Valsts: Zviedrija
Valoda: zviedru
Klimata pārmaiņas: Läkemedelsverket (Medical Products Agency)
dexametason
AcuCort AB
H02AB02
dexamethasone
4 mg
Munsönderfallande film
dexametason 4 mg Aktiv substans; glycerol Hjälpämne
Receptbelagt
Förpacknings: Dospåse, 3 x 1 film; Dospåse, 2 x 1 film; Dospåse, 5 x 1 film
Godkänd
2020-10-06
1 PACKAGE LEAFLET: INFORMATION FOR THE USER ZEQMELIT 4 MG ORODISPERSIBLE FILM ZEQMELIT 6 MG ORODISPERSIBLE FILM ZEQMELIT 8 MG ORODISPERSIBLE FILM dexamethasone 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 or pharmacist. - 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What [product name] is and what it is used for 2. What you need to know before you take [product name] 3. How to take [product name] 4. Possible side effects 5. How to store [product name] 6. Contents of the pack and other information 1. WHAT [PRODUCT NAME] IS AND WHAT IT IS USED FOR [product name] contains the active substance dexamethasone, which belongs to a group of medicinal products called corticosteroids (cortisones). Corticosteroids reduce inflammation and symptoms of allergic reactions and suppress the immune system. [product name] is used in the treatment of: - Swelling of the brain causedby brain tumours, neurosurgery or abscesses - Acute severe asthma - Severe acute skin diseases - Autoimmune diseases - Rheumatoid arthritis - Prevention and treatment of nausea and vomiting due to treatment with anti-cancer drugs - Croup - Allergic reactions, including acute allergic reactions - Treatment of coronavirus disease 2019 (COVID-19) in adult and adolescent patients (aged 12 years and older with body weight of at least 40 kg) with difficulty breathing and need of oxygen therapy. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE [PRODUCT NAME] DO NOT TAKE [PRODUCT NAME] - if you are allergic to dexamethasone or any of the other ingredients of this medicine (listed in section 6). WARNINGS AND PRECAUTION Izlasiet visu dokumentu
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Zeqmelit 4 mg orodispersible film Zeqmelit 6 mg orodispersible film Zeqmelit 8 mg orodispersible film 2. QUALITATIVE AND QUANTITATIVE COMPOSITION [product name] 4 mg orodispersible film Each orodispersible film contains 4 mg of dexamethasone. [product name] 6 mg orodispersible film Each orodispersible film contains 6 mg of dexamethasone. [product name] 8 mg orodispersible film Each orodispersible film contains 8 mg of dexamethasone. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Orodispersible film [product name] 4 mg orodispersible film White to pale yellow, translucent, rectangular film, 20 mm x 17 mm in dimensions. [product name] 6 mg orodispersible film White to pale yellow, translucent, rectangular film, 20 mm x 25 mm in dimensions. [product name] 8 mg orodispersible film White to pale yellow, translucent, rectangular film, 20 mm x 33 mm in dimensions. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Processes that require anti-inflammatory and immunosuppressant treatment among others: • Treatment of cerebral oedema secondary to brain tumours, neurosurgery, brain abscesses • Treatment of acute severe asthma • Initial treatment of severe acute dermatological diseases • Initial treatment of autoimmune diseases • Treatment of active rheumatoid arthritis • Prophylaxis and treatment of nausea and vomiting induced by cytostatic agents within the scope of anti-emetic regimens • Croup • Allergic reactions, including acute allergic reactions • Treatment of coronavirus disease 2019 (COVID-19) in adult and adolescent patients (aged 12 years and older with body weight at least 40 kg) who require supplemental oxygen therapy. 2 4.2. POSOLOGY AND METHOD OF ADMINISTRATION Posology The dose required depends on the severity of the disease and the patient’s individual response. In general, higher doses are administered initially. The dose tends to be higher during acute severe conditions than during chronic d Izlasiet visu dokumentu