Product class:
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Authorized package
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Medicinal product class:
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For human use
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Package code:
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1671735
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Name of medicinal product:
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DEXAMETHASON KRKA
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Active substances:
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ATC code:
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H02AB02
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Dosage form:
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tablet
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Route of administration:
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oral use
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Strengh:
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8mg
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Amount in package:
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30TK
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Legal status for supply*:
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Subject to medicinal prescription
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Class of active substance:
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Additional information:
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Indication:
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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 (Stills disease).
Haematological disorder
Idiopathic thrombocytopenic purpura in adults.
Infectology
Tuberculous meningitis only in conjunction with anti-infective 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.
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Safety features:
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Yes
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Summary of product characteristics (SPC):
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(last updated April 6, 2023)
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Package information leaflet (PIL):
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EST (last updated April 6, 2023)
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Labelling:
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(last updated April 6, 2023)
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Last imported to Estonia:
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Never imported to Estonia
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Marketing authorization holder:
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KRKA, d.d., Novo mesto
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Marketing authorization number:
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915016
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Marketing authorization issued on:
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September 13, 2016
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Marketing authorization expires on:
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Unlimited
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Marketing authorization procedure type:
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Decentralised
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Reference price:
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Under reference price:
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Reference price of daily dose:
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Description
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Additional condition
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Hambaarstil on õigus välja kirjutada
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Entry/Changing date:
September 13, 2023
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
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