Botulinum toxin Type A injection is treated with neurological disorders, bladder disorders, skin disorders (1 bottle)
Dosage form 1 bottle box
Specifications Albumin
Ingredient Allergan
Ingredient
| Composition information | Content |
| Albumin | 0.05mg |
Uses
Indications
neurological disorders:
Botulinum Toxin Type A Botox is designated to treat symptoms of:
Preventive headache in adults with chronic migraine (headache at least 15 days per month, at least 8 days with migraine).
Bladder disorders:
Excessive neuromuscular activity with uncontrolled urinary trauma due to cervical spinal cord injury (injury or non -injury), or multiple sclerosis.
Skin and tissue disorders:
Pharmacy
The active component in botox is a protein complex derived from Clostridium Botulinum. Protein includes neurotoxin type A and some other proteins.
Clostridium Botulinum Toxin Type A Neurotoxin Complex prevents the release of peripheral acetyl choline at the ends of the cholinergic nerves before Synap.
Intramuscular intramuscular neurotoxin complex prevents cholinergic transport at the nerve connection by preventing the release of acetylcholine. The nerve ends of the neuromuscular point no longer respond to nerve impulses and the secretion of chemical transmission is prevented (reducing chemicals).
Clinical evidence shows that botox relieves pain and neuritis and improves the threshold of heat caused by skin in a triple -sensitive sensitive model caused by capsaicin. The recovery process after intramuscularly takes place normally within 12 weeks of intramuscular injection when the nerve ends germinate and reconnect to the endothelium.
After injection in the skin, where the target is sweat glands, the effect lasts about 4-7 months in patients treated with 50 units of each armpit.
There is very little clinical trial experience on the use of botox in the increase in primary armpit sweat in teenagers aged 12 to 18.
Botox prevents the release of neurotransmitters associated with the source of the pain. The prophylactic mechanism is thought to be by preventing peripheral signals from the central nervous system, inhibiting the central sensitivity, as proposed by precantic and clinical pharmacological studies.
After injection, botox affects the effective paths of detrusor activities through inhibition of acetylcholine release. In addition, botox inhibits neurotransmitter in mind and sensory nerves.
pharmacokinetics
General characteristics of the active ingredient:
Classic studies on absorption, distribution, biological conversion and removal on active ingredients have not been performed due to the toxicity of Botulinum Toxin Type a.
Characteristics in patients:
ADME studies have not been conducted due to the nature of the product. It is believed that less body distribution of botox treatment dose. Botox can be metabolized by protease and molecular components that are recycled through normal metabolic roads.
Before taking Botulinum toxin Type A injection is treated with neurological disorders, bladder disorders, skin disorders (1 bottle)
How to use
Inject it.
Botulinum toxin units cannot be swapped from each other from one product to another. The recommended dose in Allergan Units is different from other Botulinum toxin preparations.
Botox should only be used by a doctor with qualifications in accordance with expertise in treating related indications and using necessary equipment, in accordance with national instructions.
This product is only used once and any solution is not used, so it is removed. The most suitable vial size should be selected for indications.
Should use a volume of about 0.1 ml. Botox dose can be reduced or increased by using a smaller or larger injection volume. The smaller the vol This is beneficial in reducing the impact on neighboring muscles when injecting small muscle groups.
Refer to specific instructions for each specified specified description below.
In general, the valid optimization dose and the number of injection sites on each muscle has not been agreed for all indications. In these cases, personal treatment regimen, therefore, is due to the doctor with appropriate professional qualifications. The optimal dose level should be determined by titration but not exceeding the recommended maximum dose.
Dosage
Neurological disorders
The local spasm in the child in the child
needle type
A sterile needle is suitable. The needle length should be determined based on the position and depth of the muscle.
should determine the position of related muscles by techniques such as needle electrical instructions, nerve stimulation or ultrasound. Before the injection, local anesthesia or local anesthesia can be combined with minimum or medium sedative drugs, depending on the reality. The safety and effectiveness of botox in the treatment of spasticity in children has not been evaluated when the whole body anesthesia or sedative/ deep pain.
