Label: information for the user

BOTOX 50 Units Allergan, Powder for Solution for Injection

BOTOX 100 Units Allergan, Powder for Solution for Injection

BOTOX 200 Units Allergan, Powder for Solution for Injection

Botulinum Toxin Type A

Read this label carefully before starting to use this medication, as it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.

This medication has been prescribed only for you and should not be given to others, even if they have the same symptoms as you, as it may harm them.

• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

1. What is BOTOX and how it is used

2. What you need to know before starting to use BOTOX

3. How to use BOTOX

4. Possible adverse effects

5. Storage of BOTOX

6. Contents of the package and additional information

BOTOX is a muscle relaxant used to treat various conditions in the body. It contains the active substance botulinum toxin type A and is injected into muscles, the bladder wall or under the skin. It acts by partially blocking nerve impulses in the injected muscles and reducing excessive muscle contractions.

When injected into the skin, BOTOX acts on sweat glands to reduce the amount of sweat produced.

When injected into the bladder wall, BOTOX acts on the bladder muscle to reduce urine loss (urinary incontinence). In the case of chronic migraine, it is believed that BOTOX may block pain signals, indirectly blocking the onset of a migraine. However, it has not been fully established how BOTOX acts in chronic migraine.

1. BOTOX can be injected directly into muscles and is used in the treatment of the following conditions:
   • Persistent muscle spasmsinankle and footinchildrentwo years of age or older with cerebral palsy, who can walk. BOTOX is used as a support to rehabilitation therapy;
   • Persistent muscle spasmsin theforearm and handof patientsadultswho have suffered a cerebral infarction;
   • Persistent muscle spasmsin theankle and footof patientsadultswho have suffered a cerebral infarction;
   • Persistent muscle spasmsin theeyelid and faceof patientsadults;
   • Persistent muscle spasmsin theneck and shouldersof patientsadults;

1. BOTOX is used toreducesymptoms ofchronic migrainein adultswho have headaches for 15 or more days of each month, of which at least eight days areexperiencing a migraine and who have not responded adequately or are intolerant to migraine prophylactic medications.

Chronic migraine is a disease that affects the nervous system. Generally, patients experience headaches, which are often accompanied by excessive sensitivity to light, sounds or smells, as well as nausea, vomiting or both. These headaches occur during15 or more daysof each month.

1. When injected into the bladder walls, BOTOX works on the bladder muscle to reduce urine loss (urinary incontinence) and control the following conditions in adults:
   • Overactive bladder with urine loss,the urgent need to empty the bladder and frequent trips to the bathroom, when another medication (known as an anticholinergic) has not been helpful;
   • Urine lossdue to bladder disorders associated with spinal cord injury or multiple sclerosis.

1. In adults, BOTOX can be injected deeply into the skin and may work on sweat glands to reduceexcessive sweatingin thearmpitsthat affects daily activities, when other treatments do not help.

No use BOTOX:

• if you areallergic(hypersensitive) to botulinum toxin type A or any of the other components of this medication (listed in section 6);
• if you have aninfectionat the proposed injection site;
• when receiving treatment for urinary incontinence and suffer from a urinary tract infection or are unable to suddenly empty your bladder (and do not regularly use a catheter);
• if you are receiving treatment for urinary incontinence and do not want to start using a catheter if necessary.

Warnings and precautions

Inform your doctor or pharmacist before using BOTOX::

