Privacy Policy

GENBIOPRO, Inc. (“GENBIOPRO” or “We”) values the privacy of its users and others (“You,” or individually each a “User” and collectively “Users””) who visit and use www.genbiopro.com and its associated products and services (the “Site”).

This statement (the “Privacy Policy”) governs information provided to us by you as a User of the site or that we learn from your use of the Site, and tells You how we may collect, use, in some instances share this information. This Privacy Policy is part of and incorporated into the Terms of Use, found at www.genbiopro.com which is a legally binding agreement between GENBIOPRO and you.

Please read this policy carefully to understand our policies and practices regarding your information and how we will treat it. If you do not agree with our policies and practices, your choice is not to use our Site.

BY ACCESSING, BROWSING, OR USING THE SITE, YOU ACKNOWLEDGE THAT YOU HAVE RECEIVED, READ, UNDERSTOOD, AND AGREE TO BE BOUND BY THE FOLLOWING PRIVACY POLICY, AND ANY UPDATES TO IT.

YOU FURTHERMORE ACKNOWLEDGE AND AGREE THAT GENBIOPRO IS NOT A MEDICAL PRACTICE AND DOES NOT PROVIDE MEDICAL ADVICE.

The Personal Information We Collect about you and How we collect it
It is your choice whether to provide GENBIOPRO with information by which you may be personally identifiable such as Your name, email address, postal mailing address, home/mobile telephone number, fax number (“Personal Information”).

The personal information We collect on or through our Site may include (a) information that you need to provide in order to access some areas of our Site or to benefit from some specific features of our Site and (b) Information that you provide by filling in forms on our Site to contact us by email, to report a problem, or when you use the “share this page” feature.

The Non-Personal Information We Collect about you and How we collect it
As you navigate through and interact with our Site, We may automatically collect certain information through the use of cookies, web beacons, or log files. A cookie is a small text file that is stored on your hard drive for record keeping purposes. A web beacon is a small invisible GIF file, usually embedded in the website, that helps track the online movements of Users. We also gather information in our log files, as do most web sites. This information includes Information about your computer and internet connection, including your Internet protocol (“IP”) address, browser type, referring pages and details of your visits to our Site including tracking data, location data and other data and resources that you access and use on the Site. The information in the log files is statistical data and does not identify individual Users. We use the information collected through cookies, web beacons and log files to understand how our Users navigate our Site, and to determine common traffic patterns. We may use this information to improve our Site, to make Site navigation recommendations, and to help redesign the Site in order to make Your experience on the Site more efficient and enjoyable.

You also have choices with respect to cookies. By changing Your internet browser settings, You have the choice to accept all cookies, to be notified when a cookie is set, or to reject all cookies

This Privacy Policy is incorporated in the Terms of Use
As indicated above, your use of the Site is governed by the GENBIOPRO Terms of Use. The Terms of Use contain important provisions, including provisions disclaiming, limiting, or excluding the liability of GENBIOPRO for your use of the Website and provisions determining the applicable law and exclusive jurisdiction for the resolution of any disputes regarding your use of the Website. Each of the provisions of the Terms of Use applies to any disputes that may arise in relation to this Privacy Policy and the collection, use and disclosure of your personal information and are of the same force and effect as if they had been reproduced directly in this Privacy Policy, by activating the appropriate setting on your browser. If You choose to reject all cookies, You may be unable to access certain parts of this Site that require the placement of cookies. Unless you have adjusted your browser setting so that it will refuse cookies, our system will issue cookies when you direct your browser to our Site.

The Way We Use Information
We uses the information that we collect from You to provide to You all of the features and services found on the Site. We may use Your email address, without further consent, to market and promote our services to You and for non-marketing or administrative purposes such as notifying You of major site updates. We may also use Your email address to send materials that You request (e.g. newsletters and RSS feeds).

We may use all of the information that we collect from You and our other Users to understand the usage trends and preferences, to improve the way the Site works and looks, to improve our marketing and promotional efforts, and to create new features and functionality.

We may use automatically collected information and cookies information (as described above) to (a) remember Your information so that You will not have to re-enter it during Your visit or the next time You visit the Site; (b) improve the functioning of the Site and other services that we provide and (c) provide advertisements, content, and information.