The following diagram indicates the injection site for children on the above spasticity:
recommended doses to treat spastic spasticity in children is 3 units/kg to 6 units/kg body weight divided by affected muscles.
botox dosage according to muscle for children with spasticity on
Botox 3 units/kg (maximum unit per muscle)
Botox 6 units/kg (maximum unit per muscle)
The amount of injection
1.5 units/kg (50 units)
3 units/kg (100 units)
4
elbow 1 unit/kg (30 units) 2 units/kg (60 units)
2
0.5 units/kg (20 units)
1 unit/kg (40 units)
2
1 unit/kg (25 units)
2 units/kg (50 units)
2
1 unit/kg (25 units)
2 units/kg (50 units)
2
0.5 units/kg (25 units)
1 unit/kg (50 units)
2
0.5 units/kg (25 units)
1 unit/kg (50 units)
2
The total dose of botox for each treatment in the upper limb does not exceed 6 units/ kg body weight or 200 units, depending on which value is lower. If the treating doctor is suitable, the patient should be considered for re -injection when the clinical effect of the previous injection has decreased, not earlier than 12 weeks after the previous injection. When treating the upper and lower expenditure, the total dose must not exceed the lower level of 10 units/kg body weight or 340 units, for a period of 12 weeks.
More information Botox treatment is not to replace the standard recovery regimen. Clinical improvement usually occurs within the first two weeks after injection. Repeated treatment should be done when the clinical effect of the previous injection decreases but not regularly every 12 weeks. needle type A sterile needle is suitable. The needle length should be determined based on the position and depth of the muscle. should determine the position of related muscles by techniques such as needle electrical instructions, nerve stimulation or ultrasound. Before the injection, local anesthesia or local anesthesia can be combined with minimum or medium sedative drugs, depending on the reality. The safety and effectiveness of botox in the treatment of spasticity in children has not been evaluated when the whole body anesthesia or sedative / deep pain. The following diagram shows the injection site for the lower spasticity: Recommended doses for lower spasticity in children are 4 units/ kg to 8 units/ kg body weight divided by affected muscles. botox dosage by muscle for lower spasticity in children Botox 4 units/kg (maximum unit per muscle) Botox 8 units/kg (maximum unit per muscle) The amount of injection 1 unit/kg (37.5 units) 2 units/kg (75 units) 2 1 unit/kg (37.5 units) 2 units/kg (75 units) 2 Soleus 1 unit/kg (37.5 units) 2 units/kg (75 units) 2 Tibialis Posterior 1 unit/kg (37.5 units) 2 units/kg (75 units) 2 The total dose of botox used in each lower limb treatment must not exceed 8 units/kg body weight or 300 units, depending on which value is lower. If the treating doctor is suitable, the patient should be considered for re -injection when the clinical effect of the previous injection has decreased, not earlier than 12 weeks after the previous injection. When treating both lower or upper and lower limbs, the total dose must not exceed the lower level of 10 units/kg body weight or 340 units, for a period of 12 weeks. More information Botox treatment is not to replace the standard recovery regimen. Clinical improvement usually occurs within the first two weeks after injection. Repeated treatment should be done when the clinical effect of the previous injection decreases but not regularly every 12 weeks. needle type Kim 25, 27 or 30 sterile. The needle length should be determined based on the position and depth of the muscle. should determine the location of the related muscles by techniques such as mechanical instructions, nerve stimulation or ultrasound. Many injection sites may allow Botox to exposure more evenly with the inner areas of the muscle and especially useful in larger muscles. Dosage and the number of accurate injection sites can be adjusted to suit each individual based on the size, quantity and position of the relevant muscles, the severity of spasticity, the presence of local muscle weakness and the patient's reaction to previous treatment. Total dose, number of injections 15 - 50 units; 1-2 positions 15 - 50 units; 1-2 positions flexor carpi radialis 15 - 60 units; 1-2 positions 10 - 50 units; 1-2 positions 20 units; 1-2 positions 20 units; 1-2 positions From 200 to 240 units are divided by the chosen muscles. More information If the health care doctor is appropriate, patients should be considered for re -injection when the clinical effect of the previous injection has decreased. The re -injection must be done not earlier 12 weeks after the previous injection. The level and type of muscle spasticity at the time of injection may need to change the dose of botox and muscle injected. The lowest dose is effective should be used. needle type Kim 25, 27 or 30 sterile. The needle length should be determined based on the position and depth of the muscle. should determine the location of the related muscles by techniques such as mechanical instructions, nerve stimulation or ultrasound. Many injection sites may allow Botox to exposure more evenly with the inner areas of the muscle and especially useful in larger muscles. The following diagrams indicate the injection site for lower spasticity in adults: 300 units to 400 units are divided by up to 6 muscles, as listed in the following table. Recommended doses (Total dose - Quantity of injection) MediaL Head Lateral Head 75 units; 3 positions 75 units; 3 positions Soleus 75 units; 3 positions Tibialis Posterior 75 units; 3 positions Flexor Hallucis Longus 50 units; 2 positions