PHARMACOTHERAPEUTIC CATEGORY Decongestants and antiallergics.
ACTIVE PRINCIPLES N-acetylaspartyl-glutamic acid (sodium salt) 49mg (or spaglumic acid).
EXCIPIENTS Sodium hydroxide or hydrochloric acid at pH 7.2; water for injections qs 10 ml.
INDICATIONS Treatment of mild manifestations of conjunctivitis and keratoconjunctivitis of an allergic nature, acute and chronic; spring conjunctivitis.
CONTRAINDICATIONS / SECONDARY EFFECT Hypersensitivity 'to any of the components of the drug, solution without preservative.
DOSAGE Adults and children: instill one drop, two to six times a day, into the conjunctival sac, pulling the lower eyelid down slightly and looking up. Continue therapy throughout the allergy risk period, even after symptomatology improves. >> Method of administration. The patient must be instructed to: wash hands thoroughly before and after instillation, avoid touching the eye or eyelids with the tip of the container. Gently lower the lower lid of the affected eye while looking up, and instill the drop into the eye.
STORAGE Store at a temperature not exceeding 25 degrees C.
WARNINGS Clinical studies relating to the use of the product in children under four years of age are not yet available, therefore the medicinal product, a preservative-free solution, must be administered only after careful medical evaluation, both of the possible risks and of the resulting benefits. from therapy. It is recommended not to inject or ingest the product. In severe conjunctival allergies, antiallergic eye drops based on N-acetylaspartylglutamic acid can be administered in place of the initial therapy with cortisone. Like other ophthalmic specialties for topical use, the drug, solution without preservative, can be absorbed systemically.
INTERACTIONS The available data do not suggest the presence of any significant clinical interaction. In case of simultaneous treatment with other eye drops, wait 15 minutes between one instillation and the next.
SIDE EFFECTS Occasionally the patient may experience a mild burning sensation following instillation; this phenomenon is short-lived and usually disappears with the continuation of the therapy. Possible stinging sensation after instillation.
PREGNANCY AND BREASTFEEDING No clinical studies have been conducted in women who are pregnant or presumed to be pregnant. Therefore the product should be prescribed only after a careful medical evaluation of both the possible risks and the benefits of the therapy. There are no data on the passage of the active ingredient in breast milk; breastfeeding is however not recommended during treatment.
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