Terms of Use

Teva Respiratory, LLC ("Teva Respiratory") maintains this site WWW.DIGIHALERHCP.COM (the "Site") for your personal information, education, and communication. While you should feel free to browse the Site, please understand that your access to and use of the Site is subject to the following Terms of Use ("Terms of Use") and all applicable laws. By accessing and browsing the Site, you accept, without limitation or qualification, the Terms of Use and acknowledge that any other agreements between you and Teva Respiratory concerning the Site are superseded to the extent they conflict with these Terms of Use. Your use of or linking to any content of the Site, except as provided in these Terms of Use, is strictly prohibited.

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Note that special terms apply to some services, like rules for particular contests or sweepstakes or other features or activities. These terms are posted in connection with the applicable service. Any such terms are in addition to these Terms of Use, and in the event of a conflict, prevail over these Terms of Use.

You acknowledge that these Terms of Use are supported by reasonable and valuable consideration, the receipt and adequacy of which are hereby acknowledged. Without limiting the generality of the foregoing, you acknowledge that such consideration includes your use of the Site and receipt of data, materials and information available at or through the Site, the possibility of our use or display of your Solicited Submissions.

Terms of Use

  1. You should assume that everything you see or read on the Site is copyrighted and may not be used without the written permission of Teva Respiratory, except as provided in these Terms of Use or in the text on the Site. Teva Respiratory neither warrants nor represents that your use of material displayed on the Site will not infringe rights of third parties. Nothing contained on the Site should be construed as granting, by implication, estoppel, or otherwise, any license or right to use any Teva Respiratory intellectual property right (including, but not limited to any patent, trademark, trade name, copyright or trade secret).
  2. You may download material displayed on the Site for non-commercial, personal use only, provided you also retain all copyright and other proprietary notices contained in the materials or as specified on the Site. You may not, however, distribute, modify, transmit, reuse, re-post, or use the content of the Site, including the text, images, audio, and video, for public or commercial purposes.
  3. When you access Teva Respiratory through a mobile network, your network or roaming provider's messaging, data and other rates and fees will apply. Downloading, installing or using certain features of the Site may be prohibited or restricted by your network provider and not all aspects of the Site may work with your network provider or device.
  4. Images of people or places displayed on the Site are either the property of, or used with permission by, Teva Respiratory. The use of these images by you, or anyone else authorized by you, is prohibited unless specifically permitted by these Terms of Use or as provided elsewhere on the Site. Any unauthorized use of the images may violate copyright laws, trademark laws, the laws of privacy and publicity, and communications regulations and statutes. You are also advised that Teva Respiratory will aggressively enforce its intellectual property rights to the fullest extent of the law, including the seeking of criminal prosecution.
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  6. Teva Respiratory has not reviewed all of the sites linked to the Site and is not responsible for the content of any off-Site pages or any other sites linked to the Site. Your linking to any other off-Site pages or other sites is at your own risk.
  7. In these Terms of Use, we use the word "Submissions" to mean text, messages, ideas, concepts, pitches, suggestions, stories, treatments, formats, artwork, photographs, drawings, videos, audiovisual works, musical compositions (including lyrics), sound recordings, characterizations, your and/or other persons' names, likenesses, voices, usernames, profiles, actions, appearances, performances and/or other biographical information or material, and/or other similar materials that you submit, post, upload, embed, display, communicate or otherwise distribute (collectively, "Distribute") on or through the Site.
