SODIUM CHLORIDE

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

SODIUM CHLORIDE

Available from:

Maco Pharma (UK) Ltd

ATC code:

B05BB01

INN (International Name):

SODIUM CHLORIDE

Dosage:

0.9 %w/v

Pharmaceutical form:

Solution for Infusion

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

electrolytes

Authorization status:

Marketed

Authorization date:

1999-05-31

Patient Information leaflet

WHAT IS IN THIS LEAFLET
1. What 0.9% Sodium Chloride Intravenous Infusion Solution is and what
it is used for
2. What you need to know before you are given 0.9% Sodium Chloride
Intravenous Infusion Solution
3. How 0.9% Sodium Chloride Intravenous Infusion Solution is given
4. Possible side effects
5. How to store 0.9% Sodium Chloride Intravenous Infusion Solution
6. Contents of the pack and other information
1. WHAT 0.9% SODIUM CHLORIDE
INTRAVENOUS INFUSION SOLUTION IS
AND WHAT IT IS USED FOR
0.9% Sodium Chloride Intravenous Infusion
Solution is a clear colourless to faintly straw-
coloured solution of sodium chloride in water.
The solution is stored in a sealed flexible plastic
bag.
Sodium chloride (salt) helps to maintain the
correct balance of fluid in and around the body’s
cells and tissues. Sodium chloride infusions are
given to add water to tissues which are
dehydrated and to help to restore the normal salt
balance.
Sodium chloride infusions may be given alone
but may be given with other medicines added.
You will be given sodium chloride infusions in
hospital by a doctor or nurse.
2. WHAT YOU NEED TO KNOW BEFORE
YOU ARE GIVEN 0.9% SODIUM CHLORIDE
INTRAVENOUS INFUSION SOLUTION
YOU MUST NOT BE GIVEN SODIUM CHLORIDE
INFUSIONS IF YOU:
• have an ALLERGY to sodium chloride or any of
the other ingredients.
WARNINGS AND PRECAUTIONS
Talk to your doctor or nurse if you:
• have HEART FAILURE, CARDIO-PULMONARY DISEASE,
KIDNEY PROBLEMS, HIGH BLOOD PRESSURE, LIVER
DISEASE, or OEDEMA (swelling)
• have HIGH SERUM LEVELS OF SODIUM
(“hypernatraemia”)
• have PRE-ECLAMPSIA of pregnancy
• are receiving drugs which may increase SODIUM
RETENTION
• are VERY YOUNG or ELDERLY.
OTHER MEDICINES AND 0.9% SODIUM CHLORIDE
INTRAVENOUS INFUSION SOLUTION
Tell your doctor if you are taking or have
recently taken any other medicines.
PREGNANCY, BREAST-FEEDING AND FERTILITY
If you are pregnant or breast-feeding, or think
you may be pregnant, ask your doctor for advice
before being given this medicine.
DRIVING AND USING MACHIN

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
0.9% Sodium Chloride Intravenous Infusion Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Sodium Chloride 9g per 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 5. Osmolarity approx 300mOsm/kgH
2
O.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
0.9% isotonic saline solution is indicated:
o
for fluid replacement and provision of extracellular ions in near
physiological concentration in conditions of
extracellular-volume depletion, dehydration and electrolyte imbalance
such as sodium depletion
o
as an isotonic medium for intravenous administration of medicinal
products known to be compatible with 0.9%
sodium chloride.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For intravenous infusion under medical supervision.
Single use only.
The pathophysiological response to dehydration, to electrolyte loss
and to sodium chloride infusion will vary with the
age of the patient being treated and this should be taken into account
during rehydration therapy. Fluid replacement
therapy should be administered with caution to very young and elderly
patients.
The volume of isotonic saline solution needed to replenish fluid
deficits varies with age, body weight, complementary
treatment and severity of the clinical condition. The dose and rate of
administration are subject to clinical and
laboratory assessment in each case.
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