• if youhave ever had trouble swallowing or food or liquid has accidentally entered your lungs, especially if you are to be treated for persistent muscle spasms in the neck and shoulders;
• if you are65 years of ageor older and have otherserious illnesses;
• if you suffer from any othermuscle problemsor chronic diseases that affect your muscles (such as myasthenia gravis or Lambert-Eaton syndrome);
• if you suffer from certainillnessesthat affect thenervous system(such as amyotrophic lateral sclerosis or motor neuropathy);
• if you have aweaknessorsignificant wearof the muscles in which the medication is to be injected;
• if you have undergone anysurgeryorwoundthat may have changed the muscle to be injected in some way;
• if you have ever had anyproblems with injections(such as fainting);
• if you haveinflammation of the musclesor area of theskinin which your doctor is to inject the medication;
• if you have any cardiovascular disease (heart disease or blood vessel disease);
• if you have or have had seizures;
• if you have a disease of the eye calledglaucomawith closed angle (high eye pressure) or have been told that you are at high risk of developing this type of glaucoma;
• if you are to be treated for overactive bladder with urinary incontinence and are a male with signs and symptoms of urinary obstruction, such as difficulty urinating or a weak or interrupted urine flow.

After being injected with BOTOX

You or your caregiver must go to your doctorand seek immediate medical attention if you experience any of the following symptoms:

• difficulty breathingorswallowingorspeaking;
• hives,inflammationincluding facial or throat inflammation,whistling, sensation offaintingand lack ofbreath(possible severe allergic reaction symptoms).

General precautions

As with any injection, you may experience infection, pain, inflammation, abnormal sensations in the skin (such as tingling or numbness), decreased sensation in the skin, pain on palpation, redness, bleeding/hematomas at the injection site, and a drop in blood pressure or fainting: this may be a consequence of the pain and/or anxiety associated with the injection.

There have been reports of adverse reactions possibly related to the distant spread of the toxin botulinum from the administration site (such as muscle weakness, difficulty swallowing, or passage of food or liquid not desired into the respiratory tract). These adverse effects may be mild to severe, may require treatment, and in some cases, have a fatal outcome. This is a greater risk for patients with an underlying disease that makes them more susceptible to these symptoms.

There have been reports of severe and/or immediate allergic reactions, whose symptoms may include hives, facial or throat inflammation, lack of breath, whistling, or fainting. There have also been reports of delayed allergic reactions (serum sickness), which may include symptoms such as fever, joint pain, and skin rash.

Additionally, there have been reports of cardiovascular-related adverse effects, including irregular heartbeat and heart attack in patients treated with BOTOX, sometimes with a fatal outcome. However, some of these patients had a history of cardiac risk factors.

There have been reports of seizures in adults and children treated with BOTOX, mostly in patients with a predisposition to seizures. It is not known if BOTOX can cause these seizures. The seizures reported in children occurred most of the time in patients with cerebral palsy treated for persistent muscle spasms.

If you are administered BOTOX very frequently or the dose is very high, you may experience muscle weakness and adverse reactions related to the spread of the toxin, or your body may start producing some antibodies, which may reduce the effect of BOTOX.

When BOTOX is used for an indication not included in this prospectus, it may lead to severe reactions, especially in patients who have difficulty swallowing or significant muscle weakness.

If you have not done much exercise for a long time before receiving the treatment with BOTOX, after the injections you should start some activity gradually.

It is unlikely that this medication will improve the range of motion of the joints in which the surrounding muscle has lost its ability to stretch.

BOTOX should not be used for the treatment of persistent muscle spasms in the ankle secondary to a stroke in adults if it is not expected to improve function (e.g., walking) or symptoms (e.g., pain), or facilitate patient care. If you had a stroke more than 2 years ago or if the muscle spasm in the ankle is less severe, the improvement related to activities such as walking may be limited. Your doctor will determine if this treatment is appropriate for patients who are more likely to fall.

BOTOX should only be used for the treatment of muscle spasms in the ankle and foot secondary to a stroke after evaluation by healthcare professionals with experience in the management of rehabilitation of patients after a stroke.

When BOTOX is used for the treatment of severe muscle spasms in the eyelid, it may cause you to blink less often, which may damage the surface of your eyes. To prevent this, you may need treatment with eye drops, creams, soft contact lenses, or even a protective cover that closes your eyes. Your doctor will tell you if this is necessary.

