GLUCOSE

Krajina: Írsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktívna zložka:

GLUCOSE MONOHYDRATE

Dostupné z:

Maco Pharma (UK) Ltd

ATC kód:

B05BB02

INN (Medzinárodný Name):

GLUCOSE MONOHYDRATE

Dávkovanie:

5 %w/v

Forma lieku:

Solution for Infusion

Typ predpisu:

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

Terapeutické oblasti:

electrolytes with carbohydrates

Stav Autorizácia:

Marketed

Dátum Autorizácia:

1999-05-31

Príbalový leták

WHAT IS IN THIS LEAFLET
1. What 5% Glucose Intravenous Infusion Solution is and what it is
used for
2. What you need to know before you are given 5% Glucose Intravenous
Infusion Solution
3. How 5% Glucose Intravenous Infusion Solution is given
4. Possible side effects
5. How to store 5% Glucose Intravenous Infusion Solution
6. Contents of the pack and other information
1. WHAT 5% GLUCOSE INTRAVENOUS
INFUSION SOLUTION IS AND WHAT IT IS
USED FOR
5% Glucose Intravenous Infusion Solution is a
clear colourless to faintly straw-coloured solution
of glucose in water. The solution is stored in a
sealed flexible plastic bag.
Glucose is a simple sugar, which provides a
source of energy. Glucose infusions are used to
replace fluid loss from the body, to restore the
body’s water balance.
Glucose infusions can be given alone but may be
given with added salts such as sodium or
potassium. You may be given glucose solution
with other medicines added, depending on your
condition.
Glucose infusions will be given to you in hospital
by a doctor or nurse.
2. WHAT YOU NEED TO KNOW BEFORE
YOU ARE GIVEN 5% GLUCOSE
INTRAVENOUS INFUSION SOLUTION
YOU MUST NOT BE GIVEN this solution if you have:
• an ALLERGY to glucose or any of the other
ingredients
• HYPERGLYCAEMIA (high levels of glucose in the
blood)
• a condition of WATER EXCESS, such as liver
disease or heart failure.
WARNINGS AND PRECAUTIONS
Talk to your doctor or nurse if you:
• have DIABETES MELLITUS
• have KIDNEY FAILURE
• have suffered a STROKE
• are PREGNANT or are BREAST-FEEDING
OTHER MEDICINES AND 5% GLUCOSE INTRAVENOUS
INFUSION SOLUTION
Tell your doctor if you are taking or have
recently taken any other medicines.
PREGNANCY, BREAST-FEEDING AND FERTILITY
If you are pregnant or breast-feeding, or think
you may be pregnant, ask your doctor for advice
before being given this medicine.
The solution should be used with care during
pregnancy and breast-feeding to avoid extreme
levels of glucose in the mother and the fœtus or
baby.
DRIVING AND USING MACHINES
Glucose

Súhrn charakteristických

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
5% Glucose Intravenous Infusion Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Dextrose (glucose) monohydrate equivalent to 50.00g anhydrous dextrose
per litre.
278mmol/l. Approximately 836 kJ/litre (200 kcal/litre)
_For a full list of excipients, see Section 6.1_
3 PHARMACEUTICAL FORM
Solution for infusion.
Colourless to faintly straw-coloured solution without visible
particles in bags, individually overwrapped.
pH 4.15.- Osmolality approx 300mOsm/kgH
2
O.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
5% Glucose Intravenous Infusion Solution is indicated for:
o
fluid replacement, administered alone or in regimens with electrolytes
or additives known to be compatible with
5% glucose
o
medium for intravenous administration of medicinal products known to
be compatible with 5% glucose
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
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
physiologically hypotonic fluids. 5% Glucose Intravenous
Infusion Solution may become extremely hypotonic after administration
due to glucose metabolization in the body (see
sections 4.4, 4.5 and 4.8).
To avoid dehydration in a healthy adult or in patients with no
complicating factors such as fever or excessive fluid losse
daily fluid requirements are 1.5 to 2.5 litres. The volume of glucose
solution needed to replenish deficits will vary with
body weight, complementary treatment, severity of the clinical
condition and hydration status of the patient, but in adult
will usually lie between 2 and 10 litres.
The pathophysiological response to dehydration, to electrolyte loss
and to gluco
infusion will vary with the ag