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URO-TAINER CHLORHEXIDINE 1:5000 B.BRAUN BLADDER IRRIGATION

Active substance(s): CHLORHEXIDINE ACETATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

955/NU95532R/0714

B. Braun Melsungen AG · 34209 Melsungen, Germany

Uro-Tainer Chlorhexidine 1:5000
B. Braun Bladder Irrigation
Chlorhexidine diacetate

Read all of this leaflet carefully before you start using this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:
1. What Uro-Tainer Chlorhexidine is and what it is used for
2. Before you use Uro-Tainer Chlorhexidine
3. How to use Uro-Tainer Chlorhexidine
4. Possible side effects
5. How to store Uro-Tainer Chlorhexidine
6. Further information

1. WHAT URO-TAINER CHLORHEXIDINE IS AND WHAT IT
IS USED FOR
Chlorhexidine is an antiseptic agent.
You are given this solution when an urinary catheter has been inserted
and it is to be left in place for some time. Uro-Tainer Chlorhexidine is
then used to flush the catheter, to reduce the risk of catheter related
bladder infections or to treat them.

2. BEFORE YOU USE URO-TAINER CHLORHEXIDINE
Do not use Uro-Tainer Chlorhexidine
This product must not be used if you are hypersensitive (allergic) to chlorhexidine or any of the other ingredients of the solution.
This product is not suitable for treatment of infections with some bacteria such as Pseudomonas, Alcaligenes faecalis, Mycobacterium tuberculosis and Proteus mirabilis as these do not respond to chlorhexidine
treatment.

Take special care with Uro-Tainer Chlorhexidine
• if you have a sore bladder
• if your urinary passage is blocked (urinary tract obstruction)
Your doctor will observe you in order to analyze if you get an allergic
reaction. If such a reaction occurs your doctor will give you any necessary treatment.

Taking or using other medicines
Please tell your doctor or pharmacist if you are taking or have recently
taken any other medicines, including medicines obtained without a prescription.

Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
Uro-Tainer Chlorhexidine should be used only after carefully outweighing the risks against the benefits in pregnancy and during breast feeding.
Your doctor will determine very carefully whether you need treatment
with this product.

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4. POSSIBLE SIDE EFFECTS

Dokument = 210 x 444 mm

Like all medicines, Uro-Tainer Chlorhexidine can cause side effects, although not everybody gets them.

GB___955
GIF UT
Uro-Tainer Chlorhexidine 1:5000
B. Braun Bladder Irrigation
955/NU95532R/0714
Standort Crissier

The possible side effects are listed according to their frequency, using
the following terms:
Uncommon: affecting 1 to 10 treated patients in 1,000
Very rare: affecting less than 1 treated patient in 10,000

The following side effects may be serious. If any of the following side effects occur, stop using this medicine and consult a
docor immediately:
Very rare: Cases of systemic hypersensitivity (allergic) reactions to
chlorhexidine have been reported. Among these there are
also severe forms. The following symptoms have been observed: Itching, skin eruptions (reddening, hives, wheals on
the face), flushing, sweating, breathing distress, bluish skin,
drop of blood pressure, shock, convulsions.

Other side effects:
Uncommon: Mild transient pain or irritation or passing slow and painful
urine or feeling of burning while passing urine.
If the product is not tolerated, treatment should be stopped immediately.
If any of the side effects gets serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This
includes any possible side effects not listed in the package leaflet. You
can also report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the
safety of this medicine.

Do not store above 25°C.
Store in the original package in order to protect from light and moisture.
Do not use if the solution is not clear or if the container and its closure
show visible signs of damage.
Containers are for single use only. Any unused product or waste material
should be disposed of in accordance with local requirements.

The regime to be used varies from patient to patient. Up to one or two
flushing procedures (irrigations) per day may be required. For control of
infections you may also need treatment with antibiotics. The duration of
treatment must be determined individually.

