Over-the-counter medication

SOLUTION FOR APPLICATION BISEPTINESPRAID SKIN 50ML

Name: Biseptinespraid solution pour application cutané 50ml
Brand: Bayer Santé Familiale
SKU: 10229
Price: 5.89 EUR
Availability: InStock

Brand : Bayer Santé Familiale

€5.35 EXCL. VAT €5.89 INCL. VAT

In stock

Reference : 3400936645455

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Biseptinespraid 50 ml solution for cutaneous application sale in the drugstore bio. Antisepsis small superficial wounds.

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BISEPTINESPRAID SOLUTION FOR SKIN APPLICATION 50ML

Wound disinfection.

A wound exposes cells which are usually protected by the screen that represents the most superficial part of the skin, the epidermis. These cells should remain alive as much as possible and the technique or product used should kill foreign microorganisms or prevent them from growing without damaging human cells.

Description of Biseptinespraid solution for skin application 50 ml

Biseptinespraid solution for skin application 50 ml is a local solution for skin application indicated for disinfecting small superficial wounds : scratches, scrapes, small cuts, stings,…

Using advice from Biseptinespraid solution for skin application 50 ml

Biseptinespraid solution for skin application 50 ml is applied pure and must not be rinsed off.
Usual dosage :
1 or 2 applications per day.

Composition of Biseptinespraid solution for skin application 50 ml

p 100 ml
Chlorhexidine gluconate 250 mg
Benzalkonium chloride 25 mg
Benzyl alcohol 4 ml

Precautions for use

This medication should not be used in the following cases :

allergy to quaternary ammoniums;
in application on the mucous membranes, in particular the genitals;
in the eyes or in the ear canal (risk of toxicity if the eardrum is perforated);
for disinfecting medical and surgical equipment (see Caution).

In the absence of data on skin absorption, the risk of systemic effects cannot be excluded. They are all the more to be feared that the antiseptic is used over a large area, under occlusive dressing, on injured skin, in particular burned, a mucous membrane, premature or infant skin (due to the surface / weight ratio and of the occlusion effect of the layers at the level of the seat).

As soon as an antiseptic preparation is opened, microbial contamination is possible.

Undesirable effects :

Possibility of allergic contact eczema.
A few rare cases of idiosyncrasy (in particular anaphylactic shock) have been observed with chlorhexidine.

Presentation of Biseptinespraid solution for skin application 50 ml

50 ml spray bottle.

Notice

Pharmacovigilance Report an adverse drug reaction(s)

Download PDF leaflet

NOTICE

ANSM - Updated on: 01/07/2015

Name of the medicinal product

BISEPTINESPRAID, solution for skin application

Chlorhexidine Gluconate, Benzalkonium Chloride, Benzyl Alcohol

framed

Please read this leaflet carefully before you start using this medicine because it contains important information for you.

· This medication can be used in self-medication, ie used without consultation or prescription from a doctor.

· If symptoms persist beyond 5 days, if they become worse or if new symptoms appear, seek the advice of your pharmacist or doctor.

· This leaflet is designed to help you use this medicine. Keep there, you might need to reread it.

Do not use this medication for children.

Review summary

In this notice :

1. WHAT IS BISEPTINESPRAID, a dermal application solution AND IN WHAT CASES IS IT USED?

2. BEFORE YOU USE BISEPTINESPRAID, solution for skin application?

3. HOW TO USE BISEPTINESPRAID, solution for skin application?

4. WHAT ARE POSSIBLE SIDE EFFECTS?

5. HOW TO STORE BISEPTINESPRAID, solution for skin application?

6. ADDITIONAL INFORMATION

1. WHAT IS BISEPTINESPRAID, a dermal application solution AND IN WHAT CASES IS IT USED?

Pharmacotherapeutic group

Not applicable.

Therapeutic indications

Antisepsis of small superficial wounds.

2. BEFORE YOU USE BISEPTINESPRAID, solution for skin application?

List of information needed before taking the medication

Not applicable.

Cons-indications

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

· if you are allergic to the active substance or to any of the other ingredients of this medication mentioned in section 6

· do not apply in the eyes, ears, on the mucous membranes in particular genital.

