Hexomédine TRANSCUTANEOUS BOTTLE 45ML

HEXOMEDINE TRANSCUTANEE FLACON 45ML View larger

3400930495674

Sanofi Aventis Sanofi Aventis

Transcutaneous Hexomedine in 45ml vial is a small superficial wounds antisepsis and local treatment booster of a possible secondary infection of the skin.

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For warnings, the precautions and cons-indications, please see the instructions.

Description

Hexomedine is a small superficial wound antisepsis and local adjunctive treatment of possible secondary infection of the skin.


Composition   : Diisétionate hexamidine ... 0.15g, excipients: propylene glycol, Methylal, nonoxynol, 96.5 ° ethyl alcohol, purified water to 100 ml

Dosage   : Pure use 2 times a day badigeonnages or local baths.
In infections of the nail and the periphery of the nail, the solution may be used either wet dressings (30-45 min) or bath January-March mn

Duration of use   : 15 days after opening the bottle if the product is placed on a sterile gauze before application. 5 days if the part to be treated is immersed into the vial. do not rinse.

Capacity   : 45 ml

Warnings on drugs

Warning, the drug is not a product like any other. Read the package leaflet before ordering. Do not leave medicines out of reach of children. If symptoms persist, seek the advice of your doctor or pharmacist. Attention to incompatibilities on products in your.

Tell your pharmacist online treatments underway to identify possible incompatibilities. The checkout form contains a custom message field provided for this purpose.

Click here to find record of the drug at the site of the National Security Agency of Medicines and Health Products.

Pharmacovigilance : Report or a related adverse event (s) (s) (s) the use of a drug

VIDAL OF THE FAMILY

TRANSCUTANEOUS HEXOMEDIN

Local antiseptic

hexamidine

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

PRESENTATIONS (summary)

Transcutaneous HEXOMEDIN: solution for local application; 45 ml bottle.
Refunded at 15%. - price: 1,98 euro (s).

Laboratory Sanofi-Aventis France

COMPOSITION (summary)
p 100 ml
Hexamidine di-isétionate 0.15 g
Alcohol 42.75 ml

INDICATIONS (summary)
This medication is a local antiseptic .
It is used in the adjunctive treatment of skin and nail infections.
CONTRAINDICATIONS (summary)
This medication should not be used in the following cases:
  • on the mucous membranes ,
  • on open wounds,
  • for the antisepsis of the skin before a sting,
  • for the disinfection of medical and surgical equipment (see Caution).
WARNING (Contents)
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.
This antiseptic is not suitable for the disinfection of scissors, razors and other potentially contaminating objects. Similarly, it should not be used to disinfect the skin before a sting.
DRUG INTERACTIONS (summary)
Combination with other antiseptics 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.
DIRECTIONS FOR USE AND DOSAGE (summary)
This solution should be used pure. It is very volatile: carefully close the bottle after use.

Usual dosage:

Skin infections: 1 application, 2 times a day.
Nail Infections: apply dressings previously soaked in solution for 30 to 45 minutes or soak the finger in the vial for 1 to 3 minutes. Beyond these durations: risk of local detachment of the skin.
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 .
The application should not be followed by rinsing.
The opened bottle can be kept for 15 days but only 5 days if the solution is used for finger baths.
POSSIBLE ADVERSE EFFECTS (summary)
Itching, tingling, burning, dryness of the skin.
Allergic skin reaction .


GLOSSARY (summary)


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.


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.


treatment
Treatment that complements the action of a specific treatment, but generally does not achieve healing on its own.

Cliquez ici pour retrouver la notice de ce médicament sur le site de l'Agence Nationale de Sécurité du Médicament et des produits de santé.

Pharmacovigilance : Déclarer un ou des effet(s) indésirable(s) lié(s) à l'utilisation d'un médicament

NOTICE

ANSM - Last updated: 30/11/2015

Name of the medicinal product

HEXOMEDINE TRANSCUTANEE 1.5 FOR THOUSAND, solution for local application

Hexamidine diisodetionate

framed

Read this leaflet carefully before you start using this medicine. It contains important information for your treatment.

If you have any further questions, ask your doctor or pharmacist.

· Keep this leaflet, you may need to read it again.

· If you need more information and advice, ask your pharmacist.

· If symptoms worsen or persist, consult a physician.

· If you notice any side effects not listed in this leaflet, or if you experience any of the effects listed as serious, please tell your doctor or pharmacist.

Review summary

In this notice :

1. WHAT IS HEXOMEDINE TRANSCUTANEOUS 1.5 FOR THOUSAND, solution for local application AND WHAT IT IS USED FOR?

2. BEFORE YOU USE HEXOMEDINE TRANSCUTANEOUS 1.5 FOR THOUSAND, solution for local application?

3. HOW TO USE HEXOMEDINE TRANSCUTANEOUS 1.5 FOR THOUSAND, solution for local application?

4. WHAT ARE POSSIBLE SIDE EFFECTS?

5. HOW TO STORE HEXOMEDINE TRANSCUTANEOUS 1.5 FOR THOUSAND, solution for local application?

6. ADDITIONAL INFORMATION

1. WHAT IS HEXOMEDINE TRANSCUTANEOUS 1.5 FOR THOUSAND, solution for local application AND WHAT IT IS USED FOR?

Pharmacotherapeutic group

ANTISEPTIC

(D. Dermatology)

Antiseptic of the family of diamidines.

