UTABON PEDIATRIC Nasal drops, solution Ref.[51151] Active ingredients: Oxymetazoline

Source: Medicines Authority (MT)  Publisher: J Uriach and CIA S.A., Av. Camí Reial 51-57, 08184 Palau-Solitá i Plegamans, (Barcelona), Spain

Product name and form

Utabon Pediatric.

Pharmaceutical Form

Nasal drops, solution.

Qualitative and quantitative composition

Oxymetazoline hydrochloride: 0.25 mg/ml.

Excipients: see section 6.1.

Active Ingredient Description
Oxymetazoline

Oximetazoline is an imidazoline derivative. It exhibits sympathomimetic activity and specifically stimulates the α-adrenergic receptors of the sympathetic system. When administered topically to the nose it causes vasoconstriction of the expansed arterioles of the mucosal nose and a concurrent reduction in blood flow. It also reduces the hypersecretion of the nasal mucosa, ultimately contributing to the decongestion of the nasal mucosa.
List of Excipients

Benzalkonium chloride
Disodium phosphate anhydrous
Sodium dihydrogen phosphate dihydrate
Glycine
Sorbitol
Purified water

Pack sizes and marketing

Flask with dropper cap.

Each flask contains 15 ml of nasal solution.

Marketing authorization holder

J Uriach and CIA S.A., Av. Camí Reial 51-57, 08184 Palau-Solitá i Plegamans, (Barcelona), Spain

Marketing authorization dates and numbers

MA131/00502

7th July 2007

Drugs

Drug Countries
UTABON Spain, Malta
 
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