Glucose 10 % 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:

10 percent weight/volume

Pharmaceutical form:

Solution for infusion

Therapeutic area:

Solutions for parenteral nutrition; carbohydrates

Authorization status:

Not marketed

Authorization date:

2004-01-09

Patient Information leaflet

B204752-03 - V003-IE/LV (FFX)
WHAT IS IN THIS LEAFLET:
1. What GLUCOSE 10 % is and what it is used for
2. What you need to know before you use GLUCOSE 10%
3. How to use GLUCOSE 10%
4. Possible side effects
5. How to store GLUCOSE 10 %
6. Contents of the pack and other information
1. WHAT GLUCOSE 10% IS AND WHAT IT IS USED FOR
GLUCOSE 10 % 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 10%
DO NOT USE GLUCOSE 10% 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
PACKAGE LEAFLET: INFORMATION FOR THE USER
GLUCOSE 10% W/V,
SOLUTION FOR INFUSION
Anhydrous glucose (as glucose monohydrate)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE
IT CONTAINS IMPORTANT INFORMATION FOR YOU.
_- Keep this leaflet. 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 possible side effects not listed in this leaflet. _
Do not throw away any medicines via wastewater or household waste. Ask
our
pharmacist how to throw away medicines you no longer use. These
measures
will help protect the environment.
6. FURTHER INFORMATION
WHAT GLUCOSE 10% CONTAINS
The active substance is :
Glucose anhydrous
. . . . . . . . . . . . . . . . . . . . . . .
100 g/l
As glucose monohydrate
. . . . . . . . . . . . . . . .
110 g/l
Osmolality:
. . . . . . . . . . . . . . . . . . . . . .
580 mosmol/kg
Osmolarity:
. . . . . . .

Summary of Product characteristics

Health Products Regulatory Authority
06 November 2019
CRN008J2N
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Glucose 10 % w/v Solution for Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Glucose
anhydrous...........................................................................
100 g/l
As glucose
monohydrate...................................................................
110 g/l
Each ml contains 100 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:.........................................................................
580 mosmol/kg
Osmolarity:............................................................................
555 mosmol/l
Carbohydrate caloric content: 400 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 concent