Valsts: Nīderlande
Valoda: holandiešu
Klimata pārmaiņas: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
DESLORATADINE 0,5 mg/ml
Denk Pharma GmbH & Co. KG Prinzregentenstrasse 79 81675 MÜNCHEN (DUITSLAND)
DESLORATADINE 0,5 mg/ml
Drank
CITROENZUUR 0-WATER (E 330) ; HYPROMELLOSE (E 464) ; PROPYLEENGLYCOL (E 1520) 150 mg/ml ; PROPYLEENGLYCOL (E 1520) ; SORBITOL, VLOEIBAAR, NIET-KRISTALLISEERBAAR (E 420) ; SUCRALOSE (E 955) ; TRINATRIUMCITRAAT 2-WATER (E 331) ; TUTTI-FRUTTI SMAAKSTOF ; WATER, GEZUIVERD, CITROENZUUR 0-WATER (E 330) ; HYPROMELLOSE (E 464) ; PROPYLEENGLYCOL (E 1520) ; PROPYLEENGLYCOL (E 1520) 150 mg/ml ; SORBITOL, VLOEIBAAR, NIET-KRISTALLISEERBAAR (E 420) ; SUCRALOSE (E 955) ; TRINATRIUMCITRAAT 2-WATER (E 331) ; TUTTI- FRUTTI SMAAKSTOF ; WATER, GEZUIVERD, CITROENZUUR 0-WATER (E 330) ; HYPROMELLOSE (E 464) ; PROPYLEENGLYCOL (E 1520) 150 mg/ml ; PROPYLEENGLYCOL (E 1520) ; SORBITOL, VLOEIBAAR, NIET-KRISTALLISEERBAAR (E 420) ; SUCRALOSE (E 955) ; TRINATRIUMCITRAAT 2-WATER (E 331) ; TUTTI- FRUTTI SMAAKSTOF ; WATER, GEZUIVERD
Oraal gebruik
1900-01-01
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT DESLORATADINE DENK 0,5 MG/ML DRANK desloratadine READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU Keep this leaflet. You may need to read it again If you have any further questions, ask your doctor, pharmacist or nurse. This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. If you get any side effects talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Desloratadine Denk is and what it is used for 2. What you need to know before you take Desloratadine Denk 3. How to take Desloratadine Denk 4. Possible side effects 5. How to store Desloratadine Denk 6. Contents of the pack and other information 1. WHAT DESLORATADINE DENK IS AND WHAT IT IS USED FOR WHAT DESLORATADINE DENK IS Desloratadine Denk contains desloratadine which is an antihistamine HOW DESLORATADINE DENK WORKS Desloratadine Denk oral solutions is an antiallergy medicine that does not make you drowsy. It helps control your allergic reaction and its symptoms. WHEN DESLORATADINE DENK SHOULD BE USED Desloratadine Denk relieves symptoms associated with allergic rhinitis (inflammation of the nasal passages caused by an allergy, for example, hay fever or allergy to dust mites) in adults, adolescents and children 1 year of age and older. These symptoms include sneezing, runny or itchy nose, itchy palate, and itchy, red or watery eyes. Desloratadine Denk oral solution 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. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DESLORATADINE DENK DO NOT TAKE DESLORATADINE DENK if you are allergic to desloratad Izlasiet visu dokumentu
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Desloratadine Denk 0,5 mg/ml drank 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of oral solution contains 0.5 mg desloratadine. Excipient(s) with known effect: This medicinal product contains 150 mg/ml of sorbitol and 150.51 mg/ml of propylene glycol. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Oral solution 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Desloratadine Denk is indicated in adults, adolescents and children over the age of 1 year for the relief of symptoms associated with: Allergic rhinitis (see section 5.1) Urticaria (see section 5.1) 4.2. POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults and adolescents (12 years of age and over) _ The recommended dose of Desloratadine Denk is 10 ml (5 mg) oral solution once a day. _Paediatric population _ The prescriber should be aware that most cases of rhinitis below 2 years of age are of infectious origin (see section 4.4) and there are no data supporting the treatment of infectious rhinitis with Desloratadine Denk. Children 1 through 5 years of age: 2.5 ml (1.25 mg) Desloratadine Denk oral solution once a day. Children 6 through 11 years of age: 5 ml (2.5 mg) Desloratadine Denk oral solution once a day. The safety and efficacy of Desloratadine Denk 0.5 mg/ml oral solution in children below the age of 1 year have not been established. No data are available. There is limited clinical trial efficacy experience with the use of desloratadine in children 1 through 11 years of age and adolescents 12 through 17 years of age (see sections 4.8 and 5.1). Intermittent allergic rhinitis (presence of symptoms for less than 4 days per week or for less than 4 weeks) should be managed in accordance with the evaluation of patient’s disease history and the treatment could be discontinued after symptoms are resolved and reinitiated upon their reappearance. In persistent allergic rhinitis (presence of symptoms for 4 days or more per week and for more than 4 w Izlasiet visu dokumentu