patient tearsheet abbreviated instructions for ......job#: 41071b client: boehringer ingelheim desc:...
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JOB#: 41071B CLIENT: Boehringer Ingelheim DESC: Four-Panel Tear-Off FILE NAME: BOR_RES_Q41071B_BR_D01.indd DATE: 12-29-2014 7:52 PM ROUND: 1PG: Cruz, Felix/Cole, Robb AD: E Torres x1311 PM: G Williams x4258 AE: F Somma x1319 CW: E Kaye x1316 Last Saved: 12-29-2014 7:50 PMTRIM: 14” x 8.5” BLEED: 14.25” x 8.75” SAFETY: None PROD: M Haight x4245 INK Spec: 4C PRINT SCALE: NoneFONTS: Trade Gothic LT Std (Bold Condensed No. 20, Light, Bold No. 2, Bold No. 2 Oblique), Helvetica Neue LT Std (55 Roman)
IMAGES: 41071B_TS_1_fn.tif (CMYK; 300 ppi; 100%), 41071B_TS_1_prime_6_fn.tif (CMYK; 300 ppi; 100%), 41071B_TS_1_prime_7_fn.tif (CMYK; 300 ppi; 100%), 41071B_TS_1_prepare_2_fn.tif (CMYK; 300 ppi; 100%), 41071B_TS_1_prepare_1_fn.tif (CMYK; 300 ppi; 100%), 41071B_TS_1_daily_dose_A_fn.tif (CMYK; 300 ppi; 100%), 41071B_TS_1_prepare_3_fn.tif (CMYK; 300 ppi; 100%), 41071B_TS_1_prepare_4_fn.tif (CMYK; 300 ppi; 100%), 41071B_TS_1_daily_dose_B_fn.tif (CMYK; 300 ppi; 100%), 41071B_lightbulb2_v01.eps (100%), Respimat_TPO2_4C.ai (80%)INKS: Cyan, Magenta, Yellow, BlackDOC PATH: GRAY_BOR_BOEHRINGER:Volumes:GR...BR_D01:BOR_RES_Q41071B_BR_D01.inddNOTES: None
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A. Hold the COMBIVENT RESPIMAT Inhaler upright with the orange cap closed to avoid accidental release of a dose.TURN the clear base in the direction of the white arrows on the label until it clicks (half a turn).
B. Flip the orange cap until it snaps fully OPEN.
Breathe out slowly and fully, and then close your lips around the end of the mouthpiece without covering the air vents.Point your COMBIVENT RESPIMAT Inhaler to the back of your throat. While taking in a slow, deep breath through your mouth, PRESS the dose-release button and continue to breathe in slowly for as long as you can. Hold your breath for 10 seconds or for as long as comfortable. Close the orange cap until you use your COMBIVENT RESPIMAT Inhaler again.
5
Orange cap
Dose-release button
Cartridge
3
Cartridge
4
Safety catch
Clear base
PREPARE FOR FIRST-TIME USE PRIME FOR FIRST-TIME USE DAILY DOSING
If your COMBIVENT RESPIMAT Inhaler has not been used for more than 3 days, release 1 puff toward the ground to prepare the COMBIVENT RESPIMAT Inhaler for use.
If your COMBIVENT RESPIMAT Inhaler has not been used for more than 21 days, repeat steps 5, 6, and 7 until a spray is visible. Then repeat steps 5, 6, and 7 three more times to prepare the COMBIVENT RESPIMAT Inhaler for use.
The following steps are needed to fill the dosing system the first time you use it, and will not affect the number of doses available.
Proper priming of the COMBIVENT RESPIMAT Inhaler is important to make sure the correct amount of medicine is delivered.
Safety catch
Clear base
Cap
Mouthpiece
Air vents (one on each side)
Dose-release button
Safety catch
Clear base
Piercing element
FRONT VIEW
Dose indicator
Discard by
BACK VIEW
White arrows
Patient Tearsheet
For Oral Inhalation OnlyDo not spray COMBIVENT RESPIMAT into your eyes
For complete instructions, you should read the Instructions for Use enclosed with your prescription before you start using COMBIVENT RESPIMAT and each time you get a refill.
Please refer to the pictures on this page to become familiar with the components of your COMBIVENT RESPIMAT Inhaler. The following instructions show you how to prepare and prime for first-time use, and how to use the COMBIVENT RESPIMAT Inhaler for daily dosing.
