Dexamethason solution for injection

Country: Armenia

Bahasa: Inggeris

Sumber: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Bahan aktif:

dexamethasone (dexamethasone sodium phosphate)

Boleh didapati daripada:

KRKA d.d.

Kod ATC:

H02AB02

INN (Nama Antarabangsa):

dexamethasone (dexamethasone sodium phosphate)

Dos:

4mg/ml

Borang farmaseutikal:

solution for injection

Unit dalam pakej:

(25/5x5/) ampoules 1ml

Jenis preskripsi:

Prescription

Status kebenaran:

Registered

Tarikh kebenaran:

2017-05-23

Ciri produk

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