Glucose 5 % w/v Solution for Infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Glucose anhydrous

Available from:

Fresenius Kabi Deutschland GmbH

ATC code:

B05BA; B05BA03

INN (International Name):

Glucose anhydrous

Dosage:

5 percent weight/weight

Pharmaceutical form:

Solution for infusion

Therapeutic area:

Solutions for parenteral nutrition; carbohydrates

Authorization status:

Marketed

Authorization date:

2009-07-31

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
GLUCOSE 5% W/V SOLUTION FOR INFUSION
Anhydrous glucose (as glucose monohydrate)
READ ALL OF THIS LEAFL ET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
-
Keep this leafl et. You may need to read it again.
-
If you have any further questions, ask your doctor, pharmacist or
nurse.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any side effects not listed
in this leafl et. See section 4.
WHAT IS IN THIS LEAFL ET:
1. What GLUCOSE 5 % is and what it is used for
2. What you need to know before you use GLUCOSE 5%
3. How to use GLUCOSE 5%
4. Possible side effects
5. How to store GLUCOSE 5 %
6. Contents of the pack and other information
1. WHAT GLUCOSE 5% IS AND WHAT IT IS USED FOR
GLUCOSE 5% is a sterile, colourless solution for infusion.
It is used where there has been excessive water loss from the body
(dehydration) and to prevent it. It is used
as a solvent and carrier for other compatible drugs for parenteral
administration of medicines. This infusion
may also be for the prevention and treatment of ketosis (acetone in
the blood) during malnutrition.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE GLUCOSE 5%
DO NOT USE GLUCOSE 5% IN CASE OF:
-
water retention
-
glucose intolerance.
Your doctor will check these.
WARNINGS AND PRECAUTIONS
Tell your doctor if you
•
suffer from diabetes
•
suffer from acute illness, pain, post-operative stress, infections,
burns, diseases of the
central nervous system
•
have any type of heart-, liver- or kidney disease
•
have been treated with a medicine increasing the effect of vasopressin
(a hormone regulating
the body’s water retention) because this may increase the risk of
hospital-acquired low sodium
levels in the blood (hyponatraemia).
Your doctor may want to do regular blood and urine tests to check your
condition.
Your doctor or nurse will make sure that the solution is given to you
properly.
1
V003-IE/H (FFX)
01-59-07-XXX
69
FIH (Glucose 5 %) / Ire

Summary of Product characteristics

Health Products Regulatory Authority
02 September 2019
CRN008J2M
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Glucose 5 % w/v Solution for Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Glucose
anhydrous...........................................................................
50 g/l
As glucose
monohydrate...................................................................
55 g/l
Each ml contains 50 mg anhydrous glucose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for infusion.
Clear solution, non coloured to slightly yellow.
Osmolality:.......................................................................
300 mosmol/kg
Osmolarity:..........................................................................
278 mosmol/l
Carbohydrate caloric content: 200 kcal/l
pH = 3.5 - 6.5
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
This medicine is indicated in the following situations:
- Rehydration when there is loss of water greater than loss of sodium
chloride and other osmoles.
- Prevention of dehydration.
- Vehicle for other medicines during the preoperative, peroperative
and immediate postoperative periods.
- Prevention and treatment of ketosis during malnutrition.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Intravenous infusion by peripheral or central vein.
Posology is to be adapted according to patient's clinical status, body
weight, diet and any possible other treatments.
Infusion rate must not exceed a volume corresponding to 0.5 g of
glucose per minute.
Fluid
balance,
serum
glucose,
serum
sodium
and
other
electrolytes
may
need
to
be
monitored
before
and
during
administration, especially in patients with increased non-osmotic
vasopressin release (syndrome of inappropriate antidiuretic
hormone secretion, SIADH) and in patients co-medicated with
vasopressin agonist drugs due to the risk of hyponatraemia.
Monitoring of serum sodium is particularly important for products with
lower sodium concentration compared to serum
sodium concentration.