DHASOLONE TABLET 5 mg

Land: Singapore

Taal: Engels

Bron: HSA (Health Sciences Authority)

Werkstoffen:

Prednisolone Base Micronized

Beschikbaar vanaf:

TEVA PHARMACEUTICAL INVESTMENTS SINGAPORE PTE. LTD.

ATC-code:

H02AB06

Dosering:

5 mg

farmaceutische vorm:

TABLET

Samenstelling:

Prednisolone Base Micronized 5 mg

Toedieningsweg:

ORAL

Prescription-type:

Prescription Only

Geproduceerd door:

PT Actavis Indonesia

Autorisatie-status:

ACTIVE

Autorisatie datum:

1990-04-16

Productkenmerken

PHARMACODE
AREA
88719_S1 - P: Prednisolone micronised (Dhasolone) SG, Tablets 5mg,
SmPC
03
05.05.2023
MB
11.07.2023
MB
84x224 mm
PT Actavis Indonesia, Jl. Raya Bogor
Km 28, Jakarta 13710 Indonesia
8 pt
Profile
Black
DHASOLONE TABLET
PRODUCT DESCRIPTION:
White, round and flat tablets with 6 mm diameter, score-line on one
side
and “DHA” logo on the other side.
COMPOSITION:
Each tablet contains: Prednisolone BP (micronised) 5 mg.
PHARMACOLOGY:
Prednisolone is a glucocorticoid with anti-inflammatory and immune
suppressant effects.
PHARMACOKINETICS:
Prednisolone is readily absorbed from the gastro-intestinal tract.
Peak
plasma concentrations of prednisolone are obtained 1 or 2 hours after
oral administration. It has a usual plasma half-life of 2 or 4 hours,
but its
biological half-life lasts several hours. It is extensively bound to
plasma
proteins and is excreted in urine as free and conjugated metabolites,
with an appreciable proportion of unchanged prednisolone.
INDICATIONS:
For the suppression of inflammatory and allergic disorders and for the
treatment of conditions for which corticosteroid therapy is indicated
except in adrenal-deficiency states.
RECOMMENDED DOSES:
Orally administered:
Dosage requirements are variable and must be individualized on the
basis of the disease under treatment and the response of the patient.
Adults : 5-60 mg daily in divided doses or as a single daily or double
dose on alternate days.
In long term therapy, dosage should be maintained at not more than
7 mg daily whenever possible.
Children: As directed by physician.
For short term treatment of not more than 2 weeks, as it may lead to
growth retardation in children.
SIDE EFFECTS:
SCLERODERMA RENAL CRISIS
Amongst the different subpopulations the occurrence of scleroderma
renal crisis varies. The highest risk has been reported in patients
with
diffuse systemic sclerosis. The lowest risk has been reported in
patients
with limited systemic sclerosis (2%) and juvenile onset systemic
sclerosis (1%).
Metabolic effects leading to mobilisat