Sodium Chloride 0.45% w/v Solution for Infusion

Land: Irland

Sprache: Englisch

Quelle: HPRA (Health Products Regulatory Authority)

Wirkstoff:

Sodium chloride

Verfügbar ab:

Baxter Holding B.V.

ATC-Code:

B05XA; B05XA03

INN (Internationale Bezeichnung):

Sodium chloride

Dosierung:

0.45 percent weight/volume

Darreichungsform:

Solution for infusion

Therapiebereich:

Electrolyte solutions; sodium chloride

Berechtigungsstatus:

Marketed

Berechtigungsdatum:

2010-07-02

Gebrauchsinformation

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
SODIUM CHLORIDE 0.45 % SOLUTION FOR INFUSION
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 0.45% Solution for
Infusion’, but will be referred to as `Sodium
0.45 Infusion’ throughout the remainder of this leaflet. WHAT IS IN THIS LEAFLET:
1.
What Sodium 0.45 Infusion is and what it is used for
2.
What you need to know before you are given Sodium 0.45 Infusion
3.
How you will be given Sodium 0.45 Infusion
4.
Possible side effects
5.
How to store Sodium 0.45 Infusion
6.
Contents of the pack and other information
1.
WHAT SODIUM 0.45 INFUSION IS AND WHAT IT IS USED FOR
Sodium 0.45 Infusion is a solution of sodium chloride in water. Sodium
chloride is a chemical substance
(often called “salt”) found in the blood.
Sodium 0.45 Infusion is used to treat:
-
a loss of body water, for example after being sick or having diarrhoea
(hypertonic extracellular
dehydration)
-
a lower than normal volume of blood in the body (hypovolaemia)
Sodium 0.45 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 0.45 INFUSION
DO NOT RECEIVE SODIUM 0.45 INFUSION IF YOU ARE SUFFERING FROM ANY OF
THE FOLLOWING CONDITIONS
-
lower levels of chloride in the blood than normal (hypochloraemia)
-
lower levels of sodium in the blood than normal (hyponatraemia)
-
severe kidney problems causing lower than normal or no urine
production (oliguria or anuria)
-
higher than normal levels of water or sodium in the blood (fluid or
sodium retention)
-
uncompensated heart failure. This is heart failure that is not
adequately treated

Fachinformation

Health Products Regulatory Authority
03 September 2019
CRN008LNJ
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Sodium Chloride 0.45% w/v Solution for Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Sodium Chloride: 4.5 g/l
Each ml contains 4.5 mg sodium chloride.
Na
+
Cl
-
mmol/l 77 77
mEq/l 77 77
154 mOsm/l (approx.)
pH: 4.5 – 7.0
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 0.45% w/v Solution for Infusion is indicated for the
treatment of hypertonic extracellular dehydration or
hypovolaemia in cases where the intake of fluids and electrolytes by
normal routes is not possible.
It can also be used as a vehicle or diluent of compatible medicinal
products.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults, _older people_, Adolescents and Children:
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 0.45% Solution for Infusion has a tonicity of 154
mOsm/l (approx.)
The infusion rate and volumedepend 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:_

For adults, older people and adolescents: 500 ml to 3 litres/24h,

For babies and children: 20 to 100 ml per 24 h and per kg of body
weight, depending on the age and the total
body mass.
Health Products Regulatory Au