Betadine Scrub 4% Monodose 10 ml is an iodine-based antiseptic. It is indicated for local adjunctive treatment and cleansing of skin and mucous membrane conditions that are infected or at risk of infection; for antiseptic handwashing of nursing staff and surgeons' hands; and for preoperative antiseptic cleansing.
For warnings, precautions and contraindications, please refer to the package insert.
Keep out of the reach of children.
Betadine scrub 4 per cent 10ml is an iodine-based antiseptic. It is indicated for local adjunctive treatment and cleansing of skin and mucous membrane disorders that are infected or at risk of infection; for antiseptic handwashing of nursing staff and surgeons' hands; and for preoperative antiseptic handwashing.
Skin disinfection: protecting patients and staff alike
Human skin plays a decisive dual role. Physicians and medical staff must protect their skin and ensure that it does not transmit dangerous diseases. The patient's skin has to be incised in order to work inside the body.
Skin antisepsis not only prevents the transmission of infection to the skin, mucous membranes and wounds, but also kills and eliminates airborne germs (transient flora) and reduces local flora (resident flora).
Skin disinfection targets local flora in particular. These germs represent a particular threat to the body's interior. Disinfection is necessary before any medical intervention involving penetration of the skin barrier: punctures, injections, catheter placement and surgical operations.
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Method of administration: Cutaneous route.
Precautions for use of Betadine Scrub 4 Percent 10ml
Like all medicines, Betadine Scrub 4 %, solution for cutaneous application in single-dose containers is likely to have undesirable effects, although not everyone is subject to them.
If you notice any side effects not listed in this leaflet, or if any side effects become serious, please tell your doctor or pharmacist.
Give your opinion on the advice for use and dosage of Betadine Scrub 4% Monodoses 10 ml with our partner Verified opinions after your purchase.
If in doubt, do not hesitate to ask your doctor or pharmacist for advice.
The active substance is: povidone iodine at 4.0 g per 100 ml.
The other components are 60% solution of alkylphenoxypolyethylene ethane sulfuric ester ammonium salt, bis (hydroxyethyl) lauramide, sodium hydroxide, purified water.
Presentation
Available in single-dose 10 ml packs. Box of 10.
Caution: this medicine is not a product like any other. Read the package insert carefully before ordering. Keep medicines out of the reach of children. If symptoms persist, ask your doctor or pharmacist for advice. Beware of incompatibilities with your current products.
Pharmacovigilance Report an adverse drug reaction(s)
ANSM - Updated on: 20/07/2017
BETADINE SCRUB 4%, single dose solution for skin application
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 the symptoms worsen or persist, consult your doctor.
· 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.
In this notice :
1. WHAT IS BETADINE SCRUB 4% solution for dermal application in single-dose containers AND WHAT IT IS USED FOR?
2. BEFORE YOU USE BETADINE SCRUB 4% solution for single-dose skin application.
3. HOW TO USE BETADINE SCRUB 4% solution for dermal application in a single-dose container?
4. WHAT ARE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE BETADINE SCRUB 4% solution for dermal application in a single-dose container?
6. ADDITIONAL INFORMATION
ANTISEPTICS AND DISINFECTANTS
This medication is an antiseptic containing iodine, it is indicated for:
· Local topical treatment and cleansing of skin and mucous membranes, infected or at risk of becoming infected.
· Antiseptic washing of the hands of the nursing staff and the hands of the surgeon.
2. BEFORE YOU USE BETADINE SCRUB 4% solution for single-dose skin application.
List of information needed before taking the medication
Not applicable.
Never take BETADINE SCRUB 4% solution for single-dose skin application in the following cases:
· in the case of repeated use, from the 2nd trimester of pregnancy and in the case of breastfeeding,
· for the newborn less than 1 month,
· for the disinfection of medical and surgical equipment,
· antecedent of allergy to one of the constituents, in particular povidone. There are no cross-reactions with iodinated contrast media.
Reactions of intolerance (anaphylactoid reactions) to iodinated contrast media or seafood anaphylaxis do not constitute a contraindication to the use of BETADINE SCRUB 4%.
This medication MUST NOT BE GENERALLY USED, unless otherwise advised by your doctor, in the following cases:
· in combination with mercury-derived antiseptics.
