Defal Oral Suspension 22.75

Ország: Tanzánia

Nyelv: angol

Forrás: Tanzania Medicinces & Medical Devices Authority

Aktív összetevők:

Deflazacort

Beszerezhető a:

Faes Farma. S.A, SPAIN

ATC-kód:

Corticosteroids for systemic use/ plain

INN (nemzetközi neve):

Deflazacort

Adagolás:

22.75

Gyógyszerészeti forma:

Oral Suspension

Gyártó:

Faes Farma, S.A, SPAIN

Termék összefoglaló:

Physical description: Deflazacort suspension is a homogeneous suspension of a whitish color; Local technical representative: Phillips Pharmaceuticals (Tanzania) Limited (2404)

Engedélyezési státusz:

Registered/Compliant

Engedély dátuma:

2022-07-19

Termékjellemzők

SUMMARY OF PRODUCT CHARACTERISTICS
1.
PRODUCT NAME
Defal 22,75 mg/mL oral drops suspension
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL of suspension contains 22,75 mg of deflazacort, or each drop
of suspension
contains 1 mg of deflazacort.
Excipients with a known effect: each ml of suspension contains 100 mg
of sorbitol, 2,4
mg of sodium and 10.45 mg of benzyl alcohol.
See section 6.1 for full list of excipients.
3.
PHARMACEUTICAL FORM
Defal drops.
Homogeneous suspension of a whitish colour
4.
CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
RHEUMATIC
AND
COLLAGEN
DISORDERS:
treatment
of
acute
episodes
and/or
maintenance therapy in rheumatoid arthritis, psoriatic arthritis when
conservative
treatment
has
been
ineffectual;
polymyalgia
rheumatica;
acute
rheumatic
fever;
systemic lupus erythematosus; severe dermatomyositis; periarteritis
nodosa; cranial
arteritis and Wegener's granulomatosis.
DERMATOLOGICAL DISORDERS: Pemphigus, bullous pemphigoid, exfoliative
dermatitis in
general, severe erythema multiforme, erythema nodosum and severe
psoriasis.
ALLERGIES: Bronchial asthma resistant to conventional treatment.
LUNG
DISORDERS:
pulmonary
sarcoidosis,
extrinsic
allergic
alveolitis
(pneumonoconiosis
due
to
inhalation
of
organic
dust),
desquamative
interstitial
pneumonia (idiopathic pulmonary fibrosis).
OCULAR PATHOLOGIES: choroiditis, chorioretinitis, iritis and
iridocyclitis.
HAEMATOLOGICAL DISORDERS: idiopathic thrombocytopenia, haemolytic
anaemia and
palliative treatment of leukaemia and lymphomas.
GASTROINTESTINAL AND HEPATIC PATHOLOGIES: ulcerative colitis,
Crohn’s disease and
active chronic hepatitis.
RENAL DISORDERS: nephrotic syndrome.
4.2. DOSAGE AND METHOD OF ADMINISTRATION
Dosage
The initial dose in adults may vary within ranges 6 – 90 mg/day and
in children
within ranged 0.25 – 1.5 mg/kg, depending on the severity of the
illness and on its
course.
Its
initial
dose
should
be
maintained
or
varied
so
as
to
achieve
a
satisfactory clinical response.
The
maintenance
dose
should
always
be
the
small