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BELOTERO BALANCE is a prescription injection that is approved to temporarily smooth out and fill in moderate to- severe nasolabial folds (the folds or wrinkles that go from the side of the nose to the corner of the mouth).
BELOTERO BALANCE should not be used in patients with severe allergies, including those with a history of anaphylaxis or with any other fillers. BELOTERO BALANCE should not be used in patients with allergies to gram-positive bacterial proteins.
Introduction of BELOTERO BALANCE into the vasculature may lead to embolization, occlusion of the vessels, ischemia, or infarction.
Take extra care when injecting soft tissue fillers, for example inject the product slowly and apply the least amount of pressure necessary. Rare but serious adverse events associated with the intravascular injection of soft tissue fillers in the face have been reported and include temporary or permanent vision impairment, blindness, cerebral ischemia or cerebral hemorrhage, leading to stroke, skin necrosis, and damage to underlying facial structures.
Immediately stop the injection if a patient exhibits any of the following symptoms, including changes in vision, signs of a stroke, blanching of the skin, or unusual pain during or shortly after the procedure. Patients should receive prompt medical attention and possibly evaluation by an appropriate health care practitioner specialist should an intravascular injection occur.
Tell your doctor if you are taking medicines that affect blood clotting, like aspirin, an NSAID or warfarin. These medicines may put you at an increased risk of bruising or bleeding at the treatment site. Tell your doctor if you have a skin reaction like cold sores, cysts, pimples, rashes, hives, or an infection. Treatment with BELOTERO BALANCE should be delayed until the reaction goes away. Tell your doctor if you are taking medicines that affect your immune system.
The most common adverse events seen in clinical studies with BELOTERO BALANCE were swelling, bruising, redness, hardening of the skin, pain, altered color, or itching. Other side effects that have occurred in clinical studies of BELOTERO BALANCE include headache, swelling of the side of the nose, moderate cold sore, lip numbness, and lip dryness. Side effects were often mild to moderate and often resolved within 7 days.
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