Страна: Израел
Език: английски
Източник: Ministry of Health
RIMEGEPANT AS SULFATE
PFIZER PHARMACEUTICALS ISRAEL LTD
ORALLY DISINTEGRATING TABLETS
RIMEGEPANT AS SULFATE 75 MG
PER OS
Required
BIOHAVEN PHARMACEUTICALS INC., USA
NURTEC ODT is a calcitonin gene-related peptide receptor antagonist indicated for the: • acute treatment of migraine with or without aura in adults • preventive treatment of episodic migraine in adults
2021-03-01
Nurtec PIL CC 05 Dec 2022 TC 1 2022-0082798 PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS REGULATIONS (PREPARATIONS) - 1986 This medicine is dispensed with a doctor's prescription only NURTEC ODT ® ORALLY DISINTEGRATING TABLETS FOR ORAL OR SUBLINGUAL USE ACTIVE INGREDIENT AND QUANTITY: EACH ORALLY DISINTEGRATING TABLET CONTAINS: RIMEGEPANT 75 MG (EQUIVALENT TO 85.65 MG RIMEGEPANT SULFATE) For a list of inactive ingredients and allergens - see section 6 "Further information". READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THIS MEDICINE. This leaflet contains concise information about this medicine. If you have any further questions, consult your doctor or pharmacist. This medicine has been prescribed to treat your illness. Do not pass it on to others. It may harm them, even if it seems to you that their illness is similar to yours. 1. WHAT IS THIS MEDICINE INTENDED FOR? Nurtec ODT, orally disintegrating tablets, are indicated for: • Acute treatment of migraine attacks with or without aura in adults. • Preventive treatment of episodic migraine. THERAPEUTIC GROUP: Calcitonin gene-related peptide (CGRP) receptor antagonist, antimigraine medicine. 2. BEFORE USING THIS MEDICINE DO NOT USE THIS MEDICINE IF: • You are sensitive (allergic) to the active ingredient (rimegepant) or to any of the other ingredients in this medicine (see section 6). SPECIAL WARNINGS REGARDING USE OF THE MEDICINE ALLERGIC REACTIONS. Allergic reactions, including trouble breathing and rash, can happen after you take this medicine. This can happen days after you take the medicine. If you experience an allergic reaction, stop using it and begin appropriate treatment (see section 4 "Side effect"). BEFORE TREATMENT WITH NURTEC ODT, TELL YOUR DOCTOR IF: • You have liver problems. • You have kidney problems. • You are pregnant or plan to become pregnant. • You are breastfeeding or plan to breastfeed. CHILDREN AND ADOLESCENTS There is no information regarding the safety and effectiveness of this medicine in children and adolescents. Прочетете целия документ
Nurtec LPD CC 29 May 2023 1 2023-0085070 _ _ PHYSICIAN PRESCRIBING INFORMATION NAME OF THE MEDICINAL PRODUCT Nurtec ODT Orally disintegrating tablets _ _ QUALITATIVE AND QUANTITATIVE COMPOSITION Each orally disintegrating tablet contains 75 mg rimegepant (equivalent to 85.65 mg rimegepant sulfate). For the full list of excipients, _see Description (11)_ . PHARMACEUTICAL FORM Orally disintegrating tablets _ _ 1 THERAPEUTIC INDICATIONS NURTEC ODT is a calcitonin gene-related peptide receptor antagonist indicated for the: • Acute treatment of migraine with or without aura in adults • Preventive treatment of episodic migraine in adults_ _ _ 2 DOSAGE AND ADMINISTRATION 2.1 Recommended Dosing for Acute Treatment of Migraine The recommended dose of NURTEC ODT is 75 mg taken orally, as needed. The maximum dose in a 24-hour period is 75 mg. The safety of using more than 18 doses in a 30-day period has not been established. 2.2 Recommended Dosing for Preventive Treatment of Episodic Migraine The recommended dosage of NURTEC ODT is 75 mg taken orally every other day. 2.3 Administration Information Instruct the patient on the following administration instructions: • Use dry hands when opening the blister pack. • Peel back the foil covering of one blister and gently remove the orally disintegrating tablet (ODT). Do not push the ODT through the foil. • As soon as the blister is opened, remove the ODT and place on the tongue; alternatively, the ODT may be placed under the tongue. • The ODT will disintegrate in saliva so that it can be swallowed without additional liquid. • Take the ODT immediately after opening the blister pack. Do not store the ODT outside the blister pack for future use. Nurtec LPD CC 29 May 2023 2 2023-0085070 2.4 Concomitant Administration with Strong or Moderate CYP3A4 Inhibitors Avoid concomitant administration of NURTEC ODT with strong inhibitors of CYP3A4. Avoid another dose of NURTEC ODT within 48 hours when it is concomitantly administered with moderate inhibitors of CYP3A4 _[see Drug In Прочетете целия документ