You should assume that we will use all information for all lawful purposes except insofar as this Agreement expressly limits our use of your information in some way.

When GENBIOPRO Discloses Information
We reserve the right to use, disclose, retain, share and otherwise deal with all information collected via the Site internally or to third parties, for any lawful purpose or to prevent harm to us or others. For example, and without limitation, in our discretion we may:

  • Disclose information to service providers and others in order to deal with requests and questions from you; to personalize or enhance your experience; and to assist or respond to our consultants.
  • Disclose information to government regulators, law enforcement authorities or alleged victims of identify theft, as well as voluntary disclosures; and
  • Disclose any matter relating to the Site or your account not listed in this Privacy Policy, but which is not prohibited by law from being disclosed.

We do not purport to have listed all possible disclosures that we might make. This Privacy Policy is intended to help you understand our general practices. This Privacy Policy is not a promise that your information will never be disclosed except as described above. For example, third parties may unlawfully intercept or access information transmitted to or contained on the Site, technologies may malfunction or not work as anticipated, or someone might access, abuse or misuse information, despite a lack of permission. Although we use what we believe to be commercially reasonable practices to protect your privacy, that does not mean, and you should not expect it to mean, that your information or communications will always be private or protected.

We generally will retain information for as long as required, allowed or for as long as we believe it useful. If you cease using the Site, or your permission to use the Site is terminated, we may continue to use and disclose your personal information in accordance with this Policy. We do not undertake retention obligations through this Privacy Policy. We may dispose of information in our discretion without notice, subject to applicable law.

Children under the age of 13
Our Site is not intended for children under thirteen (13) years of age. No age under age thirteen (13) may provide any information on our Site. Consistent with the Children’s Online Privacy Protection Act of 1998 (COPPA), GENBIOPRO will never knowingly request information from anyone under the age of thirteen (13) without requiring parental consent. IF YOU ARE UNDER THIRTEEN (13) YEARS OF AGE, THEN PLEASE DO NOT USE OR ACCESS THE SITE AT ANY TIME OR IN ANY MANNER. Any person who provides their personal information to GENBIOPRO through the Site represents that they are thirteen (13) years of age or older. If you believe the personally identifiable information of anyone under the age of thirteen (13) has been provided to GENBIOPRO, and you are the parent or guardian of that individual, you may contact us to request that we delete any such personally identifiable information, at info@genbiopro.com.

Our Commitment to Data Security
No data transmissions over the internet can be guaranteed to be 100% secure. Consequently, we cannot ensure or warrant the security of any information You transmit to us and You do so at Your own risk. Once we receive Your transmission of information, We implement reasonable administrative, technical and physical safeguards designed to ensure the security and confidentiality of Your information, protect against any anticipated threats or hazards to the security or integrity of such information, and protect against unauthorized access to or use of such information that could result in substantial harm or inconvenience to any User. These safeguards include use of a firewall, content filtering, intrusion detection, SSL encryption, a DMZ, and access controls. However, please note that this is not a guarantee that such information may not be accessed, disclosed, altered, or destroyed by breach of any of our physical, technical, or administrative safeguards.

If GENBIOPRO learns of a security system breach, then we may attempt to notify You electronically so that You can take appropriate protective steps. By using the Site, You agree that We can communicate with You electronically regarding security, privacy, and administrative issues relating to Your use of the Site. We may post a notice on the Site if a security breach occurs. We may also send an email to You at the email address You have provided. Depending on where You live, You may have a legal right to receive notice of a security breach in writing. To receive a free written notice of a security breach (or to withdraw Your consent from receiving electronic notices), You must notify us via email at [email address].

Special Note to International Users
The Site is hosted in the United States of America. If You are a User that is a resident of another country, or are accessing the Site from outside of the United States of America, please note that You are transferring Your data to the United States of America which does not have the same data protection laws as the European Union and other regions, and by providing Your data You explicitly consent to (i) the use of Your data for the uses identified above in accordance with the Privacy Policy and (ii) the transfer of your data, including personally identifiable information, to the United States of America as indicated above. In order to use the Site, You must be the age of majority in Your jurisdiction and fully able and competent to enter into the terms, conditions, obligations, affirmations, representations and warranties set forth in the Terms and to abide by and comply with the Terms. You represent that You meet the eligibility requirements in this Section and that You are over the age of 13, as the Site is not intended for children under 13.

