Botox 100 Units Injection 1 Vial

1. What this product is and what it is used for Botox® is a muscle relaxant used to treat a number of conditions within the body. It contains the active substance Botulinum toxin type A and is injected into either the muscles, the bladder wall or deep into the skin. It works by partially blocking the nerve impulses to any muscles that have been injected and reduces excessive contractions of these muscles. In the case of chronic migraine, it is thought that Botox® block pain signals which indirectly block the development of a migraine When injected into the skin, Botox® works on sweat glands to reduce the amount of sweat produced. When injected into the bladder wall, Botox® works on the bladder muscle to prevent leakage of urine (urinary incontinence) due to uncontrolled contractions of the bladder muscle. 1. Botox® can be injected directly into the muscles, and can be used to treat the following conditions: · persistent muscle spasms in the ankle and foot in children aged two years or older with cerebral palsy, who can walk, BOTOX is used to support rehabilitation therapy . · Persistent muscle spasms in the wrist, hand, ankle or foot of adult patients who have suffered a stroke · Persistent muscle spasms in the eyelid and face of adult patients; · Persistent muscle spasms in the neck and shoulders of adult patients 2. BOTOX® is used to prevent headaches in adult patients with chronic migraine. Chronic migraine is a disease affecting the nervous system. To be diagnosed with chronic migraine, you must have headaches 15 days or more a month. In addition, on 8 or more days a month, your headaches must have at least two of the following characteristics: · affect only one side of the head · cause a pulsating pain · cause moderate to severe pain · are aggravated by routine physical activity and they must cause at least one of the following: · nausea, vomiting, or both · sensitivity to light and sound. BOTOX® has been shown to significantly reduce the frequency of days with headache and to improve the quality of life of patients suffering from chronic migraine. After two treatment sessions, approximately 47% of patients had a 50% or greater reduction from baseline in the number of days with headache they experienced. 3) When injected into the bladder wall, Botox® works on the bladder muscle to reduce leakage of urine (urinary incontinence) and control the following conditions in adults: · overactive bladder with leakage of urine, the sudden urge to empty your bladder and needing to go to the toilet more than usual; · leakage of urine due to bladder problems associated with spinal cord injury or multiple sclerosis. In patients who have not managed to control overactive bladder with leakage of urine with medicines called anticholinergics, BOTOX® has been shown to reduce leakage of urine from an average of about 5 episodes per day down to 2 after 12 weeks. 27% of patients had no leakage of urine at all. In patients with bladder problems associated with spinal cord injury or multiple sclerosis who have not managed to control leakage of urine with medicines called anticholinergics, BOTOX® has been shown to reduce leakage of urine, from an average of about 30 episodes per week down to 10 after 6 weeks. 37% of patients had no leakage of urine at all. 4) In adults, Botox® can be injected deep into the skin and can work on sweat glands to reduce excessive sweating of the armpits, which affects the activities of daily living when other local treatments do not help. 5) Botox® is used for the temporary improvement in the appearance of: · Vertical lines between the eyebrows seen at maximum frown and/or, · Fan-shaped lines from the corner of the eyes seen at maximum smile and/or, · Forehead lines seen at maximum raised eyebrows, When the severity of the facial lines has an important psychological impact in adult patients. 2. What you need to know before you use this product Do not use Botox® if you are allergic (hypersensitive) to botulinum toxin type A or any of the other ingredients of this medicine (listed in section 6); if you have an infection at the proposed site of injection; when you are being treated for leakage of urine and have either a urinary tract infection or a sudden inability to empty your bladder (and are not regularly using a catheter), or if you have bladder stones; if you are being treated for leakage of urine and are not willing to begin using a catheter if required. Warnings and precautions Talk to your doctor or pharmacist before using Botox®: · if you have ever had problems with swallowing or food or liquid accidentally going into your lungs, especially if you will be treated for persistent muscle spasms (contractions) in the neck and shoulders; · if you are over 65 years of age and have other serious illnesses; · if you suffer from any other muscle problems or chronic diseases affecting your muscles (such as myasthenia gravis or Eaton Lambert Syndrome); · if you suffer from certain diseases affecting your nervous system (such as amyotrophic lateral sclerosis or motor neuropathy); · if you have significant weakness or wasting of the muscles which your doctor plans to inject; · if you have had any surgery that may have in some way changed the muscle to be injected; · if you have had any problems with injections (such as