icines out of the reach of children.
General Information about PERFOROMIST Inhalation Solution
Medicines are sometimes prescribed for purposes that are not mentioned in a Medication Guide. Do not use PERFOROMIST Inhalation Solution for a condition for which it was not prescribed. Do not give PERFOROMIST Inhalation Solution to other people, even if they have the same condition. It may harm them.
This Medication Guide summarizes the most important information about PERFOROMIST Inhalation Solution. If you would like more information, talk with your health care provider. You can ask your health care provider or pharmacist for information about PERFOROMIST Inhalation Solution that was written for healthcare professionals.
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For customer service, call 1-800-395-3376
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To report side effects, call 1-877-446-3679
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For medical information, call 1-800-429-7751
Instructions for Using PERFOROMIST (formoterol fumarate) Inhalation Solution
PERFOROMIST Inhalation Solution is used only in a standard jet nebulizer machine connected to an air compressor. Make sure you know how to use your nebulizer machine before you use it to breathe in PERFOROMIST Inhalation Solution or other medicines.
Do not mix PERFOROMIST Inhalation Solution with other medicines in your nebulizer machine.
PERFOROMIST Inhalation Solution comes sealed in a foil pouch. Do not open a sealed pouch until you are ready to use a dose of PERFOROMIST Inhalation Solution.
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Remove vial from the foil pouch.
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Twist the cap completely off the vial and squeeze all the medicine into the nebulizer medicine cup (reservoir) (Figure 1).
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Connect the nebulizer reservoir to the mouthpiece or facemask (Figure 2).
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Connect the nebulizer to the compressor.
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Sit in a comfortable, upright position. Place the mouthpiece in your mouth (Figure 3) or put on the facemask (Figure 4); and turn on the compressor.
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Breathe as calmly, deeply and evenly as possible through your mouth until no more mist is formed in the nebulizer reservoir. The average nebulization time is 9 minutes. At this point, the treatment is finished.
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Discard the PERFOROMIST Inhalation Solution container and top after use.
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Clean the nebulizer (see manufacturer’s instructions).
Manufactured for:
Mylan Specialty L.P.
Morgantown, WV 26505
Manufactured by:
The Ritedose Corporation
Columbia, SC 29203
Revised MARCH 2013
This Medication Guide has been approved by the U.S. Food and Drug Administration
A3-031-00
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PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL - 20 mcg/2 mL vial
NDC 49502-605-61
Perforomist®
(formoterol fumarate) INHALATION SOLUTION
20 mcg/2 mL vial
Medication Guide For Patients Enclosed
Sterile Unit Dose Vials - Individually Wrapped - For Oral Inhalation Only
CARTON CONTAINS: 60 individually wrapped 2 mL vials
EACH 2 mL VIAL CONTAINS: ACTIVE: Formoterol fumarate, USP.
INACTIVES: Citric acid, sodium citrate, sodium chloride, and water.
STORAGE CONDITIONS:
PRIOR TO DISPENSING TO THE PATIENT: Store refrigerated, 2°C to 8°C (36°F to 46°F).
AFTER DISPENSING TO THE PATIENT: Store at 2°C to 25°C (36°F to 77°F) for up to 3 months.
Protect pouch from heat. VIAL SHOULD ALWAYS BE STORED IN THE FOIL POUCH, A