Accessing and Correcting Your Information
You can review and change your personal information by sending us an e-mail at info@genbiopro.com to request access to, correct or delete any personal information that you have provided to us. We may not accommodate a request to change information if we believe the change would violate any law or legal requirement or cause the information to be incorrect.

In the Event of Merger or Sale
If GENBIOPRO should ever sell its assets or merge with another entity, or file for bankruptcy, the information GENBIOPRO receives from You through the Site, including personally identifiable information, is a GENBIOPRO asset and may be transferred as permitted by applicable law.

Privacy Policy incorporated in the Terms of Use
As indicated above, your use of the Site is governed by the GENBIOPRO Terms of Use. The Terms of Use contain important provisions, including provisions disclaiming, limiting, or excluding the liability of GENBIOPRO for your use of the Site and provisions determining the applicable law and exclusive jurisdiction for the resolution of any disputes regarding your use of the Site. Each of the provisions of the Terms of Use applies to any disputes that may arise in relation to this Privacy Policy and the collection, use and disclosure of your personal information and are of the same force and effect as if they had been reproduced directly in this Privacy Policy.

Changes and Updates to this Privacy Policy
We may occasionally update this Privacy Policy. When we do, we will also revise the “Last Updated” section below. Any information that we collect from You online is subject only to GENBIOPRO’s most current Privacy Policy in place at the time that such information is collected. We encourage You to periodically review this Privacy Policy to stay informed about how we are protecting the personal information we collect. Your continued use of the Site constitutes your agreement to this Privacy Policy and any updates. Updates will only apply after the effective date of the update.

Contacting GENBIOPRO
If You have any questions, comments, or concerns about this Privacy Policy, please email us at info@genbiopro.com or write to us at:

Postal Mail Address:
GenBioPro, Inc.
PO Box 32011
Las Vegas, NV 89103
Email: info@genbiopro.com
Telephone: 1-866-611-4716
Fax: 1-877-239-8036

Last Updated May 28, 2019

Important Safety Information

Mifepristone tablets, 200 mg is indicated, in a regimen with misoprostol, for the medical termination of intrauterine pregnancy through 70 days gestation.

IMPORTANT SAFETY INFORMATION

WARNING: SERIOUS AND SOMETIMES FATAL INFECTIONS OR BLEEDING

Serious and sometimes fatal infections and bleeding occur very rarely following spontaneous, surgical, and medical abortions, including following Mifepristone tablets, 200 mg use. No causal relationship between the use of Mifepristone tablets, 200 mg and misoprostol and these events has been established.

  • Atypical Presentation of Infection. Patients with serious bacterial infections (e.g., Clostridium sordellii) and sepsis can present without fever, bacteremia, or significant findings on pelvic examination following an abortion. Very rarely, deaths have been reported in patients who presented without fever, with or without abdominal pain, but with leukocytosis with a marked left shift, tachycardia, hemoconcentration, and general malaise. A high index of suspicion is needed to rule out serious infection and sepsis.
  • Bleeding. Prolonged heavy bleeding may be a sign of incomplete abortion or other complications and prompt medical or surgical intervention may be needed. Advise patients to seek immediate medical attention if they experience prolonged heavy vaginal bleeding.

Because of the risks of serious complications described above, Mifepristone tablets, 200 mg is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the mifepristone REMS Program.

Before prescribing mifepristone, inform the patient about the risk of these serious events. Ensure that the patient knows whom to call and what to do, including going to an Emergency Room if none of the provided contacts are reachable, if they experience sustained fever, severe abdominal pain, prolonged heavy bleeding, or syncope, or if they experience abdominal pain or discomfort, or general malaise (including weakness, nausea, vomiting, or diarrhea) for more than 24 hours after taking misoprostol.