When BOTOX is used to control urinary incontinence, your doctor will administer antibiotics before and after treatment to prevent urinary tract infections.

You will schedule an appointment with your doctor approximately 2 weeks after the injection, if you did not use a catheter before the injection.Your doctor will ask you to urinate and then measure the volume of urine that has remained in your bladder using ultrasound.Your doctor will decide if you need to return for this test again during the 12 weeks following.You should contact your doctor if you are unable to urinate at any time, as you may need a catheter.In patients with urinary incontinence due to spinal cord injury or multiple sclerosis, approximately one-third of patients whodo not use a catheter before treatment may need one after treatment.In patients with urinary incontinence due to overactive bladder, approximately 6 out of 100 patients may need to use a catheter after treatment.

Use of BOTOX with other medications:

Inform your doctoror pharmacist if:

?you are taking anyantibiotic(used to treat infections), anticholinesterases, ormuscle relaxants. Some of these medications may increase the effect of BOTOX;

?you have recently been injected with amedication containing a botulinum toxin(the active ingredient of BOTOX), as it may greatly increase the effect of BOTOX;

?you are taking any antiplatelet agents (medications like aspirin) and/or anticoagulants (medications that make the blood more fluid).

Inform your doctor or pharmacist if you are using, have usedrecentlyor may need to use any other medication.

Pregnancy and Lactation

The use of BOTOX is not recommended during pregnancyor in women of childbearing age who are not using contraceptive methodsunless it is absolutely necessary. BOTOX is not recommended in lactating women.

If you are pregnant, in the lactation period, think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machines

BOTOX may cause dizziness, drowsiness, fatigue, or vision problems. If you experience any of these effects, do not drive or operate machines. If you are unsure, ask your doctor for advice.

BOTOX contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per vial; it is essentially “sodium-free”.

BOTOX should only be injected by doctors with specific skills and experience on how to use this medication.

BOTOX should only be prescribed for your chronic migraine if you have been diagnosed by a neurologist who is an expert in this field. BOTOX should be administered under the supervision of a neurologist. BOTOX is not used for acute migraine, chronic tension-type headaches, or for patients with medication-overuse headaches.

Method and route of administration

BOTOX is injected into muscles (intramuscularly), into the bladder wall using a specific instrument (cystoscope) for injection into the bladder or into the skin (intradermally). It is injected directly into the affected area of your body; your doctor will usuallyinject BOTOX at multiple sites within each affected area.

General information on dosing

• The number of injections per muscle and the dose vary depending on the indications. Therefore, your doctor will decide how much, how often, and in which muscle(s) BOTOX will be administered to you. It is recommended that your doctor use the minimum effective dose.
• The doses for elderly patients are the same as for other adults.

The dose of BOTOX and the duration of its effect will vary depending on the disease being treated. The following details are provided for each disease.

BOTOX has been established as safe and effective in children/adolescents over 2 years of age for the treatment of persistent muscle spasms in the ankle and foot, associated with cerebral palsy.

There is limited information on the use of BOTOX in the following indications in children/adolescents over the ages listed in the following table. No dosage recommendation can be made for these indications.

Dosage

The dose of BOTOX and the duration of its effect will vary depending on the condition for which you are being treated. The following details are provided for each condition.

*The doctor may select a dose that makes the treatment last up to 6 months.

Time to Improvement and Duration of Effect

Forpersistent muscle spasms in the ankle and foot in children over 2 years of age,improvement will usually appear within the first 2 weeks following injection

Forpersistent muscle spasms in the wrist and hand of adult patients who have had a stroke,you will usually notice improvement within the 2 weeks following injection. The maximum effect is usually observed 4 to 6 weeks after treatment.

Forpersistent muscle spasms in the ankle and foot of adult patients who have had a stroke, you can receive the treatment again if necessary when the effect starts to wear off, although not more frequently than every 12 weeks.

Foreye spasms and facial spasms,you will usually see improvement within 3 days after injection and the maximum effect is usually seen 1 or 2 weeks after injection.