Flexor Digitorum Longus 50 units; 2 positions 25 units; 1 Location 400 units More information If the treating doctor is appropriate, the patient should be considered for re -injection when the clinical effect of the previous injection has decreased, not earlier than 12 weeks after the previous injection. needle type sterile, size 27-30/needle 0.40-0.30 mm. Initial recommendations are 1.25 - 2.5 units (volume of 0.05 - 0.1 ml at each position) is injected into the middle and side brain of the orbicularis side of the upper lid and the side of the Orbicularis in the lower lid. It is also possible to inject other positions in the eyebrow area, the side of the flesh and the upper area of the face if the spasm here obstructs the vision. The following diagrams indicate the possible injection site: The initial dose must not exceed 25 units per eye. In the management of brain spasms, the total dose must not exceed 100 units out of the total 12 weeks. Additional information Avoiding the injecting near the hand of the hand may reduce the complications of PTOSIS. Avoid getting into the lower lid, and thus reduces the diffusion into the lower skewer, can reduce the view of a double view. In general, the initial effectiveness of the positions is seen within three days and reaches its peak at one to two weeks after treatment. Each treatment lasts about three months, then this process may be repeated indefinitely. Normally, no additional benefits are given when treated more often every three months. In repeated treatments, the dose may increase twice if responding from the initial treatment is considered insufficient - often defined as the effect that does not last more than two months. However, it seems that there are very little benefits from the injection of more than 5 units on each website. Patients with facial spasms or VII nerve disorders should be treated as for one side of the brain spasm, with other affected facial muscles injected when necessary. Electromechanical control may be necessary to identify the muscles around the small temple. needle type Can use needles 25, 27 or 30 gauge/0.50-0.30 mm for agricultural muscles and needle 22 can be used for deeper muscles. Treatment of cervical disorders can often include botox injection into sternocleidomastoids, levator scapulae, fish scales, liditis, bust, longissimus and/or (site) of trapezoid. This list is incomplete because any muscle is responsible for controlling the head posture may be related and therefore need to be treated. Mechanical mass and hypertrophy are factors that need to be considered when choosing the appropriate dosage. Muscle activation types may change spontaneously in cervical disorders without changing the clinical manifestations of muscle disorders. In case there is any difficulty in isolating individual muscles, it should be injected under the support of electromechanical. Many injection sites allow Botox to exposure more evenly with the inner areas of dysplasia and especially useful in larger muscles. The optimal number of injection site depends on the size of the reducing chemical muscle. Dosage must be adjusted to suit each patient based on the patient's head and neck position, pain, muscle hypertrophy, body weight of the patient and the patient's reaction. Initial dose in an unknown patient should start at the lowest dose effectively. To minimize the difficulty of swallowing, do not injection of sternomastoids on both sides. Head rotated toWARD Side of Shoulder Elevation sternomastoid levator scapulae scalene splenius capitis trapezius 50 - 100 units; At least 2 positions 50 units; 1 - 2 positions 25 - 50 units; 1 - 2 positions 25 - 75 units; 1 - 3 positions 25 - 100 units; 1 - 8 positions Type II head rotation only sternomastoid 25 - 100 units; At least 2 positions if over 25 units type III Head Tilted Toward Side of Shoulder Elevation sternomastoid levator scapulae scalene trapezius 25 - 100 units in the posterior Border; At least 2 positions if over 25 units 50 units; 1 - 2 positions 25 - 50 units; 1 - 2 positions 25 - 75 units; 1 - 3 positions 25 - 100 units; 1 - 8 positions type IV Bilateral Posterior Cervical Muscle Spasm with Elevation of the Face Splenius Capitis and Cervicis 50 - 200 units; 2 - 8 positions, bilateral treatment (This is the total dose, not the dose for each neck) Should not be injected more than 50 units at any injection position. Do not give more than 100 units for sternomastoids. Total should not be injected more than 200 units for the first treatment, with the adjustments made in the next round depending on the initial reaction, up to the maximum total dose of 300 units. More information The treatment period of less than 10 weeks is not recommended. needle type A sterile measure, 0.5 inch. may need a 1 -inch needle in the neck area for patients with too thick neck muscles. The injections should be divided into 7 specifically specified specifications as specified in the diagram below. With the exception of the sternum muscle, it should be injected in one position (mid lane), all muscles should be injected by half of the sides of the injection site on the left and half on the right of the head and neck. The following diagrams indicate the injection site: If there is (s) the main sore position, can be added to one or both parties at a maximum of 3 specific muscle groups (muscle, temples and muscle ladders), with maximum dosage for each muscle as specified in the table below. The following diagrams show that the muscle groups are recommended for additional injections: 155 units to 195 0.1 ml intramuscularly (5 units) injected to 31 and up to 39 