DEXTROSE 50 % INJECTION

Israel - English - Ministry of Health

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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 number:
043 97 23637 00
Authorization date:
2010-04-30

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

Dextrose

injections

sterile,

nonpyrogenic

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

1010

(3.5-6.5)

50% Dextrose

Injection

2520

(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:

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

extensive burns.

DEXTRLOC 10. 3. 2004 , RH

Contraindications

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.

Warnings

Concentrated dextrose solutions should not be administered subcutaneously

or intramuscularly.

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

hypertonic

nutrient

solutions

should

administered

through

indwelling

intravenous catheter with the tip located in a large central vein such as the superior

vena cava.

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.

Adverse Reactions

rapid

infusion

hypertonic

dextrose

solution

result

diuresis,

hyperglycemia, glycosuria, and hyperosmolar coma. Continual clinical monitoring of

the patient is necessary in order to identify and initiate measures for these clinical

conditions.

Reactions

which

occur

because

solution

technique

administration include febrile response, infection at the site of injection, venous

thrombosis

phlebitis

extending

from

site

injection,

extravasation

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.

Precautions

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

strokes

hyperglycemia

been

implicated

increasing

cerebral

ischemic brain damage and in impairing recovery.

Care should be taken to avoid circulatory overload, particularly in patients with

cardiac insufficiency.

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

dosage.

Additives

incompatible.

Complete

information

available.

Those

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

introduced.

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.

Note:

It

is

recommended

that

all

intravenous

administration

apparatus,

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.

To Open

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

product.

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

impaired.

supplemental

medication

desired,

follow

directions

below

before

preparing for administration.

Preparation for Administration

Suspend bag.

Remove plastic bag from outlet port at bottom of bag.

Attach administration set. Refer to complete directions accompanying set.

To Add Medication

Using syringe.

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.

Registration Numbers:

20% Dextrose Injection: 043 96 23636 00.

50% Dextrose Injection: 043 97 23637 00.

Manufactured By

Teva Medical Ltd.,

P.O. Box 2, Ashdod 77100,

Israel

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