Страна: Ірландія
мова: англійська
Джерело: HPRA (Health Products Regulatory Authority)
Dexamethasone sodium phosphate
Teva B.V.
H02AB02
Dexamethasone sodium phosphate
Solution for injection
dexamethasone
Marketed
2022-01-28
1 PACKAGE LEAFLET: INFORMATION FOR THE USER DEXAMETHASONE PHOSPHATE TEVA 4 MG/ML SOLUTION FOR INJECTION 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 Teva is and what it is used for 2. What you need to know before you use Dexamethasone phosphate Teva 3. How to use Dexamethasone phosphate Teva 4. Possible side effects 5. How to store Dexamethasone phosphate Teva 6. Contents of the pack and other information 1. WHAT DEXAMETHASONE PHOSPHATE TEVA IS AND WHAT IT IS USED FOR DEXAMETHASONE IS A SYNTHETIC GLUCOCORTICOID (adrenocortical hormone) with an effect on metabolism, electrolyte balance and tissue functions. DEXAMETHASONE PHOSPHATE TEVA IS USED FOR Diseases that require treatment with glucocorticoids. These include, depending on the type and severity: SYSTEMIC USE • Swelling of the brain caused by brain tumours, neurosurgery, brain abscess, bacterial inflammation of the lining of the brain. • Shock after a serious injury, for preventative treatment for acute respiratory distress syndrome and due to a severe allergic reaction (anaphylactic shock). • Severe acute asthma attack and a specific form of lung inflammation (interstitial aspiration pneumonia). • Initial treatment of extensive, severe, acute skin diseases, including erythroderma, pemphigus vulgaris, acute eczema. • Treatment of rheumatic systemic diseases (rheumatic diseases that can affect internal organs), such as systemic lupus erythematosus. • Some blood vessel inflam Прочитайте повний документ
Health Products Regulatory Authority 03 October 2022 CRN00CXWZ Page 1 of 14 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Dexamethasone phosphate Teva 4 mg/ml solution for injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of solution for injection contains 4.37 mg dexamethasone sodium phosphate equivalent to 4 mg dexamethasone phosphate or 3.3 mg dexamethasone. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS SYSTEMIC USE Neurology Cerebral oedema (only with confirmed cerebral symptoms based on CT scan) caused by cerebral tumour, neurosurgical procedures, brain abscess, bacterial meningitis Emergency treatment Post-traumatic shock/prevention of post-traumatic acute respiratory distress syndrome Anaphylactic shock (following primary epinephrine injection) Lung and respiratory diseases Severe acute asthma attack, interstitial aspiration pneumonia Dermatology Parenteral initial treatment of extensive, severe, acute skin diseases, including erythroderma, pemphigus vulgaris, acute eczema Autoimmune diseases/Rheumatology Parenteral initial treatment of autoimmune diseases, including systemic Lupus erythematodes, especially visceral forms Active phases of systemic vasculitis, including polyarteritis nodosa (duration of treatment should be limited to 2 weeks in the case of simultaneous positive hepatitis B serology) Severe progressive form of active rheumatoid arthritis, e.g. rapidly destructive forms and/or with extra-articular manifestations Juvenile idiopathic arthritis with severe systemic variant (Still's syndrome) or iridocyclitis unable to be influenced locally Rheumatic fever with carditis Infectiology Severe infectious diseases with toxic states (e.g. tuberculosis, typhoid, brucellosis; only with concomitant anti-infective therapy) Oncology Palliative therapy of malignant tumours Prevention and treatment of post-operative or cytostatic agent-induced vomiting within the scope of antiem Прочитайте повний документ