positions. Recommended dose Total dose (number of positions) Corrugator ** 10 units (2 positions) 5 units (1 position) Frontalis ** 20 units (4 positions) Temporalis ** 40 units (8 positions) to 50 units (about 10 positions) 30 units (6 positions) to 40 units (about 8 positions) 20 units (4 positions) trapezius ** 30 units (6 positions) to 50 units (about 10 positions) Total dose 155 units to 195 units 31 to 39 positions ** Bilateral dosage Infer information Recommended recommendations for treatment every 12 weeks Excessive bladder needle type Genetic needles should be filled with (ready -made) with about 1 ml of Botox solution before starting the injection (depending on the needle length) to remove the air. Botox reconciled solution (100 units/10 ml) is injected through soft or hard bladder screens, avoiding trigone and base. Should be small into the bladder with enough salt water to be able to see all the injections and avoid the product flowing backwards, but should avoid excessive tension. The needle must be plugged in about 2 mm into the cutter and 20 times of 0.5 ml of injection at a time (total volume of 10 ml) should be about 1 cm apart (see the picture below). For the final injection, it is recommended to inject about 1 ml of normal physiological saline sterile (0.9% sodium chloride to inject) to inject enough dose. Recommended doses are 100 botox units, injection 0.5 ml (5 units) on 20 positions in muscles. More information After injecting the drug, do not withdraw the salt water to imagine the bladder so that the patient can prove their diarrhea before leaving the clinic. Patients should be monitored for at least 30 minutes after injection and until the spontaneous space appears. Patients should be considered to re -eliminate when the clinical effect of the previous injection has decreased but not 3 months earlier from the previous bladder injection. needle type Genetic needles should be filled with (ready -made) with about 1 ml of Botox solution before starting the injection (depending on the needle length) to remove the air. Botox reconciliation solution (200 units/30 ml) is injected through soft or hard bladder screens, avoiding trigone and base. Should be small into the bladder with enough salt water to be able to see all the injections and avoid the product flowing backwards, but should avoid excessive tension. The needle must be included in the cutting machine about 2 mm and 30 times 1 ml each time (total volume of 30 ml) should be about 1 cm apart (see the picture above). For the final injection, it is recommended to inject about 1 ml of normal physiological saline sterile (0.9% sodium chloride for injection) to inject enough dose. After injection, salt water should be used to imagine the bladder. recommended dose is 200 botox units, 1 ml injection (~ 6.7 units) on 30 positions in muscles. More information Patients should be considered to remove the type when the clinical effect of the previous injection has decreased, but not 3 months earlier from the previous bladder injection. There is no data on dynamic diuretic in addition to 2 treatments and no pathological tissue data after repeated treatment. Patients should not be treated many times in case of improvement of limited symptoms. Primary Hyperhidrosis of the Axillae needle type A sterile 30 metal The injected hyperhidrotic area can be determined by using standard dyeing techniques, for example: Iodine-iodine test. 50 botox units are injected in the skin to each axon, evenly distributed in many places about 1-2 cm apart. The injection volume for injection in the skin is 0.1-0.2 ml. Should not use other doses more than 50 units per axis. More information Clinical improvement usually occurs in the first week after injection and lasting for 4-7 months. Can be injected with botox repeated when the clinical effect of the previous injection decreases and the health care doctor is necessary. Injecting should not be repeated regularly every 16 weeks. needle type A sterile 30 metal. before the injection, the thumb or index finger must be firmly placed under the orbit rim to prevent the circuit below the trajectory rim. The needle must be directed to the top and the middle during the injection. In addition, it is necessary to avoid injecting near the upper muscle, especially in patients with a larger muscle complex. Injecting into folding muscles must be performed in the center of that muscle, at least 1 cm away from you (see picture). Be careful to ensure that Botox is not injected into the blood vessels when it is injected into the runways to see the maximum frown. A volume of 0.1 ml (4 units) is injected into each position of the 5 injection site (see picture): 2 times injected into each folding muscle and 1 injection into the breast muscle with a total dose of 20 units. To minimize the risk of eyelid collapse, do not exceed the maximum dose of 4 units for each injection site as well as the number of injection sites. More information The treatment period is not more often every three months. In case of failure or reducing effects after repeated injection, alternative treatments should be applied. In case of not enough dose, it is advisable to start the second treatment by adjusting the total dose of up to 40 or 50 units, taking into account the previous analysis of treatment failure. Efficiency and safety of botox repeat injections to treat wrinkles after 12 months have not been evaluated. needle type A sterile 30 metal. Inject should be injected with a beveled needle and facing away from the eyes. The first injection (A) should be made about 1.5 to 2.0 cm of the temple for the side canthus