Method of administration
The solution is instilled into the bladder by a catheter that stays permanently in your bladder (indwelling catheter).
The container should be placed sufficiently high above you to enable
flow of the solution through the catheter. If necessary, press the bag
slightly. The solution should remain in the bladder for 10 – 15 minutes.
If desired, warm solution to body temperature by shortly immersing container in an appropriately warmed water bath.
After the end of the rinsing time (which is to be determined individually),
open the tubing and place the bag lower than your level in order to allow
the solution to flow back into the container.
For all irrigation operations the following hygienic measures must be observed:
• Before preparing all the material needed, wash and disinfect hands.
• Let urine flow out until bladder is empty.
• Before removing the urine collecting bag and the catheter, disinfect
hands.
• The area where operations are carried out must be made and kept sterile.
• Rinse catheter opening with disinfectant.
• Do not touch sterile parts of connectors and tubing.
Treatment is only to be carried out on doctor’s prescription and strictly
observing germfree conditions (asepsis).

G 110614

Do not use Uro-Tainer Chlorhexidine after the expiry date which is stated
on the bag and the outer carton. The expiry date refers to the last day
of that month.

This medicine has no influence on the ability to drive and use machines

Dosage

Font size: 9 pt.

Keep out of the reach and sight of children.

The product must be used immediately after opening.

This product is usually administered by a health-care professional. If you
have to administer it yourself you should have been shown by your nurse
or doctor how to use it.

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5. HOW TO STORE URO-TAINER CHLORHEXIDINE

Driving and using machines

3. HOW TO USE URO-TAINER CHLORHEXIDINE

Lätus

6. FURTHER INFORMATION
What Uro-Tainer Chlorhexidine contains
• The active substance is chlorhexidine.
100 ml of the solution contain 0.2 g Chlorhexidine diacetate
• The other ingredients are
Sorbitol, sodium acetate trihydrate and acetic acid (glacial), water for
injections.

What Uro-Tainer Chlorhexidine looks like and contents of the
pack
Uro-Tainer Chlorhexidine is a solution for irrigation (for example, for
flushing catheters).
It is a clear colourless solution of chlorhexidine in water.
It comes in plastic bags of 100 ml size and is available in packs of
10 x 100 ml

Marketing Authorisation Holder and
B. Braun Melsungen AG,
Carl-Braun-Straße 1,
34212 Melsungen, Germany
Postal address:
34209 Melsungen, Germany
Phone: +49-5661-71-0
Fax: +49-5661-71-45 67

Manufacturer
B. Braun Medical AG,
Route de Sorge 9,
1023 Crissier, Switzerland

This leaflet was last revised in June 2014.

No adverse effects are expected to occur when this medicine is used
more frequently than prescribed.

The following information is only intended for health-care
professionels or in case of home treatment:

If you stop using Uro-Tainer Chlorhexidine

Special warnings and precautions for use

If you stop using Uro-Tainer Chlorhexidine earlier than prescribed you
may be at a higher risk of bladder infections.
If you have any further questions on the use of this product, ask your
doctor or pharmacist.

In the presence of organic materials (e.g. blood) the antimicrobial activity
of chlorhexidine may be reduced. This is due to the binding of chlorhexidine to proteins.

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If you use more Uro-Tainer Chlorhexidine than you should

955/NU95532R/0714

Further handling instructions
1. Tear open plastic bag and take out
Uro-Tainer Chlorhexidine

6. Release clamp, let solution flow into
the urinary bladder. Since some patients
may have a bladder capacity less than
100 ml, only squeeze the Uro-Tainer
Chlorhexidine very gently to instil the
solution.

2. Ensure Uro-Tainer Chlorhexidine tube
is closed by plastic clamp.

7. Close tube with clamp of the Uro-Tainer
Chlorhexidine.

3. Tear away closure ring.

8. After the required period, release clamp
and hold bag downwards to drain the
solution. The Uro-Tainer Chlorhexidine
sachet expands to 150 ml to accommodate
urine which may have been retained in
the bladder.

4. Twist and withdraw cap without touching
sterilized connector

9. C
 lamp tube and remove the connector
from the catheter by turning gently.
Connect the catheter to a sterile
drainage bag.
Do not re-use, for single use only.
Discard after treatment.

138

5. Insert connector into the catheter
of the patient.

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NU95532R_Uro-Tainer_Chlorhexidine_210x444_GB_955.indd 2

B. Braun Melsungen AG
34209 Melsungen, Germany

11.07.14 09:06

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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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