    • There are two types of Submissions: Solicited Submissions and Unsolicited Submissions. "Solicited Submissions" means those Submissions (a) that we expressly request or enable you to provide to us via any feature or activity on the Site for our review or display and possible specifically-defined consideration or compensation (collectively, "Consideration") (such as prizes or other value in games, sweepstakes, contests and promotions); and (b) that you Distribute on or through the Site for which you do not seek Consideration (as defined below). "Unsolicited Submissions" are any and all Submissions that do not fall within subparagraphs (a) or (b) of this paragraph. Our long-standing company policy does not allow us to accept or consider Unsolicited Submissions so please do not Distribute Unsolicited Submissions on or through the Site. We want to avoid the possibility of future misunderstandings when projects developed by us or under our direction might seem to others to be similar to their own creative work. We therefore ask that you not Distribute any Unsolicited Submission. In any event, you agree that any submission you make is not being made in confidence or trust and that no confidential or fiduciary relationship is intended or created between you and us in any way, and that you have no expectation of any review, compensation or consideration of any type (other than any stated Consideration). Except as expressly stated in these Terms of Use, the provisions of these Terms of Use apply equally to Unsolicited Submissions and Solicited Submissions. Accordingly, we, our licensees, distributors, agents, representatives and other authorized users shall be entitled to exploit and disclose all Submissions, and we shall not be liable to you or to any person claiming through you for any exploitation or disclosure of any Submission.
  8. While Teva Respiratory uses reasonable efforts to include accurate and up-to-date information in the Site, Teva Respiratory makes no warranties or representations as to its accuracy. Teva Respiratory shall not be held responsible for any action taken that is based on the information presented on the Site, and all users of the Site agree that access and use of the Site is at the user's own risk. Teva Respiratory assumes no liability or responsibility for any errors or omissions in the content of the Site.
  9. Your use of and browsing of the Site are at your own risk. Neither Teva Respiratory nor any other party involved in creating, producing, hosting or delivering the Site is liable for any direct, incidental, consequential, indirect, or punitive damages arising out of your access to, or use of, the Site or its contents. Without limiting the foregoing, everything on the Site is provided to you "AS IS," WITHOUT WARRANTY OF ANY KIND, EITHER EXPRESSED OR IMPLIED, INCLUDING, BUT NOT LIMITED TO THE IMPLIED WARRANTIES OF MERCHANT­ABILITY, FITNESS FOR A PARTICULAR PURPOSE, OR NON-INFRINGEMENT. Please note that some jurisdictions may not allow the exclusion of implied warranties, so some of the above exclusions may not apply to you. Check your local laws for any restrictions or limitations regarding the exclusion of implied warranties.
  10. Teva Respiratory also assumes no responsibility, and shall not be liable for, any damages to, or viruses that may infect your computer equipment or other property on account of your access to, use of, or browsing in the Site or your downloading of any materials, data, text, images, video or audio from the Site.
  11. Any communication or material you transmit to the Site by electronic mail or otherwise, including any data, questions, comments, suggestions, or the like is, and will be treated as, non-confidential and non-proprietary. Anything you transmit or post may be used by Teva Respiratory or its affiliates for any purpose, including, but not limited to, reproduction, disclosure, transmission, publication, broadcast and posting. Furthermore, Teva Respiratory is free to use any ideas, concepts, know-how, or techniques contained in any communication you send to the Site for any purposes whatsoever including, but not limited to, developing, manufacturing, marketing, and selling products using such ideas, concepts, knowhow, or techniques. We also reserve the right, but disclaim any obligation or responsibility, to (a) refuse to post or communicate or remove any Submission from the Site that violates these Terms of Use (including any rules of conduct) and (b) identify any user to third parties, and/or disclose to third parties any Submission or personally identifiable information, when we believe in good faith that such identification or disclosure will either (i) facilitate compliance with laws, including, for example, compliance with a court order or subpoena, or (ii) help to enforce these Terms of Use (including the rules of conduct) and/or our contest, sweepstakes, promotions, and game rules, and/or protect the safety or security of any person or property, including the Site. Moreover, we retain all rights to remove Submissions at any time for any reason or no reason whatsoever.
