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Galen Limited Privacy Policy

Galen Limited is committed to preserving the privacy of all visitors to synera.com. Please read the following privacy policy to understand how we use and protect the information that you provide to us. By registering on this site, you consent to the collection, use and transfer of your information under the terms of this policy.

INFORMATION THAT WE COLLECT FROM YOU

When you visit or register on galen.co.uk you may be asked to provide certain information about yourself including your name and contact. We may also collect information about your usage of our website as well as information about you from e-mails or letters you send to us.

PERSONAL DATA

You agree and warrant that the processing, including the transfer itself, of Personal Data has been and will continue to be carried out in accordance with the relevant provisions of the applicable data protection law, including but not limited to, the European Data Protection Directive 95/46/EC and the applicable national laws of the country where you are established (“Data Protection Law”) (and, where applicable, has been notified to the relevant authorities of the country where you are established) and does not violate the relevant provisions of the Data Protection Law. “Personal Data” means any information or set of information that identifies or can reasonably be used to identify an individual. Personal Data does not include information that is encoded or anonymous, or publicly available information that has not been combined with non-public information.

USE OF YOUR INFORMATION

Your information will enable us to provide you with access to all parts of our site and to supply the goods or services you have requested. We will also use and analyse the information we collect so that we can administer, support, improve and develop our business. In particular, we may use your information to contact you for your views on our services and to notify you occasionally about important changes or developments to the site or our services. Further, where you have consented, we might also use your information to let you know about other products and services which we offer which may be of interest to you and we may contact you by post, telephone or fax, as well as by e-mail. If you change your mind about being contacted in the future, please let us know.

When processing Personal Data, Galen Limited shall comply with all relevant applicable law relating to data protection, including for the avoidance of doubt, the European Data Protection Directive 95/46/EC and the Data Protection Act 1998.

DISCLOSURE OF YOUR INFORMATION

The information you provide to us will be held on our computers in the US and may be accessed by or given to our staff working outside the UK and third parties including companies within Almac Group Limited some of whom are located in the US who act for us for the purposes set out in this policy or for other purposes approved by you. Where you have consented when providing us with your details, we may also allow carefully selected third parties, including other companies in our group, to contact you occasionally about products and services which may be of interest to you including. They may contact you by post, telephone or fax, as well as by e-mail. If you change your mind about being contacted by these companies in the future, please let us know. Finally, if our business enters into a joint venture with or is sold to or merged with another business entity, your information may be disclosed to our new business partners or owners. Countries outside the European Economic Area do not always have strong data protection laws. However, we will always take steps to ensure that your information is used by third parties in accordance with this policy. Unless required to do so by law, we will not otherwise share, sell or distribute any of the information you provide to us without your consent.

SECURITY AND DATA RETENTION

We employ security measures to protect your information from access by unauthorised persons and against unlawful processing, accidental loss, destruction and damage. We will retain your information for a reasonable period or as long as the law requires.

USE OF COOKIES BY GALEN LIMITED

Galen Limited may from time to time collect information from you by using “cookies”. At Galen Limited we are strongly committed to protecting your privacy and as such we want to ensure that you are always aware of how we are using cookies on our website and how this may affect you. You can navigate yourself around our website without giving us any personal information. However the policy sets out a brief explanation explaining our practices for the occasions where cookies are used. What are cookies? A cookie is a text file that is placed on your computer, mobile phone or tablet by the website. Cookies cannot be used to run programs or deliver viruses to your computer. Cookies are uniquely assigned to you, and can only be read by a web server in the domain that issued the cookie to you. How We Use Cookies Galen Limited uses cookies to improve services for you by: Measuring how many people are using the different areas of the website so that popular sections can be improved. Analysing anonymous data to help us understand how visitors interact with the website so we can improve the services offered. Enabling a service to recognise your computer so you don’t have to give the same information several times during one task. Cookies may be used on our customer facing applications, and although we are not actively storing any information pertaining to the user in a form of a cookie, some of the application servers which Galen Limited uses may write temporary files to enable them to perform as part of their normal usage. The data is not recorded by Galen Limited. Cookies do not usually contain personally identifiable information, and if at times Galen Limited requires you to register your information, the cookie which is associated with your registration information is used in a limited manner to allow Galen Limited to offer increased functionality of our website. We do not share any of our data with any third parties. The personal or system information is not stored in the cookie. To allow you to control your own use of cookies, you will need to reset your web browser to either allow you to accept cookies, reject cookies or notify you on each occasion that a cookie is sent to you. To find out more about cookies, and how to actively manage how they are used on your computer, please visit www.allaboutcookies.org. Please check this website periodically to inform yourself of any updates.

ACCESSING AND UPDATING

You are entitled to see the information held about you and you may ask us to make any necessary changes to ensure that it is accurate and kept up to date. If you wish to do this, please contact us. We are entitled by law to charge a fee of £40 to meet our costs in providing you with details of the information we hold about you.

