Betadine 10 PERCENT TULLE DRESSING 5

Betadine 10 PERCENT TULLE DRESSING 5 View larger

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Betadine 10 PERCENT TULLE DRESSING 5 is recommended for wounds or burns superficial and extended adjunctive treatment of diseases of the skin and primitive bacterial or may become secondarily infected mucous membranes.

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The advice of your pharmacist

Used for : superficial wounds and burns

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Betadine 10 PERCENT TULLE DRESSING 5

 

 

 
 
 

For warnings, precautions for use

and cons-indications, please refer to the notice no use data.

 

DO NOT LET THIS MEDICINE OUT OF REACH OF CHILDREN

 

 

Description betadine 10 percent tulle dressing 5

  • Wounds or superficial and extensive burns.
  • Adjunctive treatment of diseases of the skin and primitive bacterial or may become secondarily infected mucous membranes.

Note: antiseptic agents are not sterilizing. They temporarily reduce the number of microorganisms.

 

Tips util ization

 

WAY SKIN

 

This medicine is for external use only.

 

·           Open the protective bag

 

·           Apply the compress on the wound impregnated

 

·           Cover with gauze or cotton wool

 

·           Maintaining by a bandage

 

·           Application every day or every two days.

 

Composition

The active substance is povidone iodine 10.00 g per 100 ml.

The other ingredients are macrogol lauryl ether (9), sodium hydroxide (qs pH = 2), purified water.

 

Precautions betadine 10 percent tulle dressing 5

Do not use this medication for prolonged periods without consulting a doctor: risk of progression of iodine in the blood, which could result in a disruption of the functioning of the thyroid.
In case of genital infection, your partner may be contaminated while it has aucunsymptôme. If it is not treated together recontamination is possible.

 

IF IN DOUBT, DO NOT HESITATE TO ASK YOUR DOCTOR OR PHARMACIST

 

Presentation betadine 10 percent tulle dressing 5

The drug 10 percent betadine tulle dressing 5 in the form of gel tube 30g.

 

Warnings on drugs

Un Conseil ? Une Question ?

Please note, 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. Beware of incompatibilities on your products in.


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

Click here to find record of this drug on the website of the National Security Agency of Medicines and Health Products.

Pharmacovigilance : Report or a related side effect (s) (s) (s) the use of a drug

 

 

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Local antiseptic

polyvidone iodine

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

PRESENTATIONS (summary)

BÉTADINE 10%: gel for skin application; 30 g tube.
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BÉTADINE TULLE 10%: medicated dressing (gel impregnated hydrophilic gauze pad ); box of 5.
-

BÉTADINE TULLE 10%: medicated dressing (gel impregnated hydrophilic gauze pad ); box of 10.
-

Laboratory Meda Pharma

COMPOSITION (summary)
p 100 g p dressing
Polyvidone iodine 10 g 300 mg

INDICATIONS (summary)
This medication is a local antiseptic that contains iodine.
It is used for the antisepsis of wounds and small surface burns the adjunctive treatment of lesions of the skin and mucous membranes , infected or at risk of infection.
CONTRAINDICATIONS (summary)
This medication should not be used in the following cases:
  • a history of allergy to polyvidone iodine,
  • newborn (less than 1 month),
  • pregnancy (from the 4th month onwards, in case of prolonged use),
  • breastfeeding , in case of prolonged treatment.
WARNING (Contents)
Avoid prolonged use of this medication, especially in children, mucous membranes and on extensive or deeply injured surfaces, without the advice of your doctor: risk of passing of iodine in the blood, which could lead to disruption of thyroid function .
As a precautionary measure, in infants , short and short applications followed by washing with boiled water. In addition, this drug is contraindicated in newborns .
DRUG INTERACTIONS (summary)
The combination with other antiseptics is not recommended: risk of cancellation of their effects or formation of caustic substances (especially with mercurial antiseptics).
PREGNANCY AND BREAST-FEEDING (summary)
This medication contains iodine, which can pass into the blood of the pregnant woman or into the milk of the breastfeeding woman and disrupt the functioning of her child's thyroid gland. This risk, theoretical, is only to be taken into account in case of prolonged use.
When in doubt, do not use this medication for more than a few days without medical advice and do not apply it to the nipple if you are breast-feeding.
DIRECTIONS FOR USE AND DOSAGE (summary)
In case of soiled wound, a preliminary cleaning followed by a careful rinsing is essential.
The gel is applied directly to the wound; it may optionally be covered with a dressing.
The medicated dressing is applied to the wound and then covered with a compress of gauze and maintained by a bandage. It is changed every day or every 2 days.
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: do not store them unnecessarily.
The brown color of the skin due to the drug is eliminated with water; similarly, stains on clothing disappear after washing.
POSSIBLE ADVERSE EFFECTS (summary)
Skin irritation, contact dermatitis .
In case of prolonged use: disruption of the functioning of the thyroid gland.


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.


antecedent
Affection healed or always in evolution. The antecedent may be personal or family. The background is the history of a person's health.


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.).


infant
Child from one to 30 months. A child under one month is a newborn.


new born
Child less than one month old.


thyroid
Gland located at the base of the neck, which secretes hormones rich in iodine.


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 - Updated on: 20/07/2017

Name of the medicinal product

BETADINE TULLE 10 PER CENT, medicated dressing

Povidone iodine

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 BETADINE TULLE 10 PER CENT, medicated dressing AND WHAT IT IS USED FOR?

