Azzalure information

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INFORMED CONSENT – Juvederm

®

INJECTION

INSTRUCTIONS

This is an informed-consent document which has been prepared to help Dr Kazmierczak inform you concerning Azzalure®. Azzalure is a local muscle relaxant adapted from the botulin toxin type-A of

Dysport and is specifically designed for use in aesthetic indications.

Azzalure is indicated for the temporary improvement in the appearance of moderate to severe glabellar lines (vertical lines between the eyebrows) seen at frown, in adult patients under 65 years, when the severity of these lines has an important psychological impact on the patient.

Azzalure injections contain the active ingredient botulin toxin type A, which is a toxin produced by the bacteria Clostridium botulin. Botulin toxin type A is a bacterial toxin that prevents nerves from functioning normally (a neurotoxin). It prevents nerves from releasing a chemical called acetylcholine, which is essential for the nerves to communicate with muscle cells.

This toxin therefore prevents muscles from receiving nerve stimulation. Preventing nerve stimulation of muscles causes the muscles to become paralyzed. Botulin toxin type A causes muscle paralysis until such time as the nerve develops new endings to communicate with the muscles. Azzalure injections normally take an average of 2 to 3 days to start working, although it may take a little longer for the full effects to be seen. The speeds of action will depend on the strength of your facial muscles and your individual response to the injection. Hopefully you will be pleased with the effects of Azzalure. Azzalure can reduce the severity of glabellar lines for up to 4 months. Azzalure injections are administered into the muscle above and between the eyebrows to temporarily paralyze and relax these muscles. They are used to cosmetically improve the appearance of vertical frown lines between the eyebrows. These injections only provide a short-term improvement. They are only used when the appearance of frown lines is prominent and is having an important psychological effect on an individual. An improvement in the appearance of the frown lines between the eyebrows is generally seen after two or three days.

The effect of these injections lasts for up to four months. For a continued effect you would need to keep having the injections every two to four months. The answer is there is no difference between these products. Botox has become a worldwide household name, but what many people do not realize is that Botox is a Brand name for the product Butulin Toxin. Azzalure is another brand of botulin which reduces the appearance of vertical frown lines by weakening the muscles just like Botox. Azzalure is not a new product, it has been around in the UK since the 1990's but it's brand has only been recognized widely since 2009.

On the Day - Before injecting Azzalure any make-up will be removed and the skin disinfected.

Your practitioner will then study your facial muscles to see how they work, as individuals can differ. The injections should be painless. To treat frown lines, Azzalure is injected with a fine needle above and in between your eyebrows. The treatment session will last around 15 minutes and you can return to your usual daily activities immediately afterwards. Your practitioner will tell you more about how to look after your skin following your treatment.

Like all medicines,

Azzalure® can cause side effects, although not everybody gets them. Any reactions are generally minimal, temporary, and typically relate to the injection itself. There may be slight discomfort as the needle enters the skin. There is also the possibility of bruising or bleeding at injection sites.

Very rarely, botulin toxin may result in muscle weakness away from the site of injection. If you

experience any discomfort you should consult us or your GP.

Other potential side effects are listed in the Azzalure® Patient Information Leaflet; please ask your practitioner if you have not been given this.

Azzalure® aftercare tips

For at least 4 hours after treatment Keep upright. Do not bend excessively. No gym on the day.

For at least 12 hours after treatment Avoid extreme facial expressions. Avoid excessive alcohol consumption. Avoid wearing make-up.

For at least 2 days after treatment Do not rub or massage the treated area, this may cause the injected solution to spread to nearby muscles. After washing, pat skin dry very gently with a soft towel.

For at least 2 weeks after treatment Avoid exposure to strong sunlight, very cold temperatures and saunas. Do not have any beauty treatments on your face e.g. facials, facial massage. Remember: the effects of Azzalure® are temporary, ask your practitioner when they recommend you return for re-treatment.

ADDITIONAL ADVISORIES

Unsatisfactory Result - Azzalure® injections alone may not produce an outcome that meets your expectations for improvement in wrinkles or soft tissue depressions. There is the possibility of a poor or inadequate response from Azzalure® injection(s). Additional Azzalure® injections may be necessary. Surgical procedures or other treatments may be recommended in additional to

Azzalure treatments.

Unknown Risks - In the he long term effect some patients might build up resistance to

Azzalure®. The possibility of additional risk factors or complications attributable to the use of botulin toxin type A as a muscle relaxer may be discovered.

Combination of Procedures - In some situations, Juvederm ® injections or other types of tissue filler materials may be used in addition to Azzalure® in order to specifically treat areas of the face or to enhance the outcome from muscle relaxant therapy.

ADDITIONAL TREATMENT NECESSARY

There are many variable conditions in addition to risk and potential complications that may influence the long-term result of Azza lure® injections. Even though risks and complications occur infrequently, the risks cited are the ones that are particularly associated with Azzalure® injections.

Other complications and risks can occur but are even more uncommon. Should complications occur, additional surgery or other treatments may be necessary? The practice of medicine and surgery is not an exact science. Although good results are expected, there is no guarantee or warranty expressed or implied, on the results that may be obtained.

FINANCIAL RESPONSIBILITIES

The cost of Azzalure® injection may involve several charges. This includes the professional fee for the injections, follow up visits to monitor the effectiveness of the treatment, and the cost of the

Juvederm material itself. It is unlikely that Juvederm injections to treat cosmetic problems would be covered by your health insurance. Additional costs of medical treatment would be your responsibility should complications develop from Juvederm injections.

Initials: ____________________________________

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