RAGWITEK short ragweed pollen allergen extract tablet

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Aktīvā sastāvdaļa:

AMBROSIA ARTEMISIIFOLIA POLLEN (UNII: K20Y81ACO3) (AMBROSIA ARTEMISIIFOLIA POLLEN - UNII:K20Y81ACO3)

Pieejams no:

Merck Sharp & Dohme Corp.

SNN (starptautisko nepatentēto nosaukumu):

AMBROSIA ARTEMISIIFOLIA POLLEN

Kompozīcija:

AMBROSIA ARTEMISIIFOLIA POLLEN 12 [Amb'a'1'U]

Autorizācija statuss:

Biologic Licensing Application

Produkta apraksts

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