Dextrose 5% DEMO solution for infusion

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

GLUCOSE ANHYDROUS

Available from:

DEMO S.A. Pharmaceutical Industry 21st km National Road Athens - Lamia 14568 Krioneri, Greece

ATC code:

V06DC01

INN (International Name):

GLUCOSE ANHYDROUS

Pharmaceutical form:

SOLUTION FOR INFUSION

Composition:

GLUCOSE ANHYDROUS

Prescription type:

POM

Therapeutic area:

GENERAL NUTRIENTS

Authorization status:

Withdrawn

Authorization date:

2007-10-25

Patient Information leaflet

DEXTROSE 5% 
ISOTONIC SOLUTION FOR INFUSION 

COMPOSITION: Active ingredient: Dextrose (Glucose) Monohydrate 

  Excipient: Water for injections 
PHARMACOTECHNICAL FORM: Solution for infusion 
CONTENT IN ACTIVE INGREDIENT: 100ml of the solution contain
5.5g of 
Dextrose Monohydrate equivalent to 5g of Dextrose.  
DESCRIPTION-PACKAGING:  Colorless, clear aqueous solution which is 
contained in polyethylene bottles of 100, 250, 500 and 1000ml
and in 
polypropylene bags of 100, 250, 500 and 1000ml. 
PHARMACOTHERAPEUTIC CATEGORY: Parenteral solution 
MARKETING AUTHORIZATION HOLDER – MANUFACTURER:  
DEMO SA, 21
st
km National Road Athens - Lamia, 145 68 Kryoneri, Athens, 
Greece, Tel. [phone], Fax: [phone] 
GENERAL
INFORMATION: Dextrose is a carbohydrate and its solution is a 
source of calories and fluids. It may reduce the proteins
and nitrogen body 
loss, promotes glucagon deposition and
reduces or prevents ketosis, 
depending on the administered dose 
INDICATIONS: Water loss and inability of its oral replacement,
when there is 
no concomitant estimation of loss and no need of electrolytic
elements. 
Dehydration may occur in patients being in a coma, intractable
vomiting or 
diarrhea, diabetic acidosis, hyperthyroidism, insipidus diabetes, 
hypercalcaemia , psychogenic fluid intake abstinence. It is
also indicated for 
calorie coverage. 
CONTRAINDICATIONS:  Sudden increase of blood volume, severe
cardiac and 
renal failure, diabetic coma.  
SPECIAL PRECAUTIONS AND WARNINGS DURING USAGE: Administration
of high 
doses may lead to hyperhydration and overloading of the circulatory system 
which may lead to pulmonary oedema.  
Aseptic methods should be used for the preparation of the
infusion 
(sterilization of the cap and the injection point, usage
of a new and sterile 
infusion machine).  
The clarity and the absence

Summary of Product characteristics

Page 1 of 3 
SUMMARY OF PRODUCT CHARACTERISTICS 
DEXTROSE 5% SOLUTION FOR INFUSION 

1. NAME OF THE MEDICINAL PRODUCT 
Dextrose 5%/DEMO, Solution for infusion 

2. QUALITATIVE AND QUANTITATIVE COMPOSITION (PER ML) 
Glucose monohydrate  

55 
mg 
Equivalent to glucose anhydrous  
50 
mg 

3. PHARMACEUTICAL FORM 
 Solution for IV infusion. Clear solution without visible
particles. 

4. CLINICAL PARTICULARS  
4.1. THERAPEUTIC INDICATIONS: Water loss and inability of its
oral replacement, when there is no 
concomitant estimation of loss and no need of
electrolytic elements. Dehydration may occur in patients 
suffering from hyperthyroidism, intractable
vomiting or diarrhea, diabetic acidosis, coma, diabetes 
insipidus, hypercalcaemia, psychogenic fluid intake abstinence.  
It is indicated for calorie coverage. 

4.2 POSOLOGY AND METHOD OF ADMINISTRATION 
Administration: Intravenous infusion 
Dosage depends on age, weight and clinical condition of
the patient.  

4.3 CONTRAINDICATIONS:  
Diabetic coma, sudden increase of blood volume,
severe cardiac and renal failure 

4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR
USE: Administration of high doses may lead to 
hyperhydration and overloading of the
circulatory system which may lead to pulmonary oedema.  
Aseptic methods should be used for the preparation of the infusion
(sterilization of the cap and the 
injection point, usage of a new and sterile infusion machine).  
The clarity and the absence of visible particles should
be checked before usage.  
The rate of administration (low and continuous) should be
checked.  
Administration to diabetics and to patients suffering from renal dysfunction or failure should
be carried 
out with great caution.  
Regular monitoring of glucose and electrolyte levels
is necessary during treatment 
There are no special precautions for administration during
pregnancy and