Forneck and shoulder spasms,you will usually notice improvement within the 2 weeks following injection. The maximum effect is usually seen 6 weeks after treatment.

Foroveractive bladder with urinary incontinence,you will usually see improvement within the first 2 weeks after injection. The effect usually lasts approximately 6-7 months after injection.

Forurinary incontinence due to bladder problems associated with spinal cord injury or multiple sclerosis,you will usually see improvement within the first 2 weeks after injection. The effect usually lasts approximately 8-9 months after injection.

Forexcessive sweating of the armpits,you will usually notice improvement within the first week following injection. The effect usually lasts, on average, 7.5 months after the first injection and approximately 1 in 4 patients still show the effect after 1 year.

If you have received more BOTOX than you should

The signs of excessive BOTOX may not appear immediately after injection. If you ingest BOTOX or it has been accidentally injected into you, you should consult your doctor who will keep you under observation for several weeks.

If you have received too much BOTOX, you may experience some of the following symptoms and should contact your doctor immediately. He/she will decide if you should go to the hospital:

• Muscle weakness that may be local or distant from the injection site;
• difficulty breathing, swallowing, or speaking due to muscle paralysis;
• some food or liquid has accidentally entered your lungs, which may cause pneumonia (lung infection) due to muscle paralysis;
• drooping eyelids, double vision;
• generalized weakness.

If you have any further questions about the use of this product, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Generally, side effects occur during the first few days after injection. They usually last a short time, but can last for several months, and in rare cases, even longer.

IF YOU EXPERIENCE ANY DIFFICULTY INBREATHING,SWALLOWINGORTALKINGBEFORE OR AFTER RECEIVING TREATMENT WITH BOTOX, CONTACT YOUR DOCTOR IMMEDIATELY.

If you experiencehives,inflammationincluding facial or throat inflammation,asthma, sensation ofdizzinessorshortness of breath, contact your doctor immediately.

Side effects are classified into the following categories, depending on how often they occur:

The following list describes side effects that vary depending on the part of the body where BOTOX is injected. If any of the side effects worsen, or if you experience any side effect not listed in this leaflet, please inform your doctor or pharmacist.

Injecting in children with persistent muscle spasms in the foot and ankle

There have been spontaneous reports of rare cases of death sometimes associated with aspiration pneumonia in children with severe cerebral palsy after treatment with BOTOX.

Injecting in the wrist and hand of adult patients who have had a stroke

Injecting in the ankle and foot of adult patients who have had a stroke

Injecting in eyelid and face

Injecting in the neck and shoulders

Injecting in the head and neck for the treatment of headache in patients with chronic migraine

Injecting into the bladder wallfor urinary incontinence due to overactive bladder

* This side effect may also be related to the injection procedure.

** This side effect is only related to the injection procedure.

Injecting into the bladder wall for urinary incontinence due to overactive bladder in pediatric patients

* This side effect is only related to the injection procedure.

Injecting into the bladder wall of adult patients for urinary incontinence due to bladder problems associated with spinal cord injury or multiple sclerosis

* Some of these common side effects may be related to the injection procedure.

Injecting into the bladder wall of pediatric patients for urinary incontinence due to bladder problems associated with spina bifida, spinal cord injury, or transverse myelitis

* This side effect is only related to the injection procedure.

Injecting for excessive sweating in the armpits

The following list describes additional side effects reported for BOTOX, in any condition, since it has been marketed:

• allergic reaction, including protein or serum injection reactions
• inflammation of deep skin layers;
• hives;
• feeding disorders, loss of appetite;
• nerve damage (brachial plexopathy),
• voice and speech problems;
• facial muscle weakness;
• decreased skin sensation;
• muscle weakness;
• chronic disease affecting muscles (myasthenia gravis);
• difficulty moving the arm and shoulder;
• numbness;
• pain/numbness/weakness starting from the spine;
• convulsions and fainting;
• increased intraocular pressure:
• strabismus;
• blurred vision;
• difficulty seeing clearly;
• decreased hearing;
• ear noises;
• dizziness or vertigo;
• heart problems including heart attack
• aspiration pneumonia (inflammation of the lungs caused by accidental passage of food, drink, saliva, or vomit into the lungs);
• breathing difficulties, respiratory depression, and/or respiratory insufficiency;
• abdominal pain;
• diarrhea, constipation;
• dry mouth;
• difficulty swallowing;
• nausea, vomiting;
• hair loss;
• itching;
• different types of skin rashes with red patches;
• excessive sweating;
• loss of eyelashes/eyebrows
• muscle pain;
• nerve conduction problems to the muscle/muscle retraction;
• general feeling of being unwell;
• fever;
• dry eyes (associated with injections around the eyes);
• muscle spasms or contractions.
• eyelid swelling

Reporting of side effects:

If you experienceany type of side effect, consult your doctor or pharmacist, even if it is apossibleside effect not listed in this leaflet.You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep out of sight and reach of children.

Your doctor should not use BOTOX after the expiration date that appears on the packaging after “EXP”. The expiration date is the last day of the month indicated.

Store in refrigerator (2 °C to 8 °C) or store in freezer (-5 °C to -20°C).

After preparing the solution, it is recommended to use the solution immediately; however, it can be stored for up to 24 hours in refrigerator (2 °C to 8 °C).

Composition of BOTOX

• The active ingredient is:Toxin Botulinum* type A from Clostridium botulinum.Each vial contains 50, 100 or 200 Allergan Units of botulinum toxin type A.
• The other components are human albumin and sodium chloride.

Aspect of the product and content of the packaging

BOTOX is presented as a fine white powderthat may be difficult to see at the bottom ofa transparent glass vial. Before injection, the product must be dissolved in a sterile, non-preserved normal saline solution (sodium chloride 0.9% injectable solution).Each package contains 1, 2, 3, or 6 vials. In addition, the 50 and 100 Allergan Units of botulinum toxin type A formats may also be presented in 10-vial packages.

Only some package sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

AbbVie Spain, S.L.U.

Avenida de Burgos 91,

28050 Madrid, Spain

Responsible for manufacturing:

Allergan Pharmaceuticals Ireland

Castlebar Road

County Mayo

Ireland

Last review date of this leaflet:April 2024

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/

The following information is exclusively for healthcare professionals:

Please refer to the Technical Dossier for the complete prescribing information for BOTOX.

The botulinum toxin unitsare not interchangeable between products. The recommended doses in Allergan Units are different from those of other botulinum toxin products.

BOTOX should only be administered by doctors with the appropriate qualifications and experience in the treatment and use of the required equipment.

Chronic migraine should be diagnosed and BOTOX should be administered exclusively under the supervision of neurologists who are experts in the treatment of chronic migraine.

BOTOX is indicated for the treatment of: focal spasticity of the foot and ankle inpediatric patients, aged two or more years;focal spasticity of the wrist and hand secondary to stroke in adults;focal spasticity of the foot and ankle secondary to stroke in adults;blepharospasm, hemifacial spasm, and focal dystonias;cervical dystonia (torticollis spasmodica);relief of symptoms in adults who meet the criteria for chronic migraine (headaches in ≥15 days per month, of which at least eight days correspond to migraine), in patients who have not responded adequately or are intolerant to migraine prophylactic medications;idiopathic detrusor overactivity with urinary symptoms of incontinence, urgency, and frequency in adult patients who have not responded adequately or are intolerant to anticholinergic medications;urinary incontinence in adults with neurogenic detrusor overactivity due to spinal cord injury or multiple sclerosis;severe and persistent axillary hyperhidrosis that interferes with daily activities and is resistant to topical treatment.

