国: アメリカ合衆国
言語: 英語
ソース: NLM (National Library of Medicine)
AMBROSIA ARTEMISIIFOLIA POLLEN (UNII: K20Y81ACO3) (AMBROSIA ARTEMISIIFOLIA POLLEN - UNII:K20Y81ACO3)
Merck Sharp & Dohme Corp.
AMBROSIA ARTEMISIIFOLIA POLLEN
AMBROSIA ARTEMISIIFOLIA POLLEN 12 [Amb'a'1'U]
Biologic Licensing Application
RAGWITEK- SHORT RAGWEED POLLEN ALLERGEN EXTRACT TABLET MERCK SHARP & DOHME CORP. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE RAGWITEK SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR RAGWITEK. RAGWITEK (SHORT RAGWEED POLLEN ALLERGEN EXTRACT) TABLET FOR SUBLINGUAL USE INITIAL U.S. APPROVAL: 2014 WARNING: SEVERE ALLERGIC REACTIONS _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ RAGWITEK CAN CAUSE LIFE-THREATENING ALLERGIC REACTIONS SUCH AS ANAPHYLAXIS AND SEVERE LARYNGOPHARYNGEAL RESTRICTION. (5.1) DO NOT ADMINISTER RAGWITEK TO PATIENTS WITH SEVERE, UNSTABLE OR UNCONTROLLED ASTHMA. (4) OBSERVE PATIENTS IN THE OFFICE FOR AT LEAST 30 MINUTES FOLLOWING THE INITIAL DOSE. (5.1) PRESCRIBE AUTO-INJECTABLE EPINEPHRINE, INSTRUCT AND TRAIN PATIENTS ON ITS APPROPRIATE USE, AND INSTRUCT PATIENTS TO SEEK IMMEDIATE MEDICAL CARE UPON ITS USE. (5.2) RAGWITEK MAY NOT BE SUITABLE FOR PATIENTS WITH CERTAIN UNDERLYING MEDICAL CONDITIONS THAT MAY REDUCE THEIR ABILITY TO SURVIVE A SERIOUS ALLERGIC REACTION. (5.2) RAGWITEK MAY NOT BE SUITABLE FOR PATIENTS WHO MAY BE UNRESPONSIVE TO EPINEPHRINE OR INHALED BRONCHODILATORS, SUCH AS THOSE TAKING BETA-BLOCKERS. (5.2) INDICATIONS AND USAGE RAGWITEK is an allergen extract indicated as immunotherapy for the treatment of short ragweed pollen-induced allergic rhinitis, with or without conjunctivitis, confirmed by positive skin test or _in vitro_ testing for pollen-specific IgE antibodies for short ragweed pollen. RAGWITEK is approved for use in adults 18 through 65 years of age. (1) DOSAGE AND ADMINISTRATION FOR SUBLINGUAL USE ONLY. One tablet daily. (2.1) Initiate treatment at least 12 weeks before the expected onset of ragweed pollen season and continue treatment throughout the season. (2.2) Place the tablet immediately under the tongue. Allow it to remain there until completely dissolved. Do not swallow for at least 1 minute. (2.2) Administer the first dose of RAGWITEK under the supervision of a ph 完全なドキュメントを読む