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  • Botox
    / Allergan


    Active Ingredient
    Botilium Toxin 50, 100, 200 U

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Vial

    1 X 5 ml X 50 units

    partial basket chart 40891 2552

    Vial

    1 X 10 ml X 100 units

    partial basket chart 10874 2553

    Vial

    1 X 10 ml X 200 units

    partial basket chart 57830 2337

    Related information


    Dosage

    Botulinum toxin units are not interchangeable from one product to another. Doses recommended in Allergan units are different from other botulinum toxin preparations.
    The following information is important: If different vial sizes of this product are being used as part of one injection procedure, care should be taken to use the correct amount of diluent when reconstituting a particular number of units per 0.1 ml. The amount of diluent varies between BOTOX 50 Allergan Units, BOTOX 100 Allergan Units and BOTOX 200 Allergan Units. Each syringe should be labelled accordingly.
    BOTOX must only be reconstituted with sterile sodium chloride 9 mg/ml (0.9%) solution for injection. The appropriate amount of diluent (see below) should be drawn up into a syringe.
    Overactive bladder – dilution instructions using a 200 Unit vial: It is recommended that a 100 Unit or two 50 Unit vials are used for convenience of reconstitution.
    Reconstitute a 200 Unit vial of BOTOX with 8 ml of 0.9% non-preserved saline solution and mix gently. 2/32.
    Draw the 4ml from the vial into a 10 ml syringe.
    Complete the reconstitution by adding 6 ml of 0.9% non-preserved saline solution into the 10 ml syringe and mix gently. This will result in a 10 ml syringe containing a total of 100 Units of reconstituted BOTOX. Use immediately after reconstitution in the syringe. This product is for single use only and any unused reconstituted product should be disposed of. Dispose of any unused saline.
    Overactive bladder – dilution instructions using a 100 Unit vial: It is recommended that a 100 Unit or two 50 Units are used for convenience of reconstitution.
    Reconstitute a 100 Unit vial of BOTOX with 10 ml of 0.9% non-preserved saline solution and mix gently.
    Draw the 10 ml from the vial into a 10 ml syringe. This will result in 10 ml syringe containing a total of 100 Units of reconstituted BOTOX. Use immediately after reconstitution in the syringe. Dispose of any unused saline.
    Overactive bladder – dilution instructions using two 50 Unit vials: It is recommended that a 100 Unit or two 50 Unit vials are used for convenience of reconstitution.
    Reconstitute two 50 Unit vials of BOTOX with 5 ml of 0.9% non-preserved saline solution and mix the vials gently. • Draw the 5 ml from each of the vials into a single 10 ml syringe. This will result in 10 ml syringe containing a total of 100 Units of reconstituted BOTOX.
    Use immediately after reconstitution in the syringe. Dispose of any unused saline.
    Urinary incontinence due to neurogenic detrusor overactivity – dilution instructions using a 200 Unit vial:
    Reconstitute a 200 Unit vial of BOTOX with 6 ml of 0.9% non-preserved saline solution and mix the vial gently.
    Draw 2 ml from the vial into each of three 10 ml syringes.
    Complete the reconstitution by adding 8 ml of 0.9% non-preserved saline solution into each of the 10 ml syringes, and mix gently. This will result in three 10 ml syringes containing a total of 200 Units of reconstituted BOTOX. Use immediately after reconstitution in the syringe. Dispose of any unused saline.
    Urinary incontinence due to neurogenic detrusor overactivity – dilution instructions using two 100 Unit vials: It is recommended that a 200 Unit vial or two 100 Unit vials are used for convenience of reconstitution.
    Reconstitute two 100 Unit vials of BOTOX, each with 6 ml of 0.9% non-preserved saline solution and mix the vials gently.
    Draw 4 ml from each vial into each of two 10 ml syringes.
    Draw the remaining 2 ml from each vial into a third 10 ml syringe. Complete the reconstitution by adding 6 ml of 0.9% non-preserved saline solution into each of the 10 ml syringes, and mix gently. This will result in three 10 ml syringes containing a total of 200 Units of reconstituted BOTOX. Use immediately after reconstitution in the syringe. Dispose of any unused saline.
    For full details see prescribing information.


