GLUCOSE

Krajina: Írsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktívna zložka:

GLUCOSE ANHYDROUS

Dostupné z:

Fresenius Kabi Limited

ATC kód:

B05BA03

INN (Medzinárodný Name):

GLUCOSE ANHYDROUS

Dávkovanie:

5 %w/w

Forma lieku:

Solution for Infusion

Typ predpisu:

Product subject to prescription which may not be renewed (A)

Terapeutické oblasti:

carbohydrates

Stav Autorizácia:

Not Marketed

Dátum Autorizácia:

2009-07-31

Príbalový leták

PACKAGE LEAFLET: INFORMATION FOR THE USER
GLUCOSE 5 %, SOLUTION FOR INFUSION
Anhydrous glucose (as glucose monohydrate)
V001-IE/FB
Read all of this leaflet carefully before you start using this
medicine.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor or pharmacist.
•
If any of the side effects gets serious, or if you notice any side
effects
not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1.
What GLUCOSE 5 % is and what it is used for?
2.
Before you receive GLUCOSE 5 %
3.
How you are given GLUCOSE 5 %?
4.
Possible side effects
5.
How to store GLUCOSE 5 %?
6.
Further information
1. WHAT GLUCOSE 5% IS AND WHAT IT IS USED FOR?
GLUCOSE 5 % 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 infu-
sion may also be for the prevention and treatment of ketosis
(acetone in the blood) during malnutrition.
2. BEFORE YOU RECEIVE GLUCOSE 5%
You must not receive GLUCOSE 5% in case of:
•
water retention
•
glucose intolerance.
Your doctor will check these.
1
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Care should be taken when being administered with GLUCOSE 5%:
Tell your doctor if you suffer from:
•
diabetes
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.
Taking other medicines:
Please tell your doctor or pharmacist if you are taking or have
recently
taken any other medicines, including medicines obtained without a
prescription.
Pregnancy and breast-feeding
GLUCOSE 5% can be used during pregnancy or breast-feeding. However,
you should tell your doctor if you are pregnant, if you think you are
preg-
nant or if you are breast-feeding.
3. HOW YOU ARE GIVEN GLUCOSE 5%?
You will receive your medicine by slow intravenous infusion ('IV
drip'). The
rate at w

Súhrn charakteristických

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.
4.3 CONTRAINDICATIONS
Administration of this medicine is contraindicated in the following
cases:
-
Water overload.
-
Glucose intolerance.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
_SPECIAL WARNINGS:_
Use a slow infusion rate because of the risk of undesirable osmotic
diuresis.
Before use, check that the container is undamaged and that the
solution is clear.
Any damage or partially used container must be discarded.
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