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SODIUM CHLORIDE 0.9%W/V SOLUTION FOR INTRAVESICAL USE

Active substance(s): SODIUM CHLORIDE

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14-225 Sodium Chloride leaflet V2_Layout 1 28/11/2014 11:31 Page 1

Artwork Information
Product Title:

Sodium Chloride leaflet

Date:

28-11-14

Label Number:

14-225

Fonts Used:

Bosis

Font size:

10pt

Version 2

Magenta text, keylines and shading are NOT to be printed

Product Size:

420 x 297mm

Colours Used:

CMYK

14-225 Sodium Chloride leaflet V2_Layout 1 28/11/2014 11:31 Page 2

PACKAGE LEAFLET: INFORMATION FOR THE USER

Sodium Chloride 0.9% w/v
Solution for Intravesical Use
(Sodium Chloride)
Read all of this leaflet carefully because it contains
important information for you.
This medicine is available without prescription. However,
you still need to use Sodium Chloride Solution carefully
to get the best results from it. Keep this leaflet. You may
need to read it again. Ask your doctor, nurse or
pharmacist if you need more information or advice. You
must contact a doctor if your symptoms worsen or do
not improve. If any of the side effects become serious, or
if you notice any side effect not listed in this leaflet,
please tell your doctor, nurse or pharmacist.
In this leaflet:
1. What Sodium Chloride Solution is and what it is used for
2. Before you use Sodium Chloride Solution
3. How to use Sodium Chloride Solution
4. Possible side effects
5. How to store Sodium Chloride Solution
6. Further information
1. WHAT SODIUM CHLORIDE SOLUTION IS AND WHAT
IT IS USED FOR
Your medicine is called Sodium Chloride Solution.
It belongs to a group of salt containing drugs that can
be placed into the urinary bladder.
Sodium Chloride Solution is used to reconstitute
another drug for administration into the urinary bladder
through a catheter.
2. BEFORE YOU USE SODIUM CHLORIDE SOLUTION
Before you start using Sodium Chloride Solution read
the information which is given below. If you think that
any of this information applies to you, or are not sure,
tell your doctor, nurse or pharmacist:
Do not use Sodium Chloride Solution if:
you are allergic (hypersensitive) to sodium chloride or
any of the other ingredients of Sodium Chloride Solution.
Take special care with Sodium Chloride Solution
Before treatment with Sodium Chloride Solution extra
care will be taken if your bladder or urethra are fragile,
for example in cases of advanced bladder cancer.
Using other medicines
There are no other medicines known that cause
problems when they are taken when you are also using
Sodium Chloride Solution.

Tell your doctor, nurse or pharmacist if you are taking
or have recently taken any other medicines, including
medicines obtained without a prescription.
Using Sodium Chloride Solution with food and drink
You can eat and drink as normal when using Sodium
Chloride Solution.
Pregnancy and breast-feeding
If you are or could be pregnant, tell your doctor before
treatment starts.
Ask your doctor, nurse or pharmacist for advice before
taking any medicine.
Driving and using machines
Your ability to drive a car or operate machinery will not
be affected following administration of Sodium
Chloride Solution.
3. HOW TO USE SODIUM CHLORIDE SOLUTION
Sodium Chloride Solution will be given to you by a
doctor or nurse. Each 50ml bag is for single use only
and any unused portion will be discarded.
Your doctor will have decided how much and for how
long you need to be given Sodium Chloride Solution.
If you have any further questions on the use of this
product, ask your doctor, nurse or pharmacist.
4. POSSIBLE SIDE EFFECTS
There are no known side effects caused by Sodium
Chloride Solution.
Reporting of side effects
If you get any side effects, talk to your doctor, nurse or
pharmacist.
This includes any possible side effects not listed in this
leaflet. You can also report side effects directly via the
internet at www.mhra.gov.uk/yellowcard. By reporting
side effects you can help provide more information on
the safety of this medicine.
5. HOW TO STORE SODIUM CHLORIDE SOLUTION
Keep out of the reach and sight of children.
Do not use Sodium Chloride Solution after the expiry
date which is stated on the bag. The expiry date refers
to the last day of that month.
Do not store above 25°C and do not freeze.
Store in the original container.
Do not use Sodium Chloride Solution if you notice that
the solution contains any particles or has become cloudy.
Do not use if the container has become damaged.

Summary of Product
Characteristics
PRODUCT SUMMARY
1. TRADE NAME OF THE MEDICINAL PRODUCT
Sodium Chloride 0.9% w/v Solution for Intravesical Use.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Sodium Chloride 0.9% w/v
Each 50ml bag contains 0.45 g of sodium chloride.
For a full list of excipients, see 6.1.
3. PHARMACEUTICAL FORM
Solution for intravesical use.
Clear colourless liquid.
Physico-chemical properties:
pH
: 3.5 – 5.5
Osmolarity : 15.4 mOsm/50ml
Na+ and Cl– : 7.7 mmol/50ml
4. CLINICAL PARTICULARS
4.1.THERAPEUTIC INDICATIONS
As a diluent for the administration of drugs within the bladder.
4.2.POSOLOGY AND METHOD OF ADMINISTRATION
Adults, children and the elderly:
The volume to be used, frequency and duration of the
treatment depend on the nature of the drug
administered and the clinical condition of the patient.
Route of Administration:
Urethral.
Refer to section 6.6, ‘Special precautions for disposal
and other handling’ for further information.

