البلد: إسرائيل
اللغة: الإنجليزية
المصدر: Ministry of Health
UBROGEPANT AS TRIHYDRATE
ABBVIE BIOPHARMACEUTICALS LTD, ISRAEL
TABLETS
UBROGEPANT AS TRIHYDRATE 100 MG
PER OS
Required
FOREST LABORATORIES IRELAND, LIMITED, IRELAND
Ubrelvy is a calcitonin gene-related peptide receptor antagonist indicated for the acute treatment of migraine with or without aura in adults.Limitations of UseUbrelvy is not indicated for the preventive treatment of migraine.
2022-06-03
UBR APL TIK JUL 23 CL P4 UBR APL TIK JUL 23 CL P4 PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS( – 1986 This medicine is dispensed with a doctor’s prescription only UBRELVY 50 mg, tablets UBRELVY 100 mg, tablets The active ingredient and its quantity: Each tablet contains: UBRELVY 50 mg, tablets ubrogepant 50.0 mg/tablet )equivalent to 54.9 mg of ubrogepant free base trihydrate( UBRELVY 100 mg, tablets ubrogepant 100.0 mg/tablet )equivalent to 109.8 mg of ubrogepant free base trihydrate( For the full list of inactive ingredients, please see section 6 “Further Information” in this leaflet. See also “Important information about some of this medicine’s ingredients” in section 2. Read this leaflet carefully in its entirety before using the medicine. This leaflet contains concise information about the medicine. If you have further questions, refer to the doctor or pharmacist. This medicine has been prescribed for your ailment/ for you. Do not pass it on to others. It may harm them even if it seems to you that their ailment/ medical condition is similar. This medicine is intended for use in adults above the age of 18. 1. WHAT IS THE MEDICINE INTENDED FOR? UBRELVY contains the active substance ubrogepant, a calcitonin gene-related peptide )CGRP( receptor antagonist. UBRELVY is used for the acute treatment of migraine attacks with or without aura in adults. Limitations of Use UBRELVY is not indicated for the preventive treatment of migraine. Therapeutic group: antimigraine preparations, calcitonin gene-related peptide )CGRP( antagonist. 2. BEFORE USING THE MEDICINE Do not use the medicine: - if you are sensitive )allergic( to the active substance ubrogepant or to any of the other ingredients of this medicine )listed in section 6(. Serious allergic reactions may include life-threatening allergic reaction )anaphylaxis(, difficulty breathing, and swelling of the face, mouth, tongue, or throat. See section “Special warnings about using this medicine” and section 4 اقرأ الوثيقة كاملة
UBR API MAR 23 CL Page 1 of 14 UBRELVY 50 MG UBRELVY 100 MG QUALITATIVE AND QUANTITATIVE COMPOSITION UBRELVY 50 mg Each tablet contains 50 mg of ubrogepant (equivalent to 54.9 mg of ubrogepant free base trihydrate) UBRELVY 100 mg Each tablet contains 100 mg of ubrogepant (equivalent to 109.8 mg of ubrogepant free base trihydrate) 1 INDICATIONS AND USAGE UBRELVY is a calcitonin gene-related peptide receptor antagonist indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use UBRELVY is not indicated for the preventive treatment of migraine. 2 DOSAGE AND ADMINISTRATION 2.1 RECOMMENDED DOSAGE The recommended dose of UBRELVY is 50 mg or 100 mg taken orally with or without food. If needed, a second dose may be taken at least 2 hours after the initial dose. The maximum dose in a 24-hour period is 200 mg. The safety of treating more than 8 migraines in a 30-day period has not been established. 2.2 DOSAGE MODIFICATIONS Dosing modifications for concomitant use of specific drugs and for patients with hepatic or renal impairment are provided in Table 1. TABLE 1: DOSE MODIFICATIONS FOR DRUG INTERACTIONS AND FOR SPECIFIC POPULATIONS DOSAGE MODIFICATIONS INITIAL DOSE SECOND DOSE a (IF NEEDED) CONCOMITANT DRUG _[SEE DRUG INTERACTIONS (7)]_ Moderate CYP3A4 Inhibitors _ (7.1)_ 50 mg Avoid within 24 hours Weak CYP3A4 Inhibitors _(7.1)_ 50 mg 50 mg Strong CYP3A4 Inducers _(7.2)_ Avoid concomitant use Weak & Moderate CYP3A4 Inducers _ (7.2)_ 100 mg 100 mg BCRP and/or P-gp only Inhibitors _(7.3)_ 50 mg 50 mg UBR API MAR 23 CL Page 2 of 14 SPECIFIC POPULATIONS _[SEE USE IN SPECIFIC POPULATIONS (8)]_ Severe Hepatic Impairment (Child-Pugh Class C) _(8.6)_ 50 mg 50 mg Severe Renal Impairment (CLcr 15-29 mL/min) _(8.7)_ 50 mg 50 mg End-Stage Renal Disease (CLcr <15 mL/min) _ (8.7)_ Avoid use a Second dose may be taken at least 2 hours after the initial dose 3 DOSAGE FORMS AND STRENGTHS UBRELVY 50 mg is supplied as white to off-white, capsule-shaped, biconvex tablets debossed with “U50” on one sid اقرأ الوثيقة كاملة