CHANGES TO OUR PRIVACY POLICY

Any changes to our privacy policy in the future will be posted to the site and, where appropriate, through e-mail notification.

CONTACT

Please contact us if you have any comments, queries and requests relating to our use of your information.

In clinical studies involving 1,449 subjects treated with SYNERA®, the most common local reactions were redness of the skin (71%), pale skin (12%) and swelling (12%); these reactions were generally mild and resolved on their own soon after patch removal. There were no treatment related serious adverse events.1

References

  1. SYNERA® Prescribing Information. Galen US Inc., Souderton, PA; March 2014.
  2. Masud S, Wasnich RD, Ruckle JL, et al. Contribution of a heating element to topical anesthesia patch efficacy prior to vascular access: results from two randomized, double-blind studies. J Pain Symptom Manage. 2010;40(4):510-519.
  3. EMLA® Cream 5% Prescribing Information. Akorn Inc., Lake Forest, IL; April 2012.
  4. Wallace MS, Kopecky EA, Ma T, Brophy F, Campbell JC. Evaluation of the depth and duration of anesthesia from heated lidocaine/tetracaine (SYNERA®) patches compared with placebo patches applied to healthy adult volunteers. Reg Anesth Pain Med. 2010;35(6):507-513.
  5. Sethna NF, Verghese ST, Hannallah RS, Solodiuk JC, Zurakowski D, Berde CB. A randomized controlled trial to evaluate S-Caine patch for reducing pain associated with vascular access in children. Anesthesiology. 2005;102(2):403-408.
  6. Sawyer J, Febbraro S, Masud S, Ashburn MA, Campbell JC. Heated lidocaine/tetracaine patch (SYNERA®, Rapydan) compared with lidocaine/prilocaine cream (EMLA) for topical anaesthesia before vascular access. Br J Anaesth. 2009;102(2):210-215.

Indication

SYNERA® (lidocaine and tetracaine) Topical Patch is indicated for use on unbroken skin to help prevent the pain of needle sticks into superficial veins (apply for 20-30 mins) and some superficial skin procedures (apply for 30 mins).

Important Safety Information

SYNERA® is not to be used in patients with a known history of sensitivity to lidocaine, tetracaine, numbing medications of the amide or ester type, or any other component of the product and in patients with para-aminobenzoic acid (PABA) hypersensitivity. Keeping a patch on longer than recommended or applying multiple patches at the same time or one right after the other could result in absorption of sufficient amounts of drug to result in serious adverse effects. Patients should not use SYNERA® if they have a history of methemoglobinemia.

Used SYNERA® patches contain a large amount of lidocaine and tetracaine (at least 90% of the initial amount). Chewing or swallowing a new or used SYNERA® patch may result in serious adverse effects. Store and dispose of SYNERA® out of the reach of children and pets.

SYNERA® should be used with caution in patients who may be more sensitive to the general effects on the body of lidocaine and tetracaine, particularly those who are seriously ill or weakened by illness, and those with reduced liver function. Patients with severe liver disease or missing adequate blood plasma enzymes are at greater risk of developing toxic plasma concentrations.

Do not use on body passages such as inside the nose or mouth or on areas with unhealthy, broken skin.

Application to broken or inflamed skin may result in toxic blood concentrations of lidocaine and tetracaine.

Allergic or extreme sensitivity (skin rash, swelling or hives, narrowing of airways, and shock) to the active or inactive components of SYNERA® can occur and should be managed by a medical professional. Seek immediate emergency help if any of these occur.

Avoid contact of SYNERA® with the eyes due to potential irritation or abrasion. If contact occurs, immediately wash out the eye with water or saline, and protect it until sensation returns.

The application of more than two SYNERA® patches at the same time or one right after another to children is not recommended as it has not been fully studied. Safety and effectiveness of SYNERA® have been established in patients 3 years of age and older.

Lidocaine, one of the numbing medications in SYNERA®, has been shown to prevent the growth of viruses and bacteria. The effect of SYNERA® on needle sticks into the skin for certain vaccines has not been determined.

The heating component contains iron powder, and the patch must be removed before some diagnostic procedures, including magnetic resonance imaging (MRI).

SYNERA® may lead to little or no feeling in the area of the skin where it is applied; therefore, patients should avoid trauma (rubbing, scratching, or exposure to heat or cold) before complete feeling returns.

SYNERA® should be used with caution in patients receiving certain heart medications and/or other local pain-preventing medications, because there may be additional toxic effects with lidocaine and tetracaine.

In clinical studies involving 1,449 subjects treated with SYNERA®, the most common local reactions were redness of the skin (71%), pale skin (12%) and swelling (12%); these reactions were generally mild and resolved on their own soon after patch removal. There were no treatment related serious adverse events.1

SYNERA® should be applied immediately after opening the pouch. Do not cut or remove the top cover of the patch as this could result in a burn injury.

If skin irritation or a burning sensation occurs during application, remove the patch and inform your doctor or nurse immediately.

Please see Full Prescribing Information including Instructions For Use before using SYNERA®.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.