Privacy Policy and Compliance

Online Privacy Policy

We at PARI Respiratory Equipment, Inc. and our affiliated companies worldwide ("PARI") are committed to respecting your online privacy and recognize your need for appropriate protection and management of any personally identifiable information ("Personal Information") you share with us. PARI has established this Online Privacy Policy so that you can understand the care with which we intend to treat your Personal Information.

Personal Information means any information that may be used to identify an individual, including, but not limited to, a first and last name, a home or other physical address and an e-mail address or other contact information. In general, you can visit PARI’s web pages (the "Site") without telling us who you are or revealing any Personal Information about yourself.

We may transfer Personal Information within PARI or to PARI’s third-party service providers, across borders, and from your country or jurisdiction to other countries or jurisdictions around the world.

By using this Site, you consent to the terms of our Online Privacy Policy and to PARI’s processing of Personal Information for the purposes provided herein, as well as those explained where PARI collects Personal Information on the Site. We reserve the right to change the terms of this Online Privacy Policy at any time, but will not do so without posting the revised Online Privacy Policy on this Site. We encourage you to review this Online Privacy Policy whenever you visit our Site to make sure you understand how we use the information we collect.

(a) Collection of Personal Information from Site Users; Cookies. PARI may collect and/or track (1) the home server domain names, e-mail addresses, type of computer, and type of web browser of users to the Site, (2) the e-mail addresses of users that communicate with PARI or the Site via e-mail, (3) information knowingly provided by the user in online forms, registration forms, surveys, etc. (including name, address, e-mail and other personal profile data), and (4) aggregate and user-specific information on which pages users access.

PARI may place Internet "cookies" on users’ hard drives. Internet cookies save data about individual users, such as the user’s name, password, user-name, screen preferences, the pages of the Site viewed by the user, and the advertisements viewed or clicked by the user. When the user revisits the Site, PARI may recognize the visitor by the Internet cookie and customize the user’s experience accordingly. Users may decline Internet cookies, if any, by using the appropriate feature of their web client software, if available. However, declining to use cookies may impede the ability of the Site to function properly.

When a user performs a search within the Site, PARI may record information identifying the user or linking the user to the search performed. PARI may also record limited information associated with every search request made by the user and use that information to, among other things, solve technical problems with the service and to calculate overall usage statistics.

(b) Use of Personal Data Collected. PARI may use the Personal Information it collects for internal purposes, namely, for solving technical problems, calculating overall usage statistics, for internal marketing and promotional purposes, product development, and content improvement.

(c) Security Measures. PARI may implement security features to prevent the unauthorized release of or access to personal information. Please note, however, that PARI cannot guarantee the confidentiality of any communication or material transmitted to/from PARI via the Site or e-mail. Accordingly, PARI is not responsible for the security of information transmitted via the Internet. For more private communication, users can contact PARI by telephone at the telephone number provided on the Site on the web page titled "Contact Us".

(d) Opt-Out Right. Users may at any time opt out of having their Personal Information used by PARI to send promotional correspondence to the user, by contacting PARI via postal mail at: PARI Respiratory Equipment, Inc., 2412 PARI Way, Midlothian, VA 23112.

(e) Access to and Ability to Correct Personal Data. Upon request via postal mail, PARI will provide to users a summary of any Personal Information retained by PARI regarding the user. Users may modify, correct, change or update Personal Information that PARI has collected at the Site or may cause their personal record to be removed from PARI’s database by contacting PARI via postal mail indicated in paragraph (d) above.

(f) Collection of Personal Data from Children. PARI does not knowingly solicit information from children and we do not knowingly market the Site or its services to children. No one under the age of 13 should submit any personal information to PARI and/or the Site.

(g) PARI’s Right to Contact Site Users. PARI reserves the right to contact users of the Site regarding changes to this Privacy Policy or any other policies or agreements relevant to Site users.