and the temples with the orbit rim. If the lines in the crow's feet are above and below the side of the crow's feet, inject as shown in Figure 1. To reduce the risk of eyelid collapse, it is recommended to be injected into the temporal area to the trajectory rim, thus maintaining a safe distance to the height of the eyelid. Be careful to ensure that botox is not injected into the blood vessels when it is injected into crow's feet visible at the maximum smile. A volume of 0.1 ml (4 units) is injected at each of the 3 injection site on each side (total of 6 injection site) in the Orbicularis Oculi muscle, with a total dose of 24 units in the total volume of 0.6 ml (12 units on each side). For simultaneous treatment with Glabellar lines seen when frowning maximum, the dosage is 24 units for crow's feet to see at the maximum smile and 20 units for the glabellar lines with a total dose of 44 units in the total weight of 1.1 ml. To minimize the risk of eyelid collapse, do not exceed the maximum dose of 4 units for each injection site as well as the number of injection sites. More information Duration of treatment must not be frequent every 3 months. Efficiency and safety of botox repeat injections to treat crow's feet after 12 months have not been evaluated. needle type A sterile 30 metal. To determine the location of the appropriate injection site in the forehead muscle, it is necessary to assess the overall relationship between the forehead size of the object and the distribution of the forehead function. The following horizontal treatment should be determined by gently touching the forehead in the resting state and maximum eyebrow height: A volume of 0.1 ml (4 units) is injected into each position of the 5 injection site in the forehead muscle, with a total dose of 20 units in the total volume of 0.5 ml. The total dose to treat the forehead lines (20 units) combined with the Glabellar line (20 units) is 40 units/1.0 ml. For simultaneous treatment with wrinkles and crow's feet, the total dose is 64 units, including 20 units for the forehead line, 20 units for the glabellar line (see recommended dosage for the road and crow's feet) and 24 units for crow's feet. More information Duration of treatment must not be frequent every 3 months. Efficiency and safety of botox repeat injections to treat wrinkles on the forehead after 12 months have not been evaluated. Dosage for elderly patients is the same as for young people. The initial dose should start at the lowest recommended dose for specific indications. Elderly patients have a significant history of disease and concurrent drugs should be treated carefully. There are some limited data in patients over 65 years old managed by botox about the non -autonomous urination due to excessive activity that stimulates nervous, ankle and feet disabled due to stroke and face -related spasms. Pediatric patients The safety and effectiveness of botox in other indications with indications for children has not been set. No recommendations are given to non -local indications in children related to cerebral palsy. Botox should only be done by doctors with appropriate qualifications, experienced people in evaluating and treating localized spasms in children and as part of the rehabilitation program. Localized spasms in children 2 years 12 years 12 years (less experience among teenagers from 12 to 17 years old) In case of failure to treat after the first treatment, that is, absent, after an injection, with a significant improvement in clinically compared to the original, the following actions should be taken: In case of failure or reduced effects after the injection repeatedly replaced treatments should be applied. When treating adult patients as prescribed, the maximum accumulation do not exceed 400 units in a period of 12 weeks. When treating pediatric patients, even when treated according to many indicators, the maximum accumulation do not exceed less than 10 units/kg body weight or 340 units, for a period of 12 weeks. Note: The above dose is for reference only. Specific dosage depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist. What to do when using overdose? There is no case of any systemic poisoning due to accidental botox injection. Excessive dose can cause paralysis of local or far, general and deep nerves. There is no case of swallowing botox. Signs and symptoms of an overdose are unclear immediately after injection. If accidentally injected or swallowed or suspected of overdose, patients should be monitored for health for a few weeks to find signs and symptoms of progressive muscle weakness, which can be located or away from the injection site and may include half -human paralysis, double look, swallowing difficult. , digestive disorders, body weakness or respiratory failure. These patients should be considered for further health assessment and appropriate medical therapy immediately, may include hospitalization. If the muscles of the throat and esophagus are affected, it may occur in the condition of the fluid and lead to the development of pneumonia due to inhalation. If the respiratory muscles are paralyzed or weakened to the extent, the intubation and respiration need to be placed until recovery and may need to open the trachea and prolonged mechanical ventilation, in addition to other common support care. In an emergency, call the 115 emergency center immediately or go to the nearest local health station. What to do when you forget a dose? However, if close to the next dose, skip the forgotten dose and take the next dose at the time as planned. Note that it should not be used double the prescribed dose.
