ZENHALE Inhalation aerosol Ref.[27835] Active ingredients: Eformoterol Mometasone

Dosage Forms

ZENHALE is a pressurized metered dosed suspension for inhalation available in three strengths.

• ZENHALE 50/5 delivers 50 mcg of mometasone furoate and 5 mcg of formoterol fumarate dihydrate per actuation.
• ZENHALE 100/5 delivers 100 mcg of mometasone furoate and 5 mcg of formoterol fumarate dihydrate per actuation.
• ZENHALE 200/5 delivers 200 mcg of mometasone furoate and 5 mcg of formoterol fumarate dihydrate per actuation.

Composition

The formulation is a white to off-white suspension. The active ingredients; mometasone furoate and formoterol fumarate dihydrate, are suspended in a mixture of ethanol anhydrous, oleic acid and HFA-227 (propellant).

After priming, each actuation of the inhaler delivers 60.5, 121.0 or 242.0 mcg of mometasone furoate and 6.1 mcg of formoterol fumarate dihydrate from the valve and delivers 50, 100 or 200 mcg of mometasone furoate and 5 mcg of formoterol fumarate dihydrate from the actuator.

Packaging

The suspension is contained in an aluminium canister internally coated with fluorinat ed ethylene/propylene copolymer (FEP) and sealed with a 50 microliter metering valve. A blue polypropylene actuator is provided with the pressurized canister to deliver a dose to the patient. A green polypropylene mouthpiece cover is provided with the actuator. The actuator has an integrated dose counter, which shows how many actuations are left. One pressurized container delivers 60 or 120 actuations to the patient. There is one inhaler in each package.