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AMELUZ- aminolevulinic acid hydrochloride gel


  1. Patient Information
  2. Distributed By:

Patient Information 

Transient amnestic episodes

Transient amnestic episodes have been reported with use of AMELUZ in combination with photodynamic therapy. Advise patients and their families or caregivers to contact their healthcare provider if memory impairment, confusion, or disorientation is observed[seeWarnings and Precautions (5)].

Photosensitivity

Advise patients that for approximately 48 hours following treatment to avoid exposure to sunlight, and prolonged or intense light on the treated lesion sites and surrounding skin.

Advise patients to avoid certain medications that may enhance the phototoxic reaction to PDT[seeWarnings and Precautions (5)andDrug Interactions (7)].

Common adverse reactions

Inform patients that treatment with AMELUZ in combination with PDT may result in adverse reactions which include local skin reactions at the application site such as erythema, pain/burning, irritation, edema, pruritus, exfoliation, induration, scab, and vesicles.

AMELUZ and BF-RhodoLED are registered trade marks of Biofrontera Pharma GmbH.

PATENT INFO

US patent 6,559,183 and pending patent application US 2009/0324727

Distributed By: 

Biofrontera Inc.

120 Presidential Way

Suite 330

Woburn, MA 01801

USA



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