Pajjiż: Malta
Lingwa: Ingliż
Sors: Medicines Authority
Medochemie Limited 1-10 Constantinoupleos Street, 3011 Limassol, Cyprus
H02AB02
DEXAMETHASONE SODIUM PHOSPHATE 4 mg/ml
SOLUTION FOR INJECTION/INFUSION
DEXAMETHASONE SODIUM PHOSPHATE 4 mg/ml
POM
CORTICOSTEROIDS FOR SYSTEMIC USE
Licence number in the source country: NOT APPLICAPABLE
Authorised
2023-02-13
1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT DEXAMETHASONE MEDOCHEMIE 4 MG/ML SOLUTION FOR INJECTION/INFUSION dexamethasone phosphate READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN 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. - 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 Dexamethasone Medochemie is and what it is used for 2. What you need to know before you are given Dexamethasone Medochemie 3. How Dexamethasone Medochemie is given 4. Possible side effects 5. How to store Dexamethasone Medochemie 6. Contents of the pack and other information 1. WHAT DEXAMETHASONE MEDOCHEMIE 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 MEDOCHEMIE IS USED IN Diseases requiring treatment with glucocorticoids. Depending on the type and severity, these include: SYSTEMIC USE: - Swelling of the brain caused by brain tumours, brain surgery, brain abscess, bacterial inflammation of the lining of the brain. - States of shock after severe injuries, for prophylactic treatment of shock lung. - Severe acute asthma attack. - Initial treatment of extensive acute severe skin diseases such as erythroderma, pemphigus vulgaris, acute eczema. - Treatment of systemic rheumatic diseases (rheumatic diseases that can affect internal organs) such as systemic lupus erythematosus. - Active rheumatic inflammation of joints (rheumatoid arthritis) with a severe progressive course, e.g. forms rapidly leading to joint destruction, and/or where tissue outside the joints is affected. - Severe infectious diseases with poisoning-like conditions (e.g. in tuberculosis, typhoid, brucellosis); only in addition to appropriate anti-infectious Aqra d-dokument sħiħ
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Dexamethasone Medochemie 4 mg/ml solution for injection/infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ampoule of 1 ml contains 4 mg dexamethasone phosphate (as dexamethasone sodium phosphate). Each ampoule of 2 ml contains 8 mg dexamethasone phosphate (as dexamethasone sodium phosphate). Excipient with known effect: sodium. Each ampoule of 1 ml contains 3.12 mg sodium. Each ampoule of 2 ml contains 6.24 mg sodium. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection/infusion Clear, colourless to slightly yellowish solution, pH 7.0 to 8.5. Osmolality: 160 to 230 mOsm/Kg 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Systemic use - Cerebral oedema associated with cerebral tumour, neurosurgical procedures, cerebral abscess, bacterial meningitis - Polytraumatic shock/prophylaxis of post-traumatic shock-lung syndrome - Severe, acute asthma attack - Initial parenteral treatment of extensive, acute, severe skin diseases like erythroderma, pemphigus vulgaris, acute eczema - Initial parenteral treatment of autoimmune diseases like systemic lupus erythematosus (especially visceral forms) - Active rheumatoid arthritis with a severe, progressive course, e.g. fast proceeding destructive forms and/or with extra-articular manifestations - Severe infectious diseases with toxic conditions (e.g. tuberculosis, typhoid, brucellosis) only with simultaneous anti-infectious therapy - Palliative therapy of malignant tumours - Prophylaxis and treatment of post-operative or cytostatic-induced vomiting as part of anti-emetic regimens. - Dexamethasone Medochemie is indicated in the 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. Local application - _Intraarticular injection_ : persistent inflammation of one or a few joints after general management of chronic inflammatory joint dise Aqra d-dokument sħiħ