SODIUM CHLORIDE

Krajina: Írsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktívna zložka:

SODIUM CHLORIDE

Dostupné z:

Fresenius Kabi Limited

ATC kód:

B05XA03

INN (Medzinárodný Name):

SODIUM CHLORIDE

Dávkovanie:

0.9 %v/w

Forma lieku:

Solvent for Parenteral Use

Typ predpisu:

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

Terapeutické oblasti:

sodium chloride

Stav Autorizácia:

Marketed

Dátum Autorizácia:

2009-08-28

Príbalový leták

Package leafl et: Information for the user
SODIUM CHLORIDE 0.9% W/V
SOLVENT FOR PARENTERAL USE
Sodium chloride
Read all of this leafl et carefully before you start using this
medicine because it contains important information for
you.
-
Keep this leafl et. 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 leafl et. See section 4.
What is in this leafl et:
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 insuffi ciency (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 n

Súhrn charakteristických

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Sodium chloride 0.9% w/v solvent for parenteral use
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Composition per 100 ml:
Electrolytes
mmol/l
mEq/l
Sodium chloride
0.9 g
Na
+
154
154
Water for injections q.s.p.
100 ml
Cl
-
154
154
Each ml of solution contains 9 mg of sodium chloride
Osmolarity: 308 mOsmol/L.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solvent for parenteral use.
Clear and colourless solution, free or practically free from
particles.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Vehicle or diluent for parenteral administration of medicines for
intravenous, intramuscular or subcutaneous route.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The amount to be used will depend on the concentration wanted for the
administration of the medicine to be dissolved.
Method of administration
Intravenous, intramuscular or subcutaneous use.
4.3 CONTRAINDICATIONS
Due to the indications of the product, contraindications depend on the
medicine to be dissolved.
In general, the administration of this product is contraindicated in
the following situations:
Hypernatremia
Hypertonia
Cardiac insufficiency
Oedematous states in patients with cardiac, hepatic or renal disorders
Severe hypertension
Metabolic acidosis
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
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