 

Contraindications 

  • Administration of Mifepristone tablets, 200 mg and misoprostol for the termination of pregnancy (the “treatment procedure”) is contraindicated in patients with any of the following conditions:
    • Confirmed or suspected ectopic pregnancy or undiagnosed adnexal mass (the treatment procedure will not be effective to terminate an ectopic pregnancy)
    • Chronic adrenal failure (risk of acute adrenal insufficiency)
    • Concurrent long-term corticosteroid therapy (risk of acute adrenal insufficiency)
    • History of allergy to mifepristone, misoprostol, or other prostaglandins (allergic reactions including anaphylaxis, angioedema, rash, hives, and itching have been reported)
    • Hemorrhagic disorders or concurrent anticoagulant therapy (risk of heavy bleeding)
    • Inherited porphyrias (risk of worsening or of precipitation of attacks)
  • Use of Mifepristone tablets, 200 mg and misoprostol for termination of intrauterine pregnancy is contraindicated in patients with an intrauterine device (“IUD”) in place (the IUD might interfere with pregnancy termination). If the IUD is removed, Mifepristone tablets, 200 mg may be used.

Warnings and Precautions

Infection and Sepsis

  • As with other types of abortion, cases of serious bacterial infection, including very rare cases of fatal septic shock, have been reported following the use of Mifepristone tablets, 200 mg. Healthcare providers evaluating a patient who is undergoing a medical abortion should be alert to the possibility of this rare event. A sustained (> 4 hours) fever of 100.4°F or higher, severe abdominal pain, or pelvic tenderness in the days after a medical abortion may be an indication of infection.
  • A high index of suspicion is needed to rule out sepsis (e.g., from Clostridium sordellii) if a patient reports abdominal pain or discomfort or general malaise (including weakness, nausea, vomiting, or diarrhea) more than 24 hours after taking misoprostol. Very rarely, deaths have been reported in patients who presented without fever, with or without abdominal pain, but with leukocytosis with a marked left shift, tachycardia, hemoconcentration, and general malaise. No causal relationship between Mifepristone tablets, 200 mg and misoprostol use and an increased risk of infection or death has been established. Clostridium sordellii infections have also been reported very rarely following childbirth (vaginal delivery and caesarian section), and in other gynecologic and non-gynecologic conditions.

Uterine Bleeding

  • Uterine bleeding occurs in almost all patients during a medical abortion. Prolonged heavy bleeding (soaking through two thick, full-size sanitary pads per hour for two consecutive hours) may be a sign of incomplete abortion or other complications, and prompt medical or surgical intervention may be needed to prevent the development of hypovolemic shock. Counsel patients to seek immediate medical attention if they experience prolonged heavy vaginal bleeding following a medical abortion.
  • Women should expect to experience vaginal bleeding or spotting for an average of 9 to 16 days. Women report experiencing heavy bleeding for a median direction of 2 days. Up to 8% of all subjects may experience some type of bleeding for 30 days or more.  In general, the duration of bleeding and spotting increased as the duration of the pregnancy increased.
  • Decreases in hemoglobin concentration, hematocrit, and red blood cell count may occur in patients who bleed heavily.
  • Excessive uterine bleeding usually requires treatment by uterotonics, vasoconstrictor drugs, surgical uterine evacuation, administration of saline infusions, and/or blood transfu­sions. Based on data from several large clinical trials, vasoconstrictor drugs were used in 4.3% of all subjects, there was a decrease in hemoglobin of more than 2 g/dL in 5.5% of subjects, and blood transfusions were administered to ≤ 0.1% of subjects. Because heavy bleeding requiring surgical uterine evacuation occurs in about 1% of patients, special care should be given to patients with hemostatic disorders, hypocoagulability, or severe anemia.

Mifepristone REMS Program

Mifepristone tablets, 200 mg is available only through a restricted program under a REMS called the mifepristone REMS Program, because of the risks of serious complications.

Notable requirements of the mifepristone REMS Program include the following:

  • Prescribers must be certified with the program by completing the Prescriber Agreement Form.
  • Patients must sign a Patient Agreement Form.
  • Mifepristone tablets, 200 mg must be dispensed to patients by or under the supervision of a certified prescriber, or by certified pharmacies on prescriptions issued by certified prescribers.

Further information is available at 1-855-MIFEINFO (1-855-643-3463).

