BELOTERO BALANCE® (+) AND BELOTERO VOLUME® (+) IMPORTANT CONSUMER SAFETY INFORMATION
What are BELOTERO BALANCE® (+) and BELOTERO VOLUME® (+)?
BELOTERO BALANCE® (+) is a hyaluronic acid dermal filler used for smoothing moderate to severe facial wrinkles and folds, such as nasolabial folds (the creases that extend from the corner of your nose to the corner of your mouth) and also used to add volume beneath the eyes to improve the hollow, sunken appearance of the infraorbital area in adults over the age of 21.
BELOTERO VOLUME® (+) is a hyaluronic acid dermal filler used to restore volume in the midface and correct midface contour deficiencies, including adding fullness to the cheeks, in adults 22 years of age or older.
Who should not use these products?
What is the most important information I should know about these products?
One of the risks with using these products is unintentional injection into a blood vessel. The chances of this happening are very small, but if it does happen, the complications can be serious and may be permanent. These complications, which have been reported for facial injections, can include vision abnormalities, blindness, stroke, temporary scabs, or permanent scarring of the skin. If you have changes in your vision, signs of a stroke (including sudden difficulty speaking, numbness or weakness in your face, arms, or legs, difficulty walking, face drooping, severe headache, dizziness, or confusion), white appearance of the skin, or unusual pain during or shortly after treatment, you should notify your health care practitioner immediately.
Because of this risk, your doctor may check your vision before and after treatment with any of these products and should know in advance which eye specialist to contact if you were to experience an eye-related complication.
Do not use these products if you have a skin infection, cold sore, pimple, cyst, or rash at the treatment site until it has healed.
It is also not known if BELOTERO BALANCE® (+) is safe or effective beyond 96 weeks.
If you have a history of cold sores, you may experience a breakout after treatment.
What should I tell my doctor before treatment?
Tell your health care provider if you are taking blood thinners or medicines that can interfere with clotting, such as aspirin or warfarin, as these may increase your risk of bruising or bleeding at the injection site. Tell your doctor if you are taking medicines that decrease your body’s natural defenses (immunosuppressants), as this may increase your risk of infection. Tell your doctor about any past skin treatments, such as laser treatment or chemical peels.
What are the most common side effects?
Delayed-onset inflammation near the site of injection is a known side effect of dermal fillers. Cases have been reported to occur following viral or bacterial illnesses or infections, vaccinations, or dental procedures. Typically, this inflammation responds to treatment or resolves on its own.
These are not all of the possible side effects with these products. Merz collects information about side effects seen with these products outside of clinical studies. These events are included in the Patient Information Guide based on an assessment of seriousness and potential causal relationship to the product. Please see the Patient Information Guide available at www.belotero.com for a list of these events. Tell your health care provider about any side effect that bothers you or does not go away.
Important: For full safety information, please visit www.belotero.com or call MyMerz Solutions at 1-844-469-6379.
Who should not use these products?
You should not use BELOTERO BALANCE® (+) or BELOTERO VOLUME® (+) if you have severe allergies with a history of anaphylaxis or multiple severe allergies, or an allergic reaction to any product component, including small amounts of protein from bacteria. You should not use BELOTERO BALANCE® (+) or BELOTERO VOLUME® (+) if you are allergic to lidocaine or similar anesthetics.
What is the most important information I should know about these products?
One of the risks with using these products is unintentional injection into a blood vessel. The chances of this happening are very small, but if it does happen, the complications can be serious and may be permanent. These complications, which have been reported for facial injections, can include vision abnormalities, blindness, stroke, temporary scabs, or permanent scarring of the skin. If you have changes in your vision, signs of a stroke (including sudden difficulty speaking, numbness or weakness in your face, arms, or legs, difficulty walking, face drooping, severe headache, dizziness, or confusion), white appearance of the skin, or unusual pain during or shortly after treatment, you should notify your health care practitioner immediately.
Because of this risk, your doctor may check your vision before and after treatment with any of these products and should know in advance which eye specialist to contact if you were to experience an eye-related complication.
Do not use these products if you have a skin infection, cold sore, pimple, cyst, or rash at the treatment site until it has healed.
It is not known if these products are safe or effective if you are pregnant or breastfeeding, or if you are under 21 years old (for treatment of the infraorbital hollow with BELOTERO BALANCE® (+)) or under 22 years old (for midface treatment with BELOTERO VOLUME® (+)).
It is also not known if BELOTERO BALANCE® (+) is safe or effective beyond 96 weeks.
If you have a history of cold sores, you may experience a breakout after treatment.
What should I tell my doctor before treatment?
Tell your health care provider if you are taking blood thinners or medicines that can interfere with clotting, such as aspirin or warfarin, as these may increase your risk of bruising or bleeding at the injection site. Tell your doctor if you are taking medicines that decrease your body’s natural defenses (immunosuppressants), as this may increase your risk of infection. Tell your doctor about any past skin treatments, such as laser treatment or chemical peels.
What are the most common side effects?
The most common side effects seen in clinical studies include swelling, bruising, redness, pain or tenderness, firmness, itching, and lumps or bumps at the injection site. Most of these side effects are temporary and resolve within 1 to 4 weeks, though in some people they may last longer. In studies of the infraorbital hollow, bruising and visible lumps were reported somewhat more often than in studies of the nasolabial folds or midface.
Delayed-onset inflammation near the site of injection is a known side effect of dermal fillers. Cases have been reported to occur following viral or bacterial illnesses or infections, vaccinations, or dental procedures. Typically, this inflammation responds to treatment or resolves on its own.
These are not all of the possible side effects with these products. Merz collects information about side effects seen with these products outside of clinical studies. These events are included in the Patient Information Guide based on an assessment of seriousness and potential causal relationship to the product. Please see the Patient Information Guide available at www.belotero.com for a list of these events. Tell your health care provider about any side effect that bothers you or does not go away.
Important: For full safety information, please visit www.belotero.com or call MyMerz Solutions at 1-844-469-6379.
BELOTERO BALANCE® (+) and BELOTERO VOLUME® (+) are available by prescription only.
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