· do not use for disinfection of medical-surgical equipment.

IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST

Precautions for use; special warnings

Take special care with BISEPTINESPRAID, solution for skin application:

Special warnings

This medicinal product is for external use only. Do not swallow

There is a risk of the active substance passing into the general circulation when used on a large surface, under occlusive dressing, on damaged (especially burned) skin, premature skin or infant skin.

Use with caution in newborns, especially premature infants. BISEPTINESPRAID may cause skin burns.

Precautions for use

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

Interaction with other medicines

Taking or using other medicines

This medicine should not be used together with other local antiseptics (risk of incompatibility or ineffectiveness). Prior use of soap should be followed by a thorough rinse before using this medicine.

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

Interactions with food and beverages

Not applicable.

Interactions with Herbal Medicines or Alternative Therapies

Not applicable.

Use during pregnancy and lactation

Pregnancy and breast feeding

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

In general, during pregnancy and breast-feeding you should always seek advice from your doctor or pharmacist before taking any medicine.

Sport

Not applicable.

Effects on ability to drive or use machines

Not applicable.

List of excipients with known effect

Not applicable.

3. HOW TO USE BISEPTINESPRAID, solution for skin application?

Instructions for proper use

Not applicable.

Dosage, Mode and / or route (s) of administration, Frequency of administration and Duration of treatment

Do not swallow.

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

Dermal

External use

The duration of use is limited to 5 days.

Symptoms and Instructions for Overdose

If you take more BISEPTINESPRAID, a skin application solution you should:

In case of massive oral ingestion, perform a gastric lavage. Acute oral toxicity of chlorexidine is low (almost negligible digestive absorption).

Contact a poison control center.

Instructions for omission of one or more doses

Not applicable.

Risk of withdrawal syndrome

Not applicable.

4. WHAT ARE POSSIBLE SIDE EFFECTS?

Description of adverse reactions

Like all medicines, this medicine may cause side effects, although not everybody gets them.

· allergic eczema in contact with the product

· rarely, general allergic accident

· chemical burns in newborns (unknown frequency).

Declaration of side effects

If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. You can also report adverse reactions directly via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and network of Regional Centers of Pharmacovigilance. Website: www.ansm.sante.fr.

By reporting adverse reactions, you are helping to provide more information about the safety of the drug.

5. HOW TO STORE BISEPTINESPRAID, solution for skin application?

Keep out of the reach and sight of children.

Expiration date

Do not use BISEPTINESPRAID, a dermal application solution after the expiry date which is stated on the outer packaging.

Storage conditions

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

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

If necessary, warnings against visible signs of deterioration

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist what to do with unused medications. These measures will help protect the environment.

6. ADDITIONAL INFORMATION

Full list of active substances and excipients

What does BISEPTINESPRAID, solution for skin application?

The active substances are:

Chlorhexidine Gluconate ............................................... .................................................. .............. 0.250 g

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

Benzyl alcohol ................................................ .................................................. ......................... 4,000 ml

For 100 ml.

The other component is:

Purified water.

Pharmaceutical form and content

What is BISEPTINESPRAID, solution for skin application and contents of the outer packaging?

This medication is in the form of a solution for skin application.

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

Name and address of the marketing authorization holder and the holder of the manufacturing authorization responsible for the release of the lots, if different

Holder

BAYER HEALTHCARE SAS

220 AVENUE OF RESEARCH

59120 LOOS

exploiting

BAYER HEALTHCARE SAS

33 STREET OF INDUSTRY

74240 GAILLARD

Maker

KVP PHARMA + VETERINAR PRODUKTE GMBH

Projensdorfer Strasse 324

24106 KIEL

GERMANY

FAMAR NEDERLAND BV

INDUSTRIEWEG 1

5531 AD BLADEL

NETHERLANDS

CHEMINEAU LABORATORIES

93, ROAD OF CURRENCY

37210 VOUVRAY

Names of the medicinal product in the Member States of the European Economic Area

Not applicable.

Date of approval of the notice

The last date on which this leaflet was approved is {date}.

AMM under exceptional circumstances

Not applicable.

Internet Information

Detailed information on this medicine is available on the ANSM website (France).

