Glucose 5% Intravenous Infusion BP

Χώρα: Μάλτα

Γλώσσα: Αγγλικά

Πηγή: Medicines Authority

Δραστική ουσία:

GLUCOSE MONOHYDRATE

Διαθέσιμο από:

Baxter Holding B.V. Kobaltweg 49, 3542CE Utrecht, Netherlands

Φαρμακολογική κατηγορία (ATC):

B05BA03

INN (Διεθνής Όνομα):

GLUCOSE MONOHYDRATE 50 g/l

Φαρμακοτεχνική μορφή:

SOLUTION FOR INFUSION

Σύνθεση:

GLUCOSE MONOHYDRATE 50 g/l

Τρόπος διάθεσης:

POM

Θεραπευτική περιοχή:

BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2010-08-19

Φύλλο οδηγιών χρήσης

Package leaflet: Information for the patient
Glucose 5% w/v Intravenous Infusion BP
Active substance: glucose
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN 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 or nurse.
•
If you get any side effects, talk to your doctor or nurse. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Glucose 5% Infusion is and what it is used for
2.
What you need to know before you are given Glucose 5% Infusion
3.
How you will be given Glucose 5% Infusion
4.
Possible side effects
5.
How to store Glucose 5% Infusion
6.
Contents of the pack and other information
1.
WHAT GLUCOSE 5% INFUSION IS AND WHAT IT IS USED FOR
Glucose 5% Infusion is a solution of sugar (glucose) in water. Glucose
is one of the body’s sources of
energy. This solution for infusion provides 200 kilocalories per
litre.
Glucose 5% Infusion is used:
•
as a source of fluid and sugar (carbohydrate)
•
to dilute or to deliver other medicines that can be given by infusion
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN GLUCOSE 5% INFUSION
DO NOT RECEIVE GLUCOSE 5% INFUSION IF YOU ARE SUFFERING FROM ANY OF
THE FOLLOWING CONDITIONS
•
diabetes that is not adequately treated, allowing your blood sugar
levels to rise above
normal (uncompensated diabetes)
•
states of glucose intolerance, for example: when the body’s
metabolism does not function
correctly, e.g. due to severe illness (metabolic stress)
•
hyperosmolar coma (unconsciousness). This is a type of coma that can
occur if you have
diabetes and do not receive enough medicine.
•
a higher amount of sugar in the blood than normal (hyperglycaemia)
•
a higher level of lactate in the blood than normal (hyperlactataemia)
•
intolerance (hypersensitivity) to glucose. This is can occur in
patients with an allergy to corn.
If another medicine is added to your solution for i

Αρχείο Π.Χ.Π.

Page 1 of 11
1.
NAME OF THE MEDICINAL PRODUCT
Glucose 5% Intravenous Infusion BP
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Glucose (as monohydrate): 50.0 g/l
Each ml contains 50 mg glucose (as monohydrate)
Approximately 840 kJ/l (or 200 kcal/l)
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for infusion.
Clear solution, free from visible particles.
Osmolarity : 278 mOsm/l.(approx.)
pH : 3.5 – 6.5
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Glucose 5% is indicated for the treatment of carbohydrate and fluid
depletion.
Glucose 5% is also used as a vehicle and diluent for compatible
medicinal products for parenteral
administration.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_ _
_Adults, the Elderly and Children: _
The concentration and dosage of Glucose 5% intravenous infusion is
determined by several factors
including the age, weight and clinical condition of the patient.
Serum-glucose concentrations may
need to be carefully monitored.
Fluid balance, serum glucose, serum sodium and other electrolytes
should 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 physiologically hypotonic fluids. may become extremely
hypotonic after administration due to glucose metabolization in the
body (see sections 4.4, 4.5 and
4.8).
The recommended dosage for treatment of carbohydrate and fluid
depletion is:
- for adults: 500 ml to 3 litres / 24h
- for babies and children :
- 0-10 kg body weight:
100 ml/kg/24h.
- 10-20 kg body weight:
1000 ml + 50 ml /kg over 10 kg / 24h.
- > 20 kg body weight:
1500 ml + 20 ml / kg over 20 kg / 24h.
_ _
The infusion rate depends on the patient’s clinical condition.
Page 2 of 11
Infusion
rate
should
not
exceed
the
patient’s
glucose
oxidation
capaciti