Side Effects
When using Botulinum Toxin Type A Botox, unwanted effects (ADR) such as:
Common, ADR> 1/100
Respiratory system: Respiratory infections.
Uncommon, 1/1000 Instructions on how to handle ADR When experiencing side effects of the drug, it is necessary to stop using and notify the doctor or go to the nearest medical facility for timely treatment.
Warnings
Before using the drug you need to read the instructions carefully and refer to the information below.
Contraindicated
Botulinum toxin Type A Botox injection drug in the following cases:
The presence of infection at the proposed injection site. To control bladder disorders: Urinary tract infections at the time of treatment; Acute urinary retention at the time of treatment, in patients who do not place regular urinary tract; Patients are not ready and/or may start placing a catheter after treatment if required; The presence of bladder stones. Dosage and frequency of use of botox are recommended not to exceed due to the potential for overdose, excessive weakness, toxins spread far away and forming neutralized antibodies. Initial doses in patients who have never been treated should start with the lowest recommended dose for specific indications. This drug product contains less than 1 mmol sodium (23 mg) each vial, which is basically "no sodium". prescribed people and patients should note that the side effects may occur even though previous injections are well tolerated. Therefore, be careful in each use. Side effects related to the propagation of toxins away from the report have been reported, sometimes leading to death, in some cases related to difficulty swallowing, pneumonia and/ or depression. Symptoms are in line with the mechanism of action of Botulinum toxins and have been reported for a few hours to a few weeks after injection. The risk of symptoms is probably the highest in patients with basic and accompanying conditions that can lead to these symptoms, including children and adults treated with spasticity and high doses treatment. Patients treated with treatment do not get too weak. Elderly and weak patients need to be treated carefully. In general, botox clinical studies do not identify the difference in response between elderly and younger patients except for facial lines. The choice of doses for elderly patients should be cautious, usually starting at the lowest level of the medicine range. It is necessary to consider the effects of benefits - risks for each patient before starting botox treatment. Difficulty swallowing also has been reported after injection in positions outside the cervix. Botox should only be used very carefully and under the close supervision in patients with subclinical or clinical evidence of the ability to conduct neurotransmitters with defects, for example, lambert - Eaton in patients with peripheral dynamic neuropathy (such as side atrophy or motor neuropathy) and in patients with basic neurological disorders. These patients may increase sensitivity to agents such as botox, even at the dose of treatment, which can lead to excessive muscle weakness and increase the risk of a significant systemic effect on clinical, including serious swallowing and respiratory effects. Botulinum detox product should be used under the supervision of a specialist in these patients and only used if the benefits of treatment are considered to be greater than the risk. Patients with a history of difficulty swallowing and inhalation should be treated very carefully. Patients or caregivers should be recommended to seek medical care immediately if disorders of swallowing, speaking or respiratory. As with any treatment that is likely to allow patients to be sedentary back to previous activity, the patient is sedentary, so it is warned to work again gradually. Related surgery and any changes for anatomy due to previous surgical procedures, must be understood before using botox and must avoid injecting into vulnerable anatomical structures. pneumothoraxes related to the injection procedure have been reported after using botox near the chest. Be careful when injecting near the lungs (especially APXEs) or other vulnerable anatomical structures. Serious adverse effects including death results were reported in patients who were injected with botox drugs that did not label directly into the salivary glands, pharyngitis, esophagus and stomach. Some patients have significant difficulty or weakness. Serious and/or instant hypersensitivity reactions are rarely reported including anaphylaxis, serum, urticaria, soft tissue edema and shortness of breath. Some of these reactions have been reported after using botox alone or in combination with other products related to similar reactions. If such a reaction occurs, botox should be stopped and appropriate medical treatment, such as epinephrine, immediately. A case of anaphylaxis was reported in which the patient died after the diluted botox injection was not suitable for 5 ml of 1%lidocaine. As with any injection, trauma related to the procedure