NAABAK 19,6 mg/0,4 mL eye drops single-dose container 36Unit

VIDAL
Medicines
Update of the 19/03/2024

NAABAK^®, eye drops in single-dose container
spaglumic acid

Forms and presentations

Eye drops at 19,6 mg/0,4 ml:  Single-dose containers of 0,4 ml, boxes of 10 and of 36.

Composition

	per single dose
N-acetyl aspartyl glutamic acid (sodium salt)	19,6 mg

Excipients: sodium hydroxide or hydrochloric acid, purified water.

Indications

Allergic conjunctivitis and blepharoconjunctivitis.

Dosage and administration

Dosage

The dosage is 2 to 6 instillations per day in adults and children.

In moderate allergic conjunctivitis, Naabak reduces the allergic inflammation and, in the medium term, protects the patient against the risk of recurrence.

In severe allergic conjunctivitis, it is often preferable to use corticosteroids, then relay with Naabak eye drops; this thus makes it possible to avoid prolonged use of corticosteroids.

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section Composition.

Warnings and precautions

Interactions

In case of concomitant treatment with another eye drop, instil the eye drops at 15 minutes' interval.

Fertility, pregnancy and breastfeeding

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

Driving and using machines

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

Adverse effects

Brief sensations of burning or stinging may sometimes occur during instillation.

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: Antiallergics (ATC code: S01GX03).

• Naabak inhibits the degranulation of mast cells of the conjunctival mucosa. These mast cells, very numerous in the conjunctiva, are responsible for the release of chemical mediators of inflammation responsible for the symptoms of allergy.
  
• Naabak blocks complement activation, a mediator that plays a role in amplifying inflammatory phenomena and histamine release.
  
• Naabak inhibits the synthesis of leukotrienes (SRS-A) by sensitised cells. Mast cells, complement proteins and leukotrienes play a determining role in the triggering and course of allergic reactions and therefore in the production of ocular inflammatory symptoms and signs.
  
• Naabak prevents ocular allergic inflammatory reactions triggered by the allergen(s) (pollen, house dust, etc.). This protective action must be maintained throughout the entire period of allergy risk. Consequently, it is necessary to continue instillations daily and without interruption throughout this period in order to prevent recurrences.
  

Preclinical safety

The non-clinical data from conventional repeated-dose toxicity, genotoxicity and reproductive function studies did not reveal any particular risk for humans.

Storage conditions

Store at a temperature not exceeding 25 °C.

HANDLING/DISPOSAL INSTRUCTIONS

No special requirements.

Prescription, supply and reimbursement

Marketing authorisation (AMM)	3400934426780 (1991, RCP rev 16.10.2023) 10 single-dose units.
	3400935651518 (1991, RCP rev 16.10.2023) 36 single-dose units.

Price:	3,96 euros (36 single-dose units).
Social Security reimbursement at 30%. Collect.
Box of 10 single-dose units: Not reimbursed by Social Security.

THÉA PHARMA
37, rue Georges-Besse
63100 Clermont-Ferrand

http://www.theapharma.fr