2. WHAT TO DO ABOUT BEFORE USING BETADINE TULLE 10 PER CENT, medicated dressing?

3. HOW TO USE BETADINE TULLE 10 PER CENT, medicated dressing?

4. WHAT ARE POSSIBLE SIDE EFFECTS?

5. HOW TO STORE BETADINE TULLE 10 PER CENT, medicated dressing?

6. ADDITIONAL INFORMATION

1. WHAT IS BETADINE TULLE 10 PER CENT, medicated dressing AND WHAT IT IS USED FOR?

Pharmacotherapeutic group

ANTISEPTICS AND DISINFECTANTS

Therapeutic indications

This medicine is an antiseptic (it combats the proliferation of microbes).

It is recommended:

· in the case of superficial wounds and burns.

· in the adjunct treatment of skin and mucosal disorders that are primarily bacterial or susceptible to superinfection.

2. WHAT TO DO ABOUT BEFORE USING BETADINE TULLE 10 PER CENT, medicated dressing?

List of information needed before taking the medication

Not applicable.

Cons-indications

Never use BETADINE TULLE 10 PER CENT, medicated dressing:

· for the newborn of less than 1 month especially in premature babies,

· in the case of repeated use, from the 2nd trimester of pregnancy and in case of breastfeeding.

· In case of history of allergy to any of the constituents, especially povidone. There are no cross-reactions with iodinated contrast media.
Reactions of intolerance (anaphylactoid reactions) to iodinated contrast media or anaphylaxis to seafood do not constitute a contraindication to the use of BETADINE TULLE 10 PER CENT.

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 BETADINE TULLE 10 PER CENT, medicated dressing:

Special warnings

Iodine can pass through the skin (especially if used repeatedly or on some fragile skin).

Special attention is required for routine applications to injured skin in patients with renal insufficiency, especially in severe burns ( see Possible side effects ).

Precautions for use

Special care must be exercised in cases of "fragile" skin, in children, pregnant women.

Use in children from 1 to 30 months is not recommended. If it is necessary, apply it briefly and not very widely. Wash with sterile water after application.

Avoid the simultaneous or successive use of different antiseptics including mercury-derived antiseptics: formation of highly irritating derivatives.

IN CASE OF DOUBT DO NOT HESITATE TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST

Interaction with other medicines

Use of other medicines

Do not combine products containing mercury.

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

Due to the presence of iodine, the use of this drug, in the case of repeated use , is contraindicated during the last 6 months of pregnancy.

It will only be used occasionally on the advice of your doctor.

Breast-feeding is contraindicated if repeated use of this medication is used.

Ask your doctor or pharmacist for advice 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 BETADINE TULLE 10 PER CENT, medicated dressing?

Instructions for proper use

Not applicable.

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

Dosage

· This medicinal product is for external use only.

o Open the protective pouch

o Apply the impregnated pad to the wound

o Cover with a compress of gauze or hydrophilic cotton

o Maintain by means of a bandage

o Application every day or every other day.

If you feel that the effect of BETADINE TULLE 10 PER CENT, medicated dressing is too strong or too weak, talk to your doctor or pharmacist.

Method and route of administration

Dermal.

Symptoms and Instructions for Overdose

If you used more BETADINE TULLE 10 PER CENT, medicated dressing you should not have:

In case of overdose, there may be an iodine overload that may affect the functioning of the thyroid gland and cause impaired renal function. Quickly see a doctor.

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.

· In case of repeated and prolonged use, there may be an iodine overload which can modify the functioning of the thyroid gland on certain fragile or brittle skins, especially in the premature and the burned,

· possibility of skin irritation and local allergic reaction,

· Exceptionally general allergy reactions: urticaria, angioedema, anaphylactic shock, anaphylactoid reaction have been described with products containing povidone including BETADINE TULLE 10 PER CENT.

· When used on large surfaces and in large burners general effects such as impaired renal function have been observed.

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 BETADINE TULLE 10 PER CENT, medicated dressing?

Keep out of the reach and sight of children.

Expiration date

Do not use BETADINE TULLE 10%, medicated dressing after the expiry date stated on the outer packaging.

Storage conditions

Store at a temperature not exceeding 30 ° C.

Keep away from heat.

Do not keep the sachet open.

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 BETADINE TULLE 10 PERCENT, medicated dressing contain?

The active substance is :

Povidone iodine ................................................ .................................................. .................................. 10 g

For an ointment distributed at a rate of 3 g / dm 2 on a cotton hydrophilic gauze of 47 g / m 2 .

The other components are :

Macrogol 400, macrogol 4000, macrogol 6000, purified water.

Pharmaceutical form and content

What is BETADINE TULLE 10 PER CENT, medicated dressing and contents of the pack?

This medication is in the form of medicinal dressings. Sachets of 5 or 10.

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

MEDA PHARMA

40-44 WASHINGTON STREET

75008 PARIS

exploiting

MYLAN MEDICAL SAS

40-44 Washington Street

75008 PARIS

Maker

MEDA MANUFACTURING

Avenue JF Kennedy

33700 MERIGNAC

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.

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Betadine antiseptic is a drug for external use, for the disinfection and the antisepsis of skin or mucous membranes.

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