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Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1792830
Name of medicinal product: DEXAMETHASON KRKA
Active substances:
Dexamethasone
Estonian, English, Latin
ATC code: H02AB02
Dosage form: tablet
Route of administration: oral use
Strengh: 4mg
Amount in package: 56TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information: Rumeenia pakend
Indication: Neurology Cerebral oedema (only with symptoms of intracranial pressure evidenced by computerised tomography) caused by a brain tumour, neuro-surgical intervention, cerebral abscess. Pulmonary and respiratory diseases Acute asthma exacerbations when use of an oral corticosteroid (OCS) is appropriate, croup. Dermatology Initial treatment of extensive, severe, acute, skin diseases responding to glucocorticoids, e.g. erythroderma, pemphigus vulgaris. Autoimmune disorders/rheumatology Initial treatment of autoimmune disorders like systemic lupus erythematodes. Active phases of systemic vasculitides like panarteritis nodosa (treatment duration should be limited to two weeks in cases of concomitant positive hepatitis B serology). Severe progressive course of active rheumatoid arthritis, e.g. fast proceeding destructive forms and/or extraarticular manifestations. Severe systemic course of juvenile idiopathic arthritis (Still’s disease). Haematological disorder Idiopathic thrombocytopenic purpura in adults. Infectology Tuberculous meningitis only in conjunction with anti-infective therapy. 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. Oncology Palliative treatment of neoplastic diseases. Prophylaxis and treatment of emesis induced by cytostatics, emetogenic chemotherapy within antiemetic treatment. Treatment of symptomatic multiple myeloma, acute lymphoblastic leukemia, Hodgkin's disease and non-Hodgkin's lymphoma in combination with other medicinal products. Various Prevention and treatment of postoperative vomiting, within antiemetic treatment.
Safety features: Yes
Summary of product characteristics (SPC):  (last updated March 1, 2022)
Package information leaflet (PIL): EST  (last updated May 23, 2022)
Labelling:  (last updated May 23, 2022)
Last imported to Estonia: Never imported to Estonia
Marketing authorization holder: First Pharma OÜ 
Marketing authorization number: 989419 
Marketing authorization issued on: June 3, 2019 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: National 
Secondary marketing authorization: Yes 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Description Additional condition
Hambaarstil on õigus välja kirjutada
Entry/Changing date: May 23, 2022
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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