may occur. A injection can lead to local infections, pain, inflammation, parcels, decreased, pain, swelling, erythema and/or bleeding/bruising. Pain and/or anxiety related to needles can lead to vascular disorder reactions, for example: fainting, hypotension, etc. Be cautious when using botox in the case of inflammation at the proposed injection site or when the target is weak or excessive atrophy. It is also advisable to be careful when botox is used to treat patients with peripheral dysplasia (for example, muscle atrophy or motor neuropathy). There have been reports on adverse effects after using botox related to the cardiovascular system, including arrhythmia and myocardial infarction, some with death results. Some patients have risk factors including cardiovascular disease. Newly started or recurrent seizures have been reported, usually in patients who tend to undergo these events. The exact relationship of these events with Botulinum toxins has not been set up. Reports in children are mainly from patients with cerebral palsy treated with spasticity. The formation of neutralized antibodies with type A botulinum toxins can reduce the effectiveness of botox treatment by inactive biological toxins. Results from some studies show that botox injections with more frequent gap or with higher doses can lead to higher antibody formation rate. When appropriate, it is possible to minimize the ability to form antibodies by injecting with the lowest effective doses given in the longest clinical indicator period between injections. Clinical fluctuations during the use of Botox repeated (as for all botulinum toxins) may be the result of different processes of vials, injection periods, injected muscles and vague values given by the biological test method used. The safety and effectiveness of botox in different indications with indicators described for children has not been set. The following reports on the ability to spread the ability of toxins are very rarely reported in patients with the accompanying disease, mainly with cerebral palsy. Overall, the dosage used in these cases exceeds the recommended level. There have been rare reports on spontaneous deaths sometimes related to inhaled pneumonia in children with severe cerebral palsy after treatment with botulinum toxins, including after the use of drugs outside the label (such as the neck). It is necessary to be very careful when treating children with significant neurasthenia, difficulty swallowing, or a history of pneumonia or recent lung disease. Treatment in patients with poor health condition should only be performed if the potential benefits for each patient are considered greater than the risk. neurological disorders Botox should only be used to treat localized spasms in adults after a stroke if reduced muscle tone is expected to lead to improvement of function (for example: improving gait), or improving symptoms (for example, pain relief or muscle spasm) and/or to facilitate care. Improving functional function may be limited if the botox is started for longer than 2 years after the stroke or in patients with the modified Ashworth scale (MAS) Be careful when treating adult patients with spasms after stroke, those who may have an increased risk of falling. There have been reports after marketing of death (sometimes related to inhaled pneumonia) and the ability to spread the poison in children with co -disease, mainly cerebral palsy after treatment with botulinum toxin. blepharospasm Reducing the blink of an eye after the injecting of botulinum toxins into the Orbicularis muscles can lead to exposure to the cornea, persistent epithelium defects and corneal ulcer, especially in patients with VII digital neuropathy. It is necessary to carefully check the feeling of the cornea in the eye that had previously had surgery, avoiding the injection of the drug in the lower eyelid to avoid the phenomenon of growing and actively treating any epithelial defects should be done. This may require drops, protective ointment, soft contact lenses, or close eyes by patching or other measures. Bleeding easily occurs in the soft tissue of the eyelid. This can be minimized by gently pressing the injection site immediately after the injection. Due to the anti -cholinergic activity of botulinum toxin, it is cautious when treating patients at risk of closing angle glaucoma, including patients with anatomical angle. cervical disorder Patients with cervical disorders should be notified of the possibility of difficulty swallowing, which may be very mild but may also be severe. Difficulty swallowing can exist for two to three weeks after the injection, but has been reported to last up to five months after the injection. The consequence of difficulty swallowing is the ability to breathe, shortness of breath and sometimes need to feed with tubes. In some rare cases, it is difficult to swallow, then the pneumonia due to breathing and death has been reported. The injection dose limit to sternocleidomastoid muscles under 100 