Sodium Chloride 0.9 % w/v solution for infusion

Ülke: İrlanda

Dil: İngilizce

Kaynak: HPRA (Health Products Regulatory Authority)

Aktif bileşen:

Sodium chloride

Mevcut itibaren:

Fresenius Kabi Deutschland GmbH

ATC kodu:

B05XA; B05XA03

INN (International Adı):

Sodium chloride

Doz:

0.9 percent weight/volume

Farmasötik formu:

Solution for infusion

Terapötik alanı:

Electrolyte solutions; sodium chloride

Yetkilendirme durumu:

Marketed

Yetkilendirme tarihi:

2003-08-22

Bilgilendirme broşürü

PACKAGE LEAFLET: INFORMATION FOR THE USER
Sodium Chloride 0.9 % w/v Solution for Infusion
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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, pharmacist or
nurse.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
:
1.
What Sodium Chloride 0.9 % Solution for Infusion is and what it is
used for
2.
What you need to know before you use Sodium Chloride 0.9 % Solution
for Infusion
3.
How to use Sodium Chloride 0.9 % Solution for Infusion
4.
Possible side effects
5.
How to store Sodium Chloride 0.9 % Solution for Infusion
6.
Contents of the pack and other information
1. WHAT SODIUM CHLORIDE 0.9%SOLUTION FOR INFUSION IS AND WHAT IT IS
USED FOR
Sodium Chloride 0.9% is a sterile, colourless solution for infusion.
It is used for the treatment of sodium depletion (deficiency),
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. WHAT YOU NEED TO KNOW BEFORE YOU USE SODIUM CHLORIDE 0.9 % SOLUTION
FOR INFUSION
DO NOT USE SODIUM CHLORIDE 0.9 % SOLUTION FOR INFUSION:
-
if you have water/sodium retention situations, and in particular :
o
decompensated heart failure (heart can't pump enough blood throughout
the body)
o
kidney failure with oliguria or anuria (decreased or absent production
of urine).
_ _
Furthermore, when Sodium Chloride 0.9 % Solution for Infusion 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.
WARNINGS AND PRECAUTIONS
Sodium Chloride 0.9 % Solution for Infusion, will be used with caution
if you suffer from:
•
high blood

Ürün özellikleri

Health Products Regulatory Authority
01 March 2024
CRN00C8HJ
Page 1 of 6
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 or17.1 mmolof
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.
4.3 CONTRAINDICATIONS