Ectopic Pregnancy

Mifepristone tablets, 200 mg is contraindicated in patients with a confirmed or suspected ectopic pregnancy because mifepristone is not effective for terminating ectopic pregnancies. Healthcare providers should remain alert to the possibility that a patient who is undergoing a medical abortion could have an undiagnosed ectopic pregnancy because some of the expected symptoms experienced with a medical abortion (abdominal pain, uterine bleeding) may be similar to those of a ruptured ectopic pregnancy. The presence of an ectopic pregnancy may have been missed even if the patient underwent ultrasonography prior to being prescribed Mifepristone tablets, 200 mg.

Patients who became pregnant with an IUD in place should be assessed for ectopic pregnancy.

Rhesus Immunization

The use of Mifepristone tablets, 200 mg is assumed to require the same preventive measures as those taken prior to and during surgical abortion to prevent rhesus immunization.

Adverse Reactions

Most common adverse reactions (>15%) are nausea, weakness, fever/chills, vomiting, headache, diarrhea, and dizziness.

For additional information about mifepristone, see the Full Prescribing Information, including Boxed Warning.

Important Safety Information
Show More

Mifepristone tablets, 200 mg is indicated, in a regimen with misoprostol, for the medical termination of intrauterine pregnancy through 70 days gestation.

IMPORTANT SAFETY INFORMATION

WARNING: SERIOUS AND SOMETIMES FATAL INFECTIONS OR BLEEDING

Serious and sometimes fatal infections and bleeding occur very rarely following spontaneous, surgical, and medical abortions, including following Mifepristone tablets, 200 mg use. No causal relationship between the use of Mifepristone tablets, 200 mg and misoprostol and these events has been established.

  • Atypical Presentation of Infection. Patients with serious bacterial infections (e.g., Clostridium sordellii) and sepsis can present without fever, bacteremia, or significant findings on pelvic examination following an abortion. Very rarely, deaths have been reported in patients who presented without fever, with or without abdominal pain, but with leukocytosis with a marked left shift, tachycardia, hemoconcentration, and general malaise. A high index of suspicion is needed to rule out serious infection and sepsis.
  • Bleeding. Prolonged heavy bleeding may be a sign of incomplete abortion or other complications and prompt medical or surgical intervention may be needed. Advise patients to seek immediate medical attention if they experience prolonged heavy vaginal bleeding.

Because of the risks of serious complications described above, Mifepristone tablets, 200 mg is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the mifepristone REMS Program.

Before prescribing mifepristone, inform the patient about the risk of these serious events. Ensure that the patient knows whom to call and what to do, including going to an Emergency Room if none of the provided contacts are reachable, if they experience sustained fever, severe abdominal pain, prolonged heavy bleeding, or syncope, or if they experience abdominal pain or discomfort, or general malaise (including weakness, nausea, vomiting, or diarrhea) for more than 24 hours after taking misoprostol.

 

Contraindications 

  • Administration of Mifepristone tablets, 200 mg and misoprostol for the termination of pregnancy (the “treatment procedure”) is contraindicated in patients with any of the following conditions:
    • Confirmed or suspected ectopic pregnancy or undiagnosed adnexal mass (the treatment procedure will not be effective to terminate an ectopic pregnancy)
    • Chronic adrenal failure (risk of acute adrenal insufficiency)
    • Concurrent long-term corticosteroid therapy (risk of acute adrenal insufficiency)
    • History of allergy to mifepristone, misoprostol, or other prostaglandins (allergic reactions including anaphylaxis, angioedema, rash, hives, and itching have been reported)
    • Hemorrhagic disorders or concurrent anticoagulant therapy (risk of heavy bleeding)
    • Inherited porphyrias (risk of worsening or of precipitation of attacks)
  • Use of Mifepristone tablets, 200 mg and misoprostol for termination of intrauterine pregnancy is contraindicated in patients with an intrauterine device (“IUD”) in place (the IUD might interfere with pregnancy termination). If the IUD is removed, Mifepristone tablets, 200 mg may be used.

