Cetavlon Antiseptic Cream 80g

Cetavlon Antiseptic Cream 80g
For Local Treatment of Infected or At-Risk Skin Conditions in Adults
Not suitable for pregnant or breastfeeding women

Product Overview
Cetavlon Antiseptic Cream is a mild, locally-acting antiseptic cream containing 0.5% cetrimide, designed to assist in the local treatment of infected or vulnerable skin areas in adults. It provides an additional layer of protection to support healing in skin conditions at risk of infection.

How to Use Cetavlon Cream

1. Clean the skin or wound with soap and water, rinse thoroughly, and dry the area carefully.
2. Apply Cetavlon cream to the affected area once or twice daily.

Important Usage Guidelines

• Avoid using with other antiseptic products or on large areas.
• Use is limited to one week to minimize contamination; avoid touching the tube tip directly to any wound.

Precautions for Use

• Allergies: Do not use if allergic to any of its ingredients (cetrimide, alcohol, cetostearyl alcohol, liquid paraffin, methyl parahydroxybenzoate, propyl parahydroxybenzoate, lavender essential oil).
• Avoid Areas: Do not use on the eyes, mucous membranes, genitals, or ear canal (particularly with a perforated eardrum).
• Special Precautions: Do not apply with occlusive dressings, on large areas, burns, or on the skin of infants or premature babies to avoid absorption into the bloodstream.

This cream contains terpene derivatives, which may cause neurological side effects, especially in children. It is unsuitable for individuals with a history of seizures or epilepsy.

Pregnancy and Breastfeeding
Cetavlon is not recommended during pregnancy or breastfeeding. Always consult a healthcare provider before use during these times.

For enhanced healing support, Cicatryl ointment sachets may be considered.

Packaging
Available in an 80g tube.

Please read the following full disclosure before purchasing or taking this product.

SUMMARY OF PRODUCT CHARACTERISTICS

ANSM - Updated: 10/02/2022

1. NAME OF THE MEDICINAL PRODUCT

CETAVLON, cream

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Cetrimide ............................................................ 0.500 g
Per 100 g of cream

Notable excipients: Methyl parahydroxybenzoate (0.135 g), propyl parahydroxybenzoate (0.011 g), cetostearyl alcohol (12 g), and ethanol (0.084 g).

For the full list of excipients, see Section 6.1.

3. PHARMACEUTICAL FORM

White, smooth, and homogeneous cream.

4. CLINICAL DATA

4.1 Therapeutic Indications

Adjunct treatment for primarily bacterial or infection-prone skin conditions in adults and children over 30 months.

Note: Antiseptic agents are not sterilizing; they temporarily reduce microorganism count.

4.2 Dosage and Method of Administration

Dosage
For adults and children over 30 months:

• Application can be renewed 1 to 2 times per day.

Pediatric Use
CETAVLON is contraindicated in children under 30 months (see Section 4.3).

Administration Method
For cutaneous use. Clean the wound with water and soap, rinse thoroughly, and dry. Apply the cream without allowing the tube tip to touch the wound directly.

4.3 Contraindications

• Hypersensitivity to the active ingredient (or quaternary ammonium derivatives) or any of the excipients listed in Section 6.1.
• Do not use on mucous membranes, particularly genital areas (risk of balanitis and erosive vaginitis).
• Avoid contact with eyes, brain, meninges, or the ear canal in case of a perforated eardrum.
• Due to terpene derivatives as excipients:
  • Contraindicated in children with a history of febrile or non-febrile seizures.
  • Not suitable for children under 30 months.

4.4 Special Warnings and Precautions for Use

Systemic effects may be of concern when the antiseptic is used on:

• Large areas,
• Under occlusive dressings,
• Damaged skin (e.g., burns),
• Mucous membranes (rectal mucosa use can cause atony similar to that seen with muscle relaxants),
• Small children’s skin (due to the surface-to-weight ratio and occlusive effects of diapers).

This product contains terpene derivatives, which may lower the seizure threshold.

Excessive doses (see Section 4.9) may cause:

• Risk of convulsions in children.
• Agitation and confusion in the elderly.

Follow dosage instructions carefully:

• Do not apply to a large body area.
• Avoid applying to the breasts if breastfeeding (see Section 4.6).