CARTRIDGE
Please see accompanying full Prescribing Information, including Instructions for Use, provided with this tearsheet. Please see reverse side for Important Safety Information.
B Air vent
1. With the orange cap closed, press the safety catch while pulling off the clear base.Be careful not to touch the piercing element located inside the bottom of the clear base.
2. Write the discard by date on the label of the inhaler. The discard by date is 3 months from the date the cartridge is inserted.
3. Take the cartridge out of the box. Push the narrow end of the cartridge into the COMBIVENT RESPIMAT Inhaler. The base of the cartridge will not sit flush with the COMBIVENT RESPIMAT Inhaler. About 1/8 of an inch will remain visible when the cartridge is correctly inserted.The cartridge can be pushed against a firm surface to make sure that it is correctly inserted.Do not remove the cartridge once it has been inserted into the COMBIVENT RESPIMAT Inhaler.
4. Put the clear base back into place.Do not remove the clear base again.Your COMBIVENT RESPIMAT Inhaler should not be taken apart after you have inserted the cartridge and put the clear base back.
5. Hold the COMBIVENT RESPIMAT Inhaler upright with the orange cap closed, to avoid accidental release of the dose.Turn the clear base in the direction of the white arrows on the label until it clicks (half a turn).
6. Flip the orange cap until it snaps fully open.
7. Point the COMBIVENT RESPIMAT Inhaler toward the ground. Press the dose-release button. Close the orange cap.Repeat steps 5, 6, and 7 until a spray is visible.Once the spray is visible, you must repeat steps 5, 6, and 7 three more times to make sure the COMBIVENT RESPIMAT Inhaler is ready for use.Your COMBIVENT RESPIMAT Inhaler is now ready to use.
A
Orange cap
Turn the clear base
O pen the cap and close your lips around the mouthpiece
P ress the dose-release button and inhale
A helpful way to recall the steps for Daily Dosing is to remember TOP:
USINGABBREVIATED INSTRUCTIONS FOR USE
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JOB#: 41071B CLIENT: Boehringer Ingelheim DESC: Four-Panel Tear-Off FILE NAME: BOR_RES_Q41071B_BR_D01.indd DATE: 12-29-2014 7:52 PM ROUND: 1PG: Cruz, Felix/Cole, Robb AD: E Torres x1311 PM: G Williams x4258 AE: F Somma x1319 CW: E Kaye x1316 Last Saved: 12-29-2014 7:50 PMTRIM: 14” x 8.5” BLEED: 14.25” x 8.75” SAFETY: None PROD: M Haight x4245 INK Spec: 4C PRINT SCALE: NoneFONTS: Trade Gothic LT Std (Light, Bold No. 2, Bold Condensed No. 20), ITC Zapf Dingbats Std (Medium), Helvetica Neue LT Std (47 Light Condensed), Conduit ITC (Bold)
IMAGES: BIlogo_PMS288_4C.eps (17.6%), 41071B_TS_2_label_fn.tif (CMYK; 300 ppi; 100%), 41071B_shake.eps (100%), 41071B_TS_2_no_Shake_fn.psd (CMYK; 300 ppi; 100%), Respimat_TPO2_4C.ai (80%), 41071B_TS_2_Small_Inhale_fn.psd (CMYK; 300 ppi; 100%), 41071B_BR_Video_icon_2_fn.psd (CMYK; 300 ppi; 100%), SolutionsPlus_PSOP_byBI_KO.eps (86.5%), 41071B_red_lock_icon.eps (100%), 41071B_trash_can_icon.eps (100%)INKS: Cyan, Magenta, Yellow, BlackDOC PATH: GRAY_BOR_BOEHRINGER:Volumes:GR...BR_D01:BOR_RES_Q41071B_BR_D01.inddNOTES: None
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Dizziness and blurred vision may occur with COMBIVENT RESPIMAT. Should you experience these symptoms, use caution when engaging in activities such as driving a car or operating appliances or other machines.
