Country: Մալայզիա
language: անգլերեն
source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
DESLORATADINE (SCH 34117)
ORGANON MALAYSIA SDN. BHD.
DESLORATADINE (SCH 34117)
50ml mL; 60ml mL; 100ml mL; 120ml mL
Organon Heist bv
_Consumer Medication Information Leaflet (RiMUP) _ AERIUS ® SYRUP Desloratadine 0.5 mg/ml 1 Copyright 2023 Organon group of companies. All rights reserved. WHAT IS IN THIS LEAFLET 1. What _AERIUS SYRUP _ is used for 2. How _AERIUS SYRUP _ works 3. Before you take _AERIUS _ _SYRUP _ 4. How to take _AERIUS SYRUP _ 5. While you are taking _AERIUS _ _SYRUP _ 6. Side effects 7. Storage and Disposal of _AERIUS SYRUP _ 8. Product description 9. Manufacturer and Product Registration Holder 10. Date of Revision WHAT _AERIUS SYRUP _IS USED FOR _AERIUS SYRUP _ relieves symptoms associated with allergic rhinitis (inflammation of the nasal passages caused by an allergy, for example, hay fever or allergy to dust mites).These symptoms include sneezing, runny or itchy nose, itchy palate, and itchy, red or watery eyes. _AERIUS SYRUP _ is also used to relieve the symptoms associated with urticaria (a skin condition caused by an allergy). These symptoms include itching and hives. Relief of these symptoms lasts a full day and helps you to resume your normal daily activities and sleep. HOW _AERIUS SYRUP _WORKS _AERIUS SYRUP _ is an anti- allergy medicine that does not make you drowsy. It helps control your allergic reaction and its symptoms. BEFORE YOU TAKE _AERIUS _ _SYRUP _ _ _ _-_ _ _ _When you must not take it _ DO NOT TAKE _AERIUS SYRUP _ • if you are allergic (hypersensitive) to desloratadine, loratadine, or to any of the other ingredients of _AERIUS _ _SYRUP_ . _AERIUS SYRUP _ is indicated for children 1 through 11 years of age, adolescents (12 years of age and older), and adults, including the elderly. _-_ _ _ _Before you start to take it _ Talk to your doctor or pharmacist before taking _AERIUS SYRUP _ if you have medical or familial history of seizure PREGNANCY AND BREAST-FEEDING Ask your doctor or pharmacist for advice before taking any medicine during pregnancy and breast-feeding. If you are pregnant or nursing a baby, taking _AERIUS SYRUP _ is not recommended. IMPORTANT INFORMATION ABOUT SOME OF THE INGREDIENTS OF _AE read_full_document
Copyright 2023 Organon group of companies. All rights reserved. LPC-OG4117-MTL-112017a AERIUS ® SYRUP Brand of desloratadine DESCRIPTION: Each 1 ml of AERIUS Syrup contains 0.5 mg of desloratadine. AERIUS Syrup is a clear, orange solution. Inactive Ingredients: propylene glycol, sorbitol liquid, citric acid anhydrous, sodium citrate dihydrate, sodium benzoate, disodium edetate, sucrose, natural and artificial flavor, FD&C Yellow Dye No. 6 and purified water. Preservative: sodium benzoate 1.00 mg/ml. ACTIONS: Desloratadine is a non-sedating long-acting histamine antagonist with potent, selective peripheral H 1 -receptor antagonist activity. Desloratadine has demonstrated antiallergic, antihistaminic, and anti-inflammatory activity. PRECLINICAL TOXICOLOGY: Desloratadine is the primary active metabolite of loratadine. Preclinical studies conducted with desloratadine and loratadine demonstrated that there are no qualitative or quantitative differences in the toxicity profile of desloratadine and loratadine at comparable levels of exposure to desloratadine. Preclinical data with desloratadine reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, and toxicity to reproduction. The lack of carcinogenic potential was demonstrated in studies conducted with loratadine. CLINICAL PHARMACOLOGY PHARMACODYNAMIC PROPERTIES : After oral administration, desloratadine selectively blocks peripheral histamine H 1 -receptors because the drug is effectively excluded from entry to the central nervous system (CNS). In addition to antihistaminic activity, desloratadine has demonstrated antiallergic and anti- inflammatory activity from numerous _in vitro _ (mainly conducted on cells of human origin) and _in vivo _ studies. These studies have shown that desloratadine inhibits the broad cascade of events that initiate and propagatE allergic inflammation, including, • the release of proinflammatory cytokines including IL-4, IL-6, IL-8, IL-13, Copyright 2023 Organon gr read_full_document