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SODIUM CHLORIDE 0.9% SOLUTION FOR INJECTION

Active substance(s): SODIUM CHLORIDE

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Package leaflet: Information for the user

Do not use Sodium Chloride 0.9%:
• If you are allergic to sodium chloride or any of the other ingredients
of this medicine (listed in section 6).

Sodium Chloride 0.9%
Solution for injection
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 further questions, please ask your doctor, pharmacist or
nurse.
• If you get any side effects, talk to your doctor, or pharmacist or
nurse. This includes any possible side effects not listed in this leaflet.
See section 4.
The name of your medicine is “Sodium Chloride 0.9% Solution for
injection” but it will be referred to as Sodium Chloride 0.9%
throughout this leaflet.
What is in this leaflet
1. What Sodium Chloride 0.9% is and what it is used for
2. What you need to know before you use Sodium Chloride 0.9%
3. How to use Sodium Chloride 0.9%

Other medicines and Sodium Chloride 0.9%
Please tell your doctor or pharmacist if you are taking or have recently
taken any other medicines, even those not prescribed.
The solution of Sodium Chloride 0.9% shows no incompatibilities with
other medicinal products.
Sodium Chloride 0.9% with food and drink
Sodium Chloride 0.9% is not known to have any interactions when given
at the same time as food and drink.
Pregnancy and breast-feeding
Please ask your doctor or your pharmacist before being administered
this medicine.
If a correct and controlled dose of Sodium Chloride 0.9% is administered,
no effects on pregnant women and during lactation are expected.
Driving and using machines
There is no evidence that Sodium Chloride 0.9% solution may affect the
ability to drive or to use machines.

3. HOW TO USE SODIUM CHLORIDE 0.9%

4. Possible side effects
5. How to store Sodium Chloride 0.9%
6. Contents of the pack and other information

1. WHAT SODIUM CHLORIDE 0.9% IS AND WHAT IT
IS USED FOR
Sodium Chloride 0.9% is a solution for injection and is used as a solvent
and carrier for drugs. It can be given by the intravenous, intramuscular
or subcutaneous route.
This product belongs to the “Electrolyte Solutions” group and is
distributed under medical prescription.

2. WHAT YOU NEED TO KNOW BEFORE YOU USE
SODIUM CHLORIDE 0.9%

Sodium Chloride 0.9% will be given to you by an appropriately trained
professional.
Sodium Chloride 0.9% will be administered by intravenous,
intramuscular or subcutaneous route.
It does not contain any type of preservative or germicide, hence,
opened ampoules should be immediately discarded once used.
The amount used will vary depending on the concentration at which the
drug to be dissolved is to be administered.
Your doctor will inform you of the duration of your treatment.
If you have received more Sodium Chloride 0.9% than you should:
Given the product’s nature, if its indication and administration are
correct and controlled, there is no risk of overdose.
If you have been given more Sodium Chloride 0.9% than you should
have had, inform your doctor immediately.
V002/VS (BP8)

4.5

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

SUMMARY OF PRODUCT
CHARACTERISTICS

4.6 Fertility, pregnancy and lactation
None stated

1. NAME OF THE MEDICINAL PRODUCT
Sodium Chloride 0.9% Solution for injection

2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Sodium chloride 0.9%w/v
Electrolytes:
Na+ 154 mmol/l
Cl- 154 mmol/l
For a full list of excipients, see section 6.1

4.7 Effects on ability to drive and use machines
No studies on the ability to drive and use machines have been performed.
4.8 Undesirable effects
None stated.

3. PHARMACEUTICAL FORM

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 at: www.mhra.gov.uk/yellowcard.

Solution for Injection
A clear colourless solution

4.9 Overdose
No particulars stated.

4. CLINICAL PARTICULARS

5. PHARMACOLOGICAL PROPERTIES

4.1 Therapeutic indications
Sodium Chloride 0.9% Solution for injection is used as a solvent and
carrier solution for injectable drugs.

5.1 Pharmacodynamic properties
ATC code: B05XA03
Sodium chloride 0.9% solution shows the same osmotic pressure as
body fluids.
The isotonic solution of sodium chloride is a suitable vehicle for
administration of a large number of drugs and electrolytes.