4.8.UNDESIRABLE EFFECTS
None known.
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.
Tel: Freephone 0808 100 3352.
Website: www.mhra.gov.uk/yellowcard.
4.9.OVERDOSE
Not applicable.
5. PHARMACOLOGICAL PROPERTIES
5.1.PHARMACODYNAMIC PROPERTIES
ATC Code
: B05C B 01
Irrigating solutions, salt solutions
There are no pharmacodynamic properties of relevance
for this product.
5.2.PHARMACOKINETIC PROPERTIES
There are no pharmacokinetic properties applicable for
this product.
5.3.PRECLINICAL SAFETY DATA
There are no preclinical data of relevance to the
prescriber, which are additional to that already included
elsewhere in the SPC.
6. PHARMACEUTICAL PARTICULARS

4.3.CONTRAINDICATIONS
Hypersensitivity to any of the excipients.

6.1.LIST OF EXCIPIENTS
Water for Injections

4.4.SPECIAL WARNINGS AND PRECAUTIONS FOR USE.
Caution should be exercised in cases of advanced
carcinoma of the bladder, as the bladder may be fragile.
An intact urethra is required.
Ensure proper mixing of any added medication.
Caution should be exercised in the attachment and
clamping of both the active medication and the urinary
catheter.

6.2.INCOMPATIBILITIES
None known.

4.5.INTERACTIONS WITH OTHER MEDICAMENTS AND
OTHER FORMS OF INTERACTION
None.
4.6.PREGNANCY AND LACTATION
No known effect.
Caution should be exercised when prescribing to
pregnant women.
4.7.EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
None known.

6.3.SHELF LIFE
24 months.
6.4.SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 25°C. Do not freeze. Store in
original container.
6.5.NATURE AND CONTENTS OF CONTAINER
A 50ml infusion bag constructed from 2 PVC tubes
welded at each end. At one end of the bag, 2 PVC tubes
are welded in place. At the other end of the bag there is
one, centrally placed suspension hole in the weld web.
A breakable male luer is located at the end of one of
the tubes and a frangible section is located at the other
end. A universal vial connector connects on to a male
luer. It has a threaded stopper end and a covered needle
which can be used to transfer fluid from a vial. A blue
connector is fitted into the administration tube of the
bladder irrigation bag.

14-225 Sodium Chloride leaflet V2_Layout 1 28/11/2014 11:31 Page 3

6.6.SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER
HANDLING
Do not use unless the solution is clear and the container
is intact.
Each 50ml bag is for single use only and any unused
portion should be discarded.
INSTRUCTIONS FOR USE
1 Take the bag with the Sodium Chloride 0.9% w/v
solution out of the packaging. Check that the bag is at
room temperature and that there are no particles in the
bag. Ensure that both clamps are closed. Remove the
flip-top cap from the drug vial.
Check that the Luer lock at this junction is secure.

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6. FURTHER INFORMATION
What Sodium Chloride Solution contains
The active substance is sodium chloride. Each bag
contains 0.45 grams of sodium chloride. The other
ingredient is water for injections.
What Sodium Chloride Solution looks like and
contents of the pack
Sodium Chloride Solution is a clear, sterile solution that
is contained in a PVC bag. The bag contains 50ml of
solution.
Marketing Authorisation Holder and Manufacturer
The marketing authorisation holder for Sodium Chloride
Solution is:
Alliance Pharmaceuticals Limited, Avonbridge House,
Bath Road, Chippenham, Wiltshire, SN15 2BB, UK.
The company responsible for manufacturing this product
is: Terumo BCT Ltd, Larne, Co. Antrim, BT40 2SH United
Kingdom.
This leaflet was last revised in November 2014.

2 Push the spike of the lilac coloured connector into the
centre of the stopper of the drug vial until all six grips
click into place around the neck of the vial. Check once
again that the Luer lock is secure.

3 Break the cone below the lilac connector and open the
clamp.

4 Invert the bag with the vial attached and gently squeeze
the bag several times. The sodium chloride solution will
flow into the vial. Gently agitate the vial to dissolve the
contents.

5 Turn the bag and vial upwards again and gently press
the air out of the bag into the drug vial. As the pressure
subsides, the dissolved drug solution will flow into the
bag. Repeat this step once or twice until the vial
contents are removed.

6 Close the clamp between the vial and the bag and
check that the clamp below the blue capped catheter
adapter is also closed.

7 Bend the end of the blue cap to break the tip of the
catheter adapter and remove the blue cap.

8 Push the connecting piece of the catheter adapter into
the catheter. Release the clamp below the catheter
adapter.

9 Instill the solution slowly into the bladder. Any
equipment or material which has come into contact with
the solution must be disposed of in accordance with
local policy.
ADMINISTRATIVE DATA
7. MARKETING AUTHORISATION HOLDER
Alliance Pharmaceuticals Limited, Avonbridge House
Bath Road, Chippenham, Wiltshire, SN15 2BB, UK.
8. MARKETING AUTHORISATION NUMBER
PL 16853/0123
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
6th January 2011
10. DATE OF REVISION OF THE TEXT
November 2014
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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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