Krajina: Malajzia
Jazyk: angličtina
Zdroj: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
DESLORATADINE
DCH AURIGA (MALAYSIA) SDN. BHD.
DESLORATADINE
60ml ml; 100ml ml
Balkanpharma-Troyan
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ DEZAL ORAL SOLUTION 0.5MG/ML Desloratadine (0.5 mg/ml) 1 WHAT IS IN THIS LEAFLET 1. What Dezal is used for 2. How Dezal works 3. Before you use Dezal 4. How to take it 5. While you are using it 6. Side Effects 7. Storage and Disposal of Dezal 8. Product description 9. Manufacturer and Product Registration Holder 10. Date of Revision WHAT DEZAL IS USED FOR Dezal 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. Dezal 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 DEZAL WORKS Dezal is an antiallergy medicine that does not make you drowsy. It helps control your allergic reaction and its symptoms. BEFORE YOU USE DEZAL _-When you must not take it_ Do not use Dezal if you are allergic (hypersensitive) to desloratadine, to any of the other ingredients of Dezal or to loratadine. Dezal oral solution 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 _ Take special care with Dezal if you have poor kidney function. If this applies to you, or if you are not sure, please check with your doctor before taking Dezal. 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 Dezal is not recommended. Important information about some of the ingredients of Dezal Oral Solution Dezal oral solution contains sorbitol. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal prod Prečítajte si celý dokument
PRODUCT NAME Dezal Oral Solution 0.5mg/ml COMPOSITION NAME AND STRENGTH OF ACTIVE SUBSTANCE(S) Each ml contains 0.5mg desloratadine PRODUCT DESCRIPTION Oral solution: Clear, colourless solution, free from foreign matter. PHARMACOLOGY Actions: Desloratadine is a non-sedating long-acting histamine antagonist with potent, selective peripheral H 1 -receptor antagonist activity. It has demonstrated anti-allergic, antihistaminic and anti-inflammatory activity. Pharmacodynamics: 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 anti-allergic 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 pro-inflammatory cytokines including IL-4, IL-6, IL-8 and IL-13; the release of important pro-inflammatory chemokines eg, Regulated upon Activation, Normal T-cell Expressed and Secreted (RANTES); superoxide anion production by activated polymorphonuclear neutrophils; eosinophil adhesion and chemotaxis; the expression of the adhesion molecules eg, P-selectin; IgE-dependent release of histamine, prostaglandin (PGD2), and leukotriene (LTC4); the acute allergic bronchoconstrictor response and allergic cough in animal models. Desloratadine does not readily penetrate the CNS. At the recommended dose of 5mg daily, there was no excess incidence of somnolence as compared to placebo. Desloratadine tablet even at a dose of 7.5 mg daily, did not affect psychomotor performance. A single dose of desloratadine 5 mg did not affect standard measures of flight performance including exacerbation of subjective sleepiness or tasks related to flying. No clinically relevant changes in desloratadine plasma concentrations were o Prečítajte si celý dokument