In this manual :
1. WHAT IS BISEPTINESPRAID, solution for cutaneous application AND WHAT IS IT USED FOR?
2. WHAT YOU SHOULD KNOW BEFORE USING BISEPTINESPRAID, solution for cutaneous application
3. HOW DO I USE BISEPTINESPRAID, solution for cutaneous application?
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
5. HOW TO USE BISEPTINESPRAID, solution for cutaneous application?
6. ADDITIONAL INFORMATION
1. WHAT IS BISEPTINESPRAID, solution for cutaneous application AND WHAT IS IT USED FOR?
Pharmacotherapeutic class
Not applicable.
Antisepsis of small superficial wounds.
2. WHAT YOU SHOULD KNOW BEFORE USING BISEPTINESPRAID, solution for cutaneous application
List of information needed before taking the medicine
Not applicable.
Never use BISEPTINESPRAID, solution for cutaneous application in the following cases:
- known allergy to chlorhexidine (or a related drug) or benzalkonium chloride (of the quaternary ammonium family)
- do not apply in the eyes, ears, on mucous membranes, especially genital ones.
- not to be used for the disinfection of medical-surgical material.
In case of doubt, it is essential to ask the advice of your doctor or your pharmacist
Precautions for use; special warnings
Take care with BISEPTINESPRAID, solution for cutaneous application:
Special warnings
This medicine is for external use only. Do not swallow
There is a risk of the active ingredient passing into the general circulation if used over a large area, under an occlusive dressing, on injured skin (especially burns), or on the skin of premature babies or infants.
Precautions for use
Use properly and do not keep an opened bottle for too long as microbial contamination is possible as soon as the bottle is opened.
Interactions with other medicines
Taking or using other medicines
This medicine should not be used at the same time as other local antiseptics (risk of incompatibility or ineffectiveness). The prior use of soap should be followed by a thorough rinsing before using this medication.
Talk to your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Interactions with food and drink
Not applicable.
Interactions with herbal products or alternative therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy and lactation
This medicine should be used with caution during pregnancy and lactation.
In general, during pregnancy and lactation, always 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 a known effect
Not applicable.
3. HOW TO USE BISEPTINESPRAID, solution for cutaneous application
Instructions for proper use
Not applicable.
Dosage, Method and/or route(s) of administration, Frequency of administration and Duration of treatment
Do not swallow.
1 to 2 applications per day. It is not necessary to rinse after application.
Dermal route
External use
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The duration of use is limited to 5 days.
|
Symptoms and instructions in case of overdose
If you have taken more BISEPTINESPRAID, Skin Application Solution than you should have:
In case of massive oral ingestion, perform gastric lavage. The acute oral toxicity of chlorexidine is low (almost negligible absorption from the digestive tract).
Contact a Poison Control Centre.
Instructions in case of missed dose(s)
Not applicable.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Description of side effects
Like all medicines, BISEPTINESPRAID, solution for cutaneous application is likely to have undesirable effects, although not everyone is subject to them.
- allergic eczema on contact with the product,
- rarely, general allergic reaction.
If you notice any side effects not mentioned in this leaflet, or if any side effects become serious, please tell your doctor or pharmacist.
5. HOW TO STORE BISEPTINESPRAID, solution for cutaneous application
Keep out of the reach and sight of children.
Do not use BISEPTINESPRAID, solution for cutaneous application after the expiry date stated on the outer packaging.
For polyethylene bottles: Store at a temperature not exceeding 30°C.
For polyethylene spray bottles: Store at a temperature not exceeding 25°C.
If necessary, warnings against certain visible signs of deterioration
Medicines should not be disposed of in the sewage system or in the household waste. Ask your pharmacist what to do with unused medicines. This will help to protect the environment.
6. ADDITIONAL INFORMATION
Full list of active ingredients and excipients
What does BISEPTINESPRAID, solution for cutaneous application, contain?
The active ingredients are
Chlorhexidine gluconate ............................................................................................................... 0.250 g
Benzalkonium chloride ................................................................................................................. 0.025 g
Benzyl alcohol ........................................................................................................................... 4.000 ml
Per 100 ml.
The other component is:
Purified water.
Pharmaceutical form and contents
What is BISEPTINESPRAID, solution for cutaneous application and what does it contain?
This medicine is presented as a solution for cutaneous application.
Bottle of 50, 100, 125, 150, 200 or 250 ml.
Name and address of the marketing authorisation holder and of the manufacturing authorisation holder responsible for batch release, if different
Holder
BAYER FAMILY HEALTH
33, RUE DE L'INDUSTRIE
74240 GAILLARD
Operator
BAYER SANTE FAMILIALE
33, RUE DE L'INDUSTRIE
74240 GAILLARD
Manufacturer
KVP PHARMA + VETERINAR PRODUKTE GMBH
Projensdorfer Strasse 324
24106 KIEL
GERMANY
or
FAMAR NEDERLAND B.V.
INDUSTRIEWEG 1
5531 AD BLADEL
NETHERLANDS
or
LABORATOIRES CHEMINEAU
93, ROUTE DE MONNAIE
37210 VOUVRAY
Names of the medicinal product in the Member States of the European Economic Area
Not applicable.
Date of approval of the package leaflet
The last date on which this package insert was approved was {date}.
MA under exceptional circumstances
Not applicable.
Detailed information on this medicinal product is available on the website of Afssaps (France).
Information reserved for health professionals
Not applicable.
Not applicable.
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