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- ©2009 Alaven Pharmeceutical LLC. All Rights Reserved.
IMPORTANT SAFETY INFORMATION
INDICATIONS: The PrimaBella™ Neuromodulation device is available by prescription only for the treatment of nausea and vomiting due to pregnancy (NVP).
WARNINGS: PrimaBella ™ should only be used on the designated area. Nausea and vomiting may be signs of a serious health problem, seek medical attention if symptoms continue. PrimaBella™ is not a curative and should always be used under medical supervision. Treatment outcomes may vary depending on patient characteristics and any medications a patient may be taking. PrimaBella™ should be kept out of reach of children. Pacemaker users: Use this device only as directed on the wrist to prevent possible interference with your pacemaker. Avoid placing the electrodes of the device directly on your chest or near pacemaker. Consult with your physician if you have other implanted devices. PrimaBella™ should not be used above an IV line attached to a patient's arm. If a patient is using an IV line, PrimaBella™ should be placed on the opposite arm.
CAUTION: PrimaBella™ contains natural rubber latex, which many cause allergic reactions, and is not recommended for use in conjunction with electrocautery or MRI equipment.
SIDE EFFECTS: Skin irritation can occur beneath or around the electrodes. If irritation occurs, move the device to the other wrist. If irritation does not disappear within 24 hours, stop using the device and consult your doctor or pharmacist. Continued use of the device on irritated skin may cause skin injury.
CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician or other health care professional licensed in the state in which they practice.