Sodium Chloride 0.9% w/v Injection BP (5ml amp)

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

SODIUM CHLORIDE

Available from:

Noridem Enterprises Ltd Evagorou & Makariou, Mitsi Building 3, Office 115,1065 Nicosia, Cyprus

ATC code:

V07AB

INN (International Name):

SODIUM CHLORIDE 9 mg/ml

Pharmaceutical form:

SOLUTION FOR INJECTION

Composition:

SODIUM CHLORIDE 9 mg/ml

Prescription type:

POM

Therapeutic area:

ALL OTHER NON-THERAPEUTIC PRODUCTS

Product summary:

Licence number in the source country: NOT APPLICAPABLE

Authorization status:

Authorised

Authorization date:

2022-02-14

Patient Information leaflet

PACKAGE LEAFLET
PATIENT INFORMATION LEAFLET
SODIUM CHLORIDE 0.9% W/V INJECTION BP
SODIUM CHLORIDE
PLEASE READ ALL OF THIS LEAFLET CAREFULLY. IT INCLUDES IMPORTANT
INFORMATION ON HOW YOU
SHOULD TAKE THIS MEDICINE CORRECTLY AND SAFELY.
•
Keep this leaflet. You may need to read it again.
•
If you are the parent of a child who is to be given this medicine,
read the leaflet replacing
‘you’ with ‘your child’ throughout.
•
This medicine is prescribed for you. Do not pass it on to others. It
may harm them, even if
their symptoms are the same as yours.
•
If any of the side effects get serious, or you notice any side effects
not listed in the leaflet
please tell your doctor, nurse or pharmacist.
•
If you have any further questions, please ask your doctor, nurse or
pharmacist.
THE NAME OF YOUR MEDICINE IS SODIUM CHLORIDE 0.9% W/V INJECTION BP. _In the rest of this leaflet Sodium Chloride 0.9% w/v Injection is
called Sodium Chloride. _
IN THIS LEAFLET:
1.
What Sodium Chloride is and what it is used for
2.
Before you take Sodium Chloride
3.
How to take Sodium Chloride
4.
Possible side effects
5.
How to store Sodium Chloride
6.
Further information
1. WHAT SODIUM CHLORIDE IS AND WHAT IT IS USED FOR
Sodium Chloride is a type of medicine called an electrolyte. It is a
sterile salt liquid which can
be used for a number of different reasons as it is very similar to
your body fluids.
The main use for Sodium Chloride injection is to dissolve or dilute
other medicines so they
can
be given as an injection or an infusion (a drip) into veins, muscles
or other tissues in the body.
Sodium Chloride can also be used for preparation for a number of
surgical and medical
procedures as follows:
•
to clean out catheters (small devices put in your vein to inject your
medicine).
•
as a priming solution to fill intravenous lines (long tubes which are
connected to your
veins).
This is to make sure there is no air being injected such as during
haemodialysis (a
procedure to clean blood when you have kidney disease).
•
as a primi

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Sodium Chloride 0.9% w/v Injection BP.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Sodium Chloride 9mg/mL or 0.9% w/v.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection and solvent for parenteral use.
A clear colourless liquid.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Sodium chloride injection is indicated as a pharmaceutical aid and
diluent for the
infusion
of
compatible
drug
additives
and for
diluting
or
dissolving
drugs for
parenteral administration.
Other indications for sodium chloride injection include flushing of IV
catheters, as a
priming solution in haemodialysis procedures and to initiate and
terminate blood
transfusions without haemolysing red blood cells. Sodium chloride
injection may be
added to compatible carbohydrate solutions such as dextrose in water
to produce
electrolytes
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
DOSAGE:
The volume given and administration rate are dependent upon the
additive.
ADMINISTRATION:
For parenteral use.
The directions for use of the additive will dictate the administration
route.
4.3
CONTRAINDICATIONS
Hypernatremia, hyperchloremia and those contraindications related to
the additive.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Newborn babies, both premature and at term, may exhibit excessively
high sodium
levels due to immaturity of renal function. As a result, in newborn
babies, both
premature and at term, repeated injections of sodium chloride may only
be given
after determining blood serum levels.
Sodium Chloride must be used with caution in patients with
hypertension, heart
failure, pulmonary or peripheral oedema, impaired renal function,
pre-eclampsia,
hyperaldosteronism, and other diseases and treatments (e.g.
corticosteroids)
associated with sodium retention.
4.5
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
None known when used as a diluent or priming solution
4.6
PREGNANCY AND LACTATION
This solution does not pre