No safety and efficacy have been established for BOTOX in pediatric indications other than those described in Section 4.1 of the Technical Dossier. No dosage recommendations can be made for indications other than focal spasticity in pediatric patients associated with cerebral palsy. The available data by indication are described in Sections 4.2, 4.4, 4.8, and 5.1 of the Technical Dossier, as shown in the following table.

No specific dose adjustment is required for elderly patients. The initial dose should start with the lowest recommended dose for each indication. For repeated injections, the lowest effective dose with the longest clinically indicated interval should be recommended. Patients with a significant clinical history and concomitant medication should be treated with caution.

Generally, optimal dose levels and number of injection points per muscle have not been established for all indications. In these cases, the doctor should establish an individual treatment regimen. The optimal dose levels should be determined by individual adjustment, but should not exceed the maximum recommended dose. As with any pharmacological treatment, the initial dose in a new patient should be the minimum effective dose.

Dosage and administration method (please see Section 4.2 and 4.4 of the Technical Dossier for more information).

Focal spasticity of the lower limb in pediatric patients

The recommended dose for treating lower limb spasticity in pediatric patients is 4 Units/kg to 8 Units/kg of body weight or 300U, whichever is less, divided among the affected muscles. When treating both lower limbs, the total dose should not exceed 10 Units/kg of body weight or 340 Units, at an interval of 12 weeks.

* Not exceeding a total dose of 150 Units

** Not exceeding a total dose of 300 Units

Focal spasticity of the upper and lower limbs secondary to stroke:

BOTOX is a treatment for focal spasticity that has only been studied in association with standard treatment regimens and is not indicated as a substitute for these therapeutic modalities. It is likely that BOTOX will not be effective in improving joint mobility in a joint affected by a fixed contracture.

Focal spasticity of the upper limb secondary to stroke:

*When injecting lumbricals and/or interosseous muscles, the maximum recommended dose is 50 U per hand.

The recommended dose for treating upper limb spasticity in adults is up to 240Units divided among the affected muscles as indicated in the table above. The maximum dose per treatment is 240Units.

The exact dose and number of injection points should be individualized based on the size, number, and location of the affected muscles, the severity of spasticity, the presence of muscle weakness, and the patient's response to treatment.

Focal spasticity of the lower limb secondary to stroke:

The recommended dose for treating lower limb spasticity in adults affecting the ankle and foot is 300Units to 400 Units divided among up to 6 muscles.

Blepharospasm/Hemifacial spasm:

A reduction in blinking after botulinum toxin injection in the orbicularis oculi muscle may cause corneal pathology. The corneal sensitivity should be carefully evaluated in previously operated eyes, avoid injecting in the lower eyelid area to prevent ectropion, and use vigorous treatment of any epithelial defect. This may require protective drops, ointments, soft therapeutic contact lenses, or closure of the eye with a patch or other means.

Cervical dystonia:

The list of muscles is not exhaustive, as any muscle responsible for controlling head position may be involved and therefore require treatment.

Chronic migraine

The recommended dose of reconstituted BOTOX for the treatment of chronic migraine is 155 Units to 195 Units, administered intramuscularly (IM), with a 30-gauge, 1.25 cm long needle, with injections of 0.1ml (5 Units), in 31 to 39 points. The injections should be divided among seven specific muscle groups of the head and neck, as specified in the following table. A 2.5 cm needle may be required in the neck region for patients with thick neck muscles.Except for the procerus muscle, which should be injected in one point (midline), all muscles should be injected on both sides, administering half the number of injections on the left side of the head and neck, and the other half on the right.If there is one or more predominant locations of pain, more injections can be administered on one or both sides, up to three specific muscle groups (occipital, temporal, and trapezius), up to the maximum dose per muscle indicated in the following table.

a1 IM injection point = 0.1 ml = 5Units of BOTOX

bDose distributed on both sides.

Urinary incontinence due to detrusor overactivity

The recommended dose is 100 Units of BOTOX in injections of 0.5 ml (5 Units) administered in 20 points of the detrusor, avoiding the trigone and base.

