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ABSTRAL® (fentanyl) Sublingual Tablets CII, First-in-class, Sublingual, Immediate Release Opioid for Managing Breakthrough Cancer Pain, Now Available in the U.S.
Date:4/4/2011

or older, who are already receiving, and who are tolerant to, opioid therapy for their underlying persistent cancer pain. ABSTRAL is available in strengths of 100 mcg, 200 mcg, 300 mcg, 400 mcg, 600 mcg and 800 mcg.

ABSTRAL is in-licensed by ProStrakan for Europe, the U.S., Canada, and Mexico from Sweden-based Orexo AB.

Important ABSTRAL® Safety Information

Do not use ABSTRAL unless you are regularly using another opioid pain medicine around-the-clock for your cancer pain and your body is used to these medicines (this means that you are opioid tolerant).

Keep ABSTRAL in a safe place away from children. ABSTRAL can cause an overdose and death in any child who takes it. Get emergency help right away if a child takes ABSTRAL. If possible, try to remove ABSTRAL from the mouth.

ABSTRAL can cause life-threatening breathing problems that can lead to death. Breathing problems are more likely to occur in patients with underlying breathing problems, elderly patients, or impaired or weak patients. These problems usually occur after large initial doses in patients who are not opioid tolerant or when opioids are given with other medicines that slow breathing.

ABSTRAL is made with the prescription medicine fentanyl. Your healthcare provider will prescribe a starting dose of ABSTRAL that may be different than other fentanyl-containing medicines you may have been taking. Do not switch from ABSTRAL to other medicines that contain fentanyl without talking with your healthcare provider.

ABSTRAL is a federally controlled substance (CII) because it is a strong opioid (narcotic) pain medicine that can be misused by people who abuse prescription medicines or street drugs.

Never give ABSTRAL to anyone else, even if they have the same symptoms you have. It may harm them or cause death.

Do not take ABSTRAL for short-term pain that you would expect to go away in a few days, such as
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SOURCE ProStrakan Group plc
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