OHTUVAYRE Inhalation suspension Ref.[110583] Active ingredients: Ensifentrine

The recommended dosage of OHTUVAYRE is 3 mg (one unit-dose ampule) twice daily, once in the morning and once in the evening, administered by oral inhalation using a standard jet nebulizer with a mouthpiece.

Administration Instructions:

• Remove OHTUVAYRE unit-dose ampule from foil pouch only immediately before use.
• Shake OHTUVAYRE ampule vigorously.
• Squeeze and completely empty contents of the ampule into the nebulizer cup for administration of OHTUVAYRE by oral inhalation. Discard ampule with any residual content.
• Administer OHTUVAYRE by oral inhalation using a standard jet nebulizer equipped with a mouthpiece, connected to an air compressor [see Instructions for Use].

Drug Compatibility:

Compatibility of OHTUVAYRE mixed with other drugs has not been established. OHTUVAYRE should not be physically mixed with other drugs or added to solutions containing other drugs.

An overdosage of OHTUVAYRE may lead to signs and symptoms such as headache, tachycardia, and palpitations. Treatment of overdosage consists of temporary interruption of OHTUVAYRE along with appropriate symptomatic and/or supportive therapy.

Store OHTUVAYRE in the protective foil pouch (only remove from foil pouch immediately before use) at controlled room temperature (68°F to 77°F [20°C to 25°C], excursions permitted from 59ºF to 86ºF [15ºC to 30ºC]) [See USP Controlled Room Temperature], maintaining the orientation indicated on the carton. Protect from direct sunlight and excessive heat. Do not freeze.