Urinary incontinence due to neurogenic detrusor overactivity:

The recommended dose is 200 Units of BOTOX in injections of 1 ml (approximately 6.7 Units) administered in 30 points of the detrusor, avoiding the trigone and base.

Axillary hyperhidrosis::

A medical history and physical examination, along with specific additional complementary tests as required, should be performed to exclude potential secondary causes of hyperhidrosis (e.g., hyperthyroidism, pheochromocytoma). This will prevent the symptomatic treatment of hyperhidrosis without diagnosing and/or treating the underlying disease.

For all indications::

Systemic adverse reactions related to the toxin spreading away from the injection site have been reported, sometimes resulting in death, and in some cases associated with dysphagia, pneumonia, and/or significant weakness. Symptoms are consistent with the mechanism of action of the toxin and have been reported from hours to weeks after injection. The risk of symptoms is likely higher in patients with underlying conditions and comorbidities that may predispose them to these symptoms, including children and adults treated for spasticity, and those being treated with high doses.

Patients treated with therapeutic doses may also experience excessive muscle weakness.

Pneumothorax associated with the injection procedure has been reported after administering BOTOX near the chest. Caution should be exercised when injecting near the lung, particularly the apices or other vulnerable anatomical structures.

Severe adverse reactions, including fatal outcome in patients who received BOTOX injections outside the indication, directly into the salivary glands, oropharyngeal and lingual region, esophagus, and stomach have been reported. Some patients had pre-existing dysphagia or significant weakness.

Rare cases of death, sometimes associated with aspiration pneumonia in children with severe cerebral palsy after treatment with botulinum toxin, including off-label use (e.g., in the neck area), have been reported. Extreme caution should be exercised when treating pediatric patients with significant neurological weakness, dysphagia, or recent history of aspiration pneumonia or pulmonary disease. Treatment should only be administered to those patients with a poor underlying health status if it is considered that the potential benefit to the individual patient outweighs the risks.

Occasionally, anaphylactic reaction may occur after botulinum toxin injection. Therefore, epinephrine (adrenaline) and other antianaphylactic measures should be available.

See the BOTOX Technical Dossier for complete information.

In the event of treatment failure after the first treatment session, for example, absence, one month after injection, of significant clinical improvement, the following actions should be taken:

• Clinical verification, which may include electromyographic examination by a specialist,of the toxin's action in the injected muscle(s);
• Analysis of the cause of failure, e.g., poor muscle selection, insufficient doses, poor injection technique, appearance of fixed contracture, antagonist muscles too weak, formation of neutralizing antibodies to the toxin;
• Re-evaluation of the appropriateness of treatment with type A botulinum toxin;
• In the absence of any undesirable secondary effect after the first treatment session, a second treatment should be performed as follows: a) adjust the dose, taking into account the analysis of the previous treatment failure, b) use EMG, and c) maintain an interval of 3 months between two treatment sessions.

In the event of treatment failure or reduced effect after repeated injections, alternative treatment methods should be used.

Reconstitution of the medication:

If different vial sizes of BOTOX are used as part of a 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 Units Allergan, BOTOX 100 Units Allergan, and BOTOX 200 Units Allergan. Each syringe should be appropriately labeled.

A good practice is to perform the reconstitution of the vial and preparation of the syringe on paper towels with plastic coating to collect any possible spillage.

BOTOX should only be reconstituted with sterile, non-preserved normal saline solution (sodium chloride 0.9% injectable solution). Aspirate the appropriate amount of diluent (see instructions or dilution table below) with a syringe.

Instructions for dilution for the treatment of urinary incontinence due to detrusor overactivity:

It is recommended to use a vial of 100 Units or two vials of 50 Units as it is more convenient to reconstitute.

