Sodium Chloride 0.45 % w/v and Glucose 2.5% w/v Solution for Infusion BP

País: Irlanda

Idioma: inglés

Fuente: HPRA (Health Products Regulatory Authority)

Ingredientes activos:

Sodium chloride; Glucose

Disponible desde:

Baxter Holding B.V.

Código ATC:

B05CB; B05CB01

Designación común internacional (DCI):

Sodium chloride; Glucose

Dosis:

0.45/2.5 percent weight/volume

formulario farmacéutico:

Solution for infusion

Área terapéutica:

Salt solutions; sodium chloride

Estado de Autorización:

Marketed

Fecha de autorización:

2004-11-12

Información para el usuario

1a
PMS
287
PACKAGE LEAFLET: INFORMATION FOR THE USER
SODIUM CHLORIDE 0.45%
W/V
& GLUCOSE
2.5% W/V
SOLUTION FOR INFUSION BP
Active substances: sodium chloride, 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.
This medicine is called ‘Sodium Chloride
0.45%
w/v & Glucose 2.5% w/v Solution for Infusion BP’,
but
will
be referred to as ‘Sodium Chloride 0.45
&
Glucose 2.5 Infusion’ throughout the remainder
of
this
leaflet.
WHAT IS IN THIS
LEAFLET
1.
What Sodium Chloride 0.45 & Glucose
2.5
Infusion is and what
it
is used
for
2.
What you need to know before you are
given Sodium Chloride 0.45 & Glucose
2.5
Infusion
3.
How you
will
be given Sodium Chloride
0.45
& Glucose 2.5
Infusion
4.
Possible side
effects
5.
How to store Sodium Chloride 0.45
&
Glucose 2.5
Infusion
6.
Contents of the pack and other
infor
mation
1.
WHAT SODIUM CHLORIDE
0.45
& GLUCOSE
2.5 INFUSION IS AND
WHAT IT IS USED FOR
Sodium Chloride 0.45 & Glucose 2.5 Infusion is a
solution of the following substances in
water:
•
sugar
(glucose)
•
sodium chloride
(salt)
Glucose is one of the body’s sources of
energy.
This solution for infusion provides 100 kilocalories
per
litr
e.
Sodium and chloride are chemical substances
found in the
blood.
Sodium Chloride 0.45 & Glucose 2.5 Infusion
is
used:
•
as a source of carbohydrate
(sugar)
•
to treat a loss of body water (dehydration)
and
chemicals (e.g. by heavy sweating,
kidney
disorders)
•
to treat you,
if
the volume of blood in your
blood vessels is low (hypovolaemia)
2.
WHAT YOU NEED TO KNOW BEFORE
YOU ARE GIVEN SODIUM CHLORIDE
0.45 & GLUCOSE
2.5 INFUSION
DO NOT
RECEIVE SODIUM CHLORIDE 0.45 &
GLUCOSE 2.5 INFUSION IF
YOU ARE SUFFERING
FROM ANY OF THE FOLLOWING

Ficha técnica

Health Products Regulatory Authority
24 September 2020
CRN008LNL
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Sodium Chloride 0.45 % w/v and Glucose 2.5% w/v Solution for Infusion
BP
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Sodium Chloride: 4.5 g/l(0.45 % w/v)
Glucose (as monohydrate): 25.0 g/l(2.5 % w/v)
Each ml contains 25 mg glucose (as monohydrate) and 4.5 mg sodium
chloride.
mmol/l: Na+: 77 Cl-:77
mEq/l: Na+: 77 Cl-:77
Nutritional value: approximately 420 kJ/l (or 100 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 293 mOsm/l (approx)
pH: 3.5 to 6.5
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Sodium Chloride 0.45 % w/v and Glucose 2.5% w/v solution is indicated
for:
- Treatment of dehydration or hypovolaemia in cases where supply of
water, sodium chloride and carbohydrates is required
due to restriction of the intake of fluids and electrolytes by normal
routes.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The choice of the specific sodium chloride and glucose concentration,
dosage, volume, rate and duration of administration
depends on the age, weight, clinical condition of the patient and
concomitant therapy. It should be determined by a physician.
For patients with electrolyte and glucose abnormalities and for
paediatric patients, consult a physician experienced in
intravenous fluid therapy.
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. Sodium Chloride 0.45 % w/v and Glucose 2.5% w/v
solution may become extremely hypotonic after administration due to
glucose metabolisat