4.2 Posology and method of administration
Posology
As required
Method of administration
Intravenous, intramuscular or subcutaneous use
4.3 Contraindications
None stated.
4.4 Special warnings and precautions for use
If Sodium Chloride 0.9% Solution for injection is to be administered
subcutaneously be aware that any additions to the isotonic normal
saline solution could render it hypertonic and thus cause pain at the
injection site.
B306142/01

V002/VS (BP8)

5.2 Pharmacokinetic properties
Sodium and chloride electrolytes distribute, primarily, in the extracellular
fluid. Because the physiological saline solution is isotonic, its
administration will not produce a change in the osmotic pressure of the
extracellular fluid, whereby water will not pass into the intracellular
compartment and both ions will practically enter the cell.
5.3 Preclinical safety data
Safety of sodium chloride isotonic solutions is adequately recognised in
the fluid therapy field worldwide, thanks to a wide experience available
in the use of this solution as a restorer of the hydro-electrolytic balance.

4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not
everyone gets them.
Reporting of side effects
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 Yellow Card System
at: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the
safety of this medicine.

Carton with 20 ampoules of 5 ml.
Carton with 20 ampoules of 10 ml.
Carton with 20 ampoules of 20 ml.
Marketing Authorisation Holder
Fresenius Kabi Limited
Cestrian Court
Eastgate Way
Manor Park
Runcorn
Cheshire
WA7 1NT.
UK.

5. HOW TO STORE SODIUM CHLORIDE 0.9%
Keep this medicine out of the sight and reach of children.
Do not store above 25°C.
For single use only.
To be used immediately after the ampoule is opened.
Do not use after expiry date which is stated on the carton after EXP.
The expiry date refers to the last day of that month. Any unused
solution should be discarded.
Use only clear, particle-free solutions and undamaged containers.
Do not throw away any medicines via wastewater. Ask your pharmacist
how to throw away medicines you no longer use. These measures will
help protect the environment.

Manufacturer
FRESENIUS KABI ESPAÑA, S.A
C/ Marina, 16-18, planta 17
08005-Barcelona (ESPAÑA)
This leaflet was last revised in 08/2015

6. CONTENTS OF THE PACK AND OTHER
INFORMATION
What Sodium Chloride 0.9% contains
Each 1 ml contains 9 mg of sodium chloride.
The other ingredients are water for injection and traces of sodium
hydroxide and hydrochloric acid.
What Sodium Chloride 0.9% looks like and contents of the pack.
Sodium Chloride 0.9% is a clear colourless, particle-free solution. It is
available in the following formats:

6. PHARMACEUTICAL PARTICULARS

1

2

3

4

6.1 List of excipients
Water for Injection.
Sodium hydroxide.
Hydrochloric acid.
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
a) Shelf life of the product as packaged for sale:
Shelf life of the pharmaceutical product: 2 years
b) Shelf life after first opening of the container:
The product should be used immediately after opening.
6.4 Special precautions for storage
Do not store above 25°C
6.5 Nature and contents of container
Low density polyethylene ampoules (LDPE).
- Carton with 20 ampoules of 5 ml
- Carton with 20 ampoules of 10 ml
- Carton with 20 ampoules of 20 ml
6.6 Special precautions for disposal and other handling
It is not necessary to sterilise the bottle before its opening.
It is not necessary to use any cutting element to open the ampoule.
Once the ampoule is opened the top of it can perfectly be adjusted
to the syringe cone (cone Luer), with which it is necessary to use the
needle.
Handling instructions:
To break off a single ampoule, twist one ampoule against the remaining
ampoules of the pack without touching the head and neck of the
ampoules (1). Shake the ampoule with one single movement as shown
below in order to remove the liquid kept in the cap (2). To open the
ampoule, twist the ampoule body and ampoule head in opposite
directions until the neck breaks off (3). Connect the ampoule to the
luer-syringe or luer-lock syringe as shown in figure (4).

The solution does not contain any type of preservative or bactericide,
so open and unused ampoules should be discarded immediately.

7. MARKETING AUTHORISATION HOLDER
Fresenius Kabi Limited
Cestrian Court
Eastgate Way
Manor Park
Runcorn
Cheshire
WA7 1NT
UK

8. MARKETING AUTHORISATION NUMBER
PL 08828/0178

9. DATE OF FIRST AUTHORISATION/RENEWAL OF
AUTHORISATION
Date of first authorisation: 30/08/2007
Date of last renewal:

10. DATE OF REVISION OF THE TEXT
08/2015

Sodium Chloride (BP8)
B306142/01
Colour: Black
Size: 297 x 210 mm
Fonts size: 11/8 pt
2.09.2015
Correction: 3
Version: 01
Paper weight: 60 gr/m2

Package leaflet: Information for the user

Do not use Sodium Chloride 0.9%:
• If you are allergic to sodium chloride or any of the other ingredients
of this medicine (listed in section 6).

