DEXAMETHASONE ROMPHARM 4 MGML

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

DEXAMETHASONE PHOSPHATE (AS SODIUM)

Available from:

A.L. MEDI-MARKET LTD.

ATC code:

H02AB02

Pharmaceutical form:

SOLUTION FOR INJECTION / INFUSION

Composition:

DEXAMETHASONE PHOSPHATE (AS SODIUM) 4 MG / 1 ML

Administration route:

I.M, I.V

Prescription type:

Required

Manufactured by:

S.C. ROMPHARM COMPANY S.R.L., ROMANIA

Therapeutic area:

DEXAMETHASONE

Therapeutic indications:

Dexamethasone Rompharm 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, 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

Authorization date:

2020-11-30

Summary of Product characteristics

1
1.
NAME OF THE MEDICINAL PRODUCT
Dexamethasone Rompharm 4 mg/ml
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml of solution contains: dexamethasone phosphate 4 mg (as
dexamethasone sodium
phosphate, 4.37 mg).
Excipients with known effect: sodium.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection/infusion
Clear, colourless solution, free from visible particles.
4.
CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
By intramuscular or intravenous route
Dexamethasone Rompharm 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