs.