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Dysport is a prescription injection for temporary improvement in the look of moderate to severe frown lines between the eyebrows (glabellar lines) in adults less than 65 years of age.
IMPORTANT SAFETY INFORMATION
What is the most important information you should know about Dysport?
Spread of Toxin Effects:
In some cases, the effects of Dysport and all botulinum toxin products may affect areas of the body away from the injection site. These effects can cause symptoms of a serious condition called botulism. Symptoms of botulism can happen hours to weeks after injection and may include swallowing and breathing problems, loss of strength and muscle weakness all over the body, double vision, blurred vision and drooping eyelids, hoarseness or change or loss of voice, trouble saying words clearly, or loss of bladder control. Swallowing and breathing problems can be life threatening and there have been reports of death.
The risk of symptoms is probably greatest in children and adults treated for muscle spasms, particularly in those patients who have underlying medical conditions that could make these symptoms more likely.
The toxic effects have been reported at doses similar to those used to treat muscle spasms in the neck. Lower doses, in both approved and unapproved uses, have also caused toxic effects. This includes treatment of children and adults for muscle spasms.
These effects could make it unsafe for you to drive a car, operate machinery, or do other dangerous activities.
Do not have Dysport treatment if you:
are allergic to Dysport or any of its ingredients (see the end of the Medication Guide for a list of ingredients), are allergic to cow’s milk protein, had an allergic reaction to any other botulinum toxin product (such as Myobloc® or Botox® ), or have a skin infection at the planned injection site.
The dose of Dysport is not the same as the dose of any other botulinum toxin product. The dose of Dysport cannot be compared to the dose of any other botulinum toxin product you may have used.
Dysport may not be right for you if:
you have surgical changes to your face, very weak muscles in the treatment area, your face looks very different from side to side, the injection site is inflamed, you have droopy eyelids or sagging eyelid folds, deep facial scars, thick oily skin, or if your wrinkles can’t be smoothed by spreading them apart.
Tell your doctor about all your medical conditions, including if you have:
A disease that affects your muscles and nerves (such as amyotrophic lateral sclerosis [ALS or Lou Gehrig’s disease], myasthenia gravis, or Lambert-Eaton syndrome), allergies to any botulinum toxin product or had any side effect from any botulinum toxin product in the past, a breathing problem (such as asthma or emphysema), swallowing problems, bleeding problems, diabetes, or a slow heart beat or other problem with your heart rate or rhythm, plans to have surgery, had surgery on your face, weakness of your forehead muscles (such as trouble raising your eyebrows), drooping eyelids, or any other change in the way your face normally looks. Patients with a disease that affects muscles and nerves who are treated with typical doses of Dysport may have a higher risk of serious side effects, including severe swallowing and breathing problems.
Human Albumin
This product contains albumin taken from human plasma. Steps taken during donor screening and product manufacturing processes make the risk of spreading viral diseases extremely rare. In theory, there is also an extremely rare risk of contracting Creutzfeldt-Jakob disease (CJD). No cases of spread of viral diseases or CJD have ever been reported for albumin.
Allergic Reaction to Injecting in the Skin
It is not known if an allergic reaction can be caused by injecting Dysport into the skin. The safety of treating excessive sweating with Dysport is not known.
Common Side Effects
The most common side effects are nose and throat irritation, headache, injection site pain, injection site skin reaction, upper respiratory tract infection, eyelid swelling, eyelid drooping, sinus inflammation, and nausea.
Tell your doctor about all the medicines you take,including prescription and nonprescription medicines, vitamins and herbal and other natural products. Using Dysport with certain other medicines may cause serious side effects. Do not start any new medicines while taking Dysport without talking to your doctor first.
Especially tell your doctor if you: have received any other botulinum toxin product in the last four months, have received injections of botulinum toxin, such as Myobloc® (rimabotulinumtoxinB) or Botox®(onabotulinumtoxinA) in the past (be sure your doctor knows exactly which product you received), have recently received an antibiotic by injection, take muscle relaxants, take an allergy or cold medicine, or take a sleep medicine.
Use In Specific Populations
Dysport should not be used in children or in women who are pregnant or breast feeding.
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What can Dysport do for you? |
Whenever you laugh, frown, concentrate or squint into the sun, your facial muscles contract and your skin creases. As you get older your skin loses its elasticity and those creases deepen into lines that become permanently etched on your face. Frown lines between your eyes can become particularly noticeable at a relatively young age, making you look angry or worried even when you’re not.
By temporarily immobilising the muscles you use to frown, Dysport can smooth out those lines, restoring a more youthful, less stressed expression to your face. Because you will be physically unable to frown after treatment, you may even lose the urge to frown. The lasting effect of treatment with Dysport can differ between individuals after which further courses of treatment may be necessary. Speak with your specialist about the results you can expect with Dysport.
Many people find after several treatments that they don’t need another one for longer, because they have “unlearned” the habit of frowning or squinting that originally led to the development of these lines. |
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What exactly is Dysport? |
Dysport is a protein extracted from the bacterium Clostridium botulinum. The protein was initially used for the treatment of motor disorders and various kinds of involuntary muscular spasms, including cerebral palsy. It was further developed to treat a wide variety of neuromuscular disorders, for which it is licensed in over 60 countries.
In New Zealand, Dysport now has registration approval under the Medicines Act for the treatment of frown lines and for excessive sweating under the armpits.
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How is Dysport used? |
Tiny amounts of Dysport are injected directly into the facial muscles underlying the frown lines. It usually takes three to five small, almost painless injections between the eyebrows for an effective treatment. No local anaesthetic is usually required but if you are concered your doctor can numb the skin over the area before injecting. You can expect treatment to take around 10-20 minutes.
Over the next few days, the muscles gradually relax. You probably won’t notice it happening – you’ll just become aware that you can’t contract your frown muscles. But because you can still blink normally and raise your eyebrows, you will not look unnatural. Rather, you can enjoy a more youthful appearance while maintaining a natural expression. |
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Who can benefit from Dysport? |
Deeply etched frown lines affect not just your appearance, but also your self-esteem and even your choice of career. Dysport can help you look younger, more relaxed and in control – for around the same price per month as a cut and color by your hairdresser.
Many people with frown lines can benefit from Dysport– and it can work as well for men as it does for women. In fact many men are already experiencing the benefits of a younger, more relaxed looking appearance that Dysport can provide. Discuss with your specialist about the benefits of Dysport for you.
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Are there any side effects and risks with Dysport? |
Along with its desired effects, treatments can cause unwanted effects. This does not happen very often. The most common side effects are temporary soreness or mild bruising around the injection site. Some people may experience a slight headache that lasts for several hours after treatment; it is safe to take a mild pain killer to relieve this.
In a very small percentage of cases there can be a complication called "ptosis" (a drooping eyelid) which may last a few days or up to 4 weeks. Rarely, an allergic reaction can cause a skin rash or "flu like" symptoms. Tell your doctor if you experience any troublesome side effects.
You should not have Dysport treatment while you are pregnant or breast feeding, or at all if you have a neuromuscular disease.
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Who can provide treatment with Dysport? |
Dysport is a prescription medicine containing 500 units of Clostridium botulinum type A toxin-haemagglutinin complex. It should be administered only by medical professionals, who have an excellent understanding of the muscles and expressions of the face and the skill to retain your natural expression while removing the signs of aging.
Tell your doctor what you expect to achieve in advance, be guided by their advice and ensure you are being treated by a specialist who has been properly trained in the use of Dysport.
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