Israel - English - Ministry of Health
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.
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:
Composition, Osmolarity, Approximate pH Values, and Calories per Liter
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.
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.
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:
the alimentary tract cannot or should not be used
gastrointestinal absorption of protein is impaired, or
metabolic requirements for protein are substantially increased, as with
DEXTRLOC 10. 3. 2004 , RH
The infusion of hypertonic dextrose solutions is contraindicated in patients having
intracranial or intraspinal hemorrhage, in patients who are severely dehydrated, in
patients who are anuric, and in patients in hepatic coma.
Concentrated dextrose solutions should not be administered subcutaneously
This product contains aluminum that may be toxic. Aluminum may reach toxic levels
with prolonged parenteral administration if kidney function is impaired. Premature
neonates are particularly at risk because their kidneys are immature, and they require
large amounts of calcium and phosphate solutions, which contain aluminum.
Research indicates that patients with impaired kidney function, including premature
neonates, who receive parenteral levels of aluminum at greater that 4 to 5 µg/kg/day
accumulate aluminum at levels associated with central nervous system and bone
toxicity. Tissue loading may occur at even lower rates of administration.
Dilute before use to a concentration which will, when administered with an amino
acid (nitrogen) source, result in an appropriate calorie to gram nitrogen ratio, and
which has an osmolarity consistent with the route of administration.
Unless appropriately diluted, the infusion of hypertonic dextrose injections into a
peripheral vein may result in vein irritation, vein damage, and thrombosis. Strongly
intravenous catheter with the tip located in a large central vein such as the superior
These solutions should not be administered simultaneously with blood through the
same infusion set because of the possibility of pseudoagglutination.
Use in Pregnancy
Animal reproduction studies have not been conducted with Dextrose Injections. It is
also not known whether Dextrose Injections can cause fetal harm when administered
to a pregnant woman, or can affect reproduction capacity. Dextrose injections should
be given to a pregnant woman only if clearly needed.
hyperglycemia, glycosuria, and hyperosmolar coma. Continual clinical monitoring of
the patient is necessary in order to identify and initiate measures for these clinical
administration include febrile response, infection at the site of injection, venous
hypervolemia. If an adverse reaction does occur, the infusion should be discontinued,
the patient evaluated, appropriate therapeutic countermeasures instituted, and the
remainder of the fluid saved for examination if deemed necessary.
Administration of hypertonic dextrose (nutrient or solution) and amino acid solutions
via central venous catheter may be associated with complications which can be
prevented or minimized by careful attention to all aspects of the procedure. This
includes attention to solution preparation, administration, and patient monitoring.
DEXTRLOC 10. 3. 2004 , RH
It is essential that a carefully prepared protocol, based upon current medical
practice, be followed, preferably by an experienced team. The package insert of
the protein (nitrogen) source should be consulted for dosage and all precautionary
information. During the prolonged parenteral therapy or whenever the condition of the
patient warrants evaluation, clinical evaluation and periodic laboratory determinations
are necessary to monitor changes in fluid balance, electrolyte concentrations, and
acid-base balance. Interruption or rapid cessation of hypertonic dextrose therapy may
result in a hypoglycemic reaction. It is suggested that the patient be titrated with a
dilute dextrose solution until the patient has reached glucose equilibrium.
Special care must be taken when giving hypertonic glucose to patients with overt or
subclinical diabetes mellitus.
It has been suggested that glucose solutions should not be used after acute
ischemic brain damage and in impairing recovery.
Care should be taken to avoid circulatory overload, particularly in patients with
Caution must be exercised in the administration of these injections to patients
receiving corticosteroids or corticotropin.
Dosage and Administration
Note: Do not administer unless solution is clear and seal is intact.
Parenteral drug products should be inspected visually for particulate matter and
discoloration prior to administration whenever solution and container permit.
Injection of the solution should be made slowly.
The maximum rate at which dextrose can be infused without producing glycosuria is
0.5 g/kg body weight/hour. About 95% of the dextrose is retained when infused at a
rate of 0.8 g/kg/hour.
The dose of 20% and 50% Dextrose Injection is dependent upon the age, weight
and clinical condition of the patient, as well as laboratory determinations.
When it is used as a caloric source in parenteral nutrition therapy, the package
insert of the protein (nitrogen) source should be consulted for the correct carbohydrate
additives known to be incompatible should not be used. A pharmacist should be
consulted, if available. If, in the informed judgment of the physician, it is deemed
advisable to introduce additives, aseptic technique should be used.
Thorough and careful mixing should be performed when additives have been
Solutions containing additives must not be stored.
These admixed injections in plastic bags are intended for intravenous administration
using sterile equipment.
Exposure of pharmaceutical products to heat should be minimized. Excessive heat
should be avoided. It is recommended that products be stored at room temperature
C). Brief exposure up to 40
C does not adversely affect the product.
including the needle, be replaced at least once every 24 hours.
DEXTRLOC 10. 3. 2004 , RH
Directions for Use of Plastic Bags
Warning : Do not use plastic bags in series connections. Such use could result in air
embolism due to residual air being drawn from the primary bag before administration
of the fluid from the secondary bag is completed.
Do not remove units from overwrap until ready for use. Use all units promptly when
pouch is opened
The overwrap is a moisture barrier. The inner bag maintains the sterility of the
Tear pouch down side at slit and remove solution container. Check for minute leaks
by squeezing inner bag firmly. If leaks are found, discard solution as sterility may be
preparing for administration.
Preparation for Administration
Remove plastic bag from outlet port at bottom of bag.
Attach administration set. Refer to complete directions accompanying set.
To Add Medication
Prepare medication site.
Using a 20-22 gauge needle, puncture resealable rubber plug at target area
and inject. Multiple additions may be made in this manner.
Mix solution and medication thoroughly. For high density medications such as
potassium chloride, squeeze ports while ports are upright, and mix thoroughly.
20% Dextrose Injection: 043 96 23636 00.
50% Dextrose Injection: 043 97 23637 00.
Teva Medical Ltd.,
P.O. Box 2, Ashdod 77100,