STERILENE 0,5% 35ML

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STERILENE 0.5% 35ML: This medicine is a topical antiseptic for external use. It is used for skin disinfection This drug is recommended in. · Antisepsis of skin antisepsis · small wounds.

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STERILENE 0.5% 35ML

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

Description sterilene 0.5% sol ext 35ml

This medicine is a topical antiseptic for external use. It is used for skin disinfection.

Application advice and opinions on sterilene 0.5% sol ext 35ml

· Avoid treatment over large areas, on damaged skin under occlusion due
the passage of the antiseptic in the bloodstream. These effects are of particular concern in
infants and young children, because the product may be retained in the skin folds or at
layers.
· Due to the nature of the components, this product should not be used for antisepsis cavities
Internal (mouth, vagina ...).

Composition 0.5% 35ml sterilene

The active substance is:

Cetrimide ......................................................................................................................................... 0.500 g

To 100 ml of solution for topical application.

The other ingredients are:

Alcohol, purified water.

Precaution for use with sterilene 0.5% 35ml

· Do not swallow.
· Do not use under occlusive dressing.
· Avoid using cetrimide at the same time as another antiseptic.
· In case of accidental ingestion, quickly notify a physician.
If in doubt do not hesitate to ask your doctor or pharmacist.
To avoid possible interactions between multiple drugs must always report any
treatment course your doctor or pharmacist.
NEVER KEEP OUT OF REACH OF CHILDREN.

Introducing sterilene 0.5% 35ml

This drug is in solution form for local application.

35 ml bottle

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

STÉRILÈNE

Local antiseptic

cetrimide

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

PRESENTATIONS (summary)

STERILENE: alcoholic solution for local application; flask of 35 ml.
-

Laboratory Gifrer Barbezat

COMPOSITION (summary)
p 100 ml
cetrimide 500 mg
Alcoholic title 63 °

INDICATIONS (summary)
This medication is a local antiseptic of the quaternary ammonium family.
It is used to ensure antisepsis of the skin and superficial wounds.
CONTRAINDICATIONS (summary)
This medication should not be used in the following cases:
  • on the mucous membranes , in particular the genital ones;
  • in application 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)
Application to the genital mucosa may cause redness, ulceration or local necrosis .
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.
Accidental absorption of this product causes serious complications: call the poison control center.
DRUG INTERACTIONS (summary)
Combination with other antiseptics or soaps is not recommended because their effects may cancel out.
PREGNANCY AND BREAST-FEEDING (summary)
The substances contained in this medication are little absorbed by the skin. However, do not use it prolonged during pregnancy or breastfeeding without the advice of your doctor or pharmacist.
This antiseptic should not be applied to the nipple without medical advice. Careful rinsing before feeding is essential.
DIRECTIONS FOR USE AND DOSAGE (summary)
Brush the surfaces to be treated with a pure solution impregnated pad.
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 .
On a wound, the application of an alcoholic solution is painful: the use of another antiseptic may be preferable.
All antiseptics can be contaminated with germs: once opened, the bottle should not be stored for too long.
POSSIBLE ADVERSE EFFECTS (summary)
Contact eczema .
Rarely: ulcer or local necrosis when used under a waterproof (occlusive) dressing.


GLOSSARY (summary)


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.).


necrosis
A term that designates the death of a tissue of the body. Infarction or eschar are necrosis called ischemic necrosis (due to localized asphyxia by deprivation of blood); other necroses may occur at the injection site of some irritating drugs.


ulcerations
Small ulcer.


ulcer
Injury of skin, mucous membranes or cornea.
  • Leg ulcer: chronic wound due to poor circulation of blood.
  • Gastroduodenal ulcer: a localized wound in the mucosa of the stomach or duodenum due to excess acidity and very often to the presence of a bacterium (Helicobacter pylori). The ulcer is favored by stress, alcohol, smoking and certain medications (aspirin, NSAIDs, etc.).

