DEXAMETHASONE PANPHARMA 4 MGML

Nchi: Israeli

Lugha: Kiingereza

Chanzo: Ministry of Health

Nunua Sasa

Shusha Tabia za bidhaa (SPC)
20-07-2021

Viambatanisho vya kazi:

DEXAMETHASONE PHOSPHATE (AS SODIUM)

Inapatikana kutoka:

PHARMALOGIC LTD

ATC kanuni:

R01AD03

Dawa fomu:

SOLUTION FOR INJECTION / INFUSION

Tungo:

DEXAMETHASONE PHOSPHATE (AS SODIUM) 4 MG / 1 ML

Njia ya uendeshaji:

I.M, I.V

Dawa ya aina:

Required

Viwandani na:

PANPHARMA, FRANCE

Eneo la matibabu:

DEXAMETHASONE

Matibabu dalili:

Dexamethasone Panpharma is indicated in the treatment ofEndocrine 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, 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

Idhini ya tarehe:

2021-04-04

Tabia za bidhaa

                                1
1.
NAME OF THE MEDICINAL PRODUCT
Dexamethasone Panpharma 4 mg/ml
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of solution contains 3.3 mg dexamethasone (as sodium
phosphate)
which is equivalent to 4 mg dexamethasone phosphate or 4.37 mg
dexamethasone sodium phosphate.
It contains 0.4 mg/ 1 ml of Sodium per ampoule.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection / Infusion
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
By intramuscular or intravenous route
Dexamethasone Panpharma 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 systemi
                                
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