50, 100, 200 Allergan units, powder for injection , solution
botulinum toxin type A
1. What Botox is and what it is used for
Botox is a muscle relaxant used to treat a number of different conditions in the body. It contains the active substance botulinum toxin type A and is injected into either muscle, the wall of the bladder, or deep into the skin. It works by partially blocking nerve impulses in the muscles injected and reduces sharp contractions of these muscles.
When injected into the skin, Botox affects the sweat glands so that sweat production is reduced.
When injected into the wall of the bladder, Botox affects the bladder muscle so that urine leakage (urinary incontinence) is reduced. When it comes to chronic migraines, it is believed that Botox blocks pain signals, which indirectly prevents migraines from developing. However, the way Botox works in chronic migraines are not completely clear.
| 1) | Botox can be injected directly into the muscles, and can be used to treat the following conditions:Persistent muscle cramps in the legs in children who are two years or older with cerebral palsy and who can walk. Botox is used to treat misalignment of the feet (so-called tip foot) caused by the persistent muscle cramps in the legs.persistent muscle cramps in the wrist and hand in adult patients who have had a strokepersistent muscle cramps in the ankle and foot in adult patients who have had a strokepersistent muscle cramps in the eyelids and face in adult patientspersistent muscle cramps in the neck and shoulders in adult patients |
| 2) | Botox is used to reduce the symptoms of chronic migraine in adults who have had headaches for 15 days or more each month, of which at least 8 days are with migraines and who have not responded well to other preventive migraine medications. Chronic migraine is a disease that affects the nervous system. Patients usually suffer from headaches that are often accompanied by excessive sensitivity to light, loud noises or smells/smells, as well as nausea and/or vomiting. This headache occurs 15 days or more each month. |
| 3) | When Botox is injected into the wall of the bladder, it acts on the bladder muscle to reduce leakage of urine (urinary incontinence) and treat the following conditions in adults:overactive bladder with urine leakage (the sudden need to empty your bladder and go to the toilet more than usual) when other drugs called anticholinergic drugs have been used but not helped.urine leakage due to bladder problems associated with spinal cord injury or multiple sclerosis . |
| 4) | For adults, Botox can reduce heavy sweating in the armpits that disrupt everyday life, if other local treatments do not help. This is done by injecting Botox deep into the skin and acting on the sweat glands. |
2. What you need to know before using Botox
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 planned injection site.
- when you are treated for urinary leakage and get a urinary tract infection or sudden inability to empty your bladder (and do not regularly use a catheter )
- if you are being treated for urine leakage and need a catheter but are not prepared for it.
Warnings and cautions
Talk to your doctor or pharmacist before using Botox:
- If you have ever had difficulty swallowing or if you have accidentally swallowed food or fluid in your lungs, especially if you will be treated for persistent muscle cramps in the neck and shoulders
- if you are over 65 and have other serious illnesses
- if you suffer from any other muscle problems or chronic diseases that affect the muscles (such as myasthenia gravis or Eaton Lambert’s syndrome)
- if you suffer from certain diseases that affect your nervous system (such as amyotrophic lateral sclerosis or motor neuropathy )
- if you have very weak or twisted muscles where your doctor plans to inject
- if you have undergone surgery or received an injury that may in any way have altered the muscle to be injected
- if you have had problems related to the injection you (such as fainting)
- if you have an inflammation in the muscles or in the area of skin where the doctor plans to inject
- if you suffer from cardiovascular disease (disease of the heart or blood vessels)
- if you suffer from or have had seizures
- if you have an eye disease called glaucoma with a narrow ventricular angle (high pressure in the eye) or are at risk of developing this type of glaucoma
- if you are to be treated for an overactive bladder with urine leakage and you have symptoms of urinary tract obstruction, such as difficulty throwing water or a weak or uneven jet.
After receiving Botox
You or your caregiver should contact a doctor and seek medical attention immediately if you experience any of the following:
- difficulty breathing, swallowing or speaking
- hives, swelling including swelling of the face or throat, wheezing, fainting, and difficulty breathing (may be symptoms of a severe allergic reaction ).
General caution
As with any injection, it is possible that the injection procedure may lead to infection, pain, swelling, abnormal sensation in the skin (eg tingling or numbness), decreased sensation in the skin, tenderness, redness, bleeding/bruising at the injection site and drop in blood pressure or fainting. This may be the result of pain and/or anxiety associated with injection one.
Botulinum toxin has been associated with side effects that may be linked to the spread of toxins far away from the injection site (eg muscle weakness, difficulty swallowing or unwanted food or fluid entering the airways). These side effects can be mild to severe, may require treatment, and can be fatal in some cases. This is a particular risk for patients with an underlying disease that makes them susceptible to these symptoms.
Severe and/or immediate allergic reactions have been reported and symptoms may include hives, swelling of the face and throat, difficulty breathing, wheezing, or fainting. Delayed allergic reactions (serum sickness) have also been reported and may include symptoms such as fever, joint pain, and rash.
Side effects related to the cardiovascular system, including irregular heartbeats and heart attacks, have also been seen in patients treated with Botox, which can sometimes be fatal. However, a previous medical history of risk factors for heart disease was found in some of these patients.
Seizures have been reported in adults and children treated with Botox, mainly in patients who are more likely to have seizures. It is not known if Botox caused these seizures. Seizures reported in children were mostly in patients with cerebral palsy who were treated for persistent leg muscle cramps.
If you take Botox too often or if the dose is too high, you may experience muscle weakness and side effects related to the spread of toxins, or your body may begin to develop antibodies, which may reduce the effect of Botox.
When Botox is used to treat a condition not mentioned in this information, it can lead to serious reactions, especially in patients who are already having difficulty swallowing or have significant weakness.
If you have not been physically active for a long time before receiving Botox, you should start physical activity gradually after injection.
This medicine is unlikely to improve joint mobility in cases where the surrounding muscle has lost its ability to stretch.
Botox should not be used to treat persistent ankle muscle cramps in adults after stroke unless the treatment is expected to provide an improved function (eg gait function), improvement of symptoms (eg pain) or to facilitate patient care. If your stroke occurred more than 2 years ago or if your ankle cramps are less severe, improvements related to activities such as walking may be limited. For patients who are prone to falls, the doctor will assess whether this treatment is appropriate.
Healthcare professionals with experience in the rehabilitation of stroke patients must first have performed an evaluation before Botox can be used to treat muscle cramps in the ankle and foot after a stroke.
When Botox is used to treat persistent muscle spasms in the eyelid, it can lead to you blinking less often, which can damage the skin of the eyes. To avoid this, you may need treatment with eye drops, ointments, soft contact lenses, or even a protective dressing that closes the eye. Your doctor will tell you if this is needed.
When Botox is used to control urine leakage, your doctor will give you antibiotics before and after treatment to prevent urinary tract infection. You will see your doctor about two weeks after injection one if you have not used a catheter before the injection zone. You will be asked to throw water and then the remaining urine in the bladder will be measured using ultrasound. Your doctor will decide if you need to come back for the same examination in the next 12 weeks. If you can not throw water, you must contact your doctor, as you may need to start using a catheter. In patients with urine leakage due to bladder problems associated with spinal cord injury or multiple sclerosis that does not use a catheter before treatment, approximately one-third of patients may need to use a catheter after treatment. In patients with urine leakage due to overactive bladder , approximately 6 out of 100 patients may need to use a catheter after treatment.
Other medicines and Botox
Tell your doctor or pharmacist about:
- you use antibiotics (used against infections ), anticholinesterase drugs, or muscle relaxants. Some of these medicines may increase the effect of Botox.
- you have recently received an injection of medicine containing a botulinum toxin (the active ingredient in Botox) as this may increase the effect of Botox too much.
- you use any antiplatelet agent (acetylsalicylic acid-like drug) and/or anticoagulants (blood thinners).
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pregnancy and breastfeeding
The use of Botox is not recommended during pregnancy or in women of childbearing potential not using contraception unless deemed necessary. Botox is not recommended for breastfeeding 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 taking this medicine.
Driving and using machines
Botox can cause dizziness, drowsiness, fatigue, or visual disturbances. If you experience any of these effects, do not drive or use any machines. If you are not sure, ask your doctor for advice.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
3. How to use Botox
Botox should only be given by doctors with special expertise and knowledge of how to use this medicine.
Botox should only be prescribed to you for a chronic migraine if you have been diagnosed by a neurologist who specializes in this area. Botox should be administered under the supervision of a neurologist. Botox is not used for acute migraine, chronic tension headache, or for patients with a headache due to overuse of drugs.
Method and method of administration
Botox is injected into your muscles ( intramuscularly ), into the wall of the bladder via a specific instrument (cystoscope), or into the skin (intradermally). It is injected directly into the affected area of your body; Your doctor will usually inject Botox in several places within the affected area.
General information on dosage
- The number of injections per muscle and dose one varies depending on the condition to be treated. Therefore, your doctor will decide how much, how often, and in which muscles you should get Botox. It is recommended that your doctor use the lowest effective dose.
- Dose one to the elderly is the same as to other adults.
Dose one of Botox and the duration of the effect varies depending on the condition you are being treated for. Below is detailed information pertaining to the various conditions.
The safety and efficacy of Botox in children/adolescents two years of age and older in the treatment of misalignment of the feet caused by persistent muscle cramps in the legs in cerebral palsy .
| Feet misalignment caused by persistent muscle cramps in the legs of children with Cerebral Palsy | 2 years |
There is limited information on the use of Botox for the following conditions in children/adolescents over 12 years of age. No dosing recommendations can be made for these indications.
| Persistent muscle cramps in eyelids and face | 12 years |
| Neck and shoulders | 12 years |
| Heavy sweating in the armpits | 12 years(limited experience in young people between 12 and 17 years) |
Dosage
| Indication | Maximum dose (units per affected area) | Minimum time between treatments | |
| First reading | Subsequent treatments | ||
| Persistent muscle cramps in the legs of children with cerebral palsy | 4 units / kg (hemiplegia)6 units / kg (diplegia) | 4 units / kg (hemiplegia)6 units / kg (diplegia) | 3 months* |
| Persistent muscle cramps in the wrist and hand in patients who have had a stroke | The exact dosage and number of injection sites per hand/wrist is adapted to individual needs up to a maximum of 240 units | The exact dosage and number of injection sites are adapted to individual needs up to a maximum of 240 units | 12 weeks |
| Persistent muscle cramps in the ankle and foot in patients who have had a stroke | The doctor may give you several injections into the affected muscles. The total dose is 300-400 units divided into up to 6 muscles at each treatment session | The total dose is 300-400 units divided into up to 6 muscles at each treatment session | 12 weeks |
| Persistent muscle cramps in eyelids and face | 1.25-2.5 units per injection site. Up to 25 units per eye in case of muscle cramps. | Up to 100 units in case of muscle cramps in the eye. | 3 months for muscle cramps in the eye. |
| Persistent muscle cramps in neck and shoulders | 200 unitsA maximum of 50 units may be given at one and the same injection site. | Up to 300 units | 10 weeks |
| Headache in adults with chronic migraine | 155 to 195 units maximum of 5 units may be given at one and the same injection site. | 155 to 195 units | 12 weeks |
| Urine leakage due to overactive bladder | 100 units | 100 units | 3 months |
| Urine leakage due to bladder problems associated with spinal cord injury or multiple sclerosis | 200 units | 200 units | 3 months |
| Heavy sweating in the armpits | 50 units per armpit | 50 units per armpit | 16 weeks |
* The doctor can choose a dose that would mean that there will be 6 months between treatments.
Time for improvement and duration of the treatment effect
In persistent leg muscle cramps in children with cerebral palsy, the improvement is usually noticed within the first 2 weeks after injection.
With persistent muscle cramps in the wrist and hand in patients who have had a stroke, you will usually notice an improvement within the first 2 weeks after injection one. The maximum effect is usually felt about 4 to 6 weeks after treatment.
In case of persistent muscle cramps in the ankle and foot in patients who have had a stroke, you may be allowed to repeat the treatment when the effect begins to subside if necessary, but treatment must not be given more often than every 12 weeks.
With persistent muscle cramps in the eyelids and face, you will usually notice an improvement within 3 days after injection one, and maximum effect is usually noticed after 1 to 2 weeks.
In case of persistent muscle cramps in the neck and shoulders , you will usually notice an improvement within 2 weeks after injection one. The maximum effect is usually felt approximately 6 weeks after treatment.
In case of urine leakage due to overactive bladder, you will usually notice an improvement within 2 weeks after injection one. The effect usually lasts about 6-7 months after injection.
In the case of urine leakage due to bladder problems associated with spinal cord injury or multiple sclerosis, you will usually notice an improvement within 2 weeks after injection one. The effect usually lasts for about 8-9 months after injection.
For heavy sweating in the armpits, you will usually notice an improvement within the first week after injection one. The effect usually lasts an average of 7.5 months after the first injection, and about 1 in 4 patients still notice an effect after one year.
If you use more Botox than you should
Signs of too much Botox do not always show up immediately after injection one. If you swallow Botox or get it injected accidentally, contact your doctor who may want to keep you under observation for several weeks.
If you have been given too much Botox, you may experience any of the following symptoms and you should contact your doctor immediately. He/she decides if you need to go to the hospital:
- muscle weakness that may be local to the injection site or far from the injection site
- difficulty breathing, swallowing, or speaking due to muscle paralysis
- food or fluid that due to muscle paralysis accidentally goes down into your lungs which can cause pneumonia ( infection of the lungs)
- drooping eyelids, double vision
- general weakness.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Generally, side effects occur within the first few days after injection. They usually last only a short time but can last for several months and in rare cases longer.
IF YOU HAVE DIFFICULTY TO BREATH, SWALLOW, OR SPEAK AFTER YOU HAVE BOTOX, CONTACT YOUR DOCTOR IMMEDIATELY.
If you get hives, swelling including swelling of the face or throat, wheezing, fainting, and difficulty breathing, contact your doctor immediately.
The side effects are presented in the following categories, depending on how often they occur:
| Very common | may occur in more than 1 in 10 users |
| Usual | may affect up to 1 in 10 users |
| Less common | may affect up to 1 in 100 users |
| Rare | can occur in up to 1 in 1,000 users |
| Very rare | may affect up to 1 in 10,000 users |
Below are lists of side effects that depend on which part of the body has been injected with Botox. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
An injection is in the legs of children with cerebral palsy
| Very common | Viral infection, ear infection. |
| Usual | Drowsiness, difficulty walking, numbness, rash, muscle pain, muscle weakness, pain in the extremities e.g. hands and fingers, urinary incontinence (urine leakage), general malaise, injection site pain, feeling of weakness, falling over. |
There have been rare spontaneous reports of deaths in some cases associated with pneumonia in children with severe cerebral palsy treated with Botox.
An injection is in the wrist and hand of patients who have had a stroke
| Usual | Increased muscle tension, bruising and bleeding under the skin that causes red spots ( ecchymosis or purpura), pain in the hand and fingers, muscle weakness, pain at the injection site, fever, flu-like symptoms , bleeding or burning at the injection site. |
| Less common | Depression, insomnia, decreased sensation in the skin, headache, numbness or tingling, coordination difficulties, memory loss, dizziness or feeling that “everything is spinning” ( vertigo ), drop in blood pressure when getting up which causes dizziness, dizziness or fainting, nausea, numbness or tingling around the mouth, inflammation of the skin ( dermatitis ), itching, rash, joint pain or inflammation, general weakness, pain, increased sensitivity at the injection site, general malaise, swelling of eg hands and feet. |
Some of these less common side effects may also be related to your illness.
The injection is in the ankle and foot of patients who have had a stroke
| Usual | Skin rash, joint pain or inflammation , stiff or sore muscles, muscle weakness, swelling of, for example, hands and feet, falls. |
Injection into the eyelids and face
| Very common | Droopy eyelids |
| Usual | Local damage to the cornea of the eye (the transparent surface that protects the front of the eye), difficulty closing the eye completely, dry eyes, photosensitivity, eye irritation, overproduction of tears, bruising under the skin, skin irritation, swelling of the face. |
| Less common | Dizziness, weakening of the facial muscles, sagging muscles on one half of the face, inflammation of the cornea of the eye (transparent surface that protects the front of the eye), abnormal outward or inward twisting of the eyelids, double vision, visual disturbances, blurred vision, skin rash, fatigue. |
| Rare | Swelling of the eyelid. |
| Very rare | Gastric ulcer , ulcers and damage to the cornea (transparent surface that protects the front of the eye). |
The injection you in the neck and shoulders
| Very common | Difficulty swallowing, muscle weakness, pain. |
| Usual | Swelling and irritation of the nose ( rhinitis ), nasal congestion or runny nose, cough, sore throat, tingling or irritation of the throat, drowsiness, increased muscle tension (cramps), decreased sensation in the skin, drowsiness, headache, dry mouth, nausea, stiff or sore muscles, feeling weak, flu-like symptoms, general malaise. |
| Less common | Double vision, fever, drooping eyelids, shortness of breath, voice changes. |
Injection into the head and neck area for the treatment of headaches in patients suffering from chronic migraine
| Usual | Headache, migraine , muscle weakness in the face, drooping eyelids, rash, itching , pain in the neck, muscle pain, muscle cramps, muscle stiffness, muscle tension, muscle weakness, pain at the injection site. |
| Less common | Difficulty swallowing, pain in the skin, pain in the jaw. |
Inject into the bladder wall for urine leakage due to overactive bladder
| Very common | Urinary tract infection, pain when urinating after the injection *. |
| Usual | Bacteria in the urine, inability to urinate ( urinary retention ), incomplete emptying of the bladder, frequent urination during the day, white blood cells in the urine, blood in the urine after the injection **. |
* This side effect may also be associated with the injection procedure.
** This side effect is only associated with the injection procedure.
Injection into the wall of the bladder for urine leakage due to bladder problems associated with spinal cord injury or multiple sclerosis
| Very common | Urinary tract infection, inability to urinate ( urinary retention ). |
| Usual | Insomnia, constipation, muscle weakness, muscle cramps, blood in the urine after the injection *, pain when urinating after the injection *, bulging in the bladder wall (bladder diverticulum), fatigue, gait problems (gait disturbance), possible uncontrolled body reactions (eg heavy sweating, throbbing headache or increased heart rate ) at the time of injection (autonomic dysreflexia) *, falling over. |
* Some of these common side effects may also be related to the injection procedure.
The injection is against heavy sweating in the armpits
| Very common | Injection site pain. |
| Usual | Headache, numbness, swelling, increased sweating in places other than the armpits, abnormal odor from the skin, itching, lumps under the skin, hair loss, pain in the extremities e.g. hands and fingers, pain, reactions, and swelling, bleeding or burning sensation as well as increased sensitivity at the injection site, general weakness. |
| Less common | Nausea, muscle weakness, feeling weak, muscle pain, joint problems. |
The following list describes additional side effects are reported for BOTOX, in any disease, after marketing:
- allergic reaction, including reactions to injected proteins or serum
- swelling in the deeper skin layers
- hives
- eating disorders, loss of appetite
- nerve damage (brachial plexopathy)
- voice and speech difficulties
- hanging muscles on one half of the face
- weakness in the facial muscles
- decreased sensation in the skin
- muscle weakness
- chronic muscle affecting muscle ( myasthenia gravis )
- difficulty moving the arm and shoulder
- numbness
- pain/numbness / or weakness emanating from the spine
- cramps and fainting
- increase in pressure in the eye
- squinting (eyes crossed)
- dimsyn
- problem to see clearly
- impaired hearing
- öronsus
- feeling dizzy or that everything is “spinning” ( vertigo )
- heart problems including heart attack
- aspiration pneumonia ( pneumonia caused by accidental inhalation of food, drink, saliva, or vomiting)
- respiratory problems, respiratory depression, and/or respiratory failure
- abdominal pain
- diarrhea, constipation
- dry mouth
- difficulty swallowing
- nausea, vomiting
- hair loss
- itching
- different types of red, spotty rashes
- heavy sweating
- loss of eyelash scars/eyebrows
- muscle pain, loss of nerves to / shrinkage of injected muscle
- general malaise
- fever
- dry eyes (in connection with an injection around the eyes)
- local muscle twitching / involuntary muscle contractions
- swelling of eyelids
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information
5. How to store Botox
Keep this medicine out of the sight and reach of children.
Your doctor should use Botox before the expiry date which is stated on the label after EXP.
The expiration date is the last day of the specified month.
Store in a refrigerator (2 ° C-8 ° C) or in a frozen state (-5 ° C to -20 ° C).
The reconstituted solution should be used immediately, however, it can be stored for up to 24 hours in a refrigerator (2 ° C – 8 ° C).
6. Contents of the packaging and other information
Content declaration
- The active substance is Botulinum toxin type A from Clostridium botulinum. Each vial contains 50, 100, or 200 Allergan units of botulinum toxin type A.
- The other ingredients are human albumin and sodium chloride.
What the medicine looks like and contents of the pack
Botox is a fine white powder and can be difficult to see at the bottom of a clear glass bottle. Prior to injection, the product must be dissolved in sterile physiological sodium chloride solution without preservative (sodium chloride 9 mg/ml (0.9%) solution for injection ).
Each pack contains 1, 2, 3, or 6 vials. In addition, 50 and 100 Allergan units of botulinum toxin type A may be available in packs of 10 vials.
Not all pack sizes may be marketed
Marketing Authorization Holder and Manufacturer
Allergan Pharmaceuticals Ireland
Castlebar Road
Westport
County Mayo
Ireland