Privacy Policy & Cookies

Privacy Policy & Cookies

This Site is owned by SERB (“Site”). This Privacy Policy is designed to tell you about our practices regarding collection, use, and disclosure of information that you may provide via this Site or that we may acquire from your use of the Site. We ask you to read this Privacy Policy carefully. There are terms and conditions associated with your usage and viewing of this Site. View these terms and conditions here.

In the event that you submit any material for inclusion on this Site (including without limitation, personal information, know-how, comments, ideas, questions, techniques, abstracts or similar), you agree (i) that such material will not be deemed to be confidential (ii) that such material will not be deemed to be proprietary and (iii) to grant to SERB an irrevocable, worldwide, perpetual, royalty-free, non-exclusive license to use, disclose, copy, modify, adapt, publicly display and translate all or any of such material for any purpose whatsoever without restriction. We reserve the right, in our absolute discretion, to remove or delete, without notice, any material you submit for inclusion on this Site. We also have the right to disclose your identity to any third party who is claiming that any material posted or uploaded by you to our Site constitutes a violation of their intellectual property rights, or of their right to privacy.

Information Collected by SERB

Website Use:

You can visit our Site and view most of the content anonymously; however, like many websites, we may collect the following personal information from you both by asking specific questions on the Site and by permitting you to communicate directly with SERB: (i) your name; (ii) email address; (iii) phone number; and (iv) any other information volunteered by you. We may hold your personal information in physical and electronic form and will hold, use and otherwise process the data in accordance with applicable data protection legislation.

In addition, as you navigate through the Site, certain information can be passively collected using various technologies. Like most website operators, we track IP addresses, use both session and persistent cookies, and assign internet tags. We may also collect personal data from third party sources, including publicly accessible data bases, marketing partners, social media platforms and information we collect when we monitor other websites.

HCPs:

If you are a healthcare professional, we may collect additional personal information about you either through your use of the Site or in relation to other interactions that you have with SERB, including:

  • personal details, including your name, age, gender and contact details;
  • professional details such as your job title, your professional field of expertise, your professional credentials, data related to your membership of associations and boards and any other professional affiliations you may have, and data relating to scientific research, publication of your research and articles, adverse event data and data related to your use of our products and your interactions with us; and
  • details of any interactions with SERB, including information relating to your use of our products, and the services you provide to your patients

Adverse Events:

If you are prescribed and/or administered one of our products, we may be notified by you or by someone acting on your behalf either directly or via one of our websites that an adverse event may have occurred. SERB takes the steps required by applicable regulations that may include attempts to and collection of personal identifiable information and treatment information related to your experience with a SERB product. When notified of a potential adverse event, the associated information is collected and used exclusively for the purposes required by applicable law and regulations.

If you provide us with personal data relating to a third party, we will assume you are authorized to share that data with us and that we are permitted to process that data in accordance with this privacy policy.

How SERB Uses Your Data – Purposes for Processing

We collect and process personal data about you to enable us to:

  • improve the content of our Site and the level of service we provide to you. This includes responding to your queries and sending administrative information to you, such as changes to our terms and policies
  • operate our business effectively and in accordance with our legal obligations as a healthcare company selling medicinal products and medical devices. This includes responding to reports that you make, or that someone else makes on your behalf, relating to adverse events suffered as a result of one of our products to enable us to monitor product safety, complying with applicable laws, regulation and guidance, which might include responding to the requests of regulators, government agencies or the courts
  • engage with third parties with whom we have a contractual relationship or a legitimate interest in so doing
    allow us to make sure you receive updated information on SERB's activities and business that may be of interest to you
  • improve our operations. This might include research to analyze trends and use of our website for internal review purposes or to improve the services we provide to you

If you are an HCP, we may collect and process your personal data to manage a contractual relationship with you (or the Healthcare Organization you work for) or if we have a legitimate business purpose in processing your data. This may include planning or effecting collaborations with you, arranging visits or meetings and better understanding your areas of expertise and interest so that we can ensure our communications to you are relevant.

Medical Contact Data Form - if you have completed a medical contact form on this Site, we will use the data provided to transfer the information to the correct SERB team who will respond as required. SERB will retain any information provided as part of a medical contact form as requested for regulatory audit purposes.

Lawful Grounds for Processing

Our processing of your personal data is necessary for the purposes of legitimate interests pursued by us, namely: (i) to keep our clients and suppliers informed about our business services; (ii) to evaluate, develop and improve our products and website; (iii) to respond appropriately to queries received about our business and products; (iv) to prevent fraud; (v) to protect our business interests; and (vi) to ensure complaints are investigated.

We may also process your personal data because it is necessary for a contract that you are a party to or are negotiating.

It may be necessary to process your personal data to comply with a legal obligation.

