Biseptinespraid skin application solution 50ml

In this manual :

1. WHAT IS BISEPTINESPRAID, solution for cutaneous application AND WHAT IS IT USED FOR?

2. WHAT YOU SHOULD KNOW BEFORE USING BISEPTINESPRAID, solution for cutaneous application

3. HOW DO I USE BISEPTINESPRAID, solution for cutaneous application?

4. WHAT ARE THE POSSIBLE SIDE EFFECTS?

5. HOW TO USE BISEPTINESPRAID, solution for cutaneous application?

6. ADDITIONAL INFORMATION

1. WHAT IS BISEPTINESPRAID, solution for cutaneous application AND WHAT IS IT USED FOR?

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Antisepsis of small superficial wounds.

2. WHAT YOU SHOULD KNOW BEFORE USING BISEPTINESPRAID, solution for cutaneous application

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Never use BISEPTINESPRAID, solution for cutaneous application in the following cases:

- known allergy to chlorhexidine (or a related drug) or benzalkonium chloride (of the quaternary ammonium family)

- do not apply in the eyes, ears, on mucous membranes, especially genital ones.

- not to be used for the disinfection of medical-surgical material.

In case of doubt, it is essential to ask the advice of your doctor or your pharmacist

Take care with BISEPTINESPRAID, solution for cutaneous application:

Special warnings

This medicine is for external use only. Do not swallow

There is a risk of the active ingredient passing into the general circulation if used over a large area, under an occlusive dressing, on injured skin (especially burns), or on the skin of premature babies or infants.

Precautions for use

Use properly and do not keep an opened bottle for too long as microbial contamination is possible as soon as the bottle is opened.

Taking or using other medicines

This medicine should not be used at the same time as other local antiseptics (risk of incompatibility or ineffectiveness). The prior use of soap should be followed by a thorough rinsing before using this medication.

Talk to your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

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Pregnancy and lactation

This medicine should be used with caution during pregnancy and lactation.

In general, during pregnancy and lactation, always ask your doctor or pharmacist for advice before taking any medicine.

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3. HOW TO USE BISEPTINESPRAID, solution for cutaneous application

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Do not swallow.

1 to 2 applications per day. It is not necessary to rinse after application.

Dermal route

External use

If you have taken more BISEPTINESPRAID, Skin Application Solution than you should have:

In case of massive oral ingestion, perform gastric lavage. The acute oral toxicity of chlorexidine is low (almost negligible absorption from the digestive tract).

Contact a Poison Control Centre.

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4. WHAT ARE THE POSSIBLE SIDE EFFECTS?

Like all medicines, BISEPTINESPRAID, solution for cutaneous application is likely to have undesirable effects, although not everyone is subject to them.

- allergic eczema on contact with the product,

- rarely, general allergic reaction.

If you notice any side effects not mentioned in this leaflet, or if any side effects become serious, please tell your doctor or pharmacist.

5. HOW TO STORE BISEPTINESPRAID, solution for cutaneous application

Keep out of the reach and sight of children.

Do not use BISEPTINESPRAID, solution for cutaneous application after the expiry date stated on the outer packaging.

For polyethylene bottles: Store at a temperature not exceeding 30°C.

For polyethylene spray bottles: Store at a temperature not exceeding 25°C.

Medicines should not be disposed of in the sewage system or in the household waste. Ask your pharmacist what to do with unused medicines. This will help to protect the environment.

6. ADDITIONAL INFORMATION

What does BISEPTINESPRAID, solution for cutaneous application, contain?

The active ingredients are

Chlorhexidine gluconate ............................................................................................................... 0.250 g

Benzalkonium chloride ................................................................................................................. 0.025 g

Benzyl alcohol ........................................................................................................................... 4.000 ml

Per 100 ml.

The other component is:

Purified water.

What is BISEPTINESPRAID, solution for cutaneous application and what does it contain?

This medicine is presented as a solution for cutaneous application.

Bottle of 50, 100, 125, 150, 200 or 250 ml.

Holder

BAYER FAMILY HEALTH

33, RUE DE L'INDUSTRIE

74240 GAILLARD

Operator

BAYER SANTE FAMILIALE

33, RUE DE L'INDUSTRIE

74240 GAILLARD

Manufacturer

KVP PHARMA + VETERINAR PRODUKTE GMBH

Projensdorfer Strasse 324

24106 KIEL

GERMANY

or

FAMAR NEDERLAND B.V.

INDUSTRIEWEG 1

5531 AD BLADEL

NETHERLANDS

or

LABORATOIRES CHEMINEAU

93, ROUTE DE MONNAIE

37210 VOUVRAY

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The last date on which this package insert was approved was {date}.

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Detailed information on this medicinal product is available on the website of Afssaps (France).

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Not applicable.