Do not use COMBIVENT RESPIMAT more often than your doctor has directed. Deaths have been reported with similar inhaled medicines in asthma patients who use the medicine too much. Seek immediate medical attention if your treatment with COMBIVENT RESPIMAT becomes less effective for symptomatic relief, your symptoms become worse, and/or you need to use the product more frequently than usual. Allergic reactions may occur, including itching, swelling of the face, lips, tongue, or throat (involving difficulty in breathing or swallowing), rash, hives, bronchospasm (airway narrowing), or anaphylaxis. Some of these may be serious. If you experience any of these symptoms, stop taking COMBIVENT RESPIMAT at once and call your doctor or get emergency help.
What should I tell my doctor before taking COMBIVENT RESPIMAT?Tell your doctor about all your medical conditions, especially if you have narrow-angle glaucoma, prostate or urinary problems, a history of heart conditions (such as irregular heartbeat, high blood pressure), seizures, thyroid disorder, diabetes, low potassium levels, or kidney or liver disease. Also tell your doctor if you are pregnant or nursing.
Tell your doctor about all medicines you are taking, especially heart medications or drugs to treat depression.
What are the most common side effects of COMBIVENT RESPIMAT?The most common side effects reported with use of COMBIVENT RESPIMAT include infection of the ears, nose, and throat, runny nose, cough, bronchitis, headache, and shortness of breath.Reference: COMBIVENT RESPIMAT Prescribing Information. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc; 2014.
How should I care for my COMBIVENT RESPIMAT Inhaler?
Clean the mouthpiece, including the metal part inside the mouthpiece, with a damp cloth or tissue only, at least once a week. Any minor discoloration in the mouthpiece does not affect your COMBIVENT RESPIMAT Inhaler.
If the outside of your COMBIVENT RESPIMAT Inhaler gets dirty, wipe it with a damp cloth.
How should I store my COMBIVENT RESPIMAT Inhaler?
■ Store COMBIVENT RESPIMAT Inhaler at room temperature, from 59°F to 86°F (15°C to 30°C)
■ Do not freeze your COMBIVENT RESPIMAT Inhaler and cartridge
■ Keep your COMBIVENT RESPIMAT Inhaler and cartridge out of the reach of children
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Copyright © 2014, Boehringer Ingelheim Pharmaceuticals, Inc. All rights reserved. Printed in U.S.A. (12/14) PC-CBR-0042CONS
Please see reverse side for Abbreviated Instructions for Use.
Who should not use COMBIVENT RESPIMAT?
Do not use COMBIVENT RESPIMAT if you are allergic to any of the ingredients in COMBIVENT RESPIMAT or to atropine or other similar drugs.
What other important information should I know about COMBIVENT RESPIMAT?
COMBIVENT RESPIMAT can cause the narrowing of the airways to get worse (paradoxical bronchospasm) which may be life threatening. If this happens, stop taking COMBIVENT RESPIMAT at once and call your doctor or get emergency help.
COMBIVENT RESPIMAT can cause serious heart-related side effects, such as palpitations, chest pain, rapid heart rate, high blood pressure, tremor, or nervousness. Call your doctor if you experience any of these symptoms.
COMBIVENT RESPIMAT may increase eye pressure which may cause or worsen some types of glaucoma.
Do not get the spray into your eyes.
COMBIVENT RESPIMAT may cause difficulty with urination.
If you have vision changes or eye pain or if you have difficulty with urination, stop taking COMBIVENT RESPIMAT and call your doctor right away.
Important Safety Information
Dose indicator shows approximately how much medicine is left. When it reaches the red zone, there’s enough medicine for 7 days. It is now time to get a new COMBIVENT RESPIMAT Inhaler
Empty
Full
COMBIVENT RESPIMAT (ipratropium bromide and albuterol) is indicated for use in patients with chronic obstructive pulmonary disease (COPD) on a regular aerosol bronchodilator (inhaler) who continue to have evidence of bronchospasm (airway narrowing) and who require a second bronchodilator.
No shaking required
NOT
REQUIRED
KEY FEATURES OF
Indication for Use
CARE OF INFORMATION ABOUT
View a demonstration video on how to use COMBIVENT RESPIMAT Inhaler at www.combivent.com
Have questions? Call Solutions PlusTM at 1-888-777-1919 to speak with a live nurse or customer service representative who can answer questions about preparing and using the COMBIVENT RESPIMAT Inhaler, dosing, and potential cost savings.
COMBIVENT RESPIMAT Inhaler locks when all medicine has been used
Throw away the COMBIVENT RESPIMAT Inhaler 3 months after insertion of cartridge or after it locks, whichever comes first
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