    Indications

    This product is indicated for the symptomatic relief of: Distant Spread of Toxin Effect Postmarketing reports indicate that the effects of this product and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These may include asthenia, generalized muscle weakness, diplopia, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence, and breathing difficulties. These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life threatening and there have been reports of death. The risk of symptoms is probably greatest in children treated for spasticity but symptoms can also occur in adults treated for spasticity and other conditions, particularly in those patients who have underlying conditions that would predispose them to these symptoms. In unapproved uses, and in approved indications, cases of spread of effect have been reported at doses comparable to those used to treat cervical dystonia and at lower doses. 1/32 Blepharospasm or VII nerve disorders in patients over 12 years, hemifacial spasm and associated focal dystonias as well as the correction of strabismus in patients 12 years of age and above. This product is also indicated for the reduction of the signs and symptoms of spasmodic torticollis (cervical dystonia) in adults. This product is also indicated for the treatment of dynamic equinus foot deformity due to spasticity in paediatric cerebral palsy patients two years of age or older. Focal upper limb spasticity associated with stroke. Management of primary axillary hyperhidrosis in patients who failed other medical symptomatic treatment. This product is also indicated for the temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adult patients aged 65 years or less.
    Bladder dysfunctions: Management of overactive bladder with symptoms of urinary incontinence, urgency and frequency in Adult patients who have an inadequate response to, or are intolerant of, anticholinergic medication. Urinary incontinence in adults with neurogenic detrusor overactivity resulting from neurogenic bladder due to stable sub-cervical spinal cord injury, or multiple sclerosis. Symptom relief in adults fulfilling criteria for chronic migraine (headaches on ≥15 days per month of which at least 8 days with migraine) in patients who have responded inadequately or are intolerant of prophylactic migraine medications.


    Contra-Indications

    This product is contraindicated: In individuals with a known hypersensitivity to botulinum toxin type A or to any of the excipients, In the presence of infection at the proposed injection sites. For management of bladder dysfunctions is also contraindicated: In patients who have urinary tract infection at the time of treatment, In patients with acute urinary retention at the time of treatment, who are not routinely catheterising, In patients who are not willing and/or able to initiate catheterisation post-treatment if required.


    Special Precautions

    NOTE: Distant Spread of Toxin Effect Postmarketing reports indicate that the effects of this product and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These may include asthenia, generalized muscle weakness, diplopia, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence, and breathing difficulties. These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life threatening and there have been reports of death. The risk of symptoms is probably greatest in children treated for spasticity but symptoms can also occur in adults treated for spasticity and other conditions, particularly in those patients who have underlying conditions that would predispose them to these symptoms. In unapproved uses, and in approved indications, cases of spread of effect have been reported at doses comparable to those used to treat cervical dystonia and at lower doses.
    The relevant anatomy, and any alterations to the anatomy due to prior surgical procedures, must be understood prior to administering and injection into vulnerable anatomic structures must be avoided. Serious adverse events including fatal outcomes have been reported in patients who had received off-label injections of this product directly into salivary glands, the oro-lingual-pharyngeal region, oesophagus and stomach. Some patients had pre-existing dysphagia or significant debility. The recommended dosages and frequencies of administration should not be exceeded. Serious and/or immediate hypersensitivity reactions have been rarely reported including anaphylaxis, serum sickness, urticaria, soft tissue oedema, and dyspnoea. Some of these reactions have been reported following the use of this product either alone or in conjunction with other products associated with similar reactions. If such a reaction occurs further injection should be discontinued and appropriate medical therapy, such as epinephrine, immediately instituted. One case of anaphylaxis has been reported in which the patient died after being injected with this product inappropriately diluted with 5 ml of 1% lidocaine. Side effects related to spread of toxin distant from the site of administration have been reported, sometimes resulting in death, which in some cases was associated with dysphagia, pneumonia and/or significant debility. 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 or caregivers should be advised to seek immediate medical care if swallowing, speech or respiratory disorders arise. Dysphagia has also been reported following injection to sites other than the cervical musculature. 12/32 Clinical fluctuations during the repeated use of this product (as with all botulinum toxins) may be a result of different vial reconstitution procedures, injection intervals, muscles injected and slightly differing potency values given by the biological test method used. Formation of neutralising antibodies to botulinum toxin type A may reduce the effectiveness of treatment by inactivating the biological activity of the toxin. Results from some studies suggest that this product’s injections at more frequent intervals or at higher doses may lead to greater incidence of antibody formation. When appropriate, the potential for antibody formation may be minimized by injecting with the lowest effective dose given at the longest clinically indicated intervals between injections. As with any treatment with the potential to allow previously-sedentary patients to resume activities, the sedentary patient should be cautioned to resume activity gradually. Caution should be used when used in the presence of inflammation at the proposed injection site(s) or when excessive weakness or atrophy is present in the target muscle. Caution should also be exercised when used for treatment of patients with peripheral motor neuropathic diseases (e.g. amyotrophic lateral sclerosis or motor neuropathy). this product should only be used with extreme caution and under close supervision in patients with subclinical or clinical evidence of defective neuromuscular transmission e.g. myasthenia gravis or Lambert-Eaton Syndrome; such patients may have an increased sensitivity to agents such as this product, which may result in excessive muscle weakness. Patients with neuromuscular disorders may be at an increased risk of clinically significant systemic effects including severe dysphagia and respiratory compromise from typical doses of this product. As with any injection, procedure-related injury could occur. An injection could result in localised infection, pain, inflammation, paraesthesia, hypoaesthesia, tenderness, swelling, erythema, and/or bleeding/bruising. Needle-related pain and/or anxiety may result in vasovagal responses, e.g. syncope, hypotension, etc. Care should be taken when injecting near vulnerable anatomic structures. Pneumothorax associated with injection procedure has been reported following the administration of this product near the thorax. Caution is warranted when injecting in proximity to the lung, particularly the apices.
    Paediatric Use: The safety and efficacy in indications other than those described for the paediatric population above in Therapeutic indications has not been established. Post-marketing reports of possible distant spread of toxin have been very rarely reported in paediatric patients with comorbidities, predominantly with cerebral palsy. In general the dose used in these cases was in excess of that recommended. There have been rare spontaneous reports of death sometimes associated with aspiration pneumonia in children with severe cerebral palsy after treatment with botulinum toxin, including following off-label use (e.g. neck area). Extreme caution should be exercised when treating paediatric patients who have significant neurologic debility, dysphagia, or have a recent history of aspiration pneumonia or lung disease. Treatment in patients with poor underlying health status should be administered only if the potential benefit to the individual patient is considered to outweigh the risks.
    Recommendations in the event of an accident when handling botulinum toxin: In the event of an accident when handling the product, whether in the vacuum-dried state or reconstituted, the appropriate measures described below must be initiated immediately.
    The toxin is very sensitive to heat and certain chemical agents.
    Any spillage must be wiped up: either with an absorbent material soaked in a solution of sodium hypochlorite (Javel solution) in the case of the vacuum-dried product, or with a dry absorbent material in the case of the reconstituted product.
    Contaminated surfaces must be cleaned with an absorbent material soaked in a solution of sodium hypochlorite (Javel solution) and then dried.
    If a vial is broken, carefully collect up the pieces of glass and wipe up the product as stated above, avoiding cutting the skin.
    If splashed, wash with a solution of sodium hypochlorite and then rinse thoroughly with plenty of water.
    If splashed into the eyes, rinse one’s eyes thoroughly with plenty of water or with an ophthalmic eyewash solution.
    If the operator injures himself (cuts, pricks himself), proceed as above and take the appropriate medical steps according to the dose injected.
    For full details see prescribing information.


