DEXTROSE 50 % INJECTION

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

GLUCOSE MONOHYDRATE

Available from:

TEVA MEDICAL LTD

ATC code:

B05CX01

Pharmaceutical form:

SOLUTION FOR INFUSION

Composition:

GLUCOSE MONOHYDRATE 50 %

Administration route:

I.V

Prescription type:

Required

Manufactured by:

TEVA MEDICAL LTD, ISRAEL

Therapeutic group:

GLUCOSE

Therapeutic area:

GLUCOSE

Therapeutic indications:

Dextrose 50 % injection is indicated as a caloric component in a parenteral nutrition regimen. It is used with an appropriate protein (nitrogen) source in the prevention of nitrogen loss or in the treatment of negative nitrogen balance in patients where: 1) the alimentary tract cannot/should not be used 2) gastrointestinal absorption of protein is impaired or 3) metabolic requirements for protein are substantially increased , as with extensive burns.

Authorization date:

2010-04-30

Summary of Product characteristics

DEXTRLOC 10. 3. 2004 , RH
"
ע עבקנ הז ןולע טמרופ
"
ודי לע רשואו קדבנ ונכותו תואירבה דרשמ
י
20%, 50% Dextrose Injections
(Dextrose in Water) in Plastic Bags.
PARENTERAL NUTRIENTS
Description
20%
and
50%
Dextrose
injections
are
sterile,
nonpyrogenic
and
hypertonic
solutions. They contain Dextrose in Water for Injection. The pH of the
50% Dextrose
injection is adjusted with hydrochloric acid. Neither solution
contains any antimicrobial
agent or buffer. The composition, osmolarity, pH and calorie content
are shown in
Table 1 below:
Table 1
Composition, Osmolarity, Approximate pH Values, and Calories per Liter
COMPOSITION
Dextrose
hydrous (g/L)
Osmolarity
(mOsm/L)
Calculated
Approx. pH
Values
Calorie
Content
(Kcal/L)
20% Dextrose
Injection
200
1010
4.5
(3.5-6.5)
684
50% Dextrose
Injection
500
2520
4.0
(3.5-6.5)
1710
The plastic bag is fabricated from a specially formulated polyvinyl
chloride. Water
can permeate from inside the bag into the overwrap in amounts
insufficient to affect
the solution significantly. Solutions in contact with the plastic bag
can leach out certain
of its chemical components in very small amounts within the expiration
period, e.g., di-
2-ethylhexyl phthalate (DEHP), up to 5 parts per million. However, the
safety of the
plastic has been confirmed in tests in animals according to USP
biological standards
for plastic containers as well as by tissue culture toxicity studies.
Clinical Pharmacology
Dextrose injections have value as a source of water and calories. They
are capable
of inducing diuresis depending on the clinical condition of the
patient.
Indications
20% and 50% Dextrose Injections are indicated as a caloric component
in a
parenteral nutrition regimen. They are used with an appropriate
protein (nitrogen)
source in the prevention of nitrogen loss or in the treatment of
negative nitrogen
balance in patients where:
(1)
the alimentary tract cannot or should not be used
(2)
gastrointestinal absorption of protein is impaired, or
(3)
metabolic req