DEXAMETHASONE KERN PHARMA

国家: 以色列

语言: 英文

来源: Ministry of Health

有效成分:

DEXAMETHASONE AS SODIUM PHOSPHATE

可用日期:

MBI PHARMA LTD., ISRAEL

ATC代码:

R01AD03

药物剂型:

SOLUTION FOR INJECTION

组成:

DEXAMETHASONE AS SODIUM PHOSPHATE 4 MG/ML

给药途径:

I.V, I.M

处方类型:

Required

厂商:

KERN PHARMA S.L, SPAIN

治疗领域:

DEXAMETHASONE

疗效迹象:

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

授权日期:

2017-12-19

资料单张

_ _
MBI PHARMA LTD, REHOV HAOREG 4,
HASHARON INDUSTRIAL PARK, PO BOX 5061, KADIMA 6092000 ISRAEL
TEL: [phone] FAX: [phone] EMAIL [e-mail]
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 _

产品特点

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