Sodium Chloride 0.9% Intravenous Infusion BP

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

SODIUM CHLORIDE

Available from:

Baxter Holding B.V. Kobaltweg 49, 3542CE Utrecht, Netherlands

ATC code:

B05XX

INN (International Name):

SODIUM CHLORIDE 9 mg/ml

Pharmaceutical form:

SOLUTION FOR INFUSION

Composition:

SODIUM CHLORIDE 9 mg/ml

Prescription type:

POM

Therapeutic area:

BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS

Authorization status:

Authorised

Authorization date:

2009-10-15

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
SODIUM CHLORIDE 0.9% W/V INTRAVENOUS INFUSION BP
Active substance: sodium chloride
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 Intravenous
Infusion BP’, but will be referred to as
‘Sodium 0.9 Infusion’ throughout the remainder of this leaflet.
WHAT IS IN THIS LEAFLET
1.
What Sodium 0.9 Infusion is and what it is used for
2.
What you need to know before you are given Sodium 0.9 Infusion
3.
How you will be given Sodium 0.9 Infusion
4.
Possible side effects
5.
How to store Sodium 0.9 Infusion
6.
Contents of the pack and other information
1. WHAT SODIUM 0.9 INFUSION IS AND WHAT IT IS USED FOR
Sodium 0.9 Infusion is a solution of sodium chloride in water. Sodium
chloride is a chemical
substance (often called “salt”) found in the blood.
Sodium 0.9 Infusion is used to treat:
•
a loss of body water (dehydration)
•
a loss of sodium from the body (sodium depletion)
Situations that may cause sodium chloride and water loss include:
•
when you cannot eat or drink, due to illness or after surgery
•
pronounced sweating due to high fever
•
extensive skin loss, as can occur in severe burns.
Sodium 0.9 Infusion may also be used to deliver or to dilute other
medicines for infusion.
2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN SODIUM 0.9 INFUSION
DO NOT RECEIVE SODIUM 0.9 INFUSION IF YOU ARE SUFFERING FROM ANY OF
THE FOLLOWING CONDITIONS
•
higher levels of chloride in the blood than normal (hyperchloraemia)
•
higher levels of sodium in the blood than normal (hypernatraemia)
If a medicine has been added to Sodium 0.9 Infusion, the Package
Leaflet of the added medicine
must be consu

Summary of Product characteristics

1. NAME OF THE MEDICINAL PRODUCT
Sodium Chloride 0.9% Intravenous Infusion BP
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Sodium chloride: 9.0 g/l
Each ml contains 9 mg sodium chloride.
mmol/l:
Na+ : 154
Cl-: 154.
pH: 4,5 -7
For the full list of excipients: see section 6.1
3. PHARMACEUTICAL FORM
Solution for infusion
Clear solution, free from visible particles.
4. CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
Sodium Chloride 0.9% intravenous infusion is indicated for:
•
Treatment of isotonic extracellular dehydration
•
Treatment of sodium depletion
•
Vehicle or diluent of compatible drugs for parenteral administration.
4.2. POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults, older people and children: _
Doses may be expressed in terms of mEq or mmol of sodium, mass of
sodium, or mass of
sodium salt (1 g NaCl = 394 mg, 17.1 mEq or 17.1 mmol of Na and Cl).
Fluid balance, serum electrolytes and acid-base balance should be
monitored before and
during administration, with particular attention to serum sodium 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
hospital acquired hyponatraemia (see sections 4.4, 4.5 and 4.8).
Monitoring of serum sodium
is particularly important for hypotonic fluids.
Sodium Chloride 0.9% intravenous infusion has a tonicity of 308 mOsm/l
(approx.)
The infusion rate and volume depend on age, weight, clinical condition
(e.g. burns, surgery,
head-injury, infections),and concomitant therapy should be determined
by the consulting
physician experienced in intravenous fluid therapy (see sections 4.4.
and 4.8).
Recommended
dosage
The recommended dosage for treatment of isotonic extracellular
dehydration and sodium
depletion is:
•
For adults : 500 ml to 3 litres/24h
•
For babies and children: 20 to 100 ml per 24h and per kg of body
weight, depending
of the age and the total body mass.
The recommended dosage when used as a vehicle