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SODIUM CHLORIDE 9 MG/ML SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE

Active substance(s): SODIUM CHLORIDE

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Sodium chloride 9 mg/ml solution for injection in pre-filled syringe

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains 9 mg sodium chloride, equivalent to 0.154 mmol Na+ and 0.154 mmol
Cl-.
Each syringe of 50 ml contains 7.7 mmol (equivalent to 177 mg) of sodium.
Each syringe of 125 ml contains 19.3 mmol (equivalent to 443 mg) of sodium.
For a full list of excipients, see section 6.1.

3

PHARMACEUTICAL FORM
Solution for injection in pre-filled syringe
Sterile, non-pyrogenic, clear, colourless and odourless aqueous solution
pH: 4.5 – 7.0
Theoretical osmolarity: 308 mOsm/l

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
This medicinal product is for diagnostic use only.
Sodium chloride 9 mg/ml solution is indicated for use in flushing compatible contrast
agents into indwelling intravascular access devices.

4.2

Posology and method of administration
Posology
Adults

The volume of the saline flush should be determined for each patient individually
based, in part, on the imaging procedure, the location of the vascular access device,
and the length of the tubing between the power injector and the vascular access
device.
Infusion rates and flush volumes should also be individualized for each patient based
on body weight, fluid status and concomitant medical conditions.
Typical sodium chloride solution flush volumes following contrast agent
administration in adults are 10 to 60 ml per injection, at rates not to exceed 10 ml/sec.
Some power injectors allow for additional infusion of Sodium chloride 9
mg/ml solution to maintain the patency of vascular access. Typical infusion rates used
for this purpose are in the range of 0.5 to 1 ml per minute.
Paediatric population
Sodium chloride 9 mg/ml solution is not recommended for use in children and
adolescents up to 18 years due to the lack of sufficient data on safety and efficacy.

Method of administration
Intravenous or intraarterial use.
50 ml syringe: to administer the solution manually or by power injector;
125 ml syringe: to administer the solution by power injector.
Administration by power injector
If this medicinal product is intended to be used with a power injector, its suitability
for the intended use has to be demonstrated by the manufacturer of the medical
device.
Any additional instructions from the respective equipment manufacturer must also be
strictly adhered to.

4.3

Contraindications
None known.

4.4

Special warnings and precautions for use
Air Embolism
Remove all air from the syringe and associated tubing prior to injection to avoid air
embolus with the associated risk of stroke, organ ischemia and/or infarction or death.

Fluid Overload
Sodium chloride 9 mg/ml solution should be used with great care, if at all, in patients
with congestive heart failure, severe renal insufficiency, and in clinical states with
oedema, sodium retention, hypernatraemia or -chloraemia.
Each patient’s age, body weight, fluid status, concomitant medical conditions and
planned radiological procedure should be taken into account to determine if use of
Sodium chloride 9 mg/ml solution is appropriate for him/her.
Extravasation
Mechanical compression of neurovascular structures may result from extravasation of
the normal saline. Intravascular catheter patency must be established prior to the
administration of Sodium chloride 9 mg/ml solution.
Paediatric population
Safety and efficacy of Sodium chloride 9 mg/ml solution in children and adolescents
up to 18 years have not been established.
Elderly population
In general, dose selection for an elderly patient should be cautious, usually starting at
the low end of the dosing range, reflecting the greater frequency of decreased hepatic,
renal, or cardiac function and of concomitant disease or other drug.
Special warnings
This medicinal product contains 0.154 mmol (or 3.54 mg) of sodium per ml.
For doses of up to 6.5 ml
This medicinal product contains less than 1 mmol sodium (23 mg), i.e. it is essentially
‘sodium-free’.
For doses of more than 6.5 ml
To be taken into consideration for patients on a controlled sodium diet.

4.5

Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed.

4.6

Fertility, Pregnancy and lactation
Pregnancy

There are no data from the use of Sodium chloride 9 mg/ml solution in pregnant
women. As a precautionary measure, it is preferable to avoid the use of
Sodium chloride 9 mg/ml solution during pregnancy. Furthermore, procedures with
ionizing radiation carried out in pregnant women also involve a radiation dose to the
foetus. Only essential investigations should therefore be carried out during pregnancy,
when the likely benefit far exceeds the risk incurred by the mother and foetus.
Breast-feeding
Sodium chloride is excreted in human milk, but at therapeutic doses no effects on the
breastfed newborns/infants are anticipated.
Fertility
No data are available. No effects are anticipated.

4.7

Effects on ability to drive and use machines
Sodium chloride 9 mg/ml solution has no or negligible influence on the ability to
drive and use machines.

