SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

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

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

100 ml of solution for irrigation contain Chlorhexidine diacetate 0.02 g

Excipients:

For a full list of excipients, see section 6.1

3    PHARMACEUTICAL FORM

Solution for irrigation

Clear colourless aqueous solution

pH    5.0 - 5.8

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

Uro-Tainer Chlorhexidin is suitable for supportive irrigation therapy to treat or prevent bladder infections with chlorhexidine-sensitive germs in patients with an indwelling urinary catheter .

4.2    Posology and method of administration

Posology

Adults

One or two irrigations per day simultaneously with oral or parenteral antimicrobial treatment.

Paediatric patients

No data are available for the use of Uro-tainer Chlorhexidine in children.

Method of administration

Intravesical use

(For particulars of the technique of administration please refer to product-specific literature)

The solution is instilled into the bladder via an indwelling catheter.

The container should be placed sufficiently high above the patient to enable flow of the solution through the catheter. If necessary, press 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 tempered water bath.

After the end of the irrigation time (which is to be determined individually), open the tubing and place the bag deeper than the patient’s level in order to allow the solution to flow back into the container.

For all irrigation operations the following hygienic measures must be adhered to:

•    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.

•    Make and keep the area sterile where operations are carried out.

•    Rinse catheter orifice 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 asepsis.

The duration of treatment must be determined individually.

4.3 Contraindications

•    Known hypersensitivity to Chlorhexidine or to any of the excipients

•    Infections with Pseudomonas, Alcaligenes faecalis, Staphylococcus albus, Mycobacterium tuberculosis and Proteus mirabilis that do not respond to chlorhexidine treatment.

4.4 Special warnings and precautions for use

The Uro-Tainer Chlorhexidine 1:5000 solution must not be administered intravenously. In cases of symptomatic infections of the urinary tract, treatment with antibiotics is necessary.

Patients must be observed for the occurrence of systemic hypersensitivity reactions, see also section 4.8. If such a reaction occurs, treatment must be stopped immediately, the allergenic agent must be removed, and appropriate emergency measures must be initiated.

4.5 Interaction with other medicinal products and other forms of interaction

4.6 Fertility, pregnancy and lactation

Pregnancy

There are no data on the use of chlorhexidine gluconate solutions during pregnancy. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3). Therefore the medicinal product should be used in pregnancy only after careful benefit-risk assessment.

Lactation

There is insufficient information on the excretion of chlorhexidine in human milk.

Available toxicological data in animals did not show evidence of impaired parturition or toxic effects to suckling pups (for details see 5.3).Therefore the medicinal product should be used during lactation only after careful benefit-risk assessment.

Fertility

Animal studies did not reveal any evidence of impaired fertility.

4.7 Effects on ability to drive and use machines

Not applicable

4.8 Undesirable effects

Immune system disorders:

Isolated cases of systemic hypersensitivity reactions to chlorohexidine up to severity grade III have been reported. The following symptoms have been observed: Itching, skin eruptions (erythema, urticarial, facial wheals), flushing, sweating, dyspnoea, cyanosis, hypotension, shock, convulsions.

Administration site conditions:

Mild transient pain or irritation and sensations of strangury or burning on micturition.

In case of intolerance interrupt treatment. 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.

4.9 Overdose

Toxic reactions as symptoms of overdose are not to be expected with respect to the concentration of the active substance in the solution.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: irrigating solutions, antiinfectives ATC code: B05C A02

Mechanism of action

Chlorhexidine diacetate is an antiseptic agent belonging to the group of biguanidine derivatives. The active moiety is chlorhexidine.

Thus it has a fungistatic and fungicidal effect on several yeasts.

The antimicrobial activity of chlorhexidine results from its reaction with the cytoplasmatic membrane of the bacteria. By means of its lipohilic group chlorhexidine causes damage to the bacterial lipoprotein membrane.

Microbial susceptibility, resistance

Chlorhexidine is very active against a wide range of gram-positive and gram-negative bacteria.

The following germs have been shown to be sensitive:

-    Escherischia coli

-    Klebsiella spp.

-    Serratia marcescens

-    Proteus vulgaris

-    Pseudomonas aeruginosa

-    Enterobacter aerogenes

-    Staphylococcus aureus

-    Streptococcus epidermidis

-    Streptococcus pyogenes

-    Corynebacterium diphtheriae

-    Candida albicans

-    Serratia marcescens

-    Enterococcus faeclis

-    Bacillus subtilis

Some strains of the following germs are resistant against chlorhexidine: Pseudomonas - Alcaligenes faecalis

Proteus mirabilis Mycobacterium tuberculosis.

Therapeutic effect

Owing to its broad spectrum of antibacterial activity chlorhexidine is suitable for the prevention and supportive treatment of bladder infections. Prophylactic treatment is always advisable because the danger of urinary tract infections leading to ascendent pyelonephritis is great in patients with indwelling urinary catheter, despite most careful catheterisation, observing all precautions of asepsis, and the use of sterile closed collecting systems.

5.2    Pharmacokinetic properties

Absorption

During irrigation with Uro-Tainer Chlorhexidine the solution is transferred into the bladder. Absorption of chlorhexidine through mucosal membranes and tissues is low. In one small study involving 23 patients undergoing blaader irrigation, 13 (57%) had detectable blood levels of chlorhexidine ranging from 5.5 to 37.5pg/l.

Metabolism

If small amounts of chlorhexidine have been absorbed through mucosal membranes and tissues they undergo very limited metabolism in the liver and the metabolic cleavage of the molecule does not occur to a significant extent. The toxic degradation product para-chloroaniline is not detectable.

5.3    Preclinical safety    data

Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential and toxicity to reproduction and development.

6    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Sorbitol,

Sodium acetate trihydrate,

Acetic acid, glacial Water for injections.

6.2    Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products

6.3    Shelf life

Unopened 24 months

After first opening

The product must be used immediately after opening

After reconstitution, dilution or admixture of additives Not applicable

6.4    Special precautions for storage

Do not store above 25 °C.

Store in the original package in order to protect from light.

6.5    Nature and contents of container

• PVC plastic bags that have a flexible tube with a clamp, contents 100 ml available in packs of 10 x 100 ml,

Not all pack sizes may be marketed.

6.6    Special precautions for disposal

Any unused product or waste material should be disposed of in accordance with local requirements. Do not use if the solution is not clear or the container and its closure show visible signs of damage.

Containers are for single use only. Discard any unused content after use.

The bag should not be removed from its overwrapping until required for use. If the capacity of the bladder is less than the bag contents, the solution should be instilled gently. For details on the conditions of administration, see section 4.2.

7. MARKETING AUTHORISATION HOLDER

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

MARKETING AUTHORISATION NUMBER(S)

PL 03551/0037

DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

01/10/1996 / 14/09/2005

DATE OF REVISION OF THE TEXT

07/10/2014