RAGWITEK- ambrosia artemisiifolia pollen tablet

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

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

Dostupné s:

ALK-Abello A S

INN (Mezinárodní Name):

AMBROSIA ARTEMISIIFOLIA POLLEN

Složení:

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

Podání:

SUBLINGUAL

Terapeutické indikace:

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 persons 5 through 65 years of age. RAGWITEK is not indicated for the immediate relief of allergic symptoms. RAGWITEK is contraindicated in patients with: - Severe, unstable or uncontrolled asthma - A history of any severe systemic allergic reaction - A history of any severe local reaction after taking any sublingual allergen immunotherapy - A history of eosinophilic esophagitis - Hypersensitivity to any of the inactive ingredients [gelatin, mannitol, and sodium hydroxide] contained in this product [see Description ( 11 )]. Risk Summary All pregnancies have a risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarr

Přehled produktů:

RAGWITEK 12 Amb a 1-U tablets are white to off-white, circular sublingual tablets with a debossed double hexagon on one side. RAGWITEK is supplied as follows: 3 blister packages of 10 tablets (30 tablets total). NDC 52709-1601-3 Store at controlled room temperature, 20ºC to 25ºC (68ºF to 77ºF); excursions permitted between 15ºC to 30ºC (59ºF to 86ºF). Store in the original package until use to protect from moisture.

Stav Autorizace:

Biologic Licensing Application

Informace pro uživatele

ALK-Abello A S
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MEDICATION GUIDE
RAGWITEK® (RAG-wi-tek)
(Short Ragweed Pollen Allergen Extract)
Carefully read this Medication Guide before you or your child start
taking RAGWITEK® and each time you
get a refill. This Medication Guide does not take the place of talking
with your doctor about your medical
condition or treatment. Talk with your doctor or pharmacist if there
is something you do not understand or if
you want to learn more about RAGWITEK.
What is the Most Important Information I Should Know about RAGWITEK?
RAGWITEK can cause severe allergic reactions that may be
life-threatening. Stop taking RAGWITEK and
get medical treatment right away if you or your child have any of the
following symptoms after taking
RAGWITEK:
•
Trouble breathing
•
Throat tightness or swelling
•
Trouble swallowing or speaking
•
Dizziness or fainting
•
Rapid or weak heartbeat
•
Severe stomach cramps or pain, vomiting, or diarrhea
•
Severe flushing or itching of the skin
For home administration of RAGWITEK, your doctor will prescribe
auto-injectable epinephrine, a medicine
you can inject if you or your child have a severe allergic reaction
after taking RAGWITEK. Your doctor will
train and instruct you on the proper use of auto-injectable
epinephrine.
Talk to your doctor or read the epinephrine patient information if you
have any questions about the use of
auto-injectable epinephrine.
What is RAGWITEK?
RAGWITEK is a prescription medicine used for sublingual (under the
tongue) immunotherapy to treat
ragweed pollen allergies that can cause sneezing, runny or itchy nose,
stuffy or congested nose, or itchy and
watery eyes. RAGWITEK may be prescribed for persons 5 through 65 years
of age who are allergic to
ragweed pollen.
RAGWITEK is taken for about 12 weeks before ragweed pollen season and
throughout ragweed pollen
season.
RAGWITEK is NOT a medication that gives immediate relief for symptoms
of ragweed allergy.
RAGWITEK is not approved for use in children younger than 5 years of
age or in adults older than 65 y

Charakteristika produktu

RAGWITEK- AMBROSIA ARTEMISIIFOLIA POLLEN TABLET
ALK-ABELLO A S
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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
OR
PARENTS/GUARDIANS ON ITS APPROPRIATE USE, AND INSTRUCT PATIENTS OR
PARENTS/GUARDIANS
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)
RECENT MAJOR CHANGES
Indications and Usage (1) 04/2021
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 persons 5 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