  12. You are responsible for maintaining the confidentiality of your username(s), password(s), and your account(s), as well as all activities that occur under your account(s). You hereby agree to indemnify, defend, and hold us, our licensors, licensees, distributors, agents, representatives and other authorized users, and each of the foregoing entities' respective resellers, distributors, service providers and suppliers, and all of the foregoing entities' respective officers, directors, owners, employees, agents, representatives and assigns (collectively, the "Indemnified Parties") harmless from and against any and all losses, damages, liabilities and costs (including settlement costs and any legal or other fees and expenses for investigating or defending any actions or threatened actions) incurred by the Indemnified Parties in connection with any claim arising out of any breach by you of these Terms of Use or claims arising from your use of the Site and/or your account(s). You shall use your best efforts to cooperate with us in the defense of any claim. We reserve the right, at our own expense, to employ separate counsel and assume the exclusive defense and control of any matter otherwise subject to indemnification by you.
  13. Teva Respiratory reserves the right, in its sole discretion, to terminate or block your access to the Site or to modify or remove any content from the Site at any time and without notice, for any reason.
  14. Any failure by Teva Respiratory to exercise or enforce any right under these Terms of Use shall not constitute a waiver of such right. If any portion of these Terms of Use is held to be unenforceable, that portion shall be deemed severable from these Terms of Use and shall not affect the validity and enforceability of the remaining provisions contained herein.
  15. Teva Respiratory may at any time revise these Terms of Use including by modification, deletion and/or addition of any portion thereof of this posting. You are bound by any such revisions and should, therefore, periodically visit this page to review the current Terms of Use to which you are bound. If we make a material amendment to these Terms of Use, we will notify you of such amendment by sending you an e-mail at the last e-mail address that you provided us, and/or by posting notice of such amendment on the Site. Any such amendment to these Terms of Use will be effective thirty (30) calendar days following either our dispatch of an e-mail notice to you or our posting of notice of the changes on the Site. Please note that, at all times, you are responsible for updating your personal information to provide us your current email address. In the event that the last e-mail address that you have provided us is not valid, or for any other reason is not capable of delivering to you the notice described above, our dispatch of the e-mail containing such notice will nonetheless constitute effective notice of any amendment described in the notice.
  16. Teva Respiratory maintains the Site as a service to the internet community. The Site has been designed to provide general information about Teva Respiratory and its products. These pages are not intended to provide investment or medical advice, nor do they provide instruction on the appropriate use of products manufactured for or sold by Teva Respiratory or products currently under development by Teva Respiratory, its affiliates, related companies, or its licensors or joint venture partners. Information on the Site regarding products approved for marketing is qualified in its entirety by reference to the full prescribing information for such products. Users of the Site should be aware that products under development described herein have not been found safe or effective by any regulatory agency and are not approved for any use outside of clinical trials.
  17. The Site is intended only to provide information about ProAir® Digihaler®, AirDuo® Digihaler®, and ArmonAir® Digihaler® drug therapy. The Site was intended specifically for individuals who are U.S. residents. This content has not been approved for non-U.S. residents. The information should not be considered complete and should not be used in place of a visit, call, consultation or advice of your physician or other healthcare provider. The Site does not recommend the self-management of health problems. Information obtained through the Site is not exhaustive and does not cover all ailments, physical conditions or their treatment. Should you have any healthcare-related questions, please call or see your physician or other healthcare provider promptly. You should never disregard medical advice or delay in seeking it because of something you have read here.
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  20. Contact Teva: If you have any questions about these Terms of Use, please contact us by e-mail at USSMLegalNotice@tevapharm.com or write to us:

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Effective Date: October 29, 2020

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Indications and Important Safety Information for ProAir Digihaler

INDICATIONS FOR PROAIR DIGIHALER

INDICATIONS

ProAir® Digihaler®
 (albuterol sulfate) Inhalation Powder is indicated in patients ≥4 years of age for the treatment or prevention of bronchospasm with reversible obstructive airway disease and in patients ≥4 years of age for the prevention of exercise-induced bronchospasm.

IMPORTANT SAFETY INFORMATION

IMPORTANT SAFETY INFORMATION

  • Contraindications: ProAir Digihaler (albuterol sulfate) Inhalation Powder is contraindicated in patients with hypersensitivity to albuterol or patients with a severe hypersensitivity to milk proteins. Rare cases of hypersensitivity reactions, including urticaria, angioedema, and rash have been reported after the use of albuterol sulfate. There have been reports of anaphylactic reactions in patients using inhalation therapies containing lactose
  • Paradoxical Bronchospasm: ProAir Digihaler can produce paradoxical bronchospasm that may be life-threatening. Discontinue ProAir Digihaler and institute alternative therapy if paradoxical bronchospasm occurs
  • Deterioration of Asthma: Need for more doses of ProAir Digihaler than usual may be a marker of acute or chronic deterioration of asthma and requires reevaluation of treatment, such as possible need for anti-inflammatory treatment, e.g., corticosteroids
  • Use of Anti-Inflammatory Agents: ProAir Digihaler alone may not be adequate to control asthma in many patients. Early consideration should be given to adding anti-inflammatory agents, e.g., corticosteroids
  • Cardiovascular Effects: ProAir Digihaler, like other beta-adrenergic agonists, can produce clinically significant cardiovascular effects in some patients, as measured by heart rate, blood pressure, and/or symptoms. If such effects occur, the drug may need to be discontinued. ProAir Digihaler, like all sympathomimetic amines, should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension
  • Do Not Exceed Recommended Dose: Fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs in patients with asthma
  • Immediate Hypersensitivity Reactions may occur after administration of albuterol sulfate, as demonstrated by rare cases of urticaria, angioedema, rash, bronchospasm, anaphylaxis, and oropharyngeal edema. Hypersensitivity reactions including anaphylaxis, angioedema, pruritus, and rash have been reported with the use of therapies containing lactose, an inactive ingredient in ProAir Digihaler.
  • Coexisting Conditions: ProAir Digihaler, like all sympathomimetic amines, should be used with caution in patients with convulsive disorders, hyperthyroidism, or diabetes mellitus; and in patients who are unusually responsive to sympathomimetic amines.
  • Hypokalemia: As with other beta-agonists, ProAir Digihaler may produce significant hypokalemia in some patients. The decrease is usually transient, not requiring supplementation
  • Adverse Reactions: In controlled studies in patients 12 years of age and older, adverse events that occurred in ≥1% and >placebo included back pain (2% vs 1%), pain (2% vs <1%), gastroenteritis viral (1% vs <1%), sinus headache (1% vs <1%), and urinary tract infection (1% vs <1%). In controlled studies in patients 4 to 11 years of age, adverse events that occurred in ≥2% and >placebo included nasopharyngitis (2% vs 1%), oropharyngeal pain (2% vs 1%), and vomiting (3% vs 1%)
  • Drug Interactions: Other short-acting sympathomimetic bronchodilators should not be used concomitantly with ProAir Digihaler
    • Beta-Blockers: Beta-adrenergic-receptor blocking agents not only block the pulmonary effect of beta-agonists, such as ProAir Digihaler, but may produce severe bronchospasm in asthmatic patients. Therefore, patients with asthma should not normally be treated with beta-blockers
    • Diuretics: Caution is advised in the coadministration of beta-agonists with non-potassium sparing diuretics (such as loop or thiazide diuretics). Consider monitoring potassium levels
    • Digoxin: Carefully evaluate the serum digoxin levels in patients who are currently receiving digoxin and ProAir Digihaler
    • Monoamine Oxidase Inhibitors or Tricyclic Antidepressants: ProAir Digihaler should be administered with extreme caution to patients being treated with these agents, or within 2 weeks of discontinuation of these agents, because the action of albuterol on the cardiovascular system may be potentiated. Consider alternative therapy

Please read the full Prescribing Information for ProAir Digihaler.