If you need to use a vial of 200 Units, reconstitute avial of 200 Unitsof BOTOX with 8 ml of sterile, non-preserved normal saline solution (sodium chloride 0.9% injectable solution) and mix the vial gently. Extract 4 ml from the vial in a 10 ml syringe. Complete the reconstitution by adding 6 ml of sterile, non-preserved normal saline solution (sodium chloride 0.9% injectable solution)in the 10 ml syringe, and mix gently. You will obtain a 10 ml syringe containing a total of 100 Units of reconstituted BOTOX. Use immediately after reconstitution in the syringe. Discard unused saline solution.

Reconstitutea vial of 100 Unitsof BOTOX with 10 ml of sterile, non-preserved normal saline solution (sodium chloride 0.9% injectable solution)and mix gently. Extract the 10 ml from the vial in a 10 ml syringe. You will obtain a 10 ml syringe containing a total of 100 Units of reconstituted BOTOX. Use immediately after reconstitution in the syringe. Discard unused saline solution.

Reconstitutetwo vials of 50 Unitsof BOTOX, each with 5 ml of sterile, non-preserved normal saline solution (sodium chloride 0.9% injectable solution)and mix each vial gently. Extract the 5 ml from each vial in a single 10 ml syringe.You will obtain a single 10 ml syringe containing a total of 100 Units of reconstituted BOTOX. Use immediately after reconstitution in the syringe. Discard unused saline solution.

This product is for single use only, and any unused reconstituted product should be discarded.

Instructions for dilution for the treatment of urinary incontinence due to neurogenic detrusor overactivity:

It is recommended to use a vial of 200 Units or two vials of 100 Units as it is more convenient to reconstitute.

Reconstitute avial of 200 Unitsof BOTOX with 6 ml of sterile, non-preserved normal saline solution (sodium chloride 0.9% injectable solution) and mix the vial gently. Extract 2 ml from the vial in each of the three 10 ml syringes. Complete the reconstitution by adding 8 ml of sterile, non-preserved normal saline solution (sodium chloride 0.9% injectable solution)in each of the 10 ml syringes, and mix gently. You will obtain three 10 ml syringes containing a total of 200 Units of reconstituted BOTOX. Use immediately after reconstitution in the syringe. Discard unused saline solution.

Reconstitutetwo vials of 100 Unitsof BOTOX, each with 6 ml of sterile, non-preserved normal saline solution (sodium chloride 0.9% injectable solution)and mix the vials gently. Extract 4 ml from each vial in each of the two 10 ml syringes. Extract the 2 ml remaining from each vial in a third 10 ml syringe. Complete the reconstitution by adding 6 ml of sterile, non-preserved normal saline solution (sodium chloride 0.9% injectable solution)in each of the 10 ml syringes, and mix gently. You will obtain three 10 ml syringes containing a total of 200 Units of reconstituted BOTOX. Use immediately after reconstitution in the syringe. Discard unused saline solution.

If you need to use vials of 50 Units, reconstitutefour vials of 50 Unitsof BOTOX, each with 3 ml of sterile, non-preserved normal saline solution (sodium chloride 0.9% injectable solution)and mix the vials gently. Extract 3 ml from the first vial and 1 ml from the second in a 10 ml syringe. Extract 3 ml from the third vial and 1 ml from the fourth in a second 10 ml syringe. Extract the 2 ml remaining from the second and fourth vials in a third 10 ml syringe. Complete the reconstitution by adding 6 ml of sterile, non-preserved normal saline solution (sodium chloride 0.9% injectable solution)in each of the three 10 ml syringes, and mix gently. You will obtain three 10 ml syringes containing a total of 200 Units of reconstituted BOTOX. Use immediately after reconstitution in the syringe. Discard unused saline solution.

Dilution table for BOTOX 50, 100, and 200 Units Allergan vials for other indications:

Страна регистрации

Spain

Активное вещество

Toxina botulinica tipo a

Требуется рецепт

Да

Производитель

Abbvie Spain, S.L.U.

Состав

Cloruro de sodio (0,9 mg mg)

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