Therapeutic indications

Antiseptics of small superficial wounds and local treatment of a possible superinfection of the skin.

2. BEFORE YOU USE HEXOMEDINE TRANSCUTANEOUS 1.5 FOR THOUSAND, solution for local application?

List of information needed before taking the medication

Not applicable.

Cons-indications

Do not use HEXOMEDINE TRANSCUTANEE 1.5 FOR THOUSAND, solution for local application in the following cases:

· antisepsis before sampling (puncture, injection),

· disinfection of medical and surgical equipment,

· in case of allergic reaction to hexamidine or to any of the components of the solution.

· Do not use on open wounds or mucous membranes.

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 HEXOMEDINE TRANSCUTANEE 1,5 FOR THOUSAND, solution for local application:

Special warnings

Do not use on a large surface, under occlusive dressing, on a burnt skin, a skin of premature, infant.

This medicine contains propylene glycol and may cause skin irritation.

Precautions for use

As soon as the bottle is opened, microbial contamination is possible.

Take care not to keep too long an antiseptic vial ( see section Dosage ).

IN CASE OF DOUBT DO NOT HESITATE TO REQUEST THE NOTICE OF YOUR DOCTOR OR PHARMACIST.

Interaction with other medicines

Taking or using other medicines:

Avoid the simultaneous or successive use of different antiseptics with this antiseptic (in particular the previous use of soap must be followed by careful rinsing).

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, you should seek advice from your doctor or pharmacist before taking any medication.

Sport

Not applicable.

Effects on ability to drive or use machines

Not applicable.

List of excipients with known effect

Excipient with a known effect: propylene glycol.

3. HOW TO USE HEXOMEDINE TRANSCUTANEOUS 1.5 FOR THOUSAND, solution for local application?

Instructions for proper use

Not applicable.

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

Dosage

Do not swallow.

Use purely twice a day in whitewash or in local baths.

In the infections of the nail and the periphery of the nail, the solution can be used:

· either as a short wet wound dressing (30 to 45 minutes)

· or in a bath of 1 to 3 minutes (The bottle with large neck is provided for this use).

In this case, the solution should not be used for another antiseptic use, nor should the bottle be used after use.

Rinsing after application is unnecessary.

Close the bottle.

Operating time after opening:

· 15 days if used under hygienic conditions (the product is deposited on a sterile compress before application on the part to be treated).

· 5 days maximum, if the part to be treated is immersed in the bottle (local baths for a nail affection).

Method and route of administration

Dermal.

Symptoms and Instructions for Overdose

Not applicable.

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, HEXOMEDINE TRANSCUTANEE 1.5 FOR THOUSAND, solution for local application is likely to have undesirable effects, although not everyone is subject to it.

· Possible local allergic reactions: redness, irritation, itching, dryness of the skin.

· More severe allergic reactions may occur.
They regress slowly.

If you notice any side effects not listed in this leaflet, or if any of the side effects gets serious, contact your doctor or pharmacist.

5. HOW TO STORE HEXOMEDINE TRANSCUTANEOUS 1.5 FOR THOUSAND, solution for local application?

Keep out of the reach and sight of children.

Expiration date

Do not use HEXOMEDINE TRANSCUTANEE 1.5 FOR THOUSAND, solution for local application after the expiry date stated on the bottle.

Storage conditions

Store at a temperature not exceeding 25 ° C.

After 1 st opening: the product can be kept for up to 15 days (5 days if used in local baths for nail infections).

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 is HEXOMEDINE TRANSCUTANEE 1.5 FOR THOUSAND, solution for local application?

The active substance is:

Hexamidine di-istionate ............................................ .................................................. 0.150 g

For 100 ml of solution for local application.

The other components are:

Propylene glycol, methylal, nonoxynol, 96.5 ° ethyl alcohol, purified water.

Pharmaceutical form and content

What is HEXOMEDINE TRANSCUTANEE 1.5 FOR THOUSAND, solution for local application and contents of the outer packaging?

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

Bottle of 45 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

SANOFI-AVENTIS FRANCE

82 AVENUE RASPAIL

94250 GENTILLY

exploiting

SANOFI AVENTIS FRANCE

82 AVENUE RASPAIL

94250 GENTILLY

Maker

RPR PHARMA SPECIALTIES

20, AVENUE RAYMOND ARON

92160 ANTONY

or

RPR PROGIPHARM

BP 77

INDUSTRIAL ZONE

45502 GIEN

or

FAMAR HEALTH CARE SERVICES MADRID SAU

AVENIDA LEGANES, 62

28923 ALCORCON MADRID

SPAIN

or

UNITHER LIQUID MANUFACTURING

1-3 ALLEE OF THE NESTE

31770 COLOMIERS

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 Afssaps website (France).

Information for health professionals only

Not applicable.

Other

Not applicable.

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