5% Glucose Intravenous Infusion Solution

Ország: Írország

Nyelv: angol

Forrás: HPRA (Health Products Regulatory Authority)

Aktív összetevők:

Glucose

Beszerezhető a:

Carelide

ATC-kód:

B05BB; B05BB02

INN (nemzetközi neve):

Glucose

Adagolás:

5 percent weight/volume

Gyógyszerészeti forma:

Solution for infusion

Terápiás terület:

Solutions affecting the electrolyte balance; electrolytes with carbohydrates

Engedélyezési státusz:

Not marketed

Engedély dátuma:

1999-05-31

Betegtájékoztató

PACKAGE LEAFLET: INFORMATION FOR THE USER 5% GLUCOSE INTRAVENOUS INFUSION SOLUTION
GLUCOSE ANHYDROUS
READ ALL OF THIS LEAFLET CAREFULLY BEFORE BEING 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 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 MEDI

Termékjellemzők

Health Products Regulatory Authority
02 November 2022
CRN00D6C9
Page 1 of 6
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 losses, 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 adults will usually lie
between 2 and 10 litres. The pathophysiological response