French pharmacy
RED CENT Betadine SCRUB 125ML 4 is an antiseptic with iodine indicated for the local and extra cleaning conditions of the skin and mucous membranes, infected or at risk of becoming infected treatment.
For warnings, precautions for use and contraindications, please consult the instructions for use .
BETADINE ROUGE SCRUB 4 PERCENT 125ML is an iodine- based antiseptic indicated for the local adjunct treatment and the cleaning of the affections of the skin and the mucous membranes, infected or likely to become infected .
This antiseptic foaming solution is prescribed in the case of prevention of bacterial skin infections in the form of a shower to be performed pre-operatively.
Antiseptics are very numerous and belong to various chemical families. They differ in their ability to destroy a greater or lesser number of germs. The most commonly used antiseptics are biguanides (chlorhexidine and hexamidine), as well as chlorine and iodine derivatives.
The combination of several antiseptics should always be avoided. It may cancel their effects or, in some cases, it may cause the formation of irritants.
Dermal.
Hygienic hand washing with red betadine : the product is used pure at the rate of 4 ml poured on hands previously wet. Rub for 1 minute and rinse thoroughly with water. Surgical hand washing: repeat this protocol for 3 to 5 minutes, on the hands and forearms. Washing contaminated wounds: use the product diluted by a third. Rinse thoroughly with water.
Operative Preparation Protocol with a shower of red foaming betadine srcub: the preparation of the operative must be carried out less than two hours before the intervention, with 60 ml of product for:
Rub until discoloration of the foam (betadine scrub is red):
The active substance is : povidone iodized at 4.0 g per 100 ml.
The other ingredients are : 60% ammonium salt solution of the alkylphenoxypolyethylene ethane sulfuric ester, bis (hydroxyethyl) lauramide, sodium hydroxide, purified water.
IN CASE OF DOUBT DO NOT HESITATE TO ASK FOR THE OPINION OF YOUR DOCTOR OR PHARMACIST
This medication is in the form of medicated dressings. Bags of 10.
Please note, the drug Betadine red scrub is not a product like the others. Read the package leaflet carefully before ordering. Keep medicines out of the reach of children. If symptoms persist, seek the advice of your doctor or pharmacist. Beware of incompatibilities on your current products.
Pharmacovigilance Report an adverse drug reaction(s)
ANSM - Updated on: 20/07/2017
BETADINE SCRUB 4%, solution for skin application (foaming)
Povidone iodine
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.
· This is an authorized and controlled medicinal product (see identification number on the outer packaging).
· This medication can be used in self-medication, ie without consultation or prescription from a doctor.
· This leaflet is designed to help you use this medicine. Keep it, you may need to reread it.
· If symptoms worsen or persist, consult a physician.
· If you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
· Do not use this medication for children.
In this notice :
1. WHAT IS BETADINE SCRUB 4%, solution for dermal application (foaming) AND WHAT IT IS USED FOR?
2. BEFORE YOU USE BETADINE SCRUB 4%, solution for skin application (foaming)?
3. HOW TO USE BETADINE SCRUB 4%, solution for skin application (foaming)?
4. WHAT ARE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE BETADINE SCRUB 4%, solution for skin application (foaming)?
6. ADDITIONAL INFORMATION
1. WHAT IS BETADINE SCRUB 4%, solution for dermal application (foaming) AND WHAT IT IS USED FOR?
ANTISEPTICS AND DISINFECTANTS.
This medication is an antiseptic based on 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.
· Pre-operative antiseptic wash.
2. BEFORE YOU USE BETADINE SCRUB 4%, solution for skin application (foaming)?
List of information needed before taking the medication
Not applicable.
Never use BETADINE SCRUB 4% solution for skin application (foaming) in the following cases:
· in case of repeated use, from the 2nd trimester of pregnancy and in case of breast-feeding,
· for the newborn less than 1 month,
· for the disinfection of medical and surgical equipment,
· in combination with mercury-derived antiseptics.
