GLUCOSE 50 %

Approval for Printing

Melsungen AG

Approved for Printing

Approved for Printing

when corrected

New draft required

Date

Signature

1d0d0d0d0d1d0d1d0d1

0/12220787/0911

1d0d0d0d0d1d0d1d0d1

Composition

Each 1000 ml contains:

Glucose Monohydrate

220.0 g

550.0 g

Water for injection to

1000 ml

1000 ml

Caloric value

(kJ/l)

3350

8375

(kcal/l)

2000

Osmolarity

(mOsm/l)

1100

2770

Indication

High caloric carbohydrate infusion, (in a minimal volume

of water), Hypoglycemia.

Dosage

Adults:

The dosage depends on age, weight and clinical condi-

tion of the patient.

Glucose 20 %: Up to 35 ml/kg body weight/day

Glucose 50 %: Up to 14 ml/kg body weight/day

Flow rate:

Glucose 20 %: Up to 2.5 ml/kg bw/h or

(for 70 kg patient) up to 58 drops/min = 175 ml/h

Glucose 50 %: Up to 1.0 ml/kg bw/h or

(for 70 kg patient) up to 23 drops/min = 70 ml/h.

For patients in a markedly depleted nutritional state, the

above drop/flow rates have to be reduced accordingly.

Insulin induced hypoglycemia:

Determine blood glucose before injecting dextrose.

Children:

According to individual requirements.

Route of administration

I.V. via a central venous catheter.

For total parenteral nutrition Glucose Injection is admin-

istered by slow intravenous infusion (a) after admixture

with amino acid solutions via an indwelling catheter

with the tip positioned in a large central vein, preferably

the superior vena cava, or (b) after dilution with sterile

water for injection. Dosage should be adjusted to meet

individual patient requirements.

Contraindications

Hyperglycemia

Overhydration,

Hypotonic dehydration,

Hypokalemia,

Acidosis

In diabetic come while blood sugar is excessively high.

Do not use concentrated solutions when intracranial or

intraspinal hemorrhage is present, in the presence of

delirium tremens in dehydrated patients, or in patients

with glucose-galactose malabsorption syndrome.

Warnings

Fluid/solute overload:

Glucose solutions I.V. can cause fluid or solute over load

resulting in dilution of serum electrolyte concentrations,

overhydration, congested states or pulmonary edema.

Hypertonic dextrose solutions may cause thrombosis if

infused via peripheral veins, therefore, administer slowly

via a central venous catheter.

Diabetes mellitus:

Glucose-containing

solutions

with

caution

patients with subclinical or overt diabetes mellitus or

carbohydrate intolerance.

It has been suggested that glucose solution should not

be used after acute ischaemic strokes as hyperglycaemia

has been implicated in increasing cerebral ischaemic

brain damage and in impairing recovery.

Rapid administration of hypertonic solutions may pro-

duce significant hyperglycemia or hyperosmolar syn-

drome, especially in patients with chronic uremia or car-

bohydrate intolerance.

Pregnancy:

Category C. safety for use during pregnancy has not been

established. Use only when clearly needed and when the

potential benefits outweigh the potential hazards to the

fetus.

Directions for Use

B. Braun Melsungen AG · 34209 Melsungen, Germany

Glucose Intravenous

Infusion BP

20 %, 50 % w/v

B|BRAUN

Schwarz

148x210 mm

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Lätus: 1513

Israel

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Children:

Use with caution in infants of diabetic mothers, except

as may be indicated in hypoglycemic neonates.

Glucose infusions should not be administered through

the same infusion equipment, simultaneously, before or

after an administration of blood, because of the possibil-

ity of pseudo-agglutination.

This fluid should only be administered with great care to

patients with diabetes mellitus or renal insufficiency.

Precautions

Clinical supervision should include regular checks of

blood glucose level, serum electrolytes and water bal-

ance.

Electrolytes are to be supplemented as required. Caution

is to be exercised in patients with hyponatremia.

No other medication or substance should be added to

this fluid, unless it is known to be compatible. Not suit-

able for osmotherapy.

Hyperglycemia and glycosuria may be functions of rate

of administration or metabolic insufficiency. To minimize

these conditions, slow the infusion rate, monitor blood

and urine glucose; if necessary, administer insulin. When

concentrated Glucose infusion is abruptly withdrawn,

administer 5 % or 10 % Glucose to avoid reactive hypo-

glycemia.

Administer

that

extravasation

does

occur.

thrombosis occurs during administration, stop injection

and correct.

When a concentrated Glucose infusion is abruptly with-

drawn, it is advisable to follow with the administration

of 5 % or 10 % Glucose injection to avoid rebound hypo-

glycemia.

Drug interactions

Corticosteroids:

Cautiously

administer

parenteral

fluids

patients

receiving corticosteroids or corticotrophin.

Adverse Reactions

Significant hyperglycemia, hyperosmolar syndrome and

glycosuria may occur with too rapid administration of

hypertonic solutions.

Expiry date

The product must not be used beyond the expiry date

stated on the labeling.

Storage

Do not store above 25 °C.

Presentation

Glucose 20 %:

500 ml and 1000 ml bottles

Glucose 50 %:

500 ml plastic bottles

50 ml glass vial

20 ml Mini Plasco® ampoules

License number

Glucose 20 %: 137-53-27992-00

Glucose 50 %: 119-08-25555-11, 134-97-25555-00

License Holder

Lapidot Medical Import and Marketing Ltd.

8 Hashita st., Caesarea Industrial Zone 38900

The format of this leaflet was determined by the Ministry

of Health and its content was checked and approved in

July 2009.

B|BRAUN

B. Braun Melsungen AG

34209 Melsungen

Germany

Schwarz

148x210 mm

0/12220787/0911

Lätus: 1513

Israel

Projekt14:Layout 1 06.09.2011 10:15 Uhr Seite 2