Sodium Chloride 0.9 % w/v and Glucose 5% w/v Solution for Infusion BP (Viaflo container)

Država: Irska

Jezik: engleski

Izvor: HPRA (Health Products Regulatory Authority)

Aktivni sastojci:

Sodium chloride; Glucose

Dostupno od:

Baxter Holding B.V.

ATC koda:

B05CB; B05CB01

INN (International ime):

Sodium chloride; Glucose

Doziranje:

0.9/5 percent weight/volume

Farmaceutski oblik:

Solution for infusion

Područje terapije:

Salt solutions; sodium chloride

Status autorizacije:

Marketed

Datum autorizacije:

2004-11-12

Uputa o lijeku

PACKAGE LEAFLET: INFORMATION FOR THE
USER
SODIUM CHLORIDE 0.9%
W/V
& GLUCOSE 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
0.9%
w/v & Glucose 5% w/v Solution for Infusion BP’,
but
will
be referred to as ‘Sodium Chloride 0.9
&
Glucose 5 Infusion’ throughout the remainder
of
this
leaflet.
WHAT IS IN THIS
LEAFLET
1.
What Sodium Chloride 0.9 & Glucose
5
Infusion is and what
it
is used
for
2.
What you need to know before you ar
e
given Sodium Chloride 0.9 & Glucose
5
Infusion
3.
How you
will
be given Sodium
Chloride
0.9 & Glucose 5
Infusion
4.
Possible side
effects
5.
How to store Sodium Chloride 0.9
&
Glucose 5
Infusion
6.
Contents of the pack and other
information
1.
WHAT SODIUM CHLORIDE
0.9
& GLUCOSE
5 INFUSION IS AND
WHAT IT IS USED FOR
Sodium Chloride 0.9 & Glucose 5 Infusion is a
solution of the following substances in
w
ater:
•
sugar
(glucose)
•
sodium chloride
(salt)
Glucose is one of the body’s sources of
energy.
This solution for infusion provides 200 kilocalories
per
litr
e.
Sodium and chloride are chemical substances
found in the
blood.
Sodium Chloride 0.9 & Glucose 5 Infusion is
used:
•
as a source of carbohydrate
(sugar)
•
to treat a loss of sodium from the blood
and
the body (sodium
depletion)
•
to treat a loss of body water, for example
after
being sick or having diarrhoea
(e
xtr
acellular
dehydration)
•
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 0.9 & GLUCOSE
5
INFUSION
DO NOT
RECEIVE SODIUM CHLORIDE 0.9 &
GLUCOSE 5 INFUSION IF
YOU

Svojstava lijeka

Health Products Regulatory Authority
24 September 2020
CRN008LNL
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Sodium Chloride 0.9 % w/v and Glucose 5% w/v Solution for Infusion BP
(Viaflo container)
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Sodium Chloride: 9.0 g/l (0.9% w/v)
Glucose (as monohydrate): 50.0 g/l (5.0% w/v)
Each ml contains 50 mg glucose (as monohydrate) and 9.0 mg sodium
chloride.
Mmol/l: Na
+
: 154 Cl
-
:154
Meq/l: Na
+
: 154 Cl
-
:154
Nutritional value: 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: 585 mOsm/l (approx)
pH: 3.5 to 6.5
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Sodium Chloride 0.9 % w/v and Glucose 5% w/v solution is indicated
for:
- Treatment of sodium depletion, extracellular dehydration or
hypovolaemia in cases where supply of water 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 0.9 % w/v and Glucose 5% w/v
solution may become extremely hypotonic after admin