Medine.co.uk

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

955/NU95532R/0714

PACKAGE LEAFLET: INFORMATION FOR THE USER

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.


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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.

Driving and using machines

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

3.    HOW TO USE URO-TAINER CHLORHEXIDINE_

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.

Dosage

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).

If you use more Uro-Tainer Chlorhexidine than you should

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

If you stop using Uro-Tainer Chlorhexidine

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.

4.    POSSIBLE SIDE EFFECTS_

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

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.

5.    HOW TO STORE URO-TAINER CHLORHEXIDINE ~

Keep out of the reach and sight of children.

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.

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.

The product must be used immediately after opening.

Containers are for single use only. Any unused product or waste material should be disposed of in accordance with local requirements.

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-StraBe 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.

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

Special warnings and precautions for use

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.

Dokument = 210 x 444 mm

GB___955

GIF UT

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


Latus


138


Font size: 9 pt.


G 110614


BBRAUN

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.

Further handling instructions

1. Tear open plastic bag and take out Uro-Tainer Ch lorhexid ine





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.


5. Insert connector into the catheter of the patient.


4. Twist and withdraw cap without touching sterilized connector

9. Clamp 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.




BBRAUN



B. Braun Melsungen AG

34209 Melsungen, Germany


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