We may also use your personal data for purposes that are compatible with the purposes we have described to you including archiving purposes in the public interest, scientific research or statistical purposes, if permitted by data protection laws.

Sharing Your Personal Information

  • We occasionally use other companies to provide limited services on our behalf, including (but not limited to) travel agents, hotels and transportation services, as well as printing, packaging and mailing company reports. We will only provide those companies with your personal data to the extent it is needed to deliver the service and they are prohibited from using that information for any other purpose(s)
  • In relation to our adverse event reporting obligations, we may need to share your personal data with appropriate regulatory authorities as described previously
  • We may also share your personal information with a potential buyer in connection with (a) the sale, assignment, or other transfer of our business, in which case we will require any such buyer to agree to treat it in accordance with applicable Data Protection Legislation; or (b) where required by applicable laws, court orders, or government regulations
  • We only disclose your personal data to other third parties where we consider this necessary as a matter of law; to exercise, defend or protect our legal rights; or, to protect your vital interests or those of other people
  • We may disclose your personal data to any of our affiliates worldwide that agree to treat such information in accordance with this Privacy Policy or a policy which is no less restrictive than this Privacy Policy

Data Transfer Abroad

Information about you in our possession may be transferred to other countries (for the avoidance of doubt, if your residence is within the European Economic Area (EEA), this may include countries outside the EEA). You understand and accept that these countries may have differing (and potentially less stringent) laws relating to the degree of confidentiality afforded to the information it holds and that such information can become subject to the laws and disclosure requirements of such countries.

Where cross-border data transfer requirements exist (e.g. EEA), SERB and any third parties working on our behalf will comply with applicable legal and/or regulatory requirements. We or they may also require the recipient to subscribe to international frameworks intended to enable secure data sharing. In the case of transfers by us, we may also transfer your information where:(i) the transfer is to a country deemed to provide adequate protection of your information by the European Commission; or (ii) where you have consented to the transfer.

Your Rights

You have a number of rights concerning the way that we use your information. At any time, you have the right to:

  • be informed about the processing of your personal data (i.e. for what purposes, what types, to what recipients it is disclosed, storage periods, any third party sources from it was obtained, confirmation of whether we undertake automated decision-making, including profiling, and the logic, significance and envisaged consequences);
  • request access to or a copy of any personal data we hold about you;
  • request the rectification of your personal data, if you consider that it is inaccurate;
  • request the erasure of your personal data, if you consider that we do not have the right to hold it;
  • object to your personal data being processed for a particular purpose or to request that we stop using your information in certain circumstances;
  • ask us to transfer a copy of your personal data to you or to another service provider or third party where technically feasible; or
  • ask us to stop or start sending you marketing messages at any time by using the below contact details

Any request for access to or a copy of your personal data must be in writing and we will endeavor to respond within a reasonable period and in any event within one month in compliance with applicable data protection legislation.

When you are asked to provide your personal data to us, you have the option to decline. However, if you choose not to provide such data or, if you initially consent to processing but later withdraw your consent, SERB may not be able to provide the services you have requested.

Personal Information Retention

We will only keep the information we collect about you on our systems or with third parties for as long as required for the purposes set out above or as required to comply with any legal obligations to which we are subject. We will delete, destroy or anonymize data that is no longer needed for the purposes.

Automated processing

We do not carry out automated decision-making or profiling in relation to your personal data.

Children

This Site is not directed at children under 16, and we do not knowingly collect, use or disclose personally identifiable information from anyone under the age of 16. If we become aware that we have unknowingly collected personally identifiable information from a child under the age of 16, we will make reasonable efforts to delete such information from our records.

Security

We take appropriate steps to protect your personally identifiable information as you transmit your information from your computer to our Site or otherwise provide us with your information and to protect such information from loss, misuse, unauthorized access, disclosure, alteration, or destruction. You should keep in mind that no Internet transmission is ever 100% secure or error-free.

Cookies

A cookie is a small piece of data (text file) that a website – when visited by a user – asks your browser to store on your device in order to remember information about you, such as your language preference or login information. Those cookies are set by us and called first-party cookies. We also use third-party cookies – which are cookies from a domain different than the domain of the website you are visiting – for our advertising and marketing efforts. More specifically, we use cookies and other tracking technologies for the following purposes:

Strictly Necessary Cookies

These cookies are necessary for the website to function and cannot be switched off in our systems. They are usually only set in response to actions made by you which amount to a request for services, such as setting your privacy preferences, logging in or filling in forms. You can set your browser to block or alert you about these cookies, but some parts of the site will not then work. These cookies do not store any personally identifiable information.

Performance Cookies

These cookies allow us to count visits and traffic sources so we can measure and improve the performance of our site. They help us to know which pages are the most and least popular and see how visitors move around the site. All information these cookies collect is aggregated and therefore anonymous. If you do not allow these cookies we will not know when you have visited our site, and will not be able to monitor its performance.

