Sodium chloride 0.9% w/v solvent for parenteral use

Maa: Irlanti

Kieli: englanti

Lähde: HPRA (Health Products Regulatory Authority)

Aktiivinen ainesosa:

Sodium chloride

Saatavilla:

Fresenius Kabi Deutschland GmbH

ATC-koodi:

B05XA; B05XA03

INN (Kansainvälinen yleisnimi):

Sodium chloride

Annos:

0.9 %v/w

Lääkemuoto:

Solvent for parenteral use

Terapeuttinen alue:

Electrolyte solutions; sodium chloride

Valtuutuksen tilan:

Marketed

Valtuutus päivämäärä:

2009-08-28

Pakkausseloste

4750-2_Mise en page 1 11/09/15 16:24 Page1
Premature or term infants may retain an excess of sodium due to
immature renal
Do not throw away any medicines via wastewater or household waste. Ask
your
PACKAGE LEAFLET: INFORMATION FOR THE USER
function. In premature or term infants, repeated infusions of sodium
chloride
should therefore only be given after determination of the serum sodium
level.
pharmacist how to throw away medicines you no longer use. These
measures will help protect the environment.
-
The physician should judge the incompatibility of an additive drug
with the 0.9%
sodium chloride solution by checking for any possible change in colour
and/or
possible formation of precipitate, insoluble complex or crystals.
-
Before adding any drug, check that the pH range in which it is
effective is the
same as that of 0.9% sodium chloride solution (pH = 4.5 – 7.0).
-
Please refer to the drug’s package insert.
-
When any drug is added to the 0.9% sodium chloride solution, the
mixture must
be administered immediately.
INSTRUCTIONS FOR USE AND HANDLING
Do not use unless the solution is clear and free from particles and
the container
is undamaged.
Discard any damaged or partially used container.
Use in aseptic conditions.
Precautions when using bags:
-
do not use an air entry.
-
flush the infusion system in order to avoid any passage of air.
-
do not connect in series since the residual of the first container
might be
carried on by the solution coming from the second container, with the
risk of
air embolism.
-
for single use only; do not reconnect partially used container.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
WHAT
SODIUM CHLORIDE 0.9% SOLUTION FOR INFUSION CONTAINS
The active
substance is :
Sodium chloride
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
9 g/l
Sodium:
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
154 mmol/l
Chloride:
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
154 mmol/l
Osmolality:
. . . . . . . . . . . . . . . . . . . . . . .
290 mosmol/k

Valmisteyhteenveto

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 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
Once the container is opened the solution should be used immediately.
In case of subcutaneous administration no supplement should be added,
since isotonia would change.
Health Products Regulatory Authority
01 May 2019
CRN008S7Q
Page 2 of 5
Do not use the solution if it is not clear and without precipitates.
Before adding the medicine to the ampoule compatibility between the
substance to be administered and sodium chloride
should be checked.
Newborns, whether premature or not, can present too high sodium levels
due to immaturity of renal function. Therefore, in
newborns, whether pre