MONOSEPT 0,25 pour mille (0,1 mg/0,4 ml) Collyre sol récip unidose 30unid/0,4ml

VIDAL
Medicines
Update of 04/03/2024

MONOSEPT^®
cethexonium

Forms and presentations

Eye drops in solution at 0,25 ‰ (0,1 mg/0,4 mL):  Single-dose containers of 0,4 mL (approximately 10 drops per single dose), box of 30.

Composition

	single-dose p
Cetexonium bromide	0,1 mg

Excipients: sodium chloride, water for injectable preparations.

Indications

Antiseptic treatment of superficial conditions of the eye and its adnexa.

Dosage and administration

Topical use.

For ocular instillation.

Instil 1 drop into the lower conjunctival sac, gently pulling the lower eyelid down and looking upward, 3 to 4 times a day, for 7 days on average.

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section Composition, or other quaternary ammoniums.

Warnings and precautions

• In case of hypersensitivity, discontinue treatment.
  
• Treatment must be limited to 15 days: intensive or prolonged use may cause alterations of the conjunctival and/or corneal epithelium. Caution is required particularly in cases of epithelial abnormalities.
  
• Avoid use in contact lens wearers: quaternary ammoniums may be adsorbed by hydrophilic lenses and cause local intolerance to them.
  
• In case of concomitant treatment with an eye drop containing a different active ingredient, space the instillations by 15 minutes.
  
• The single-dose container must be discarded immediately after use and must not be kept for reuse during subsequent administrations.
  
• Do not touch the eye with the tip of the single-dose container.
  

Interactions

• Do not combine two antiseptics.
  
• In case of concomitant treatment with an eye drop containing a different active ingredient, space the instillations by 15 minutes.
  

Fertility, pregnancy and breastfeeding

Given the available data, use in pregnant or breastfeeding women is possible.

Driving and using machines

A temporary visual disturbance may be felt after instillation of the eye drops. In this case, it is advised not to drive or operate machinery until normal vision returns.

Adverse effects

• Possibility of a local intolerance reaction (see Warnings and Precautions for Use).
  
• Risk of a hypersensitivity reaction.
  

Reporting of suspected adverse reactions:

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continuous monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals should report any suspected adverse reaction via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centres. Website: https://signalement.social-sante.gouv.fr.

Overdose

In case of overdose, rinse with sterile physiological saline.

Pharmacodynamics

Pharmacotherapeutic class: Local antiseptic (S: sense organs).

Cethexonium is an antiseptic belonging to the class of quaternary ammoniums.

Pharmacokinetics

The wetting properties of quaternary ammoniums promote their passage through the cornea.

Preclinical safety

The non-clinical data from toxicological studies did not reveal any particular risk for humans.

Effects were observed in animals only at exposures far exceeding the maximum exposure observed in humans, and they have little clinical significance.

Storage conditions

Do not keep after use.

HANDLING/DISPOSAL INSTRUCTIONS

Each single-dose container contains approximately 10 drops.

To use the single dose, proceed as follows:

• at first use, open the envelope in which a strip of single doses is packaged;
  
• remove the strip from its protective envelope and detach one single dose;
  
• to open the single dose, vigorously make a complete rotation of the flat part in order to break the seal;
  
• invert the single dose, so as to make the contents descend towards the open end;
  
• instil the eye drops into the eye or eyes to be treated by gently squeezing the single-dose container;
  
• discard the single-dose container after use.
  

Prescription, supply and reimbursement

Marketing authorisation (AMM)

3400936366848 (1996, SmPC rev 15.03.2019).

Price:	2,92 euros (30 single-dose containers).
Social Security reimbursement at 30%. Collect.

HORUS PHARMA
22, Allée Camille-Muffat
INEDI 5. 06200 Nice
Tel: 04 93 19 54 03. Fax: 04 93 19 54 09
https://www.horus-pharma.com