Sodium Chloride 0.9%
Solution for injection
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 further questions, please ask your doctor, pharmacist or
nurse.
• If you get any side effects, talk to your doctor, or pharmacist or
nurse. This includes any possible side effects not listed in this leaflet.
See section 4.
The name of your medicine is “Sodium Chloride 0.9% Solution for
injection” but it will be referred to as Sodium Chloride 0.9%
throughout this leaflet.
What is in this leaflet
1. What Sodium Chloride 0.9% is and what it is used for
2. What you need to know before you use Sodium Chloride 0.9%
3. How to use Sodium Chloride 0.9%

Other medicines and Sodium Chloride 0.9%
Please tell your doctor or pharmacist if you are taking or have recently
taken any other medicines, even those not prescribed.
The solution of Sodium Chloride 0.9% shows no incompatibilities with
other medicinal products.
Sodium Chloride 0.9% with food and drink
Sodium Chloride 0.9% is not known to have any interactions when given
at the same time as food and drink.
Pregnancy and breast-feeding
Please ask your doctor or your pharmacist before being administered
this medicine.
If a correct and controlled dose of Sodium Chloride 0.9% is administered,
no effects on pregnant women and during lactation are expected.
Driving and using machines
There is no evidence that Sodium Chloride 0.9% solution may affect the
ability to drive or to use machines.

3. HOW TO USE SODIUM CHLORIDE 0.9%

4. Possible side effects
5. How to store Sodium Chloride 0.9%
6. Contents of the pack and other information

1. WHAT SODIUM CHLORIDE 0.9% IS AND WHAT IT
IS USED FOR
Sodium Chloride 0.9% is a solution for injection and is used as a solvent
and carrier for drugs. It can be given by the intravenous, intramuscular
or subcutaneous route.
This product belongs to the “Electrolyte Solutions” group and is
distributed under medical prescription.

2. WHAT YOU NEED TO KNOW BEFORE YOU USE
SODIUM CHLORIDE 0.9%

Sodium Chloride 0.9% will be given to you by an appropriately trained
professional.
Sodium Chloride 0.9% will be administered by intravenous,
intramuscular or subcutaneous route.
It does not contain any type of preservative or germicide, hence,
opened ampoules should be immediately discarded once used.
The amount used will vary depending on the concentration at which the
drug to be dissolved is to be administered.
Your doctor will inform you of the duration of your treatment.
If you have received more Sodium Chloride 0.9% than you should:
Given the product’s nature, if its indication and administration are
correct and controlled, there is no risk of overdose.
If you have been given more Sodium Chloride 0.9% than you should
have had, inform your doctor immediately.
V002/VS (BP9)

4.5

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

SUMMARY OF PRODUCT
CHARACTERISTICS

4.6 Fertility, pregnancy and lactation
None stated

1. NAME OF THE MEDICINAL PRODUCT
Sodium Chloride 0.9% Solution for injection

2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Sodium chloride 0.9%w/v
Electrolytes:
Na+ 154 mmol/l
Cl- 154 mmol/l
For a full list of excipients, see section 6.1

4.7 Effects on ability to drive and use machines
No studies on the ability to drive and use machines have been performed.
4.8 Undesirable effects
None stated.

3. PHARMACEUTICAL FORM

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 at: www.mhra.gov.uk/yellowcard.

Solution for Injection
A clear colourless solution

4.9 Overdose
No particulars stated.

4. CLINICAL PARTICULARS

5. PHARMACOLOGICAL PROPERTIES

4.1 Therapeutic indications
Sodium Chloride 0.9% Solution for injection is used as a solvent and
carrier solution for injectable drugs.

5.1 Pharmacodynamic properties
ATC code: B05XA03
Sodium chloride 0.9% solution shows the same osmotic pressure as
body fluids.
The isotonic solution of sodium chloride is a suitable vehicle for
administration of a large number of drugs and electrolytes.

