País: Irlanda
Idioma: inglés
Fuente: HPRA (Health Products Regulatory Authority)
Dexamethasone sodium phosphate
AS Kalceks
H02AB02
Dexamethasone sodium phosphate
Solution for injection/infusion
dexamethasone
2022-03-11
PACKAGE LEAFLET: INFORMATION FOR THE USER DEXAMETHASONE PHOSPHATE 4 MG/ML SOLUTION FOR INJECTION/INFUSION dexamethasone phosphate READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 Dexamethasone phosphate is and what it is used for 2. What you need to know before you are given Dexamethasone phosphate 3. How Dexamethasone phosphate will be given 4. Possible side effects 5. How to store Dexamethasone phosphate 6. Contents of the pack and other information 1. WHAT DEXAMETHASONE PHOSPHATE IS AND WHAT IT IS USED FOR Dexamethasone phosphate contains the active substance dexamethasone phosphate (further referred to as dexamethasone). Dexamethasone is a synthetic glucocorticoid (adrenocortical hormone). It reduces inflammatory symptoms and intervenes in essential metabolic processes. SYSTEMIC USE (AFFECTS THE ENTIRE BODY) Dexamethasone phosphate is often used following emergency treatment started at high dose: − Treatment and prophylaxis of cerebral oedema (swelling of the brain) in brain tumours (after surgery and after X-ray radiation) and after spinal cord trauma. − State of shock due to a severe allergic reaction called ‘anaphylactic shock’ (e.g. contrast medium reaction). − States of shock after severe injuries, prevention of post-traumatic ‘shock lung’ (acute respiratory insufficiency). − Persistent severe symptoms of an asthma attack. − Initial treatment of some extensive, acute, severe skin conditions (e.g. pemphigus vulgaris, erythroderma). − Severe blood diseases (e.g. Leer el documento completo
Health Products Regulatory Authority 25 April 2023 CRN00DDC3 Page 1 of 14 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Dexamethasone phosphate 4 mg/ml solution for injection/infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 1 ml ampoule contains 3.32 mg of dexamethasone (as dexamethasone sodium phosphate) which is equivalent to 4 mg of dexamethasone phosphate or 4.37 mg dexamethasone sodium phosphate. Each 2 ml ampoule contains 6.64 mg of dexamethasone (as dexamethasone sodium phosphate) which is equivalent to 8 mg of dexamethasone phosphate or 8.74 mg dexamethasone sodium phosphate. Excipient with known effect Each ml of solution contains about 3 mg sodium. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection/infusion. Clear, colourless solution free from visible particles. pH of solution between 7.0 – 8.5 Osmolality 270-310 mOsmol/kg. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _1. Systemic use_ Dexamethasone phosphate solution for injection/infusion is often used following emergency treatment initiated at high dose: Treatment and prophylaxis of cerebral oedema in brain tumours (postoperatively and after X‑ray radiation) and after spinal cord trauma. State of anaphylactic shock (e.g. contrast medium reaction) in combination with adrenaline, antihistamines and appropriate volume replacement (caution: mixed syringes). Polytraumatic shock / prophylaxis of post-traumatic shock lung. Severe exacerbations of asthma (only with concomitant sympathomimetics). Acute severe dermatosis (e.g. pemphigus vulgaris, erythroderma). Severe blood diseases (e.g. acute thrombocytopenic purpura, haemolytic anaemia, as concomitant medication as part of leukaemia treatments). As second‑line treatment for acute adrenocortical insufficiency (Addisonian crisis). Dexamethasone phosphate is indicated in the treatment of coronavirus disease 2019 (COVID-19) in adult and adolescent patients (aged 12 years and older with body weight a Leer el documento completo