Septivon is an antiseptic foaming solution for skin use. Formulated with chlorhexidine digluconate 1.5%, it helps temporarily reduce microorganisms on the skin. It is used to cleanse minor superficial wounds and for local cleansing of skin that is infected or at risk of infection.
Who it’s for
Suitable for adults, adolescents, and children from 30 months (2.5 years).
Pregnancy and breastfeeding: use only on medical advice.
What it does
Provides local antiseptic cleansing while the foaming base helps wash the area effectively, supporting hygiene around small, superficial skin lesions.
How to use
For external skin use only. Use undiluted or diluted with water. Always rinse thoroughly after use.
Undiluted use: apply to cleanse a small, limited lesion or to wash a targeted area of skin.
Diluted use (mix with water):
For washing an area of skin: use 3 capfuls per 1 liter of water.
For soaking an area of skin: use 3 capfuls per 2 liters of water.
For women’s external intimate hygiene (vulvar cleansing): use 3 capfuls per 1 liter of water.
Ingredients
Active ingredient: Chlorhexidine digluconate 1.5% (1.5 g per 100 mL).
Other ingredients: Alcanamidopropyl betaine, decyl glucoside, sodium acetate, polyalkylene glycol 3000, pine fragrance, purified water.
Warnings and precautions
Avoid contact with eyes. If accidental eye exposure occurs, rinse immediately and thoroughly with water and seek medical advice. Use with caution on the face or scalp due to eye exposure risk (including potential vision disturbance).
Do not use in the ear if there is a perforated eardrum.
Do not use at the same time as other topical antiseptics (may reduce effectiveness).
Use with caution over large skin areas, under an occlusive/waterproof dressing, on deeply burned skin, and in premature infants, newborns, or young infants due to potential systemic absorption.
Use on mucous membranes is not recommended; Septivon is intended for cutaneous use only.
Because microbial contamination can occur after opening, it is recommended not to keep the bottle for an extended period once opened (especially larger formats).
Format
250 mL bottle (foaming solution).
Always read the leaflet before use and stop use if irritation or an allergic reaction occurs, seeking medical advice as needed.
Please read the following full disclosure before purchasing our using this product.
SUMMARY OF PRODUCT CHARACTERISTICS
ANSM – Updated on: 17/07/2024
1. NAME OF THE MEDICINAL PRODUCT
SEPTIVON 1.5%, solution for cutaneous application
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Chlorhexidine digluconate .................................................... 1.5 g
per 100 mL.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Solution for cutaneous application.
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
SEPTIVON 1.5%, solution for cutaneous application is indicated for cleansing and as an adjunctive treatment of skin conditions that are primarily bacterial or liable to become secondarily infected.
Note
Antiseptic agents are not sterilizing: they temporarily reduce the number of microorganisms.
4.2 Posology and method of administration
Posology
This product is used undiluted or diluted.
If diluted, the preparation must be extemporaneous (prepared immediately before use).
The product may be used:
-
On small, limited lesions, undiluted, by swabbing/painting on;
-
For washing, undiluted or diluted: 3 capfuls per 1 liter of water;
-
For soaking, diluted: 3 capfuls per 2 liters of water;
-
For vulvar cleansing, diluted: 3 capfuls per 1 liter of water.
Rinse after use.
Method of administration
CUTANEOUS USE.
Do not swallow.
4.3 Contraindications
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Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
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This product must not come into contact with the brain, the meninges, or the eye, nor enter the auditory canal in the event of a perforated eardrum.
-
This preparation must not be used to disinfect medical or surgical equipment.
4.4 Special warnings and precautions for use
For external use.
Although transcutaneous absorption of chlorhexidine is very low, the risk of systemic effects cannot be excluded.
These effects are all the more to be feared when the antiseptic is used over a large surface area, on damaged skin (particularly burned skin), on a mucous membrane, or on the skin of a premature infant or an infant (because of the surface area/weight ratio and the occlusive effect of diapers in the diaper area).
The use of alcoholic or aqueous chlorhexidine solutions for skin antisepsis prior to an invasive procedure has been associated with chemical burns in newborns. Based on reported cases and published literature, this risk appears to be higher in premature infants, particularly those born before 32 weeks of gestation and during the first 2 weeks of life.
