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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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Saline Syringe-GB-06/2015

Sodium chloride  9 mg/ml solution for injection in pre-filled syringe

Special warnings
This medicinal product contains 0.154 mmol (or 9 mg) of sodium per ml.

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.

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’.

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.

Read all of this leaflet carefully before you start using this
medicine because it contains important information for you.
-

1.
2.

No interaction studies have been performed.

3.
4.
5.
6.

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.

Sodium chloride 9 mg/ml solution is indicated for use in flushing
compatible contrast agents into indwelling intravascular access devices.

sodium chloride

Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
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

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

This medicinal product is for diagnostic use only.

Sodium chloride 9 mg/ml solution for injection in
pre-filled syringe

4.5 Interaction with other medicinal products and other
forms of interaction

4.6 Fertility, pregnancy and lactation

4.1 Therapeutic indications

Package leaflet: Information for the user

For doses of more than 6.5 ml
To be taken into consideration for patients on a controlled sodium diet.

3. PHARMACEUTICAL FORM

4. CLINICAL PARTICULARS

IN1188GB-0615

1. NAME OF THE MEDICINAL PRODUCT

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.

Saline Syringe-GB-06/2015

IN1188GB-0615

SUMMARY OF PRODUCT CHARACTERISTICS

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.

1.

What Sodium chloride 9 mg/ml solution is and what it is used for
What you need to know before you use Sodium chloride 9 mg/ml
solution
How to use Sodium chloride 9 mg/ml solution
Possible side effects
How to store Sodium chloride 9 mg/ml solution
Contents of the pack and other information

What Sodium chloride 9 mg/ml solution is and
what it is used for

Sodium chloride 9 mg/ml solution is used for flushing well-suited contrast
agents through devices into vessels.

2.

What you need to know before you use
Sodium chloride 9 mg/ml solution

Warnings and precautions
Talk to your doctor before using Sodium chloride 9 mg/ml solution if you
have

heart failure;

severe kidney disease;

accumulation of fluid in the body tissues with swelling;

increased sodium or chloride level in the blood.

Children and adolescents
Sodium chloride 9 mg/ml solution is not recommended for use in children
and adolescents up to 18 years.

Other medicines and Sodium chloride 9 mg/ml solution
There are no medicines known which influence or are influenced by
Sodium chloride 9 mg/ml solution.

Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are
planning to have a baby, ask your doctor or pharmacist for advice before
taking this medicine.

Pregnancy
There are no data from the use of sodium chloride in pregnant women.
Your doctor will only administer Sodium chloride 9 mg/ml solution during
pregnancy if it is absolutely necessary. However, it is preferable to avoid
any X-ray investigations during pregnancy because they may have a risk for
the unborn baby.

Breast-feeding
Sodium chloride is excreted in human milk, but at therapeutic doses no
effects on the breastfed newborns/infants are anticipated.

Driving and using machines
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.

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

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.

4.3 Contraindications
None known.

5. PHARMACOLOGICAL PROPERTIES

4.4 Special warnings and precautions for use

5.1 Pharmacodynamic properties

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.

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.

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.

1

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-angiotensinaldosterone system, antidiuretic hormone and the natriuretic hormone.

2

Sodium chloride 9 mg/ml solution contains sodium
This medicinal product contains 0.154 mmol (or 9 mg) of sodium per ml.
For doses of up to 6.5 ml
This medicinal product contains more less than 1 mmol (23 mg) of
sodium, i.e. it is essentially ‘sodium-free’ per dose.
For doses of more than 6.5 ml
To be taken into consideration for patients on a controlled sodium diet.

3.

How to use Sodium chloride 9 mg/ml solution

Sodium chloride 9 mg/ml solution investigations will only be performed by
a doctor, who will also decide the dose.
Sodium chloride 9 mg/ml solution is injected into a blood vessel.
The dose depends on the specific procedure you are having and other
factors such as your health and age.
The lowest dose possible will be used.