(h) Third Party Services. Third parties provide certain services for PARI. PARI may provide information, including Personal Information that PARI collects on the Site to third-party service providers to help us deliver programs, products, information, and services. Service providers are also an important means by which PARI maintains its Site and mailing lists. PARI will take reasonable steps to ensure that these third-party service providers are obligated to protect Personal Information on PARI’s behalf.

PARI does not intend to transfer Personal Information without your consent to third parties who are not bound to act on PARI’s behalf unless such transfer is legally required. Similarly, it is against PARI’ policy to sell Personal Information collected online without consent.

California Compliance Law

Statement regarding compliance with California Health & Safety Code § 119402

California Health & Safety Code, Sections 119400 – 119402, requires pharmaceutical companies to adopt a compliance program in accordance with the April 2003 publication "Compliance Program Guidance for Pharmaceutical Manufacturers."

For purposes of compliance with the requirements of the California Compliance Law and as part of the Compliance Program, PARI Respiratory Equipment (hereafter, "PRE") has established an annual spending limit of no more than $2,000 per health care professional. Such items generally are provided to physicians and certain other health care professionals in order to facilitate an educational or scientific discussion about the company’s products, the company’s research and development efforts, and other health care-related issues. PRE’s limit also includes educational items provided to a physician (such as a medical textbook) that are intended to benefit patient care. Any promotional items provided to a physician must comply with PRE policies and the PhRMA Code on Interactions with Healthcare Professionals. This limit may be revised, in which case the revised limit will be published in this section of the Company website. In many cases the amount spent per physician may be substantially less than the cap amount. This figure is a maximum limit. It is neither a spending goal nor does it represent a typical amount spent on medical or health care professionals. PRE has established an internal monitoring system designed to help ensure compliance with the annual spending limits in California.

The annual limits do not include the following:

  • Drug samples given to physicians and healthcare professionals

  • Financial support for continuing medical education forums or support for health educational scholarships

  • Payments for legitimate professionals services, and any meals or expenses associated with the provision of such services

  • Items of nominal value with a retail value of less than $10 (e.g., visual aids, reprints of medical journal articles)

  • Patient educational materials provided to patients by their physician with the purpose of educating the patient or enhancing the patient’s understanding or management of the condition

PRE Annual Declaration (July 2024)

PRE Holding has established a Corporate Compliance Program and hereby declares that to the best of its knowledge, information, and belief that it meets the requirements of California Health and Safety Code 119400-119402. In making this declaration of compliance, PRE is asserting that its Compliance Program is reasonably designed to prevent and detect violations of law, regulations, and company policies, and provides for disciplinary and corrective actions when appropriate. PRE does not assert that it can prevent individual employees from engaging in improper conduct. For a copy of PRE’s Compliance Program or a written declaration of compliance, email info@kitabis.com

Indication

Kitabis Pak (co-packaging of tobramycin inhalation solution and a PARI LC PLUS Reusable Nebulizer) is indicated for the management of cystic fibrosis in adults and pediatric patients 6 years of age and older with P. aeruginosa. Safety and efficacy have not been demonstrated in patients under the age of 6 years, patients with FEV1 <25% or >75% predicted, or patients colonized with Burkholderia cepacia.

Important Safety Information

Do not take Kitabis Pak (Tobramycin Inhalation Solution) if you are allergic to tobramycin, or any of the ingredients in Kitabis Pak, or any aminoglycoside antibiotic.

Before taking Kitabis Pak, inform your health care provider if you have or have had any hearing problems (including noises in your ears such as ringing or hissing), hearing loss, your mother has had hearing problems after taking an aminoglycoside, you have been told you have certain gene variants related to hearing abnormalities inherited from your mother, dizziness, kidney problems, muscle weakness such as myasthenia gravis or Parkinson's disease, breathing problems such as wheezing, coughing or chest tightness, or have had an organ transplant. Before you inhale Kitabis Pak, inform your health care provider if you are pregnant, plan to become pregnant, are breastfeeding, or plan to breastfeed. It is not known if Kitabis Pak will pass into breast milk.

