Sodium Chloride 0.9% w/v Solution for Infusion

Riik: Iirimaa

keel: inglise

Allikas: HPRA (Health Products Regulatory Authority)

Toimeaine:

Sodium chloride

Saadav alates:

Fresenius Kabi Limited

ATC kood:

B05XA; B05XA03

INN (Rahvusvaheline Nimetus):

Sodium chloride

Annus:

0.9 percent weight/volume

Ravimvorm:

Solution for infusion

Retsepti tüüp:

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

Terapeutiline ala:

Electrolyte solutions; sodium chloride

Volitamisolek:

Marketed

Loa andmise kuupäev:

2003-08-22

Infovoldik

PACKAGE LEAFLET: INFORMATION FOR THE USER
SODIUM CHLORIDE 0.9% W/V SOLUTION FOR INFUSION
READ ALL OF THIS LEAFL ET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.
-
Keep this leafl et. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
If any of the side effects gets serious, or if you notice any side
effects not listed in this leafl et, please tell
your doctor or pharmacist.
IN THIS LEAFL ET:
1. What SODIUM CHLORIDE 0.9% is and what it is used for?
2. Before you receive SODIUM CHLORIDE 0.9%
3. How you are given SODIUM CHLORIDE 0.9%?
4. Possible side effects
5. How to store SODIUM CHLORIDE 0.9%?
6. Further information
1. WHAT SODIUM CHLORIDE 0.9% IS AND WHAT IT IS USED FOR?
SODIUM CHLORIDE 0.9% is used for the treatment of sodium depletion
(defi ciency), dehydration (water loss),
hypovolaemia (sudden drop in volume of circulating blood) and as a
solvent and carrier for other compatible
drugs for parenteral administration of medicines.
2. BEFORE YOU RECEIVE SODIUM CHLORIDE 0.9%
YOU WILL NOT RECEIVE SODIUM CHLORIDE 0.9% in case of water/sodium
retention situations, and in particular:
-
decompensated heart failure (heart can’t pump enough blood
throughout the body)
-
kidney failure with oliguria or anuria (decreased or absent production
of urine).
Furthermore, when sodium chloride solution is used as a carrier for
other medicines, your doctor will consider
contraindications related to the added medicinal product(s) before
administering this medicine to you. Your
doctor will explain this to you.
CARE SHOULD BE TAKEN WHEN BEING ADMINISTERED WITH SODIUM CHLORIDE
0.9%:
Sodium chloride will be used with caution if you suffer from:
•
high blood pressure
•
heart failure
•
severe liver function (with swelling and excess liquid)
•
fl uid in the lungs (pulmonary oedema)
•
abnormal build up of fl uid in the ankles, feet, and legs (peripheral
oedema)
•
impaired kidney function
•
are pregnant and have been told you suffer from pre-eclampsia
•
aldosteronism (over

Toote omadused

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Sodium Chloride 0.9% w/v Solution for Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Sodium
chloride:...............................................................................
9 g/l
Each ml contains 9 mg sodium chloride.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for infusion.
Clear and non coloured solution_._
Sodium:..................................................................................
154 mmol/l
Chloride:................................................................................
154 mmol/l
Osmolality:.......................................................................
290 mosmol/kg
Osmolarity:.........................................................................
308 mosmol/l
pH between 4.5 and 7.0.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
This medicine is indicated in the following situations:
-
Treatment of sodium depletion.
-
Treatment of isotonic extracellular dehydration.
-
Treatment of hypovolaemia.
-
Vehicle or diluent of compatible drugs for parenteral administration
of medicines.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
By intravenous infusion using sterile equipment and aseptic method.
1 g of sodium chloride corresponds to 394 mg or 17.1 mEq or 17.1 mmol
of sodium ion.
The recommended dosage for treatment of isotonic extracellular
dehydration and sodium depletion is:
-
FOR ADULTS : 500 ml to 3 Liters/24 h
-
FOR BABIES AND CHILDREN : 20 to 100 ml per 24 h and per kg of body
weight,
depending of the age and the total
body mass.
The infusion rate depends on the patient’s clinical condition.
The recommended dosage when used as a vehicle or diluent ranges from
50 to 250 ml per dose of medicinal product to
be administered.
When Sodium Chloride
0.9 %,
solution for infusion,
is used as a diluent for injectable preparations of other drugs,
the
dosage and the infusion rate will be principally dictated by the
nature and the dose regimen of the prescribed drug
H
E