Χώρα: Ηνωμένες Πολιτείες
Γλώσσα: Αγγλικά
Πηγή: NLM (National Library of Medicine)
AMBROSIA ARTEMISIIFOLIA POLLEN (UNII: K20Y81ACO3) (AMBROSIA ARTEMISIIFOLIA POLLEN - UNII:K20Y81ACO3)
ALK-Abello A S
AMBROSIA ARTEMISIIFOLIA POLLEN
AMBROSIA ARTEMISIIFOLIA POLLEN 12 [Amb'a'1'U]
SUBLINGUAL
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
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.
Biologic Licensing Application
ALK-Abello A S ---------- 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 Διαβάστε το πλήρες έγγραφο
RAGWITEK- AMBROSIA ARTEMISIIFOLIA POLLEN TABLET ALK-ABELLO A S ---------- 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 Διαβάστε το πλήρες έγγραφο