5% Glucose Intravenous Infusion Solution

Negara: Irlandia

Bahasa: Inggris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

Glucose

Tersedia dari:

Laboratoire AGUETTANT

Kode ATC:

B05BB; B05BB02

INN (Nama Internasional):

Glucose

Bentuk farmasi:

Solution for infusion

Area terapi:

Solutions affecting the electrolyte balance; electrolytes with carbohydrates

Status otorisasi:

Not marketed

Tanggal Otorisasi:

1999-05-31

Selebaran informasi

PACKAGE LEAFLET: INFORMATION FOR THE USER
, SOLUTION FOR INFUSION
(Compound Sodium Lactate Intravenous Infusion B.P.)
SODIUM CHLORIDE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE DIHYDRATE,
SODIUM LACTATE 60%
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 is and what it is used for?
2.
What
you
need
to
know
before
you
are
given
?
3.
How is given?
4.
Possible side effects ?
5.
How to store ?
6.
Contents of the pack and other information?
1. WHAT
IS AND WHAT
IT IS USED FOR

is
a
clear
solution
of
sodium
chloride,
potassium
chloride,
calcium
chloride
dihydrate
and
sodium
lactate
60%
in
water.
The
solution is stored in a sealed plastic container.
Sodium, potassium, calcium and chloride ions are
important for maintaining the correct balance of fluid
in and around the body’s cells and tissues and are
involved in nerve signals and muscle contractions.

may
be
given
for
a
variety
of
reasons: -to help restore fluid levels and the normal
salt balance
-to correct for low blood pressure or decreased blood
volume
-to treat metabolic acidosis, a condition where there is
increased acid in the body. The solution may be given
alone but may be given with other medicines added.
You will be given in hospital by a
doctor or nurse.
2. WHAT YOU NEED TO KNOW BEFORE
YOU ARE GIVEN
YOU MUST NOT BE GIVEN
if you
have:
•
increased levels of
SODIUM
,
POTASSIUM
,
CALCIUM
or
CHLORIDE
in the blood.
These conditions can be detected in blood tests
•
severe
KIDNEY DISEASE
and you are passing little or
no urine
•
suffered
HEA

Karakteristik produk

Health Products Regulatory Authority
17 July 2023
CRN00DKN4
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:

fluid replacement, administered alone or in regimens with electrolytes
or additives known to be compatible with
5% glucose

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