OTSU-D512NS 5% DEXTROSE & 0.45% SODIUM CHLORIDE INJ 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

Manufactured by:

PT OTSUKA (INDONESIA)

Summary of Product characteristics

OTSU-D5,1/2NS 5% DEXTROSE AND
0.45% SODIUM CHLORIDE INJECTION
U.S.P.
COMPOSITION:
Each 500 mL contains:
Dextrose monohydrate
25.00 g
Sodium
77 mEq/L
Sodium Chloride 2.25 g Chloride 77 mEq/L
Water for Injection ad 500 mL Osmolarity 406 mOsm/L
DESCRIPTION:
Clear, colorless, sterile and pyrogen free solution.
INDICATION:
As an intravenous supply of nutrition, restabilize the electrolyte
balance for dehydration.
DOSAGE:
Intravenous administration, the dosage depending on the patients
condition individually.
WARNING AND PRECAUTION:
-
Careful administration for patients with heart failure, renal
malfunction, perifer and
pulmonary edema, severe sepsis, pre-post trauma condition and for
children and the
elder.
-
Do not use if bottle is leaking, solution is cloudy or contains
foreign matter.
SIDE EFFECT:
-
No significant side effect appears, but on long duration of
administration, blood picture
should be monitored closely, so that no imbalance of the blood
electrolyte solution occur.
-
Large doses will cause accumulation and edema.
-
Low pH may cause thrombophlebitis.
CONTRAINDICATION:
-
Hypertensions, acidosis, hypokalemia, diabetes, patients with
glucose-galactose
malabsorption syndrome.
DRUG INTERACTION:
-
If use Natrium Tiopenton as infusion, observe on the possibilities of
precipitate.
-
Preferable do not add to blood for infusion, because blood cell
flocculation and the
possibilities of hemolysis could occur.
SYMPTOMS AND TREATMENT FOR OVERDOSAGE AND ANTIDOTE (S):
-
Infusion of glucose much above 800 mg per kg weight per hour, glucose
will appear in the
urine, causing hyperglycaemia.
-
Large doses will cause accumulation and edema, hypokalemia.
-
Antidote: Insulin injection.
PACKAGE:
Plastic bottle of 500mL.
STORAGE:
Store below 30°C.
Keep medicine out of reach of children Jauhi
daripada Kanak-kanak
“CONTROL MEDICINE/UBAT TERKAWAL”
ON MEDICAL PRESCRIPTION ONLY
Manufactured by:
Jl Sumber Waras No. 25
Lawang, Malang 65216, Indonesia
Distributed by:
Luen Wah Medical Co. Sdn. Bhd.
No. 43G & 43-1 F, The Highway
Cent