LECROSINE COLL FL 10ML 40MG/ML

LECROSINE 40 MG/ML COLLIRIUM, DEVELOPMENT

active ingredients

Each ml contains 40 mg of chromoglycated sodium. One drop (about 0.03 ml) contains approximately 1.2 mg of chromoglycated sodium. For the full list of excipients, see paragraph 6.1.

Excellent

Glycerol Disodio edetato Alcohol polyvinyl Water for injectable preparations.

Therapeutic indications

Syntomatic treatment of allergic conjunctivitis in adults and children.

Contraindications

Hypersensitivity to the active ingredient or any of the excipients listed in paragraph 6.1.

Population

Population The dose must be individually established for each patient. Recommended doses for children and adults: 1 to 2 drops in each eye twice a day. If the intensity of symptoms requires a more frequent dose, the frequency of dose administration should not exceed 4 times a day. Use in the elderly No modification of the dosage in elderly patients is required. To obtain optimal control of symptoms, Lecrosine must be used regularly. It is recommended to continue treatment during exposure to allergen.Method of administration Lecrosine 40 mg/ml colliery, solution is exclusively for eye use. It must be administered in the joint sack of the eye. To prevent possible contamination of the solution, patients should not touch eyelids, surrounding areas or any other surface with the tip of the bottle applicator. In case of treatment with other collieries, instillations must be made at a distance of 15 minutes.

Conservation

Store at a temperature below 25 °C. Don't freeze.

Warnings

If symptoms continue or worsen, the patient must consult the doctor.

Interactions

No interaction studies have been carried out.

Effects

Below are the unwanted effects for preferred term MedDRA according to the classification for systems and organs and by absolute frequency. The frequencies are defined as follows: Common (≥1/100, immune system disorders Not known: hypersensitivity reactions. Pathologies of the eye Common: local pain or irritation of a transitory character. Reporting of suspicious adverse reactions The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at the address: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdosing

No information on adverse reactions related to overdose is available.

Pregnancy

The data relating to a limited number of pregnancies on display indicate the absence of adverse effects of chromoglycato on pregnancy or fetus/neonate. Animal studies show no direct or indirect harmful effects on pregnancy, embryo/fetus development, birth or postnatal development. Since the systemic exposure of chromoglycated after the topical application in the eye is negligible, no effects are expected on the breastfeeding fetus/child. Lecrosine can be used in pregnancy.

Food

There are no effects on breast-feeding babies/children, since the systemic exposure to chromogized sodium of nursing women is negligible. Lecrosine can be used during breastfeeding.

Fertility

There are no effects on fertility, since systemic exposure to chromoglycated sodium is negligible. Chromoglycated sodium has no effect on fertility in animals, even at high doses by systemic means.

Source: Farmadati