units may reduce the appearance of difficulty swallowing. Patients with smaller neck mass, or patients injected on both sides into the breast muscle, have been reported to be more difficult to swallow. Difficult to swallow is caused by the spread of toxins to the esophagus. Injecting into the shoulder blades can increase the risk of upper respiratory infection and difficulty swallowing. Difficulty swallowing can contribute to reducing food and drinking water, leading to weight loss and dehydration. Patients with clinical disordered underdog can increase the risk of difficulty swallowing more severe after injection of botox. Chronic migraine Botox's effectiveness has not been seen in the treatment of headache prophylaxis in patients with migraine (headache bladder disorders Preventive antibiotics should be used for patients with sterile urine or no symptoms in accordance with local standards. The decision to stop anti -platelet treatment must follow local instructions and consider benefits/risks for each patient. Patients undergo coagulation should be appropriate to reduce the risk of bleeding. Need appropriate medical caution when performing bladder endoscopy. Patients should be monitored for at least 30 minutes after injection. In patients who do not regularly place a catheter, the amount of urine should be evolved after treatment within 2 weeks after treatment and periodically if appropriate medical. Patients should be instructed to contact their doctors if they have difficulty clogging because they may have to put urine pipes. Excessive bladder Before the injection, the local diluted anesthetic can be used, with or not accompanied by sedatives, used before the injection, depending on the practice on the spot. If local anesthesia, bladder must be drained and washed with sterile saline before performing the next steps of the injection process. urination due to excessive neurotransmitters Botox injection can be performed under systemic or on -site anesthesia with or without sedatives. If the injection of local anesthetic is performed, the bladder must be drained and washed with aseptic saline before performing the next steps of the injection process. Autonomous reflexes related to the possible procedure and need to be more vigilant in patients who are known to be at risk. Skin and subcutaneous disorders Hyperhidrosis of the primary Axillae History and health examination, along with specific additional surveys required, should be performed to eliminate the hidden causes of secondary hyperhidrosis (for example: hyperthyroidism, phagocytosis). This will avoid the treatment of hyperhidrosis symptoms without diagnosis and/or previous diseases. Wrinkle lines seen in the maximum eyebrows and/or crow's feet seen at the maximum smile and/or the forehead visible at the maximum height of the eyebrows Botox is only used for a patient treatment in a single treatment session. It is necessary to take special preventive measures for the preparation and use of the product as well as the disinfection and elimination of the remaining unused solution. The use of botox is not recommended in people under 18. Stage 3 clinical data is limited to botox in patients over 65 years old. Be careful to ensure that botox is not injected into the blood vessels when it is injected into the folds visible when frowning maximum, in the crow's feet visible when smiling maximum, or in the forehead visible at the maximum eyebrow height. There is a risk of eyelid bulging after treatment. There is no research on affecting the ability to drive and use machines. However, botox can cause weakness, muscle weakness, drowsiness, dizziness and visual disorders, which can affect driving and operating machinery. There is no adequate data on the use of Botulinum Toxin A in pregnant women. Animal studies show reproductive toxicity. The potential risks for humans are unknown. Botox is not recommended during pregnancy and women of reproductive age do not use contraception. There is no information on whether Botox is excreted through breast milk or not. The use of botox during breastfeeding is not recommended. Theoretically, the effect of botulinum toxins can be enhanced by Aminoglycoside antibiotics or spectinomycin, or other drug products interfering with neurotransmitters (for example, neuromuscular substances). The effect of the use of botulinum nerve serums at the same time or within a few months is unknown. Excessive neuromuscular depression may be worse when using another Botulinum toxin before resolving the effects of the previously used Botulinum toxin. There are no interactive studies conducted. There is no clinical significance that is reported. There is no data on simultaneous use of anti -cholinergic drugs with botox injections in excessive bladder control. Precautions when used
The ability to drive and operate machinery
Pregnancy
The period of breastfeeding
Drug interaction
Storage
Temperature does not exceed 30 ° C.
Other drugs
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