This product contains:

• Methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216), which may cause allergic reactions (potentially delayed).
• Cetostearyl alcohol, which may cause local skin reactions (e.g., contact dermatitis).
• Ethanol (0.84 mg per g of CETAVLON), which may cause a burning sensation on damaged skin.

Precautions
After opening, antiseptic products may become microbially contaminated.
Consider terpene derivatives for patients with a history of epilepsy.

4.5 Interactions with Other Medicinal Products and Other Forms of Interaction

Avoid simultaneous or successive use of antiseptics or soap due to possible antagonistic effects.

4.6 Fertility, Pregnancy, and Lactation

Pregnancy
There is limited or no data on CETAVLON use during pregnancy. Animal studies are insufficient to assess reproductive toxicity (see Section 5.3). CETAVLON is not recommended during pregnancy or in women of childbearing age not using contraception.

Lactation
Due to terpene derivatives' potential neurotoxicity in neonates, CETAVLON should be avoided during breastfeeding. It should not be applied to the breasts if breastfeeding (see Section 4.4).

Fertility
No conventional fertility studies in animals are available.

4.7 Effects on Ability to Drive and Use Machines

Not applicable.

4.8 Undesirable Effects

Side effects are listed by System Organ Class (SOC). The frequency is categorized as very common (≥ 1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); or unknown (cannot be estimated from available data).

*Erosive lesions may progress to ulcers and necrosis under occlusive dressing.

Due to terpene derivatives as excipients, and if dosage recommendations are not followed:

• Risk of convulsions in children.
• Possible agitation and confusion in the elderly.

Reporting Adverse Effects
Healthcare professionals should report any suspected adverse effects via the national reporting system: www.signalement-sante.gouv.fr.

4.9 Overdose

Overdose may lead to:

• Neurological risk, including convulsions in children.
• Agitation and confusion in the elderly.

5. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic Properties

Pharmacotherapeutic Class: Antiseptics and Disinfectants – Quaternary Ammoniums, ATC Code: D08AJ04

This product contains cetrimide, a quaternary ammonium antiseptic. It is bacteriostatic, primarily effective against gram-positive bacteria, and inactive against Pseudomonas species. Its effectiveness is reduced in the presence of biological materials (pus, blood, and exudates).

5.2 Pharmacokinetic Properties

Not applicable.

5.3 Preclinical Safety Data

In rats, acute toxicity of a 40% cetrimide solution is low (LD50 = 1000 mg/kg). Standard studies on repeated toxicity, genotoxicity, carcinogenicity, and reproductive toxicity for CETAVLON or its active ingredient cetrimide are not available. Cetyltrimethylammonium bromide, comprising 10% of cetrimide, is irritating to the skin and eyes, suggesting that CETAVLON may also be irritating.

6. PHARMACEUTICAL DATA

6.1 List of Excipients

Ethanol, cetostearyl alcohol (mixture of cetyl alcohol (min. 63%) and stearyl alcohol (min. 33%)), liquid paraffin, methyl parahydroxybenzoate, propyl parahydroxybenzoate, lavender essential oil, purified water.

6.2 Incompatibilities

Quaternary ammoniums are incompatible with soaps and anionic compounds and are inactivated by cellulose and cotton fibers.

6.3 Shelf Life

3 years.

6.4 Special Precautions for Storage

Store at a temperature below 25°C.

6.5 Nature and Contents of Container

Low-density polyethylene tube, 80 g.

6.6 Special Precautions for Disposal and Handling

No special requirements.

7. MARKETING AUTHORIZATION HOLDER

PIERRE FABRE MEDICAMENT
Les Cauquillous
81500 Lavaur, France

8. MARKETING AUTHORIZATION NUMBER(S)

• 34009 381 204 6 2: 1 polyethylene tube (80 g)

9. DATE OF FIRST AUTHORIZATION/RENEWAL

To be completed by the holder

10. DATE OF TEXT UPDATE

To be completed by the holder

11. DOSIMETRY

Not applicable.

12. INSTRUCTIONS FOR THE PREPARATION OF RADIOPHARMACEUTICALS

Not applicable.

PRESCRIPTION AND DISPENSING CONDITIONS

This medication is available over the counter and does not require a prescription.