· in the case of a history of allergy to one of the constituents, in particular polyvidone. 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%.
Precautions for use; special warnings
Take special care with BETADINE SCRUB 4%, solution for skin application (foaming):
Special warnings
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 ( see section 4 ).
Special attention is required during regular applications on injured skin in patients with renal insufficiency.
In the preparation of the operation, avoid sagging and maceration between the patient and the table cloth. Prolonged contact with undried solution may cause irritation and rarely severe burn-type skin reactions.
Use in children less than 2.5 years of age requires the advice of your doctor or pharmacist.
IN CASE OF DOUBT DO NOT HESITATE TO REQUEST THE NOTICE OF YOUR DOCTOR OR PHARMACIST.
Precautions for use
Rinse after use.
Interaction with other medicines
Taking or using other medicines
In order to avoid possible interactions between several medicines, you should systematically report any other treatment in progress 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, use of this medication is contraindicated from the 2nd trimester, in case of repeated use .
It will only be used occasionally on the advice of your doctor.
feeding
Breast-feeding is contraindicated if repeated use of this medication is used.
Ask your doctor 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 skin application (foaming)?
Not applicable.
Administration mode
Dermal.
· Hygienic hand washing: 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.
· Surgical handwashing: repeat this procedure for 3 to 5 minutes, on the hands and forearms.
· Washing of soiled wounds: use the product diluted to one third . Rinse thoroughly with water.
Preparation of the operation:
Preparation of the operation should be done less than two hours before surgery with 60 ml of pure product:
· Wet the head, hair and whole body under the shower.
· Perform antiseptic wash in four steps. Rub until foam discoloration:
1. Head and hair with 10 ml of Betadine Scrub 4%. Do not rinse.
2. Trunk and upper limbs with 10 ml Betadine Scrub 4%, insisting on the armpits and navel. Do not rinse.
3. The genital area and lower limbs with 10 ml of Betadine Scrub 4%, insisting on the genitalia, the infussed fold and between the toes. Do not rinse.
4. Then rinse thoroughly the entire body.
· Repeat the washing procedure using the same procedure, then dry with a clean towel and put on clean clothes.
If you feel that the effect of BETADINE SCRUB 4% is too strong or too weak, talk to your doctor or pharmacist.
Symptoms and Instructions for Overdose
In case of massive oral ingestion, contact a doctor immediately.
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, BETADINE SCRUB 4% is likely to have 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, especially in premature infants and infants.
· Local skin reactions may occur: burning-type caustic dermatitis in case of maceration and contact dermatitis.
· Exceptionally general allergy reactions: urticaria, angioedema, allergic shock, have been described with products containing polyvidone including Betadine Scrub 4%.
· In the case of use of large surfaces and in large burns, general effects have such that impairments of 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 skin application (foaming)?
Keep out of the reach and sight of children.
Do not use BETADINE SCRUB 4% after the expiry date stated on the vial after {EXP}. The expiry date refers to the last day of that month
After first opening the vial, this medication should be stored for up to 6 months at room temperature.
Before opening, keep at a temperature not exceeding 25 ° C.
If necessary, warnings against visible signs of deterioration
Full list of active substances and excipients
What is BETADINE SCRUB 4%, solution for skin application (foaming)?
The active substance is:
Povidone iodine ................................................ .................................................. .................................. 4.0 g
For 100 ml.
The other components are:
60% solution of ammonium salt of sulfuric ester of alkylphenoxypolyethylene ethane, bis (hydroxyethyl) lauramide, sodium hydroxide, purified water.
Pharmaceutical form and content
What is BETADINE SCRUB 4%, solution for skin application (foaming) and contents of the pack?
This medication is in the form of a solution for skin application.
Bottle of 30 ml, 50 ml, 125 ml, 250 ml, 500 ml, 1 liter or 5 l.
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 Afssaps 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:
Wash hands: pour the contents of a pod or 4 ml of solution into the wet hands and rub with the pure solution for a few minutes, then rinse thoroughly with water.
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