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

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

4.1. Therapeutic indications

Local relief of the symptoms of nasal congestion in patients suffering from colds, allergic rhinitis and other nasal disorders such as sinusitis.

4.2. Posology and method of administration

Nasal use.

Children over 6 years of age: two drops in each nostril, keeping the head of the child tilted backward, maximum twice a day.

After each use, clean the tip of the nozzle with a clean, moist cloth before closing the flask.

4.9. Overdose

The administration of excessive doses, very continued doses or accidental ingestion can lead to systemic absorption causing headache, shivering, sleep disorders, excessive sweating, palpitations and nervousness.

In case of overdose (mean lethal dose in children under 2 years of age, 10 mg; in adults at least 10 times more) the stomach should be emptied by emesis or gastric lavage followed by repeated doses of activated charcoal (every 4-6 hours) plus a saline laxative.

Blood pressure, pulse, convulsions and excitement shall be monitored, as well as the sympathomimetic effects.

Vasopressor drugs are contraindicated.

6.3. Shelf life

3 years.

6.4. Special precautions for storage

Maintain below 25ยฐC.

6.5. Nature and contents of container

Flask with dropper cap.

Each flask contains 15 ml of nasal solution.

6.6. Special precautions for disposal and other handling

Any unused product or waste material should be disposed of in accordance with local requirements.

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