Botulinum Type A - Consent & Consultation Form Logo

  • Consent and consultation form for patients treated with BOTOX® / AZALLURE® (Botulinum Toxin Type A)

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  • (Botulinum Toxin Type A)

  • Treatment record

  • Prescribing information can be found at the end of this document

  • PLEASE COMPLETE THE BELOW;

  • Medical history

  • Please complete the following medical questionnaire

    Have you previously received any aesthetic treatments (e.g. laser, peels, dermabrasion etc

  • Have you suffered from any of the following?

     

  • If you have ticked yes to any of the above it is advised to get your doctors sign off ahead of treatment

  • If you have any questions about the above please discuss these with your practitioner. If the answer is yes to any of the above, your practitioner may ask for further details. Treatment may be refused if it is not considered in your own interest to proceed.

  • I have read the above about common and uncommon side effects related to Azallure® and agree that i fully understand the risk of treatment.

    Provided me with sufficient information about the treatment detailed overleaf in order to make an informed decision


    – Given me the opportunity to ask all remaining questions I may have about the treatment, and has answered them to the best of their ability


    – Given me the time to consider the treatment detailed overleaf


    – Received the relevant medical history information from me to the best of my knowledge


    I therefore consent to receiving the described treatment by my treating practitioner.

  • I confirm that i have veen informed that;

    - Azzalure/ Botulinum Toxin Type A uses the toxin produced by bacteria responsible for botulism in food poisioning. However the amount of toxin used is minimal and generally well tolerated in clinic trials. The toxin temporarily weakens the muscles responsible for developing facial expression lines caused by muscke activity. Static facial lines e.g those due to sun damage, will not usually respond to treatment with Botulinum toxin, as they have not been caused  by muscle activity.

     

    - Azzalure/ Botulinum Toxin Type A is licensed for the temporary improvement of moderate to severe vertical lines between the eyebrows (glabellar lines) and is injected into the skin to reduce these lines. You are having these injections because the severity of your lines has had an important psychological impact on you.

    - Treatment is not recommended if you are pregnant or breastfeeding.

    - After treatment with Azzalure you should start to see an improvement within 2-3 days, however the full effect can take up to 30 days. The benefits of treatment usually last between 3-6 months but can vary depending on individual response.

    - Most common side effects of Azzalure are headache and injection reactions e.g redness, swelling, irritation, rash, itching, numbness, pain, discomfort, stinging, bruising and bleeding. Normally these reactions are mild to moderatte, reversible and occur in the first week after treatment. There is also a small posibility of slight drooping of the eyelid or visual problems.

    - Very rarely, botulinum toxin may result in muscle weakness way from the site of injection.

    - If symptoms last for more than one week or you are concerned about any symptoms you should report to your practioner as soon as possible. Seek urgent medical help if you have difficulties breathing, speaking or if your face swells up.

    Azzalure may cause temporary blurred vision or muscle weakness. If affected you should  not drive or use machinery.

    Azzalure contains a very small amount of albumin which comes from human blood. It is very unlikely that this could pass on infection, but it cannot be entirely ruled out. 

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  • Advised consent - PLEASE READ POSSIBLE SIDE EFFECTS

    BOTOX® AZALLURE® is indicated for the temporary improvement in the appearance of moderate to severe vertical lines between the eyebrows seen at maximum frown (glabellar lines); moderate to severe lateral canthal lines (crow’s feetlines) seen at maximum smile; moderate to severe crow’s feet lines seen at maximum smile and glabellar lines seen at maximum frown when treated simultaneously in adults, when the severity of these lines has an important psychological impact for the patient. Like all medicines, BOTOX® AZALLURE® can have side effects, although not everybody gets them. In general, side effects occur within the first few days following injection. They usually last only for a short time, but they may last for several months and in rare cases, longer. These adverse reactions may be related to treatment, injection technique or both. Diffusion of botulinum toxin into nearby muscles is possible when high doses are injected, particularly in the neck area. As expected for any injection procedure, pain/burning/stinging, swelling and/or bruising may be associated with the injection. Speak to your doctor if you are worried about this. Adverse reactions possibly related to the spread of toxin distant from the site of administration have been reported very rarely with botulinum toxin (e.g. muscle weakness, constipation, difficulty in swallowing, food or liquid accidentally going into the lungs which in some cases may lead to pneumonia). Injection of BOTOX® AZALLURE® is not recommended in patients with a history of dysphagia (difficulty to swallow) and impaired swallowing. The chance of having a side effect is described by the following categories: Common - More than 1 out of 100 persons and less than 1 out of 10persons. Uncommon - More than 1 out of 1,000 persons and less than 1 out of 100persons. Injections in the forehead for vertical lines Common side effects are: Headaches, drooping eye lid, skin redness, localised muscle weakness, face pain. Uncommon side effects are: Infection, anxiety, numbness, dizziness, inflammation of the eyelid, eye pain, visual disturbance, nausea (feeling sick),dry mouth, skin tightness, swelling (face, eyelid, around the eyes), sensitivity to light, itching, dry skin, muscle twitching, flu syndrome, lack of strength, fever. Injections in the fan-shaped lines from the corner of the eyes Common side effects are: Swelling of the eyelid, injection site bleeding and/or bruising.

  • Advised consent - PLEASE READ POSSIBLE SIDE EFFECTS

    Uncommon side effects are: Injection site pain and/or tingling or numbness .Injections in the fan-shaped lines from the corner of the eyes, when treated at the same time as injections in the forehead for vertical lines. Common side effects are: Injection site bruising. Uncommon side effects are: Injection site bleeding and/or pain. The following additional side effects have been reported for BOTOX® AZALLURE® since it has been marketed: allergic reactions, which can be serious (swelling of the face and airways, difficulty in breathing), loss of nerve supply to/shrinkage of injected muscle, respiratory depression and/or respiratory failure, aspiration pneumonia (lung inflammation caused by accidentally breathing in food, drink, saliva or vomit), chronic disease affecting the muscles (myasthenia gravis),blurred vision, difficulties in seeing clearly, slurred speech, strabismus (squint),numbness, tingling and pain in hands and feet, fainting, pain/numbness/or weakness starting from the spine, drooping of the muscles on one side of the face, weakness of the face muscles, difficulty moving the arm and shoulder, decreased skin sensation, muscle pain, abdominal pain, diarrhoea, vomiting, loss of appetite, dry mouth, feeling sick, fever, different types of red blotchy skin rashes, feeling generally unwell, speech problems, itching, excessive sweating, hair loss, loss of eyebrows, decreased hearing, noises in the ear, feeling of dizziness or “spinning” (vertigo).Allergic reactions, difficulties to swallow, speak or breathe, have been reported rarely when botulinum toxin type A has been used for other uses. Visit your doctor immediately if such signs develop after BOTOX® AZALLURE® treatment. If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. BOTOX® AZALLURE® should only be administered by medically qualified physicians with appropriate qualifications and expertise in this treatment and having the required equipment. Too frequent or excessive dosing of BOTOX® AZALLURE® may increase the risk of antibodies in the blood which may lead to failure of treatment with botulinum toxin when used for this and other conditions. The aesthetic effects of BOTOX® last for an average of 3-4 months but will vary depending on the condition of the skin, area treated, amount of product injected, injection technique and lifestyle factors such as sun exposure and smoking. After treatment, please avoid extreme facial expressions, alcohol consumption and applying make up for 12 hours. Please avoid extreme sun exposure, UV light, freezing temperatures and saunas for 2 weeks after treatment.
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