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EFUDEX (fluorouracil) TOPICAL SOLUTIONS AND CREAM FOR …

WEBCONTRAINDICATIONS). Rarely, life-threatening toxicities such as stomatitis, diarrhea, neutropenia, and neurotoxicity have been reported with intravenous administration of …

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URL: https://pi.bauschhealth.com/globalassets/BHC/PI/Efudex-pi.pdf

HIGHLIGHTS OF PRESCRIBING INFORMATION

WEB6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be …

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HIGHLIGHTS OF PRESCRIBING INFORMATION

WEBfull prescribing information: contents* 1 indications and usage 2 dosage and administration 3 dosage forms and strengths 4 contraindications 4.1 hypersensitivity

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HIGHLIGHTS OF PRESCRIBING INFORMATION

WEBFULL PRESCRIBING INFORMATION: CONTENTS* WARNING: SUICIDAL THOUGHTS AND BEHAVIORS 1 INDICATIONS AND USAGE 1.1 Major Depressive Disorder (MDD) …

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HIGHLIGHTS OF PRESCRIBING INFORMATION Ileus (4) These …

WEB2 DOSAGE AND ADMINISTRATION 2.1 Important Preparation and Administration Instructions • Correct fluid and electrolyte abnormalities before treatment with MoviPrep …

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Cuprimine®(penicillamine) Capsules, USP

WEBThe structural formula is: It reacts readily with formaldehyde or acetone to form a thiazolidine-carboxylic acid. CUPRIMINE (penicillamine) Capsules, USP for oral …

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TRULANCE. TRULANCE PATIENTS See full prescribing …

WEB1. Place the TRULANCE tablet in a clean cup. 2. Pour approximately 30 mL of room temperature water into the cup. 3. Mix by gently swirling the tablet and water mixture for …

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FULL PRESCRIBING INFORMATION: CONTENTS*

WEB8.4 Pediatric Use Safety and effectiveness of ACANYA Gel in pediatric patients under the age of 12 have not been evaluated. 8.5 Geriatric Use Clinical trials of ACANYA Gel did …

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Bausch Health US, LLC ZYCLARA- imiquimod cream

WEB5.5 Immune Cell Activation in Autoimmune Disease ZYCLARA Cream should be used with caution in patients with pre-existing autoimmune conditions because imiquimod …

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13 NONCLINICAL TOXICOLOGY

WEBpsoriasis involving ≥20% of their body surface area. The subjects were treated once daily for 8 weeks and assessed for HPA axis suppression at Weeks 4 and 8.

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Cream · Gel For Topical Use Only

WEBNonteratogenic Effects Topical tretinoin has been shown to be fetotoxic in rabbits when administered 0.5 mg/kg/day (8 times the maximum human systemic dose adjusted for total

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VIRAZOLE® (Ribavirin for Inhalation Solution, USP)

WEBVIRAZOLE® mask or mist tent for 20 hours each day for 5 days had plasma concentrations ranging (Ribavirin for Inhalation Solution, USP) PRESCRIBING INFORMATION …

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HIGHLIGHTS OF PRESCRIBING INFORMATION

WEB6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be …

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ELIDEL (pimecrolimus) Cream, 1%

WEBTable 1. Treatment Emergent Adverse Events (≥1%) in ELIDEL Cream, 1% Treatment Groups Pediatric Subjects* Vehicle-Controlled (6 weeks) Pediatric Subjects*

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OSSIX PLUS The Resorbable Collagen Membrane Instructions …

WEBocclusal adjustment when indicated. A postoperative maintenance phase can help to ensure long-term therapeutic success. 2. The bony defect should be exposed by full thickness …

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ARESTIN®(minocycline hydrochloride) microspheres, 1 mg

WEBDESCRIPTION. ARESTIN (minocycline hydrochloride) microspheres, 1 mg is a subgingival sustained-release product containing the antibiotic minocycline hydrochloride …

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WARNING: BIRTH DEFECTS

WEBhormone replacement. Obtain baseline thyroid function tests and patients monitor during treatment. 5.5 Neutropenia Leukopenia in the range of 1000 to <3000 WBC x 10 /L …

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FULL PRESCRIBING INFORMATION: CONTENTS*

WEB8.2 Lactation 8.4 Pediatric Use 8.5 Geriatric Use 11 DESCRIPTION 12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action 12.2 Pharmacodynamics 12.3 …

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(erythromycin- Topical Gel Benzamycin®

WEBIt has the following structural formula: Erythromycin has the molecular weight of 733.94. It is a white crystalline powder and has a solubility of approximately 1 mg/mL in water and is …

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