ORALITE NATURAL ORAL REHYDRATION SALT

国家: 马来西亚

语言: 英文

来源: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

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11-12-2020

有效成分:

Glucose anhydrous; POTASSIUM CHLORIDE; Sodium Chloride; TRISODIUM CITRATE DIHYDRATE

可用日期:

POLYLAB BIOTECH SDN. BHD.

INN(国际名称):

Glucose anhydrous; POTASSIUM CHLORIDE; Sodium Chloride; TRISODIUM CITRATE DIHYDRATE

每包单位数:

4.92gm mcg/mL; 50sachet Sachets; 100sachet Sachets

厂商:

PT NOVELL PHARMACEUTICAL LABORATORIES

产品特点

                                ORALITE NATURAL ORAL REHYDRATION SALT®
ACTIVE SUBSTANCES AND EXCIPIENTS:
Glucose Anhydrous
3.24 g
Sodium Chloride
0.624 g
Potassium Chloride
0.36 g
Trisodium Citrate
Dihydrate
0.696 g
DESCRIPTION:
Oralite Natural Oral Rehydration Salt® is a white
powder
packed
in
4.92
g
aluminium
sachet.
Reconstituted
ionic
concentration
mmol/litre:
Glucose 75, Na+ 75, K+ 20, Cl- 65, Citrate 10. Total
Osmolarity
245.
Description
after
reconstitution;
Appearance: Clear; Precipitation: Not Detected.
ROUTE OF ADMINISTRATION: Oral
PHARMACODYNAMICS:
Administration of fluid and electrolytes by mouth to
prevent
or
treat
acute
diarrhoea
due
to
fluid
and
electrolytes lost through diarrhoea, vomiting and of
normal
losses
due
to
respiration,
sweating
and
urination which are especially high in infants. Acute
diarrhoea leads to loss of essential water and salts and
unless these are adequately replaced dehydration will
develop. Prevention of dehydration is therefore the
first appropriate response to diarrhoea. It is firmly
established that, regardless of the causative agent of
diarrhoea
or
the
age
of
the
patient,
an
oral
rehydration solution containing glucose and essential
salts
is
adequately
absorbed
and
replaces
both
previous and continuing fluid and salts loses. It does
not
stop
the
diarrhoea,
but
the
diarrhoea
usually
continues for only a limited time.
PHARMACOKINETICS:
Glucose
accelerate
the
absorption
of
sodium
and
water from the small intestine and this process is not
impaired during acute diarrhoea. Sodium chloride is
readily absorbed from the gastro-intestinal tract. It is
present in all body fluids but is mainly found in the
extracellular fluid. The amount of sodium chloride
normally lost in the sweat is small and the osmotic
equilibrium is maintained by the excretion of surplus
amounts in the urine. Potassium salts other than the
phosphate, sulphate, and tartrate are generally readily
absorbed from the gastro-intestinal tract. Potassium is
excreted mainly by the distal tubules of the kidney; 5
to 10 mmol a day maybe excreted in t
                                
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