Search results with tag "Reference id"
Reference ID: 3115694
www.accessdata.fda.govReference ID: 3115694 . Allergic Urticaria. • Pregnancy [see Use in Specific Populations (8.1)] • Nursing [see Use in Specific Populations (8.3)] • Known hypersensitivity, or idiosyncrasy to the sympathomimetic amines . WARNINGS AND PRECAUTIONS . Coadministration With Other Drug Products for Weight Loss
Reference ID: 3058238
www.accessdata.fda.gov112 . 6.2 Postmarketing Experience : 113 : The following adverse reactions have been identified during post-approval use of : 114 (Reference ID: 3058238
Reference ID: 3433133
www.accessdata.fda.govReference ID: 3433133 . 5.4 Genital Mycotic Infections . FARXIGA increases the risk of genital mycotic infections. Patients with a history of genital mycotic infections were more likely to develop genital mycotic infections [see Adverse Reactions (6.1)]. Monitor and treat appropriately.
Reference ID: 3324257 - Food and Drug Administration
www.accessdata.fda.govPage 4 monkeys resulted in increased fetal loss, stillbirths, and postnatal mortality, along with evidence of absent peripheral lymph nodes, abnormal bone growth, and decreased neonatal growth [see Use in Specific Populations (8.1) and (8.7)].
Reference ID: 3537640 - Food and Drug Administration
www.accessdata.fda.govC-tavaborole solution, tavaborole conjugates and metabolites were shown to be excreted primarily in the urine. The pharmacokinetics of tavaborole was investigated in 24 subjects with distal subungual onychomycosis
Reference ID: 3075879 - LEO Pharma
www.leo-pharma.usFULL PRESCRIBING INFORMATION . 1 INDICATIONS AND USAGE . Picato® gel is indicated for the topical treatment of actinic keratosis.. 2 DOSAGE AND ADMINISTRATION . For topical use only; Picato® gel is not for oral, ophthalmic, or intravaginal use.. For …
Reference ID: 4030092 - Food and Drug Administration
www.accessdata.fda.govDose . Starting Dose . 600 mg twice daily (two 300 mg tablets) First Dose Reduction 500 mg twice daily (one 300 mg tablet . and : one 200 mg tablet) Second Dose Reduction
Reference ID: 2939597 - Food and Drug Administration
www.accessdata.fda.gov1 INDICATIONS AND USAGE • Fusilev ® is a folate analog. • Fusilev rescue is indicated after high-dose methotrexate therapy in osteosarcoma.
Reference ID: 3366104 - ZEVALIN® (ibritumomab …
www.zevalin.comfull prescribing information warning: serious infusion reactions, prolonged and severe cytopenias, and severe cutaneous and mucocutaneous reactions
Reference ID: 4090621 - Home - Radius
radiuspharm.com2.2 Administration Instructions • Administer TYMLOS as a subcutaneous injection into the periumbilical region of the abdomen. Rotate the site of the injection every day and administer at approximately the same