Terms
of Use

Terms of Use

Copyrights and Trademarks

The contents of this site are the property of Jazz Pharmaceuticals and are protected under copyright and trademark laws. The site may also include trademarks or service marks of third parties, which are the property of their respective owners.

Use of Site

Jazz Pharmaceuticals gives you permission to browse through any public areas of the site or secure areas accessible with your user ID and password, and to print and download copies of material in such areas for your personal, non-commercial use only, so long as you do not remove any copyright or other notices that appear on the material you print or download. Any such printing and downloading is at your own risk. You agree that you will not otherwise copy, display or transmit any material on the site in any manner or medium. You also agree not to create derivative works of, sell or distribute any material on the site.

IMPORTANT DISCLAIMERS

THIS SITE IS INTENDED FOR EDUCATIONAL PURPOSES ONLY AND IS NOT INTENDED TO DIAGNOSE ANY DISEASE OR PRESCRIBE TREATMENT FOR ANY PARTICULAR PATIENT. WHILE JAZZ PHARMACEUTICALS HAS ATTEMPTED TO BE ACCURATE AND FAIRLY BALANCED IN PRESENTING THE INFORMATION HEREIN, IN ALL CASES, TREATMENT CARRIES RISKS AND BENEFITS WHICH ARE MORE FULLY DESCRIBED IN THE PRESCRIBING INFORMATION ON THIS WEBSITE. THE DECISION REGARDING TREATMENT MODALITY SHOULD INCLUDE REVIEW OF THE FULL PRESCRIBING INFORMATION AND BE CAREFULLY DISCUSSED WITH, AND WEIGHED BY, THE MEDICAL CAREGIVER BASED UPON THE SPECIFIC AND INDIVIDUALIZED NEEDS OF THE PATIENT. THIS SITE IS PROVIDED ON AN "AS IS" AND "AS AVAILABLE" BASIS. JAZZ PHARMACEUTICALS RESERVES THE RIGHT TO RESTRICT OR TERMINATE YOUR ACCESS TO THE SITE AND TO MODIFY THE SITE AT ANY TIME. JAZZ PHARMACEUTICALS DISCLAIMS ALL WARRANTIES OF ANY KIND, WHETHER EXPRESS OR IMPLIED, INCLUDING THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE AND ANY WARRANTIES THAT MATERIAL ON THE SITE IS NONINFRINGING, THAT ACCESS TO THE SITE WILL BE UNINTERRUPTED OR ERROR-FREE, THAT THE SITE WILL BE SECURE, OR THAT INFORMATION ON THE SITE WILL BE COMPLETE OR ACCURATE.

Limitation of Liability

TO THE FULLEST EXTENT PERMISSIBLE UNDER APPLICABLE LAW, YOU AGREE THAT NEITHER JAZZ PHARMACEUTICALS NOR ANY OF ITS AFFILIATES, SUCCESSORS OR SERVICE PROVIDERS SHALL BE LIABLE FOR ANY DIRECT, INDIRECT, INCIDENTAL, SPECIAL, CONSEQUENTIAL, PUNITIVE, EXEMPLARY OR ANY OTHER DAMAGES RELATING TO OR RESULTING FROM YOUR USE OF OR INABILITY TO USE THIS SITE. THIS LIMITATION APPLIES REGARDLESS OF THE LEGAL BASIS FOR YOUR ASSERTING A CLAIM TO DAMAGES, AND EVEN IF WE OR OUR REPRESENTATIVES HAVE BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES.

Arbitration

Any dispute relating in any way to these Terms, the site or the Registry shall be submitted to confidential arbitration in Los Angeles, California, except that Jazz Pharmaceuticals may seek injunctive or other appropriate relief in any state or federal court of competent jurisdiction in the case of any claim that a user of the site has violated the "Use of Site" section of these Terms. Such arbitration shall be conducted under the Commercial Arbitration Rules of the American Arbitration Association. The arbitrator's award shall be binding and may be entered as a judgment in any court of competent jurisdiction.