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 SCRUB 4% solution for skin application in single-dose containers:
Special warnings
Special attention is required for routine applications to injured skin in patients with renal insufficiency, especially in severe burns ( see Adverse effects ).
The iodine contained in this medicinal product may pass through the skin, particularly in the case of repeated use or on certain fragile or fragile skin and pass into the general circulation (undesired and troublesome effects).
Use in children under 30 months of age requires PRIOR NOTICE OF YOUR DOCTOR OR YOUR PHARMACIST.
IN CASE OF DOUBT DO NOT HESITATE TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST
Precautions for use
Rinse after use.
Avoid dripping. Prolonged contact with undried solution may cause irritation and rarely severe burn-type skin reactions.
Interaction with other medicines
Taking or using other medicines
Avoid simultaneous or sequential use of different antiseptics.
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
Due to the presence of iodine, the use of this drug, in the case of repeated use , is contraindicated from the 2nd trimester.
It will only be used occasionally on the advice of your doctor.
Ask your doctor or pharmacist for advice before taking any medicine.
feeding
Breast-feeding is contraindicated if repeated use of this medication is used.
Ask your doctor or pharmacist for advice before taking any medicine.
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 SCRUB 4% solution for dermal application in a single-dose container?
Not applicable.
Administration mode
Dermal.
Dosage
For handwashing, the product is used purely at the rate of 4 ml poured on the wet hands. Scrub for 1 min and rinse thoroughly with water.
For surgical handwashing, repeat this procedure for 3 to 5 minutes, on the hands and forearms.
For the washing of soiled wounds, use the product diluted to one third . Rinse thoroughly with water.
Symptoms and Instructions for Overdose
Not applicable.
Instructions for omission of one or more doses
Not applicable.
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 on certain fragile or fragile skins especially in the premature and the big burned, an overload of iodine may occur which can modify the functioning of the thyroid gland.
· Local skin reactions may occur: burning-type caustic dermatitis in case of maceration and contact dermatitis.
· Possibility of skin irritation and local allergic reaction.
· a reversible and transient coloration may appear on the skin.
· exceptionally general allergic reactions: urticaria, angioedema, anaphylactic shock, anaphylactoid reaction have been described with products containing povidone including BETADINE SCRUB 4%.
· When used on large surfaces and in severe burns, 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 SCRUB 4% solution for dermal application in a single-dose container?
Keep out of the reach and sight of children.
Do not use BETADINE SCRUB 4% solution for single dose skin application after the expiry date which is stated on the vial.
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.
Full list of active substances and excipients
What does BETADINE SCRUB 4% contain, solution for single-dose skin application?
The active substance is:
Povidone iodine ................................................ .................................................. ................................ 0.40 g
For a single-dose container of 10 ml.
The other components are:
A 60% ammonium salt solution of the alkylphenoxypolyethylene ethane sulfuric ester (ammonium salt of alkylphenoxypolyethylene ethane sulfuric ester, ethanol denatured ethanol, purified water), lauric acid condensate and diethanolamine, sodium hydroxide, purified water.
Pharmaceutical form and content
What is BETADINE SCRUB 4% solution for dermal application in single-dose containers and contents of the pack?
This medication is in the form of a solution for skin application. Box of 5, 10, 50 or 100 single-dose containers.
40-44 WASHINGTON STREET
75008 PARIS
40-44 Washington Street
75008 PARIS
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.
Detailed information on this medicine is available on the ANSM website (France).
Information for health professionals only
Not applicable.
Not applicable.
Local antiseptic
polyvidone iodine
. Presentations . Composition . Indications . Contraindications . Warning . Drug Interactions . Pregnancy and breastfeeding . Directions for use and dosage . Advice . Undesirable effects . Lexicon
BÉTADINE SCRUB 4%: foaming solution for skin application; 125 ml bottle.
Refunded at 30%. - price: 1,54 euro (s).
BÉTADINE SCRUB 4%: solution for skin application; box of 10 unidose containers.
-
Laboratory Meda Pharma
| p 100 ml | unidose | |
| Polyvidone iodine | 4 g | 0.4 g |
| Foaming agent | + | + |
Usual dosage:
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