If you use more Sodium chloride 9 mg/ml solution than you
should
Inform your doctor immediately if you notice overdose symptoms such as
tissue swelling caused by excess fluid after receiving Sodium chloride
9 mg/ml solution.
If you have any further questions on the use of this medicine, ask your
doctor or pharmacist.

4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not
everybody gets them.

1

Side effects can occur with the following frequency:
not known: frequency cannot be estimated from the available data

injection site reactions

blood clot in a blood vessel

vein inflammation

5.3 Preclinical safety data

10. DATE OF REVISION OF THE TEXT

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

10/2015

Reporting of side effects

6. PHARMACEUTICAL PARTICULARS

If you get any side effects, talk to your doctor or pharmacist. This includes any
possible side effects not listed in this leaflet. You can also report side effects
directly via the Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard.
By reporting side effects, you can help provide more information on the safety
of this medicine.

6.1 List of excipients
Water for injections

6.2 Incompatibilities

5.

How to store Sodium chloride 9 mg/ml solution

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label
after “EXP”. The expiry date refers to the last day of that month.
Do not freeze.
Discard any unused solution.

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

6.4 Special precautions for storage

Do not use this medicine if you notice discolouration or particulate matter.

6.

Contents of the pack and other information



The active substance is sodium chloride.
1 ml contains 9 mg sodium chloride, equivalent to 0.154 mmol Na+
and 0.154 mmol Cl .
Each syringe of 50 ml of the solution contains 7.7 mmol (equivalent
to 177 mg) of sodium.
Each syringe of 125 ml of the solution contains 19.3 mmol
(equivalent to 443 mg) of sodium.
The other ingredient is water for injections.



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

Do not freeze.
Discard the solution in case of discolouration or particulate matter.

6.5 Nature and contents of container
(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
contents of the pack
(polypropylene) with tip cap and piston (natural rubber).
Pre-filled syringes: 50 ml (box of 1 and 10)
Pre-filled syringes: 125 ml (box of 1 and10)
Not all pack sizes and box sizes may be marketed in all countries.

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:

Marketing Authorisation Holder and Manufacturer

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

Marketing Authorisation Holder
Mallinckrodt UK Commercial Ltd., Building 1000, Lakeside, Portsmouth,
PO6 3EZ, UK
Manufacturer
Mallinckrodt Medical Imaging Ireland, Damastown, Mulhuddart, Dublin
15, Ireland

Prior to using the syringe, twist
off blue tip cap and discard.
Syringe is now ready for needle
or infusion tubing attachment.

This medicinal product is authorised in the Member States of the EEA
under the following names:
Denmark

Natriumchlorid Mallinckrodt 9 mg/ml
injektionsvæske, opløsning i fyldt injektionssprøjte

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.

injektioneste, liuos, esitäytetty ruisku
France

Chlorure de sodium Mallinckrodt 9 mg/mL
solution injectable en seringue préremplie

Germany

Natriumchlorid Mallinckrodt 9 mg/ml
Injektionslösung in Fertigspritze

Italy

Sodio cloruro Mallinckrodt 9 mg/ml soluzione
iniettabile in siringa preriempita

Spain

Cloruro de sodio Mallinckrodt 9 mg/ml solución
inyectable en jeringa precargada

Sweden

Natriumklorid Mallinckrodt 9 mg/ml
injektionsvätska, lösning i förfylld spruta

United Kingdom

Sodium chloride 9 mg/ml solution for injection in
pre-filled syringe

This leaflet was last revised in 10/2015.

The following information is intended for medical and healthcare
professionals only:
the product package, with the objective to provide healthcare professionals
with other additional scientific and practical information about the
administration and use of this medicinal product. Please refer to the SmPC.

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
Mallinckrodt UK Commercial Ltd.,
Building 1000, Lakeside, Portsmouth, PO6 3EZ,
UK

PL41744/0022

9. DATE OF FIRST AUTHORISATION/
RENEWAL OF THE AUTHORISATION
14/10/2014
2

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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