Sodium Chloride Intravenous Infusion BP 0.9% w/v (viaflex container)

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:

0.9 percent weight/volume

Darreichungsform:

Solution for infusion

Therapiebereich:

Electrolyte solutions; sodium chloride

Berechtigungsstatus:

Marketed

Berechtigungsdatum:

1983-04-01

Gebrauchsinformation

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
SODIUM CHLORIDE INTRAVENOUS INFUSION BP 0.9% W/V
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 Intravenous Infusion BP 0.9%
w/v (Viaflex container), 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)

your blood is being pumped slower than normal (heart failure)

severely reduced kidney func

Fachinformation

Health Products Regulatory Authority
03 September 2019
CRN008LNJ
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Sodium Chloride Intravenous Infusion BP 0.9% w/v (viaflex container)
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each litre contains 9.0 g (0.9% w/v) sodium chloride.
This provides 150 mmol/l Sodium and 150 mmol/l Chloride.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for Infusion.
Clear, colourless solution, free from visible particles.
pH: 4.0-7.0.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For use in prophylactic and replacement therapy requiring the use of
sodium chloride or as a vehicle for the reconstitution and
administration of intravenous medications.
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