Sodium Chloride 0.9% w/v Solution for Infusion, polyethylene bottle

Kraj: Irlandia

Język: angielski

Źródło: HPRA (Health Products Regulatory Authority)

Składnik aktywny:

Sodium chloride

Dostępny od:

Fresenius Kabi Deutschland GmbH

Kod ATC:

B05XA; B05XA03

INN (International Nazwa):

Sodium chloride

Dawkowanie:

0.9 percent weight/volume

Forma farmaceutyczna:

Solution for infusion

Dziedzina terapeutyczna:

Electrolyte solutions; sodium chloride

Status autoryzacji:

Marketed

Data autoryzacji:

2009-08-28

Ulotka dla pacjenta

Package leaflet: Information for the user
SODIUM CHLORIDE 0.9% W/V
SOLVENT FOR PARENTERAL USE
Sodium chloride
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 or
pharmacist.
-
This medicine has been prescribed for you only. Do not
pass it on to others. It may harm them, even if their signs
of illness are the same as yours.
-
If you
get
any
side
effects,
talk
to
your
doctor
or
pharmacist. This includes any possible side effects not
listed in this leaflet. See section 4.
What is in this leaflet:
1.
What Sodium Chloride is and what it is used for
2.
What you need to know before you use Sodium Chloride
3.
How to use Sodium Chloride
4.
Possible side effects
5.
How to store Sodium Chloride
6.
Contents of the pack and other information
1.
What Sodium Chloride is and what it is used for
Sodium Chloride is indicated as a solvent of medicines that
should be administered intravenously, intramuscularly or
subcutaneously as a support of the addition of medicines.
2.
What you need to know before you use Sodium Chloride
Do not use Sodium Chloride
-
If you have had some allergic or unusual reaction to
sodium chloride.
-
If you have a high concentration of sodium in your blood
(hypernatremia)
-
If you have an increase of muscle tone (hypertonia)
-
If you suffer from cardiac insufficiency (incapability of
the heart to pump the necessary amount of blood)
-
If you have some heart, liver or kidney disorder and if
you suffer from an accumulation of water (oedema) in
your body
-
If you have a severe high blood pressure (severe
hypertension)
-
If you have an excess of acidity in your blood (metabolic
acidosis)
Warnings and precautions
Talk to your doctor or nurse before using Sodium Chloride.
-
Once opened the solutions should be used immediately.
-
In case of subcutaneous administration do not add any
supplement, since isotonia would change.
-
Do not use

Charakterystyka produktu

Health Products Regulatory Authority
01 May 2019
CRN008S7Q
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Sodium Chloride 0.9% w/v Solution for Infusion, polyethylene bottle
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.
Health Products Regulatory Authority
01 May 2019
CRN008S7Q
Page 2 of 5
4.3 CONTRAINDICATIONS
This medicine should not be administr