Země: Izrael
Jazyk: angličtina
Zdroj: Ministry of Health
DEXAMETHASONE AS SODIUM PHOSPHATE
MBI PHARMA LTD., ISRAEL
R01AD03
SOLUTION FOR INJECTION
DEXAMETHASONE AS SODIUM PHOSPHATE 4 MG/ML
I.V, I.M
Required
KERN PHARMA S.L, SPAIN
DEXAMETHASONE
Dexamethasone Kern Pharma is indicated in the treatment of:• Endocrine diseases such as nonsuppurative thyroiditis, hypercalcaemia associated with cancer and congenital adrenal hyperplasia.• Allergy: Severe or disabling allergic conditions resistant to conventional treatments, as in: bronchial asthma, contact or atopical dermatitis, seasonal or perennial allergic rhinitis, hypersensitivity reactions to drugs.• Ophtalmic: Serious inflammatory and allergic processes, acute and chronic, affecting the eyes, such as: iritis and iridocyclitis, chorioretinitis, choroiditis and diffuse posterior uveitis, optical neuritis, allergic conjunctivitis, allergic marginal corneal ulcers.• Inflammatory Bowel dis.: Systemic treatment in exacerbations of ulcerative colitis and regional enteritis.• Dermatological diseases (pemphigus, Stevens Johnson syndrome, exfoliative dermatitis, severe psoriasis and mycosis fungoides) • Respiratory diseases (symptomatic sarcoidosis, berylliosis, Loeffler's syndrome)• Haematologica
2017-12-19
_ _ MBI PHARMA LTD, REHOV HAOREG 4, HASHARON INDUSTRIAL PARK, PO BOX 5061, KADIMA 6092000 ISRAEL TEL: +972 -9-7719003 FAX: +972-9-7719990 EMAIL INFO@MBIPHARMA.CO.IL COMPANY REGISTRATION NO: 514500248 _ _ _ _ ה/אפור ה/דבכנ , ה/דבכנ ת/חקור , תרבח MBI Pharma ןודנבש רישכתב םייוניש לע עידוהל תשקבמ EXAMETHASONE KERN PHARMA D ןתמ תרוצ : Solution for injection I.V :ליעפ ביכרמ Dexamethasone (as sodium phosphate) 4mg/ml :םייונישה תוהמ 1 . הלומרופה רופיש - הלומרופה ךותמ םירמשמה תאצוה 2 . ל רישכתה לש ףדמה ייח רוציק - 30 .םישדוח לבקל ןתינו ,תואירבה דרשמ רתאבש תופורתה רגאמב םסרופמ אפורל ןולעה ו לעבל הינפ ידי לע ספדומ םושירה , תרבח המרפ ייא.יב.םא .ד.ת , 5061 ןופלטב וא ,המידק 7719903 - 09 . ,הכרבב רוד רנבא הנוממ חקור _ _ _BI _ Přečtěte si celý dokument
1 1. NAME OF THE MEDICINAL PRODUCT Dexamethasone Kern Pharma 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Composition per 1 ml (per ampoule): Dexamethasone phosphate 4 mg (as dexamethasone sodium phosphate, 4.37 mg). For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection Clear solution pH: 7-8.5 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS By intramuscular or intravenous route Dexamethasone Kern Pharma is indicated in the treatment of: • Endocrine diseases such as nonsuppurative thyroiditis, hypercalcaemia associated with cancer and congenital adrenal hyperplasia. • Allergy: Severe or disabling allergic conditions resistant to conventional treatments, as in: bronchial asthma, contact or atopical dermatitis, seasonal or perennial allergic rhinitis, hypersensitivity reactions to drugs. • Ophtalmic: Serious inflammatory and allergic processes, acute and chronic, affecting the eyes, such as: iritis and iridocyclitis, chorioretinitis, choroiditis and diffuse posterior uveitis, optical neuritis, allergic conjunctivitis, allergic marginal corneal ulcers. • Inflammatory Bowel dis.: Systemic treatment in exacerbations of ulcerative colitis and regional enteritis. • Dermatological diseases (pemphigus, Stevens Johnson syndrome, exfoliative dermatitis, severe psoriasis and mycosis fungoides) • Respiratory diseases (symptomatic sarcoidosis, berylliosis, Loeffler's syndrome) • Haematological: acquired )autoimmune( haemolytic anaemia, idiopathic thrombocytopenic purpura in adult, pure red cell aplasia • Nephrotic syndrome of the idiopathic type or that due to lupus erythematosus • Cerebral oedema caused by brain tumor, neurosurgery, brain abscess, bacterial meningitis • Collagen diseases: Active rheumatoid arthritis with severe progressive course, fast destructive remitting forms and / or extra-articular manifestations, Juvenile idiopathic arthritis with severe systemic-onset form (Still's disease) or locally with no control, rheumatic fever with carditis, dermat Přečtěte si celý dokument