Warnings and Precautions

Infection and Sepsis

  • As with other types of abortion, cases of serious bacterial infection, including very rare cases of fatal septic shock, have been reported following the use of Mifepristone tablets, 200 mg. Healthcare providers evaluating a patient who is undergoing a medical abortion should be alert to the possibility of this rare event. A sustained (> 4 hours) fever of 100.4°F or higher, severe abdominal pain, or pelvic tenderness in the days after a medical abortion may be an indication of infection.
  • A high index of suspicion is needed to rule out sepsis (e.g., from Clostridium sordellii) if a patient reports abdominal pain or discomfort or general malaise (including weakness, nausea, vomiting, or diarrhea) more than 24 hours after taking misoprostol. Very rarely, deaths have been reported in patients who presented without fever, with or without abdominal pain, but with leukocytosis with a marked left shift, tachycardia, hemoconcentration, and general malaise. No causal relationship between Mifepristone tablets, 200 mg and misoprostol use and an increased risk of infection or death has been established. Clostridium sordellii infections have also been reported very rarely following childbirth (vaginal delivery and caesarian section), and in other gynecologic and non-gynecologic conditions.

Uterine Bleeding

  • Uterine bleeding occurs in almost all patients during a medical abortion. Prolonged heavy bleeding (soaking through two thick, full-size sanitary pads per hour for two consecutive hours) may be a sign of incomplete abortion or other complications, and prompt medical or surgical intervention may be needed to prevent the development of hypovolemic shock. Counsel patients to seek immediate medical attention if they experience prolonged heavy vaginal bleeding following a medical abortion.
  • Women should expect to experience vaginal bleeding or spotting for an average of 9 to 16 days. Women report experiencing heavy bleeding for a median direction of 2 days. Up to 8% of all subjects may experience some type of bleeding for 30 days or more.  In general, the duration of bleeding and spotting increased as the duration of the pregnancy increased.
  • Decreases in hemoglobin concentration, hematocrit, and red blood cell count may occur in patients who bleed heavily.
  • Excessive uterine bleeding usually requires treatment by uterotonics, vasoconstrictor drugs, surgical uterine evacuation, administration of saline infusions, and/or blood transfu­sions. Based on data from several large clinical trials, vasoconstrictor drugs were used in 4.3% of all subjects, there was a decrease in hemoglobin of more than 2 g/dL in 5.5% of subjects, and blood transfusions were administered to ≤ 0.1% of subjects. Because heavy bleeding requiring surgical uterine evacuation occurs in about 1% of patients, special care should be given to patients with hemostatic disorders, hypocoagulability, or severe anemia.

Mifepristone REMS Program

Mifepristone tablets, 200 mg is available only through a restricted program under a REMS called the mifepristone REMS Program, because of the risks of serious complications.

Notable requirements of the mifepristone REMS Program include the following:

  • Prescribers must be certified with the program by completing the Prescriber Agreement Form.
  • Patients must sign a Patient Agreement Form.
  • Mifepristone tablets, 200 mg must be dispensed to patients by or under the supervision of a certified prescriber, or by certified pharmacies on prescriptions issued by certified prescribers.

Further information is available at 1-855-MIFEINFO (1-855-643-3463).

Ectopic Pregnancy

Mifepristone tablets, 200 mg is contraindicated in patients with a confirmed or suspected ectopic pregnancy because mifepristone is not effective for terminating ectopic pregnancies. Healthcare providers should remain alert to the possibility that a patient who is undergoing a medical abortion could have an undiagnosed ectopic pregnancy because some of the expected symptoms experienced with a medical abortion (abdominal pain, uterine bleeding) may be similar to those of a ruptured ectopic pregnancy. The presence of an ectopic pregnancy may have been missed even if the patient underwent ultrasonography prior to being prescribed Mifepristone tablets, 200 mg.

Patients who became pregnant with an IUD in place should be assessed for ectopic pregnancy.

Rhesus Immunization

The use of Mifepristone tablets, 200 mg is assumed to require the same preventive measures as those taken prior to and during surgical abortion to prevent rhesus immunization.

Adverse Reactions

Most common adverse reactions (>15%) are nausea, weakness, fever/chills, vomiting, headache, diarrhea, and dizziness.

For additional information about mifepristone, see the Full Prescribing Information, including Boxed Warning.