4.2 Posology and method of administration
Posology
As required
Method of administration
Intravenous, intramuscular or subcutaneous use
4.3 Contraindications
None stated.
4.4 Special warnings and precautions for use
If Sodium Chloride 0.9% Solution for injection is to be administered
subcutaneously be aware that any additions to the isotonic normal
saline solution could render it hypertonic and thus cause pain at the
injection site.
B306267/01

V002/VS (BP9)

5.2 Pharmacokinetic properties
Sodium and chloride electrolytes distribute, primarily, in the extracellular
fluid. Because the physiological saline solution is isotonic, its
administration will not produce a change in the osmotic pressure of the
extracellular fluid, whereby water will not pass into the intracellular
compartment and both ions will practically enter the cell.
5.3 Preclinical safety data
Safety of sodium chloride isotonic solutions is adequately recognised in
the fluid therapy field worldwide, thanks to a wide experience available
in the use of this solution as a restorer of the hydro-electrolytic balance.

4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not
everyone gets them.
Reporting of side effects
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 Yellow Card System
at: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the
safety of this medicine.

Carton with 20 ampoules of 5 ml.
Carton with 20 ampoules of 10 ml.
Carton with 20 ampoules of 20 ml.
Marketing Authorisation Holder
Fresenius Kabi Limited
Cestrian Court
Eastgate Way
Manor Park
Runcorn
Cheshire
WA7 1NT.
UK.

5. HOW TO STORE SODIUM CHLORIDE 0.9%
Keep this medicine out of the sight and reach of children.
Do not store above 25°C.
For single use only.
To be used immediately after the ampoule is opened.
Do not use after expiry date which is stated on the carton after EXP.
The expiry date refers to the last day of that month. Any unused
solution should be discarded.
Use only clear, particle-free solutions and undamaged containers.
Do not throw away any medicines via wastewater. Ask your pharmacist
how to throw away medicines you no longer use. These measures will
help protect the environment.

Manufacturer
FRESENIUS KABI ESPAÑA, S.A
C/ Marina, 16-18, planta 17
08005-Barcelona (ESPAÑA)
This leaflet was last revised in 08/2015

6. CONTENTS OF THE PACK AND OTHER
INFORMATION
What Sodium Chloride 0.9% contains
Each 1 ml contains 9 mg of sodium chloride.
The other ingredients are water for injection and traces of sodium
hydroxide and hydrochloric acid.
What Sodium Chloride 0.9% looks like and contents of the pack.
Sodium Chloride 0.9% is a clear colourless, particle-free solution. It is
available in the following formats:

6. PHARMACEUTICAL PARTICULARS

1

2

3

4

6.1 List of excipients
Water for Injection.
Sodium hydroxide.
Hydrochloric acid.
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
a) Shelf life of the product as packaged for sale:
Shelf life of the pharmaceutical product: 2 years
b) Shelf life after first opening of the container:
The product should be used immediately after opening.
6.4 Special precautions for storage
Do not store above 25°C
6.5 Nature and contents of container
Low density polyethylene ampoules (LDPE).
- Carton with 20 ampoules of 5 ml
- Carton with 20 ampoules of 10 ml
- Carton with 20 ampoules of 20 ml
6.6 Special precautions for disposal and other handling
It is not necessary to sterilise the bottle before its opening.
It is not necessary to use any cutting element to open the ampoule.
Once the ampoule is opened the top of it can perfectly be adjusted
to the syringe cone (cone Luer), with which it is necessary to use the
needle.
Handling instructions:
To break off a single ampoule, twist one ampoule against the remaining
ampoules of the pack without touching the head and neck of the
ampoules (1). Shake the ampoule with one single movement as shown
below in order to remove the liquid kept in the cap (2). To open the
ampoule, twist the ampoule body and ampoule head in opposite
directions until the neck breaks off (3). Connect the ampoule to the
luer-syringe or luer-lock syringe as shown in figure (4).

The solution does not contain any type of preservative or bactericide,
so open and unused ampoules should be discarded immediately.

7. MARKETING AUTHORISATION HOLDER
Fresenius Kabi Limited
Cestrian Court
Eastgate Way
Manor Park
Runcorn
Cheshire
WA7 1NT
UK

8. MARKETING AUTHORISATION NUMBER
PL 08828/0178

9. DATE OF FIRST AUTHORISATION/RENEWAL OF
AUTHORISATION
Date of first authorisation: 30/08/2007
Date of last renewal:

10. DATE OF REVISION OF THE TEXT
08/2015

Sodium Chloride (BP9)
B306267/01
Colour: Black
Size: 297 x 210 mm
Size folding: 50 x 210 mm
Fonts size: 11/8 pt
2.09.2015
Correction: 3
Version: 01
Paper weight: 60 gr/m2

Anexo 6.00 do PT.G.087

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CÓDIGO:

DESIGNAÇÃO:

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Made by

VERSÃO:

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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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