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Terms of Use

IMPORTANT LEGAL NOTICE

ATTENTION: This legal notice applies to the entire contents of the Website under the domain name www.synera.com and to any correspondence by e-mail between us and you. Please read these terms carefully before using the Website. Using the Website indicates that you accept these terms regardless of whether or not you choose to register with us. If you do not accept these terms, do not use the Website. This notice is issued by Galen Limited.

1. INTRODUCTION

1.1 You may access most areas of the Website without registering your details with us. Certain areas of the Website are only open to you if you register. 1.2 By accessing any part of the Website, you shall be deemed to have accepted this legal notice in full. If you do not accept this legal notice in full, you must leave the Website immediately. 1.3 The Company may revise this legal notice at any time by updating this posting. You should check the Website from time to time to review the then current legal notice, because it is binding on you. Certain provisions of this legal notice may be superseded by expressly designated legal notices or terms located on particular pages at the Website.

2. LICENCE

2.1 You are permitted to print and download extracts from the Website for your own use on the following basis: no documents or related graphics on the Website are modified in any way; no graphics on the Website are used separately from the corresponding text; and the Company’s copyright and trade mark notices and this permission notice appear in all copies. 2.2 Unless otherwise stated, the copyright and other intellectual property rights in all material on the Website (including without limitation photographs and graphical images) are owned by the Company or its licensors. For the purposes of this legal notice, any use of extracts from the Website other than in accordance with clause 2.1 for any purpose is prohibited. If you breach any of the terms in this legal notice, your permission to use the Website automatically terminates and you must immediately destroy any downloaded or printed extracts from the Website. 2.3 Subject to clause 2.1, no part of the Website may be reproduced or stored in any other website or included in any public or private electronic retrieval system or service without the Company’s prior written permission. 2.4 Any rights not expressly granted in these terms are reserved.

3. SERVICE ACCESS

3.1 While the Company endeavours to ensure that the Website is normally available 24 hours a day, the Company shall not be liable if for any reason the Website is unavailable at any time or for any period. 3.2 Access to the Website may be suspended temporarily and without notice in the case of system failure, maintenance or repair or for reasons beyond the Company’s control.

4. VISITOR MATERIAL AND CONDUCT

4.1 Other than personally identifiable information, which is covered under our Privacy Policy, any material you transmit or post to the Website shall be considered non-confidential and non-proprietary. The Company shall have no obligations with respect to such material. The Company and its designees shall be free to copy, disclose, distribute, incorporate and otherwise use such material and all data, images, sounds, text and other things embodied therein for any and all commercial or non-commercial purposes. 4.2 You are prohibited from posting or transmitting to or from the Website any material: that is threatening, defamatory, obscene, indecent, seditious, offensive, pornographic, abusive, liable to incite racial hatred, discriminatory, menacing, scandalous, inflammatory, blasphemous, in breach of confidence, in breach of privacy or which may cause annoyance or inconvenience; or for which you have not obtained all necessary licences and/or approvals; or which constitutes or encourages conduct that would be considered a criminal offence, give rise to civil liability, or otherwise be contrary to the law of or infringe the rights of any third party, in any country in the world; or which is technically harmful (including, without limitation, computer viruses, logic bombs, Trojan horses, worms, harmful components, corrupted data or other malicious software or harmful data). 4.3 You may not misuse the Website (including, without limitation, by hacking). 4.4 The Company shall fully co-operate with any law enforcement authorities or court order requesting or directing the Company to disclose the identity or locate anyone posting any material in breach of clause 4.2 or clause 4.3.

5. LINKS TO AND FROM OTHER WEBSITES

5.1 Links to third party websites on the Website are provided solely for your convenience. If you use these links, you leave the Website. The Company has not reviewed all of these third party websites and does not control and is not responsible for these websites or their content or availability. The Company therefore does not endorse or make any representations about them, or any material found there, or any results that may be obtained from using them. If you decide to access any of the third party websites linked to the Website, you do so entirely at your own risk. 5.2 If you would like to link to the Website, you may only do so on the basis that you link to, but do not replicate, the home page of the Website, and subject to the following conditions: you do not remove, distort or otherwise alter the size or appearance of any Galen or Product logos; you do not create a frame or any other browser or border environment around the Website; you do not in any way imply that the Company is endorsing any products or services other than its own; you do not misrepresent your relationship with the Company nor present any other false information about the Company; you do not otherwise use any Galen Limited trade marks displayed on the Website without express written permission from the Company; you do not link from a website that is not owned by you; and your website does not contain content that is distasteful, offensive or controversial, infringes any intellectual property rights or other rights of any other person or otherwise does not comply with all applicable laws and regulations. 5.3 The Company expressly reserves the right to revoke the right granted in clause 5.2 for breach of these terms and to take any action it deems appropriate. 5.4 You shall fully indemnify the Company for any loss or damage suffered by the Company or any of its group companies for breach of clause 5.2.

6. REGISTRATION

6.1 Each registration is for a single user only. The Company does not permit you to share your user name and password with any other person nor with multiple users on a network. 6.2 Responsibility for the security of any passwords issued rests with you.

7. DISCLAIMER

7.1 While the Company endeavours to ensure that the information on the Website is correct, the Company does not warrant the accuracy and completeness of the material on the Website. The Company may make changes to the material on the Website, or to the products and prices described in it, at any time without notice. The material on the Website may be out of date, and the Company makes no commitment to update such material. The material on the website shall not be construed in any way as providing or offering medical advice to consumers. 7.2 The material on the Website is provided “as is”, without any conditions, warranties or other terms of any kind. Accordingly, to the maximum extent permitted by law, the Company provides you with the Website on the basis that the Company excludes all representations, warranties, conditions and other terms (including, without limitation, the conditions implied by law of satisfactory quality, fitness for purpose and the use of reasonable care and skill) which, but for this legal notice, might have effect in relation to the Website.

8. LIABILITY

8.1 The Company, any other party (whether or not involved in creating, producing, maintaining or delivering the Website), and any of the Company’s group companies and the officers, directors, employees, shareholders or agents of any of them, exclude all liability and responsibility for any amount or kind of loss or damage that may result to you or a third party (including without limitation, any direct, indirect, punitive or consequential loss or damages, or any loss of income, profits, goodwill, data, contracts, use of money, or loss or damages arising from or connected in any way to business interruption, and whether in tort (including without limitation negligence), contract or otherwise) in connection with the Website in any way or in connection with the use, inability to use or the results of use of the Website, any websites linked to the Website or the material on such websites, including but not limited to loss or damage due to viruses that may infect your computer equipment, site unavailability, distributed denial of service attack or other technologically harmful material, software, data or other property on account of your access to, use of, or browsing the Website or your downloading of any material from the Website or any websites linked to the Website. 8.2 Nothing in this legal notice shall exclude or limit the Company’s liability for: death or personal injury caused by negligence (as such term is defined by the Unfair Contract Terms Act 1977); or fraud; or misrepresentation as to a fundamental matter; or any liability which cannot be excluded or limited under applicable law. 8.3 If your use of material on the Website results in the need for servicing, repair or correction of equipment, software or data, you assume all costs thereof.

9. GOVERNING LAW AND JURISDICTION

This legal notice shall be governed by and construed in accordance with Northern Ireland law. Disputes arising in connection with this legal notice shall be subject to the exclusive jurisdiction of the courts of Northern Ireland.

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.