Remove all soaked materials, gowns, or surgical drapes before proceeding with the procedure. Do not use excessive quantities and do not allow the solution to pool in skin folds or remain on the patient, on sheets, or on any other material in direct contact with the patient. When occlusive dressings are used on areas previously exposed to SEPTIVON 1.5%, all precautions must be taken to ensure there is no excess product before applying the dressing.
SEPTIVON 1.5% must not come into contact with the eye. Severe cases of persistent corneal injury, which may require corneal transplantation, have been reported following accidental ocular exposure to medicines containing chlorhexidine, despite protective measures for the eyes, due to migration of the solution beyond the intended surgical preparation area. During application, extreme caution should be exercised to ensure that SEPTIVON 1.5% does not migrate beyond the intended application site into the eyes. Particular precautions must be taken in anesthetized patients who are unable to immediately report ocular exposure. If SEPTIVON 1.5% comes into contact with the eyes, rinse promptly and thoroughly with water. Ophthalmological advice should be sought.
From the moment an antiseptic preparation container is opened, microbial contamination is possible.
A bottle volume greater than 250 mL exposes to a risk of contamination of the solution if used for a prolonged period after opening.
4.5 Interaction with other medicinal products and other forms of interaction
Given possible interferences (antagonism, inactivation), the simultaneous or successive use of antiseptics and soap should be avoided.
4.6 Fertility, pregnancy and breastfeeding
Not applicable.
4.7 Effects on ability to drive and use machines
Not applicable.
4.8 Undesirable effects
Risk of local allergy, generally presenting as contact dermatitis, particularly when used on:
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Damaged skin,
-
Mucous membranes,
-
Lower-limb ulcers, with the possibility of worsening a superinfected lesion during prolonged use.
Risk of generalized allergy which may (rarely) progress to anaphylactic shock.
Chemical burns in newborns (frequency not known).
Eye disorders:
-
Corneal erosion, epithelial injury/corneal injury, significant permanent visual impairment (frequency not known)*
* Severe corneal erosion and significant permanent visual impairment due to inadvertent ocular exposure have been reported post-marketing, leading to the need for corneal transplantation in some patients (see section 4.4).
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals report any suspected adverse reactions via the national reporting system: French National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centers – Website:
4.9 Overdose
In the event of massive oral ingestion, contact a poison control center.
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: ANTISEPTICS AND DISINFECTANTS, ATC code: D08AC02.
Mechanism of action
Chlorhexidine solution (a biguanide derivative) in amphoteric and non-ionic surfactant excipients that produce foam.
Bactericidal antiseptic against Gram-positive organisms and, to a lesser extent, Gram-negative organisms.
Antifungal activity against Candida albicans.
This product combines a detergent effect and a bactericidal effect.
5.2 Pharmacokinetic properties
Transcutaneous absorption through normal skin is negligible, even in newborns.
5.3 Preclinical safety data
Not applicable.
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Alcanamidopropyl betaine, decyl glucoside, sodium acetate, polyalkylene glycol 3000, pine fragrance, purified water.
6.2 Incompatibilities
Physico-chemical incompatibility with all anionic derivatives (soaps, certain antiseptics, etc.).
Do not use cork stoppers, as these may reduce the antibacterial activity of chlorhexidine.
6.3 Shelf life
Before opening: 2 years
After opening: Do not keep for more than 3 months.
6.4 Special precautions for storage
Store at a temperature not exceeding +25°C.
6.5 Nature and contents of container
Bottle (HDPE) of 250 mL, 500 mL, or 2000 mL, closed with a stopper (LDPE).
6.6 Special precautions for disposal and other handling
Any unused medicinal product or waste must be disposed of in accordance with applicable regulations.
7. MARKETING AUTHORIZATION HOLDER
LABORATOIRE PERRIGO FRANCE
20, RUE ANDRE GIDE
92320 CHATILLON
8. MARKETING AUTHORIZATION NUMBER(S)
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34009 364 166 2 8: 250 mL in bottle (HDPE).
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34009 364 167 9 6: 500 mL in bottle (HDPE).
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34009 565 405 4 9: 2000 mL in bottle (HDPE).
9. DATE OF FIRST AUTHORIZATION/RENEWAL OF THE AUTHORIZATION
[To be completed later by the holder]
10. DATE OF REVISION OF THE TEXT
[To be completed later by the holder]
11. DOSIMETRY
Not applicable.
12. INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS
Not applicable.
CONDITIONS OF PRESCRIPTION AND DISPENSING
Medicinal product not subject to medical prescription.