Jurisdiction

The laws of the State of California govern these Terms and your use of the site. This site is provided in connection with the marketing of Elestrin® in the United States. Nothing on this site should be regarded as marketing of Elestrin® in any other jurisdiction. We market products only in compliance with the laws of the particular jurisdictions in which they are sold. We recognize that it is possible for you to obtain access to this site from any jurisdiction in the world, but we have no practical ability to prevent such access. If any material on this site, or your use of the site, is contrary to the laws of the place where you are when you access it, the site is not intended for you, and we ask you not to use the site.

Miscellaneous

These Terms are the entire agreement between you and Jazz Pharmaceuticals regarding the site and the Registry. If any provision of these Terms is unlawful, void or unenforceable, that condition shall not affect the enforceability of the remaining provisions. Jazz Pharmaceuticals' waiver or failure to require performance of these Terms in any instance shall not act as a waiver or bar in any subsequent or other instance. These Terms bind and inure to the benefit of your and our respective heirs, successors and assigns.

Indication

Elestrin is indicated for the treatment of moderate-to-severe vasomotor symptoms associated with menopause.

Important Safety Information

Estrogens, with or without progestins, should not be used for the prevention of cardiovascular disease or dementia. The use of estrogens and progestins has shown an increased risk of breast cancer, myocardial infarction, and pulmonary embolism. The use of estrogen, with or without progestins, has shown an increased risk of stroke, dementia, and DVT while estrogen alone therapy increases the risk of endometrial cancer. The most frequently reported adverse events in clinical trials were nasopharyngitis, breast tenderness, upper respiratory tract infection, and metrorrhagia.

Estrogen products should not be used in women with undiagnosed abnormal genital bleeding; known, suspected, or history of breast cancer; known or suspected estrogen-dependent neoplasia; active or history of deep vein thrombosis or pulmonary embolism; active or recent (within the past year) arterial thromboembolic disease (e.g., stroke, myocardial infarction); liver dysfunction or disease; known or suspected pregnancy.

ESTROGENS INCREASE THE RISK OF ENDOMETRIAL CANCER Close clinical surveillance of all women taking estrogens is important. Adequate diagnostic measures, including endometrial sampling when indicated, should be undertaken to rule out malignancy in all cases of undiagnosed persistent or recurring abnormal vaginal bleeding. There is no evidence that the use of "natural" estrogens results in a different endometrial risk profile than synthetic estrogens at equivalent estrogen doses.

CARDIOVASCULAR AND OTHER RISKS Estrogens, with or without progestins, should not be used for the prevention of cardiovascular disease or dementia.

The Women's Health Initiative (WHI) estrogen alone substudy reported increased risks of stroke and deep vein thrombosis (DVT) in postmenopausal women (50 to 79 years of age) during 6.8 years and 7.1 years, respectively, of treatment with oral conjugated estrogens (CE 0.625 mg) per day relative to placebo.

The estrogen plus progestin WHI substudy reported increased risk of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, and deep vein thrombosis in postmenopausal women (50 to 79 years of age) during 5.6 years of treatment with oral conjugated estrogens (CE 0.625 mg) combined with medroxyprogesterone acetate (MPA 2.5 mg) per day relative to placebo.

The Women's Health Initiative Memory Study (WHIMS), a substudy of the WHI study, reported increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 5.2 years of treatment with CE 0.625 mg alone and during 4 years of treatment with CE 0.625 mg combined with MPA 2.5 mg relative to placebo. It is unknown whether this finding applies to younger postmenopausal women.

Other doses of conjugated equine estrogens with medroxyprogesterone acetate and other combinations and dosage forms of estrogens and progestins were not studied in the WHI clinical trials and, in the absence of comparable data, these risks should be assumed to be similar. Because of these risks, estrogens with or without progestins should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman.

Please see full Prescribing Information, including Boxed Warning and Patient Information Sheet.

You are encouraged to report negative side effects of prescription drugs to the FDA (Food and Drug Administration).
Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

For more information, call 1-800-890-3098.