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: 17/07/2012

Name of the medicinal product

0.5% STERILENE, solution for local application

cetrimide

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 0.5% STERILENE, solution for local application AND WHAT IT IS USED FOR?

2. BEFORE YOU USE 0.5% STERILENE, solution for local application?

3. HOW TO USE STERILENE 0.5%, solution for local application?

4. WHAT ARE POSSIBLE SIDE EFFECTS?

5. HOW TO STORE STERILENE 0.5%, solution for local application?

6. ADDITIONAL INFORMATION

1. WHAT IS 0.5% STERILENE, solution for local application AND WHAT IT IS USED FOR?

Pharmacotherapeutic group

Not applicable.

Therapeutic indications

This medication is a local antiseptic for external use. It is used for the disinfection of the skin.

This medication is recommended in:

· the antisepsis of the skin,

· the antisepsis of small wounds.

2. BEFORE YOU USE 0.5% STERILENE, solution for local application?

List of information needed before taking the medication

Not applicable.

Cons-indications

Never use STERILENE 0.5%, solution for local application in the following cases:

· known hypersensitivity to any of the components,

· do not apply to the genital mucosa (risk of ulceration),

· this product should not be brought into contact with the eyes and should not enter the ear.

If in doubt, it is essential to seek the advice of your doctor or pharmacist.

Precautions for use; special warnings

Take special care with STERILENE 0.5%, solution for local application:

Special warnings

· Treatment should be avoided on large surfaces, on injured skin, under an occlusive dressing, due to the passage of the antiseptic into the bloodstream. These effects are particularly to be feared in infants and young children, as the product can be retained in the folds of the skin or in the layers.

· Due to the nature of the components, this product should not be used for antisepsis of the internal cavities (mouth, vagina ...).

Precautions for use

· Do not swallow.

· Do not use under occlusive dressing.

· Avoid using cetrimide together with another antiseptic.

· If swallowed accidentally, promptly notify a physician.

In case of doubt do not hesitate to ask the advice of your doctor or pharmacist.

In order to avoid possible interactions between several medicines, you must systematically report any other treatment in progress to your doctor or pharmacist.

NEVER LEAVE TO CHILDREN.

Interaction with other medicines

Use of other medicines

If you are using or have recently used 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

It is best not to use this medication during pregnancy and lactation. If you discover that you are pregnant, consult your doctor, alone can judge the need to continue treatment.

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

Not applicable.

3. HOW TO USE STERILENE 0.5%, 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

Use the pure product as a local paint on the area to be treated.

In all cases strictly comply with your doctor's prescription.

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, STERILENE 0.5%, solution for local application is likely to have undesirable effects, although not everyone is subject to it.

It is possible that:

· in case of accidental use under occlusive dressing, eroded or ulcerated areas may appear on the skin, the treatment should be discontinued immediately and your doctor notified.

· rarely: in some people allergic to this product, possibility of reaction of eczema type, it is necessary to stop the treatment and to inform your doctor.

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 STERILENE 0.5%, solution for local application?

Keep out of the reach and sight of children.

Expiration date

Do not use 0.5% STERILENE, solution for local application after the expiry date which is stated on the outer packaging or on the vial.

Storage conditions

No special storage conditions.

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 0.5% STERILENE contain, solution for local application?

The active substance is :

Ketrimide ................................................. .................................................. ...................................... 0.500 g

For 100 ml of solution for local application.

The other components are :

Alcohol, purified water.

Pharmaceutical form and content

What is 0.5% STERILENE, solution for local application and contents of the outer packaging?

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

Flask of 35 ml, 50 ml, 125 ml, 250 ml, 500 ml, 1000 ml or 5000 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

LABORATOIRES GIFRER BARBEZAT

8-10, rue Paul Bert

BP 165

69150 Décines Cedex

exploiting

GIFRER BABEZAT

8 - 10 RUE PAUL BERT

69153 DECINES CEDEX

Maker

GIFRER BABEZAT

8 - 10 RUE PAUL BERT

69153 DECINES CEDEX

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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