Indications And Important Safety Information for Armonair Digihaler and AirDuo Digihaler

INDICATIONS FOR AIRDUO DIGIHALER AND
ARMONAIR DIGIHALER

INDICATIONS

ArmonAir® Digihaler® (fluticasone propionate) inhalation powder is indicated for the maintenance treatment of asthma as prophylactic therapy in patients 12 years of age and older.

Important Limitation of Use: ArmonAir Digihaler is NOT indicated for the relief of acute bronchospasm.

AirDuo® Digihaler® (fluticasone propionate and salmeterol) inhalation powder is indicated for the treatment of asthma in patients aged 12 years and older. AirDuo Digihaler is only for patients uncontrolled on an inhaled corticosteroid (ICS) or whose disease severity clearly warrants an ICS/Long-acting beta2-agonist (LABA).

Important Limitation of Use: AirDuo Digihaler is NOT indicated for the relief of acute bronchospasm.

IMPORTANT SAFETY INFORMATION

Important safety information

  • Contraindications: ArmonAir Digihaler and AirDuo Digihaler are contraindicated in:
    • Primary treatment of status asthmaticus or other acute episodes of asthma requiring intensive measures
    • Patients with known severe hypersensitivity to milk proteins or any ingredients of ArmonAir Digihaler or AirDuo Digihaler
  • Serious Asthma-Related Events – Hospitalizations, Intubations, Death: Use of AirDuo Digihaler, LABA as monotherapy (ICS) for asthma is associated with an increased risk of asthma-related death. Available data from controlled clinical trials also suggest that use of LABA as monotherapy increases the risk of asthma-related hospitalization in pediatric and adolescent patients. These findings are considered a class effect of LABA monotherapy. When LABA are used in fixed-dose combination with ICS (such as AirDuo Digihaler), data from large clinical trials do not show a significant increase in the risk of serious asthma-related events (hospitalizations, intubations, death) compared with ICS alone
  • Deterioration of Disease and Acute Episodes: AirDuo Digihaler should not be initiated in patients during rapidly deteriorating or potentially life-threatening episodes of asthma. ArmonAir Digihaler and AirDuo Digihaler are not indicated for the relief of acute bronchospasm. An inhaled, short-acting beta2-agonist, not ArmonAir Digihaler or AirDuo Digihaler, should be used to relieve acute symptoms such as shortness of breath
  • Excessive Use and Use with Other Long acting Beta2-Agonists: AirDuo Digihaler should not be used more often than recommended, at higher doses than recommended, or in conjunction with other medicines containing LABA, as an overdose may result. Clinically significant cardiovascular effects and fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs. Patients using AirDuo Digihaler should not use another medicine containing a LABA (e.g., salmeterol, formoterol fumarate, arformoterol tartrate, indacaterol) for any reason
  • Local Effects of ICS: Oropharyngeal candidiasis has occurred in patients treated with ArmonAir Digihaler or AirDuo Digihaler. Advise patients to rinse the mouth with water without swallowing following inhalation
  • Immunosuppression: Patients who use corticosteroids, such as found in AirDuo Digihaler and ArmonAir Digihaler are at risk for potential worsening of existing tuberculosis; fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex. A more serious or even fatal course of chickenpox or measles may occur in susceptible patients. Use with caution in patients with the above because of the potential for worsening of these infections
  • Transferring Patients from Systemic Corticosteroid Therapy: Particular care is needed for patients who have been transferred from systemically active corticosteroids to ICS because deaths due to adrenal insufficiency have occurred in patients with asthma during and after transfer from systemic corticosteroids to less systemically available ICS. Taper patients slowly from systemic corticosteroids if transferring to ArmonAir Digihaler or AirDuo Digihaler
