Sodium Chloride 0.9% Intravenous Infusion BP

Land: Malta

Sprache: Englisch

Quelle: Medicines Authority

Wirkstoff:

SODIUM CHLORIDE

Verfügbar ab:

Baxter Healthcare Limited

ATC-Code:

B05XX

INN (Internationale Bezeichnung):

SODIUM CHLORIDE

Darreichungsform:

SOLUTION FOR INFUSION

Zusammensetzung:

SODIUM CHLORIDE 0.9 percent weight/volume

Verschreibungstyp:

POM

Therapiebereich:

BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS

Berechtigungsstatus:

Authorised

Berechtigungsdatum:

2009-10-15

Gebrauchsinformation

1
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 consulted to determine

Fachinformation

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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
condition (e.g. burns, surgery, head-
injury, infections), and concomitant therapy should be determined by
the consulting physician experienced in
paediatric 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 recommen