0.9 % w/v Sodium Chloride Intravenous Infusion

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

SODIUM CHLORIDE

Available from:

B Braun Melsungen AG Carl-Braun-Strasse 1, D34212 Melsungen, Germany

ATC code:

B05BB01

INN (International Name):

SODIUM CHLORIDE 0.9 % (W/V)

Pharmaceutical form:

SOLUTION FOR INFUSION

Composition:

SODIUM CHLORIDE 0.9 % (W/V)

Prescription type:

POM

Therapeutic area:

BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS

Authorization status:

Authorised

Authorization date:

2006-01-16

Patient Information leaflet

005l5.0MM0520H14
PACKAGE LEAFLET: INFORMATION FOR THE USER
0.9 % W/V SODIUM CHLORIDE INTRAVENOUS INFUSION
Sodium chloride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 pharmacist.
–
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if
their signs of illness are the same as yours.
–
If you get any side effects, talk to your doctor or pharmacist. This
includes any possibleside effects not
listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
:
1.
What 0.9 % w/v Sodium Chloride Intravenous Infusion is and what it is
used for
2.
What you need to know before you use 0.9 % w/v Sodium Chloride
Intravenous Infusion
3.
How to use 0.9 % w/v Sodium Chloride Intravenous Infusion
4.
Possible side effects
5.
How to store 0.9 % w/v Sodium Chloride Intravenous Infusion
6.
Contents of the pack and other information
1. WHAT 0.9 % W/V SODIUM CHLORIDE INTRAVENOUS INFUSION IS AND WHAT IT IS
USED FOR
This medicine is a solution of sodium chloride administered to you
through a tube placed into a vein (in-
travenous drip).
It contains sodium chloride at a concentration similar to the
concentration of salts in your blood.
You will receive it for fluid and salt supplies when:
●
you have a lack of body fluids (isotonic dehydration)
●
you have a lack of body fluids and your blood sodium level is
abnormally low (hypotonic dehydra-
tion)
●
you have a low blood chloride level and abnormally high blood pH
(hypochloraemic alkalosis)
●
you have lost chloride
This solution is also used:
●
for immediate replenishment of your blood volume after you have lost
blood,
●
as a vehicle to deliver other electrolytes or medicinal products,
●
for treatment of wounds and moistening of wound tamponades and
dressings.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE 0.9 % W/V SODIUM CHLORIDE
INTRAVENOUS INFUS

Summary of Product characteristics

005l5.0SL0920H14
Page 1
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
0.9 % w/v Sodium Chloride Intravenous Infusion
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
1000 ml of solution contain
Sodium chloride
9.00 g
_Electrolyte concentrations:_
Sodium
154 mmol/l
Chloride
154 mmol/l
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Solution for infusion
A clear, colourless aqueous solution
Theoretical osmolarity
308 mOsm/l
Acidity (titration to pH 7.4)
< 0.3 mmol/l
pH
4.5 – 7.0
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_●_
_ _
Fluid and electrolyte substitution in hypochloraemic alkalosis,
_●_
_ _
Chloride losses,
_●_
_ _
Short-term intravascular volume substitution,
_●_
_ _
Hypotonic dehydration or isotonic dehydration,
_●_
_ _
Vehicle solution for compatible electrolyte concentrates and medicinal
products,
_●_
_ _
Externally for wound irrigation and for moistening of wound tamponades
and dressings.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY_ _
Adults
The dose is adjusted according to the actual requirements of water and
electrolytes.
_Maximum daily dose: _
Up to 40 ml per kg body weight per day, corresponding to 6 mmol of
sodium per kg body
weight.
Any additional losses (due to e.g. fever, diarrhoea, vomiting, etc.)
should be substituted ac-
cording to the volume and composition of the lost fluids.
005l5.0SL0920H14
Page 2
In the management of acute volume deficiency, i.e. imminent or
manifest hypovolaemic
shock, higher doses may be applied, e.g. by pressure infusion.
_Infusion rate: _
The infusion rate will depend on the conditions of the individual
patient (see section 4.4).
Elderly population
Basically the same dosage as for adults applies, but caution should be
exercised in patients
suffering from further diseases like cardiac insufficiency or renal
insufficiency that may fre-
quently be associated with advanced age.
Paediatric population
The dose has to be adjusted according to the individual need of water
and electrolytes as
well as the p