octenisept® - schülke

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Fields of Application

Wound treatment

Antiseptic treatment of traumatic, acute, chronic, surgical and burn wounds.

Mucous membrane antiseptic

prior to diagnostic and surgical interventions in the anogenital (e.g. before obliteration of haemorrids), the urogenital area (e.g. before placing an intra-uterine device (IUD), the vaginal area, before prenatal, intranatal and postnatal manipulations) and in the oral cavity (e.g. before tooth extractions)
before placing urinary tract catheters
for preop. skin antisepsis in the area close to mucous membranes

Instructions for use

Moisturize the treated area evenly and thoroughly with the antiseptic.
Swab method: Rub concerned areas with saturated swabs. Swabbing is the prefered method of application.
Spray method: In individual cases spray octenisept® directly on poorly accessible areas of the skin and mucous membrane. Make sure all areas are evenly moistened.
octenisept® may also be applied by rinsing the oral cavity

Microbiological efficacy

Efficacy	Concentration	Contact time
bactericidal EN13727 - dirty conditions	ready-to-use	15 sec.
MRSA EN13727 - dirty conditions	ready-to-use	15 sec.
Pseudomonas aeruginosa EN13727 - dirty conditions	ready-to-use	15 sec.
Candida albicans EN13624 - dirty conditions	ready-to-use	15 sec.
virucidal against enveloped viruses EN14476 - dirty conditions	ready-to-use	15 sec.
HSV EN14476 - dirty conditions	ready-to-use	15 sec.

Application area	Concentration	Contact time
ano- and urogenital	ready-to-use	1 min.
before bladder catheterisation	ready-to-use	1 min.
dabbing of the oral cavity	ready-to-use	1 min.
rinsing of the oral cavity	ready-to-use	20 sec.
skin antisepsis before caesarean operation	ready-to-use	2 min.
wounds	ready-to-use	1 min.

Product data

Composition:
100g solution contains: Octenidine dihydrochloride 0.1g, 2-Phenoxyethanol (Ph.Eur.) 2.0g
Other ingredients:
cocamidopropylbetaine, sodium D gluconate, glycerol 85%, sodium chloride, sodium hydroxide, purified water

Chemical-physical data

Form:liquid

Viscosity, dynamic:No data available

Flash point:Not applicable

Color:colourless

Density:ca. 1,005 g/cm3 / 20 °C

pH:6 / 100 % / 20 °C

Special advice

To prevent possible tissue injury, the product must not be injected into the deep tissue using a syringe. The product is intended for superficial use only (application by swab or spray pump).
octenisept® should not be used for irrigating the abdominal cavity (e.g. intraoperatively), the urinary bladder and nose or eardrum.
Do not swallow octenisept®.
Do not enter it into the blood circuit, e.g. by being accidently injected.
Do not mix octenisept® with other compounds.
Do not use octenisept® in combination with PVP-iodine based antiseptics.
Bandages and incision foils can be applied after octenisept® has dried off completely.
In rare cases octenisept® may cause slight burning.
octenisept® can be heated up to body temperature.
octenisept® expires three years after opening.
Once the container has been opened octenisept® should not be used for more than three years but not beyond the expiry date.
As a general prinicple: administrating of any pharmaceuticals within the first trimester of pregnancy should be carried out under strict indication and medical supervision.
Microbiological efficacies on specific germs have only been carried out in in-vitro tests.
Usage of octenisept® in the eye should be avoided. In case of contact with eyes, rinse immediately with plenty of water.
Do not freeze.

Information for order

Item	Delivery form	Item no.
octenisept 1 l FL	10/Carton	on request
octenisept 250 ml FL	10/Carton	on request
octenisept mit Sprühpumpe 250 ml FL	10/Carton	on request
octenisept colourless -CH- 50 ml FL	20/Carton	on request
octenisept 500 ml FL	20/Carton	on request
octenisept KP 250 ml FL	10/Carton	on request
octenisept KP 1 l FL	10/Carton	on request
octenisept KP 500 ml FL	20/Carton	on request
octenisept KP mit Sprühpumpe 250 ml FL	10/Carton	on request

These products are not available in every country. For more information please contact our local subsidiary or distributor.

Environmental information

schülke manufactures products economically and with advanced, safe and environmentally friendly production processes while at the same time maintaining out high quality standards.

¹Briese et al. (2010): Efficacy and tolerability of a local acting antiseptic agent in the treatment of vaginal dysbiosi during pregnancy; in Arch Gynecol Obste
*Please read the package leaflet.

octenisept®
Active substances: octenidine dihydrochloride, phenoxyethanol (Ph.Eur.). Composition: 100 g solution contain: 0.1 g octenidine dihydrochloride, 2.0 g phenoxyethanol (Ph.Eur.). Other ingredients: cocamidopropylbetaine, sodium D gluconate, glycerol 85%, sodium chloride, sodium hydroxide, purified water. Indications: For repeated, short-term antiseptic treatment of mucous membranes and adjacent tissues prior to diagnostic and surgical procedures - in the ano-genital region including the vagina, vulva and glans penis as well as prior to bladder catheterization - in the oral cavity. For short-term supporting therapy of interdigital mycotic infections and adjuvant antiseptic wound treatment. Contraindications: octenisept® may not be used in cases of hypersensitivity to any of the components of the preparation. octenisept® should not be used for rinsing the abdominal cavity (e.g. intra-operatively) or the bladder, nor the tympanic membrane. Undesirable effects: rare: burning, redness, itching and warmth at the application site, very rare: allergic contact reaction, e.g. temporary redness at the application site; frequency unknown: after lavage of deep wounds with a syringe, persistent edema, erythema and also tissue necrosis have been reported, in some cases requiring surgical revision. Rinsing of the oral cavity may cause a transitory bitter sensation. Revision 11/22

To prevent possible tissue injury, the product must not be injected into the deep tissue using a syringe. The product is intended for superficial use only (application by swab or spray pump).

Schülke & Mayr GmbH, 22840 Norderstedt, Germany, Tel. +49 40 52100-666, info@schuelke.com

octenisept^®

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