OTSU-D5NS 5% DEXTROSE AND 0.9% SODIUM CHLORIDE INJECTION USP

Country: Malaysia

Language: English

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

Active ingredient:

DEXTROSE MONOHYDRATE/DEXTROSE/GLUCOSE; SODIUM CHLORIDE (SALT)

Available from:

LUEN WAH MEDICAL CO. SDN. BHD.

INN (International Name):

DEXTROSE MONOHYDRATE/DEXTROSE/GLUCOSE; SODIUM CHLORIDE (SALT)

Units in package:

500ml mL; 1000 ml mL

Manufactured by:

PT OTSUKA (INDONESIA)

Summary of Product characteristics

P.I.
80 mm
210 mm
OTSU-D5,NS 5% DEXTROSE AND
0.9% SODIUM CHLORIDE
INJECTION U.S.P.
COMPOSITION:
Each 500mL solution contains 25.00 g Dextrose Monohydrate and 4.50 g
Sodium
Chloride.
DESCRIPTION:
Clear, colorless, sterile and pyrogen free solution.
DRUG ACTION:
Dextrose and Sodium Chloride injection have value as a source of
water,
electrolytes and calories. They are capable of inducing diuresis
depending of the
clinical conditions of patient.
INDICATION:
As an intravenous supply of nutrition, restabillize the electrolyte
balance for
dehydration.
DOSAGE:
Intravenous administration, the dosage depending on the patients
condition
individually.
SYMPTOMS AND TREATMENT FOR OVERDOSAGE AND ANTIDOTE (S):
-
Infusion of dextrose much above 800 mg per kg body weight per hour,
dextrose
will appear in the urine, causing hyperglycemia.
-
Large doses will cause accumulation and edema, hypokalemia.Antidote:
Insulin
injection.
WARNING
-
Dextrose and Sodium Chloride Injection should be used with great care.
If at all,
in patients with congestive heart failure, severe renal insufficiency,
and in clinical
states in which there exists oedema with sodium retention.
-
Dextrose
Injection
with
low
electrolyte
concentrations
should
not
be
administered simultaneously with blood through the same administration
set
because of the possibility of pseudo agglutination or hemolysis. The
container
label for those injections bears the statement: Do not administer
simultaneously
with blood.
-
The intravenous administration of Dextrose and Sodium Chloride
Injection can
cause fluid and/or solute over loading resulting in dilution of serum
electrolyte
concentration, over hydration, congested states, or pulmonary oedema.
The risk
of dilutional states is inversely proportional to the electrolyte
concentration of the
injection. The risks of solute overload causing congested states with
peripheral
and pulmonary oedema. It's directly proportional to the electrolyte
concentrations
of the injections.
-
Excessive administration of Dextrose and Sodium Chloride