Tell your health care provider about all the medicines you take. Taking Kitabis Pak with certain other medications can cause serious side effects. If you are taking Kitabis Pak, you should discuss with your health care provider if you should take other medicines that may harm your nervous system, kidneys or hearing, or diuretics (water pills) such as Edecrin® (ethacrynic acid), Lasix® (furosemide), mannitol, or urea.

Kitabis Pak can cause serious side effects including hearing loss or ringing in the ears (ototoxicity), worsening kidney problems (nephrotoxicity), worsening muscle weakness, harm to an unborn baby, and/or severe breathing problems (bronchospasm). Tell your health care provider right away if you have hearing loss or hear noises in your ears (such as ringing or hissing), develop vertigo, dizziness, difficulty with balance, shortness of breath with wheezing, or coughing or chest tightness. Your health care provider may do a blood test and urine test to check how your kidneys are working while you are taking Kitabis Pak.

The most common side effects of Kitabis Pak include cough, sore throat, productive cough, shortness of breath, coughing up blood, worsening of lung problems or cystic fibrosis, changes in your voice (hoarseness), altered taste, and rash. Tell your health care provider about any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see full prescribing information.

This web site is intended for United States residents only.

Indication

Kitabis Pak (co-packaging of tobramycin inhalation solution and a PARI LC PLUS Reusable Nebulizer) is indicated for the management of cystic fibrosis in adults and pediatric patients 6 years of age and older with P. aeruginosa. Safety and efficacy have not been demonstrated in patients under the age of 6 years, patients with FEV1 <25% or >75% predicted, or patients colonized with Burkholderia cepacia.

Important Safety Information

Do not take Kitabis Pak (Tobramycin Inhalation Solution) if you are allergic to tobramycin, or any of the ingredients in Kitabis Pak, or any aminoglycoside antibiotic.

Before taking Kitabis Pak, inform your health care provider if you have or have had any hearing problems (including noises in your ears such as ringing or hissing), hearing loss, your mother has had hearing problems after taking an aminoglycoside, you have been told you have certain gene variants related to hearing abnormalities inherited from your mother, dizziness, kidney problems, muscle weakness such as myasthenia gravis or Parkinson's disease, breathing problems such as wheezing, coughing or chest tightness, or have had an organ transplant. Before you inhale Kitabis Pak, inform your health care provider if you are pregnant, plan to become pregnant, are breastfeeding, or plan to breastfeed. It is not known if Kitabis Pak will pass into breast milk.

Tell your health care provider about all the medicines you take. Taking Kitabis Pak with certain other medications can cause serious side effects. If you are taking Kitabis Pak, you should discuss with your health care provider if you should take other medicines that may harm your nervous system, kidneys or hearing, or diuretics (water pills) such as Edecrin® (ethacrynic acid), Lasix® (furosemide), mannitol, or urea.

Kitabis Pak can cause serious side effects including hearing loss or ringing in the ears (ototoxicity), worsening kidney problems (nephrotoxicity), worsening muscle weakness, harm to an unborn baby, and/or severe breathing problems (bronchospasm). Tell your health care provider right away if you have hearing loss or hear noises in your ears (such as ringing or hissing), develop vertigo, dizziness, difficulty with balance, shortness of breath with wheezing, or coughing or chest tightness. Your health care provider may do a blood test and urine test to check how your kidneys are working while you are taking Kitabis Pak.

The most common side effects of Kitabis Pak include cough, sore throat, productive cough, shortness of breath, coughing up blood, worsening of lung problems or cystic fibrosis, changes in your voice (hoarseness), altered taste, and rash. Tell your health care provider about any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see full prescribing information.

This web site is intended for United States residents only.

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Tobi® is a registered trademark of Novartis AG.

BETHKIS® is a registered trademark of Chiesi Farmaceutici, S.p.A.