DEXAMETHASONE KERN PHARMA

Riik: Iisrael

keel: inglise

Allikas: Ministry of Health

Toimeaine:

DEXAMETHASONE PHOSPHATE ( AS SODIUM PHOSPHATE )

Saadav alates:

MBI PHARMA LTD., ISRAEL

ATC kood:

H02AB02

Ravimvorm:

SOLUTION FOR INJECTION / INFUSION

Koostis:

DEXAMETHASONE PHOSPHATE ( AS SODIUM PHOSPHATE ) 4 MG/ML

Manustamisviis:

I.V, I.M

Retsepti tüüp:

Required

Valmistatud:

KERN PHARMA S.L, SPAIN

Terapeutiline ala:

DEXAMETHASONE

Näidustused:

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 idioplathic type or that due to lupus erythematosus• Cerebral edema 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, dermatomyositis, polymyositis, SLE, temporal arteritis.• Infectious Diseases: Bacterial meningitis – adjunct to antibiotics in suspected Pneumococcal meningitis and TB meningitis. Severe infectious diseases with toxic states (eg tuberculosis, typhoid, brucellosis;. Only with simultaneous anti-infective therapy)• Fetal lung maturation• Chemotherapy – associated nausea and vomiting• Multiple Myeloma – part of chemotherapy protocols (eg VAD)• Prevention and treatment of acute mountain sickness/HACE

Loa andmise kuupäev:

2021-02-28

Infovoldik

_ _
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 _

Toote omadused

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Dexamethasone Kern Pharma
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 ml ampoule of Dexamethasone Kern Pharma contains dexamethasone
phosphate 4 mg
(as dexamethasone sodium phosphate, 4.37 mg),
which is equivalent to 3.33 mg
dexamethasone base.
Each 5 ml ampoule of Dexamethasone Kern Pharma contains dexamethasone
phosphate
20 mg (as dexamethasone sodium phosphate, 21.85 mg) which is
equivalent to 16.65 mg
dexamethasone base.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection/infusion
Clear and colourless 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 atopic dermatitis, seasonal or perennial
allergic rhinitis,
hypersensitivity reactions to drugs.
•
Ophthalmic: 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).
•
Hematological: acquired (autoimmune) hemolytic anemia, idiopathic
thrombocytopenic
purpura in adult, pure red cell aplasia.
•
Nephrotic syndrome of the idiopathic type or that due to lupus
erythematosus.
•
Cerebral edema caused by brain tumor, neurosurgery, brain abscess,
bacteria