Targeting Cookies

These cookies may be set through our site by our advertising partners. They may be used by those companies to build a profile of your interests and show you relevant adverts on other sites. They do not store directly personal information, but are based on uniquely identifying your browser and internet device. If you do not allow these cookies, you will experience less targeted advertising.

Functional Cookies

These cookies enable the website to provide enhanced functionality and personalization. They may be set by us or by third party providers whose services we have added to our pages. If you do not allow these cookies then some or all of these services may not function properly.

Use of Google Analytics

This Site uses Google Analytics, a web analytics service provided by Google, Inc.

Google Analytics sets a cookie in order to evaluate your use of the Site and compile reports for us on activity on the Site to help us understand how visitors engage with the Site and track visitor interactions. Google Analytics collects information anonymously and without identifying individual visitors.

Google stores the information collected by the cookie on servers in the United States. Google may also transfer this information to third parties where required to do so by law, or where such third parties process the information on Google's behalf. Google will not associate your IP address with any other data held by Google. Google Analytics uses its own cookies to store information, such as what time the visit occurred, whether the visitor has been to the Site before, and what Site referred the visitor to the web page. To disable this type of cookie, some browsers will indicate when a cookie is being sent and allow you to decline cookies on a case-by-case basis. In addition to declining cookies, you can also install the Google Analytics Opt-out Add-on in your browser, which prevents Google Analytics from collecting information about your Site visits.

Learn more about the Google Analytics Opt-out Browser Add-on and other Google Analytics privacy information:

Changes

As part of SERB's commitment to compliance with data protection legislation, and to reflect changes in SERB's operating procedures, SERB may update the terms of this policy from time to time. We therefore ask you to check it occasionally to ensure that you are aware of the most recent version which will apply each time you access this Site. If the changes we make are material, we also may post a notice regarding the changes on our website or mobile applications and related licensing agreements. Subsequent changes in this Privacy Policy will not apply to information that was collected before such change was made. This Privacy Statement was last updated on 13 July 2018.

Contact Information

SERB Plc or its affiliates Legal Notice are the controllers of your personal data as described in this Privacy Policy.

If you have any questions, concerns or comments about this Privacy Policy, wish to exercise any of your rights or if you wish to contact SERB (and its data protection officer) about the personally identifiable information held about you, please email SERB at dpo@serb.com.

If you have any concerns about our use of your information, you also have the right to make a complaint to the Information Commissioner's Office, which regulates and supervises the use of personal data in the UK, via their helpline on 0303 123 1113.

Indication and Important Safety Information
Indication

CroFab® Crotalidae Polyvalent Immune Fab (Ovine) is a sheep-derived antivenin indicated for the management of adult and pediatric patients with North American crotalid envenomation. The term crotalid is used to describe the Crotalinae subfamily (formerly known as Crotalidae) of venomous snakes which includes rattlesnakes, copperheads and cottonmouths/water moccasins.

Important Safety Information
Contraindications

Do not administer CroFab® to patients with a known history of hypersensitivity to any of its components, or to papaya or papain unless the benefits outweigh the risks and appropriate management for anaphylactic reactions is readily available.

Warnings and Precautions

Coagulopathy: In clinical trials, recurrent coagulopathy (the return of a coagulation abnormality after it has been successfully treated with antivenin), characterized by decreased fibrinogen, decreased platelets, and elevated prothrombin time, occurred in approximately half of the patients studied; one patient required re-hospitalization and additional antivenin administration. Recurrent coagulopathy may persist for 1 to 2 weeks or more. Patients who experience coagulopathy due to snakebite should be monitored for recurrent coagulopathy for up to 1 week or longer. During this period, the physician should carefully assess the need for re-treatment with CroFab® and use of any type of anticoagulant or anti-platelet drug.

Hypersensitivity Reactions: Severe hypersensitivity reactions may occur with CroFab®. In case of acute hypersensitivity reactions, including anaphylaxis and anaphylactoid reactions, discontinue infusion and institute appropriate emergency treatment. Patients allergic to papain, chymopapain, other papaya extracts, or the pineapple enzyme bromelain may also have an allergic reaction to CroFab®. Follow-up all patients for signs and symptoms of delayed allergic reactions or serum sickness (e.g., rash, fever, myalgia, arthralgia).

Adverse Reactions

The most common adverse reactions (incidence ≥ 5% of subjects) reported in the clinical studies were urticaria, rash, nausea, pruritus and back pain. Adverse reactions involving the skin and appendages (primarily rash, urticaria, and pruritus) were reported in 12 of the 42 patients. Two patients had a severe allergic reaction (severe hives and a severe rash and pruritus) following treatment and one patient discontinued CroFab® due to an allergic reaction. Recurrent coagulopathy due to envenomation and requiring additional treatment may occur.

Please see full Prescribing Information.