4.8

Undesirable effects
There may be reactions due to the technique of administration, which include
infection at the site of injection, venous thrombosis or phlebitis extending from
injection site, extravasation.
Frequencies for adverse drug reactions are defined as follows:
Very common (≥1/10)
Common (≥1/100 to <1/10)
Uncommon (≥1/1000 to <1/100)
Rare (≥1/10,000 to <1/1000)
Very rare (<1/10,000)
Not known (cannot be estimated from the available data)
Vascular disorders:
Not known

Venous thrombosis; phlebitis

General disorders and administration site conditions:
Not known

Injection site infection; extravasation

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is
important. It allows continued monitoring of the benefit/risk balance of the medicinal
product. Healthcare professionals are asked to report any suspected adverse reactions
via the Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard.

4.9

Overdose
Use of Sodium chloride 9 mg/ml solution may pose a threat of overdose marked by
electrolyte disturbance and/or fluid overload, particularly in patients with
compromised renal or cardiac function. In the event this should occur, discontinue the
infusion, re-evaluate the patient and institute appropriate corrective action.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
Pharmacotherapeutic group: Solvents and diluting agents, incl. irrigating solutions
ATC code: V07AB
Sodium is the primary cation of the extracellular space and together with various
anions, regulates its size. Sodium and potassium are the major mediators of
bioelectric processes within the body. The sodium content and the fluid status of the
body are closely coupled to each other. Each deviation of the plasma sodium
concentration from the physiological one simultaneously affects the fluid status of the
body. An increase in the sodium content of the body also means reduction of the
body's free water content independent of the serum osmolality.

5.2

Pharmacokinetic properties
A 0.9 per cent sodium chloride solution has the same osmolarity as plasma.
Administration of this solution primarily leads to a replenishment of the interstitial
space which is about 2/3 of the entire extracellular space. Only 1/3 of the
administered volume remains in the intravascular space. The solution, therefore, has a
short-term haemodynamic effect.
The total sodium content of the body is ca. 80 mmol/kg of which ca. 97 % is
extracellular and ca. 3 % intracellular. The daily turnover is ca. 100 -180 mmol
(corresponding to 1.5 - 2.5 mmol/kg body weight).
The kidneys are the major regulator of the sodium and water balances in co-operation
with the hormonal control mechanisms, renin-angiotensin-aldosterone system,
antidiuretic hormone and the natriuretic hormone.

5.3

Preclinical safety data
There are no pre-clinical data of relevance to the prescriber which are additional to
those already stated in other sections of the SmPC.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Water for injections

6.2

Incompatibilities
When mixing with other medicinal products, possible incompatibilities should be
considered.

6.3

Shelf life
3 years
After use, discard the remaining solution.

6.4

Special precautions for storage
Do not freeze.
Discard the solution in case of discolouration or particulate matter.

6.5

Nature and contents of container
Sodium chloride 9 mg/ml solution is supplied in pre-filled syringes (polypropylene)
with tip cap and piston (natural rubber).
Pack sizes:
Pre-filled syringes:
1 x 50 ml and 10 x 50 ml
1 x 125 ml and 10 x 125 ml
Not all pack sizes may be marketed.

6.6

Special precautions for disposal
Pre-filled syringes:
The outside of the syringe is not sterile.
Inspect the syringe for signs of leakage. Do not use if leakage is observed.
Use of the pre-filled syringe (50 ml), manual use and use with power injector:

After screwing the push rod into the
syringe piston, it is important to turn
the push rod an additional ½ turn
so that the blue piston rotates freely
Prior to using the syringe, twist off
blue tip cap and discard. Syringe is
now ready for needle or infusion
tubing attachment.
Use of the pre-filled syringe (125 ml) with a power injector:

Load syringe into pressure jacket.
To remove blue tip cap from
syringe, push in and twist off, then
discard. The area under the cap is
sterile. Caution should now be used
when handling.
Next remove cap from luer locknut
dust cover by twisting to break
tamper evident seal. Discard cap.
Attach luer locknut to syringe by
holding dust cover and screwing to
the stop. Remove and discard dust
cover when ready to attach sterile
connector tubing.
For single use. Discard syringe and unused portion of the solution after use.
Any unused product or waste material should be disposed of in accordance with local
requirements.
Air Embolism
Remove all air from the syringe and associated tubing prior to injection to avoid air
embolus with the associated risk of stroke, organ ischemia and/or infarction and
death.

7

MARKETING AUTHORISATION HOLDER
Guerbet
BP 57400
95943 Roissy CdG Cedex
France

8

MARKETING AUTHORISATION NUMBER(S)
PL 12308/0031

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
14/10/2014

10

DATE OF REVISION OF THE TEXT
18/01/2017

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