fainting) in the past; · if you have inflammation in the muscles or skin area where your doctor plans to inject; · if you have had problems in the past with previous botulinum toxin injections; · if you suffer from cardiovascular disease (disease of the heart or blood vessels); · if you suffer or have suffered from seizures; · if you have an eye disease called closed-angle glaucoma (high pressure in the eye) or were told you are at risk for developing this type of glaucoma; · if you will have an operation soon; · if you are taking any blood thinning medicine. After you have been given Botox® You or your caregiver should contact your doctor and seek medical attention immediately if you experience any of the following: · difficulty in breathing, swallowing, or speaking; · hives, swelling including swelling of the face or throat, wheezing, feeling faint and shortness of breath (possible symptoms of severe allergic reaction). If you have been treated for vertical and/or fan-shaped and/or forehead lines, please inform your doctor if you see no significant improvement of your lines one month after your first course of treatment. General precautions As with any injection, it is possible for the procedure to result in infection, pain, swelling, burning and stinging, increased sensitivity, tenderness, redness, and/or bleeding/bruising at the site of injection. Side effects possibly related to the spread of toxin distant from the site of administration have been reported with botulinum toxin (e.g. muscle weakness, difficulty swallowing or unwanted food or liquid in the airways). This is a particular risk for patients with an underlying illness that makes them susceptible to these symptoms. If you are given Botox® too often or the dose is too high, you may experience muscle weakness and side effect related to the spread of toxin, or your body may start producing some antibodies, which can reduce the effect of Botox®. To limit this risk, the interval between two treatments must not be less than three months depending on the indication. When Botox® is used in the treatment of a condition that it is not listed in this leaflet, it could result in serious reactions, particularly in patients who already experience difficulty in swallowing or have significant debility. If you have not done much exercise for a long time before receiving Botox® treatment, then after your injections you should start any activity gradually. It is unlikely that this medicine will improve the range of motion of joints where the surrounding muscle has lost its ability to stretch. When treating adults with post-stroke ankle muscle spasms, BOTOX® should only be used if it is expected to result in improvement in function (e.g. walking) or symptoms (e.g. spasms or pain) or to help with patient care. Furthermore, for patients who may be more likely to fall, your doctor will judge if this treatment is suitable. When Botox® is used in the treatment of persistent muscle spasms in the eyelid, it could make your eyes blink less often, which may harm the surface of your eyes. In order to prevent this, you may need treatment with eye drops, ointments, soft contact lenses or even protective covering which closes the eye. Your doctor will tell you if this is required. BOTOX® does not prevent headaches in patients with episodic migraine, which occur less than 15 days a month. When Botox® is used for the treatment of vertical and/or fan-shaped and/or forehead lines drooping of the eyelid may occur after treatment. Other medicines with Botox® Tell your doctor or pharmacist if: · you are using any antibiotics (used to treat infections) , or any medicines that affect the nerves that control muscles (for example anticholinesterase medicines or muscle relaxants). Some of these medicines may increase the effect of BOTOX®. · you have recently been injected with a medicine containing a botulinum toxin (the active substance of Botox®), as this may increase the effect of Botox® too much. · you are using any anti-platelet (aspirin-like products) and/or anti-coagulants (blood thinners). Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicine. Pregnancy and breast-feeding The use of Botox® is not recommended during pregnancy and in women of childbearing potential not using contraception. Botox® is not recommended in breast-feeding women. If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine. Driving and using machines Botox® may cause dizziness, sleepiness, tiredness or problems with your vision. If you experience any of these effects, do not drive or use any machines. If you are not sure, ask your doctor for advice. 3. How to use this product. Botox® must only be injected by doctors with specific skills and experience on how to use the medicine. Method and route of administration Botox® is injected into your muscles (intramuscularly), into the bladder wall via a specific instrument (cystoscope) to inject into the bladder or into the skin (intradermally). It is injected directly into the affected area of your body; your doctor will usually inject Botox® into several sites within each affected area. General information about dosage · 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 given to you. It is recommended that your doctor uses the lowest effective dose. · Dosages for older people are the same as for other adults.