    Side Effects

    Localized pain, tenderness and/or bruising, local weakness represents the expected pharmacological action of botulinum toxin. Excessive doses may cause paralysis in muscles distant to the injection site. In the treatment of blepharospasm, the most commonly reported side effects are ptosis, tearing and irritation. Ecchymosis occurs easily in soft eyelid tissues. Diffuse skin rash and local swelling of the eyelid skin, reduced blinking. In the treatment of hemifacial spasm: Blurring of vision, facial droop, dizziness, and tiredness. In the treatment of spasmodic torticollis: Dysphagia, pain and soreness at the injection site, local weakness and symptomatic general weakness/malaise. In strabismus treatment: Spatial disorientation, double vision, or past-pointing. Extraocular muscles adjacent to injection site are often affected, causing ptosis or verticle deviation.


    Drug interactions

    The effect of botulinum toxin may be potentiated by aminoglycoside antibiotics or other drugs that interfere with neuromuscular transmission, e.g. tubocurarine-type muscle relaxants and other muscle relaxants. Neuromuscular weakness may be exacerbated by administration of another botulinum toxin prior to the resolution of the effects of a previously administered botulinum toxin.


    Pregnancy and Lactation

    Pregnancy: There are no adequate data from the use of botulinum toxin type A in pregnant women. Studies in animals have shown reproductive toxicity. The potential risk for humans is unknown. this product should not be used during pregnancy and in women of childbearing potential not using contraception unless clearly necessary.
    Breastfeeding: There is no information on whether this product is excreted in human milk. The use of this product during lactation cannot be recommended.
    Fertility: There are no adequate data on the effects on fertility from the use of botulinum toxin type A in women of childbearing potential. Studies in male and female rats have shown fertility reductions.


    Overdose

    Overdose of this product is a relative term and depends upon dose, site of injection, and underlying tissue properties. No cases of systemic toxicity resulting from accidental injection have been observed. Excessive doses may produce local, or distant, generalised and profound neuromuscular paralysis. No cases of ingestion have been reported. Signs and symptoms of overdose are not apparent immediately post-injection. Should accidental injection or ingestion occur or overdose be suspected, the patient should be medically monitored for up to several weeks for progressive signs and symptoms of muscular weakness, which could be local or distant from the site of injection, that may include ptosis, diplopia, dysphagia, dysarthria, generalised weakness or respiratory failure. These patients should be considered for further medical evaluation and appropriate medical therapy immediately instituted, which may include hospitalisation. If the musculature of the oropharynx and oesophagus are affected, aspiration may occur which may lead to development of aspiration pneumonia. If the respiratory muscles become paralysed or sufficiently weakened, intubation and assisted respiration will be required until recovery takes place and may involve the need for a tracheostomy and prolonged mechanical ventilation in addition to other general supportive care.


    Manufacturer
    Allergan
    Licence holder
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