  • Hypercorticism and Adrenal Suppression may occur with high doses of ICS, including fluticasone propionate, or at the recommended dose in susceptible individuals. If such changes occur, discontinue ArmonAir Digihaler or AirDuo Digihaler slowly
  • Drug Interactions with Strong Cytochrome P450 3A4 Inhibitors: The use of strong cytochrome P450 3A4 (CYP3A4) inhibitors (e.g., ritonavir, ketoconazole) with ArmonAir Digihaler or AirDuo Digihaler is not recommended because increased systemic corticosteroid adverse effects may occur; increased cardiovascular adverse effects may also occur with AirDuo Digihaler
  • Paradoxical Bronchospasm and Upper Airway Symptoms: Paradoxical bronchospasm may occur. If bronchospasm occurs treat immediately with an inhaled, short-acting bronchodilator discontinue AirDuo Digihaler or ArmonAir Digihaler and institute alternative therapy
  • Hypersensitivity Reactions, Including Anaphylaxis: Immediate hypersensitivity reactions (e.g., urticaria, angioedema, rash, bronchospasm, hypotension), including anaphylaxis, may occur after administration of ArmonAir Digihaler or AirDuo Digihaler. Discontinue ArmonAir Digihaler or AirDuo Digihaler if such reactions occur
  • Cardiovascular and Central Nervous System Effects: The salmeterol component of AirDuo Digihaler, can be associated with excessive beta-adrenergic stimulation which could present as the following symptoms: seizures, angina, hypertension or hypotension, tachycardia with rates up to 200 beats/min, arrhythmias, nervousness, headache, tremor, palpitation, nausea, dizziness, fatigue, malaise, and insomnia. Use with caution in patients with cardiac arrhythmias, hypertension, coronary insufficiency. Drug may need to be discontinued in certain patients.
  • Reduction in Bone Mineral Density (BMD): Decreases in BMD have been observed with long-term administration of products containing ICS. Patients with major risk factors for decreased bone mineral content, such as prolonged immobilization, family history of osteoporosis, or chronic use of drugs that can reduce bone mass (e.g., anticonvulsants, oral corticosteroids) should be monitored and treated with established standards of care when using ArmonAir Digihaler or AirDuo Digihaler
  • Effect on Growth: ICS may cause a reduction in growth velocity. Patients should be maintained on the lowest dose of inhaled corticosteroid that effectively controls their asthma. Monitor growth of pediatric patients receiving ArmonAir Digihaler and AirDuo Digihaler.
  • Glaucoma and Cataracts: Long-term use of ICS, including fluticasone propionate, a component of ArmonAir Digihaler and AirDuo Digihaler, may increase the risk for cataracts or glaucoma. Regular eye exams should be considered
  • Eosinophilic Conditions and Churg‑Strauss Syndrome: Systemic eosinophilic conditions, such as Churg-Strauss syndrome, may occur when using ArmonAir Digihaler or AirDuo Digihaler. Be alert to eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy
  • Coexisting Conditions: Use AirDuo Digihaler with caution in patients with convulsive disorders, thyrotoxicosis, diabetes mellitus, ketoacidosis, and in patients who are unusually responsive to sympathomimetic amines
  • Hypokalemia and Hyperglycemia: Beta‑adrenergic agonist medicines may produce significant hypokalemia in some patients, possibly through intracellular shunting, which has the potential to produce adverse cardiovascular effects. Decreases in serum potassium are usually transient, not requiring supplementation. Be alert to hypokalemia and hyperglycemia in patients using AirDuo Digihaler
  • Adverse Reactions with ArmonAir Digihaler: Most common adverse reactions (reported in greater than or equal to 3% of subjects) are: upper respiratory tract infection, nasopharyngitis, oral candidiasis, headache, and cough
  • Adverse Reactions with AirDuo Digihaler: Most common adverse reactions (reported in greater than or equal to 3% of patients) include nasopharyngitis, oral candidiasis, headache, cough and back pain

Please see full Prescribing Information for AirDuo Digihaler and ArmonAir Digihaler.

 

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