Information for health professionals only

Not applicable.

Other

Not applicable.

Vidal file

VIDAL OF THE FAMILY

BISEPTINESPRAID

Local antiseptic

chlorhexidine, benzalkonium chloride, benzyl alcohol

. Presentations . Composition . Indications . Contraindications . Warning . Drug Interactions . Pregnancy and breastfeeding . Directions for use and dosage . Advice . Undesirable effects . Lexicon

PRESENTATIONS ^(summary)

BISEPTINESPRAID: solution for local application; 50 ml spray bottle.
-

BISEPTINESPRAID: solution for local application; 125 ml bottle with bucket.
-

Laboratory

COMPOSITION ^(summary)

	p 100 ml
Chlorhexidine gluconate	250 mg
Benzalkonium chloride	25 mg
Benzyl alcohol	4 ml

INDICATIONS ^(summary)

This medication is a local antiseptic .
It is used for the antisepsis of small superficial wounds.

CONTRAINDICATIONS ^(summary)

This medication should not be used in the following cases:

allergy to quaternary ammoniums ;
in application to the mucous membranes , in particular the genital ones;
in the eyes or in the ear canal (risk of toxicity in case of perforation of the eardrum);
for the disinfection of medical and surgical equipment (see Caution).

WARNING ^(Contents)

This antiseptic is not suitable for the disinfection of scissors, razors and other potentially contaminating objects.
Avoid prolonged use of this medication, especially in children, on extensive or deeply injured surfaces, without the advice of your doctor: risk of drug passage through the blood.

DRUG INTERACTIONS ^(summary)

Combination with other antiseptics or soaps is not recommended because their effects may cancel out.

PREGNANCY AND BREAST-FEEDING ^(summary)

The timely use of this medication during pregnancy or lactation does not seem to pose any particular problem.
This antiseptic should not be applied to the nipple without medical advice. Careful rinsing before feeding is essential.

DIRECTIONS FOR USE AND DOSAGE ^(summary)

The solution is applied pure and should not be rinsed.

Usual dosage:

1 or 2 applications per day.

TIPS ^(summary)

Simple washing with soap and water makes it possible to eliminate the majority of germs ; it should be followed by a careful rinse because the soap can inactivate some antiseptics .
All antiseptics may be contaminated with germs: once opened, the vial should not be stored unnecessarily.
This medicinal product may be freely available in certain pharmacies; nevertheless, do not hesitate to ask your pharmacist for advice.

POSSIBLE ADVERSE EFFECTS ^(summary)

Contact eczema .
Exceptionally: allergic reaction .

GLOSSARY ^(summary)

allergy
Skin reaction (itching, pimples, swelling) or general discomfort occurring after contact with a particular substance, use of a medication, or ingestion of food. The main forms of allergy are eczema, urticaria, asthma, angioedema and allergic shock (anaphylactic shock). Food allergy can also result in digestive disorders.

quaternary ammoniums
Family of antiseptics present in many medicines of local use. Generally well supported, they can however give rise to rare allergies.

antisepsis
Action to destroy bacteria, microscopic fungi or viruses present especially on the skin, mucous membranes and wounds.
The action of an antiseptic is not always immediate: a delay of a few minutes is sometimes necessary before the germs are inactivated.

antiseptic
A substance that locally destroys bacteria, reducing their numbers and preventing their proliferation. Some antiseptics are also active on microscopic fungi and viruses.

Eczema
Skin disease manifested by pimples and itching. Eczema may be due to contact with an allergic substance (contact eczema) or be linked to a genetic predisposition (atopic eczema).

seeds
A general term that refers to all microscopic organisms likely to cause infection: bacteria, viruses, parasites, fungi.

mucous
Tissue (membrane) that lines the cavities and ducts of the body communicating with the outside (digestive tract, respiratory tract, urinary tract, etc.).

allergic reaction
Reaction due to hypersensitivity of the organism to a drug. Allergic reactions can take a wide variety of aspects: urticaria, angioedema, eczema, eruption of pimples resembling measles, etc. Anaphylactic shock is a generalized allergic reaction that causes discomfort due to a sudden drop in blood pressure.