Nazione: Armenia
Lingua: inglese
Fonte: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
dexamethasone (dexamethasone sodium phosphate)
KRKA d.d.
H02AB02
dexamethasone (dexamethasone sodium phosphate)
4mg/ml
solution for injection
(25/5x5/) ampoules 1ml
Prescription
Registered
2017-05-23
1.3.1 Dexamethasone sodium phosphate SPC, Labeling and Package Leaflet AM SmPCPIL143374_3 20.01.2020 – Updated: 25.02.2020 Page 1 of 12 1. NAME OF THE PRODUCT Dexamethason solution for injection 4 mg/1 ml 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml of solution for injection (1 ampoule) contains 4.00 mg of dexamethasone phosphate as 4.37 mg dexamethasone sodium phosphate. Excipients are listed under 6.1. 3. PHARMACEUTICAL FORM Solution for injection: colourless to pale yellow, clear solution 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Dexamethasone is given intravenously or intramuscularly in urgent states or to patients who cannot be treated orally. _ENDOCRINE DISORDERS_: substitution therapy for primary and secondary (pituitary) adrenocortical insufficiency; congenital adrenal hyperplasia; _SHOCK: _ shock not responding to classical treatment, shock in patients with adrenocortical insufficiency. anaphylactic shock (intravenously, after adrenaline has been administered), preoperatively for prevention of shock in suspected or established adrenocortical insufficiency. _CEREBRAL EDEMA_: cerebral edema due to primary or metastatic brain tumours, craniotomy or head injuries. _MALIGNANT DISEASES_: palliative treatment of leukemia and lymphoma in adults, acute leukemia in children hypercalcemia in patients with malignoma. _RESPIRATORY TRACT DISEASES: _ chronic bronchitis, asthma (acute exacerbations), _SEVERE ALLERGIC REACTIONS. _ _INDICATIONS FOR INTRA-ARTICULAR OR SOFT TISSUE ADMINISTRATION OF DEXAMETHASONE _ rheumatoid arthritis (severe inflammation of an individual joint) ankylosing spondylitis (when inflamed joints do not respond to conventional treatment), psoriatic arthritis (oligoarticular affection and tendosynovitis), monoarthritis (after fluid evacuation from the joint), osteoarthritis of the joints (only in synovitis and exudation), extra-articular rheumatism (epicondylitis, tendosynovitis, bursitis). _LOCAL ADMINISTRATION (I Leggi il documento completo