Botox

JEUVEAU ™(PRABOTULINUMTOXINA -XVFS) FOR INJECTION PATIENT CONSENT FORM

Name(Required)
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The purpose of this informed consent form is to provide written information regarding the risks, benefits and alternatives of the procedure named above. This material serves as a supplement to the discussion you have with your doctor/healthcare provider. It is important that you fully understand this information, so please read this document thoroughly. If you have any questions regarding the procedure, ask your doctor/healthcare professional prior to signing the consent form.
The Treatment1

Jeuveau ™ is a prescription medicine that is injected into muscles and used in adults for a short period of time (temporary) to improve the look of moderate to severe frown lines between the eyebrows (glabellar lines). JeuveauTM can relax the muscle contractions that form frown lines. Treatment with JeuveauTM can temporarily reduce the appearance of moderate to severe frown lines. JeuveauTM is injected into the muscles with a very thin needle. Patients may experience localized pain, infection, inflammation, tenderness, swelling, erythema, and/or bleeding/bruising associated with the injection. In 2 long-term safety studies, patients received an average of 3 treatments over the course of 1 year.1

RISKS AND COMPLICATIONS

Before undergoing this procedure, understanding the risks is essential. The following risks may occur, but there may be unforeseen risks and risks that are not included on this list: allergic reactions (such as itching, rash, red itchy welts, wheezing, asthma symptoms, or dizziness or feeling faint), heart problems (such as irregular heartbeat and heart attack), and eye problems (including dry eye, reduced blinking, and corneal problems). Tell your healthcare provider or get medical emergency help right away if you experience a serious side effect.

The most common side effects observed in the clinical trials included: headache; eyelid drooping, upper respiratory tract infection, and increased white blood cell count.

PREGNANCY, ALLERGIES & NEUROLOGIC DISEASE

I am not aware that I am pregnant and I am not trying to get pregnant, I am not lactating (nursing). I do not have any significant neurologic disease including but not limited to myasthenis gravis, multiple sclerosis, lambert-eaton syndrome, amyotrophic lateral sclerosis (ALS), and parkinson’s. I do not have any allergies to the toxin ingredients, or to human albumin.

ALTERNATIVE PROCEDURES

Alternatives to the procedures and options that I have volunteered for have been fully explained to me.

Payment

I understand that this is an “elective” procedure and that payment is my responsibility and is expected at the time of treatment.

RIGHT TO DISCONTINUE TREATMENT

I understand that I have the right to discontinue treatment at any time.

PHOTOS/VIDEO RELEASE

I authorize the taking of clinical photographs and videos and their use for marketing, presentations, social media, etc. I waive my rights to any royalties, fees and to inspect the finished materials in conjunction with these photographs.

I understand this is an elective procedure and I hereby voluntarily consent to treatment with JeuveauTM for frown lines. The procedure has been fully explained to me. I also understand that any treatment performed is between me and the doctor/healthcare provider who is treating me and I will direct all post-operative questions or concerns to the treating clinician. I have read the above and understand it. My questions have been answered satisfactorily. I accept the risks and complications of the procedure and I understand that no guarantees are implied as to the outcome of the procedure. I also certify that if I have any changes in my medical history, I will notify the doctor/healthcare professional who treated me immediately. I also state that I read and write in English.

Name(Required)
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I am the treating healthcare professional. I discussed the above risks, benefits, and alternatives with the patient. The patient had an opportunity to have all questions answered and was offered a copy of this informed consent. The patient has been told to contact my office should they have any questions or concerns after this treatment procedure.
Health Care Professional Name(Required)
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1Jeuveau™ Prescribing Information, 2019
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