Important Safety Information. Rectiv is contraindicated in patients taking phosphodiesterase type 5 (PDE5) inhibitors (eg, sildenafil, vardenafil, and tadalafil), which can potentiate the hypotensive effect of nitrate, and in patients with severe anemia, increased intracranial pressure, or known hypersensitivity to nitroglycerin, other nitrates and nitrites, or any components of the ointment. The most common adverse reactions are headache and dizziness. For full US prescribing information please see: xxx.xxxxxxxxxx.xxx.xxx/xxxxxxxxxx_xxxx/xxxxx/0000/000000x000xxx.xxx
Important Safety Information. STENDRA® (avanafil) is prescribed to treat erectile dysfunction (ED). Do not take STENDRA if you take nitrates, often prescribed for chest pain, as this may cause a sudden, unsafe drop in blood pressure. Discuss your general health status with your healthcare provider to ensure that you are healthy enough to engage in sexual activity. If you experience chest pain, nausea, or any other discomforts during sex, seek immediate medical help. STENDRA may affect the way other medicines work. Tell your healthcare provider if you take any of the following; medicines called HIV protease inhibitors, such as ritonavir (Norvir®), indinavir (Crixivan®), saquinavir (Fortavase® or Invirase®) or atazanavir (Reyataz®); some types of oral antifungal medicines, such as ketoconazole (Nizoral®), and itraconazole (Sporanox®); or some types of antibiotics, such as clarithromycin (Biaxin®), telithromycin (Ketek®), or erythromycin. In the rare event of an erection lasting more than 4 hours, seek immediate medical help to avoid long-term injury. In rare instances, men taking PDE5 inhibitors (oral erectile dysfunction medicines, including STENDRA) reported a sudden decrease or loss of vision. It is not possible to determine whether these events are related directly to these medicines or to other factors. If you experience sudden decrease or loss of vision, stop taking PDE5 inhibitors, including STENDRA, and call a doctor right away. Sudden decrease or loss of hearing has been rarely reported in people taking PDE5 inhibitors, including STENDRA. It is not possible to determine whether these events are related directly to the PDE5 inhibitors or to other factors. If you experience sudden decrease or loss of hearing, stop taking STENDRA and contact a doctor right away. If you have prostate problems or high blood pressure for which you take medicines called alpha blockers or other anti-hypertensives, your doctor may start you on a lower dose of STENDRA. Drinking too much alcohol when taking STENDRA may lead to headache, dizziness, and lower blood pressure. STENDRA in combination with other treatments for ED is not recommended. STENDRA does not protect against sexually transmitted diseases, including HIV. The most common side effects of STENDRA are headache, flushing, runny nose and congestion. Please see full patient prescribing information for STENDRA (50 mg, 100 mg, 200 mg) tablets.
Important Safety Information. The most frequently reported adverse events with ZEGERID are headache, diarrhea, and abdominal pain. In critically ill patients treated with ZEGERID, adverse events generally reflected the serious, underlying medical condition of the patients, and were similar for patients treated with ZEGERID and with the comparator (acid-controlling) drug. Symptomatic response to therapy does not preclude the presence of gastric malignancy. Atrophic gastritis has been noted occasionally in gastric corpus biopsies from patients treated long term with omeprazole. ZEGERID Capsules contain 303 mg of sodium per dose. ZEGERID Powder for Oral Suspension contains 460 mg of sodium per dose. This should be taken into consideration for patients on a sodium-restricted diet. Sodium bicarbonate is contraindicated in patients with metabolic alkalosis and hypocalcemia. ZEGERID is contraindicated in patients with known hypersensitivity to any component of the formulation. Since both 20 mg and 40 mg ZEGERID contain the same amount of sodium bicarbonate (1100 mg in capsules, 1680 mg in packets of powder for oral suspension), two 20 mg capsules are not equivalent to, and should not be substituted for, one 40 mg capsule, and two 20 mg packets are not equivalent to, and should not be substituted for, one 40 mg packet. About Santarus Santarus, Inc. is a specialty pharmaceutical company focused on acquiring, developing and commercializing proprietary products that address the needs of patients treated by gastroenterologists or primary care physicians. The company’s current marketing efforts are primarily focused on ZEGERID Capsules and Powder for Oral Suspension. These products are immediate-release formulations of omeprazole, a widely prescribed PPI. More information about Santarus is available on the company’s Web site at wxx.xxxxxxxx.xxx. Santarus cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. The inclusion of forward-looking statements should not be regarded as a representation by Santarus that any of its plans will be achieved. Actual results may differ materially from those set forth in this release due to the risks and uncertainties inherent in Santarus’ business, including, without limitation: risks related to the license and distribution agreements with GSK, including the success of GSK’s development, distribution, sales and marketing activities, GSK’s ability to obtain regulatory approvals in t...
Important Safety Information. Natural gas emergencies include: • A strong odor of natural gas inside or outside your home • A natural gas appliance that will not shut off • Suspicion of a carbon monoxide leak What to Do During a Natural Gas Emergency If you are facing any of these situations, don’t wait! Take the following action immediately: • MOVE to a safe environment. • CALL 911 and your local natural gas utility (not NJRHS) at once to report the natural gas emergency. • DO NOT smoke or operate electrical switches or appliances of any kind. DO NOT operate anything that may produce a spark that might ignite the natural gas and cause an explosion. Natural gas appliances should always be operated and maintained according to the manufacturer’s instructions. Always take the time to become familiar with the instructions – especially safety warnings. GENERATOR MAINTANCE CONTRACT PARTS COVERED: The following items are covered during one maintenance visit per contract year under this contract (any subsequent maintenance/repair visit during a contract year by NJRHS is not included under the contract, and would require additional payments for parts and labor, as appropriate): • One maintenance per contract year • Change air filter element (replaceable) • Change oil and oil filter (replaceable) • Change spark plugs (replaceable) • Check and clean enclosure louvers • Check battery electrolyte level and charger • Clean battery terminals • Check, clean air intake filter compartment—change air intake filter (replaceable) if necessary • Check complete fuel system, fuel regulator and fuel line integrity • Check generator control panel • Clean and remove any residue from the generator transfer switch • Complete electrical check, voltage and frequency • Electrical diagnostic check of automatic standby system and voltage regulator • Overall inspection of engine compartment The maintenance service covers one maintenance visit per contract year for the work described only, and does not relieve the owner of periodic maintenance and testing as described in the owner’s manual (any subsequent maintenance/repair visit during a contract year by NJRHS is not included under the contract, and would require additional payments for parts and labor, as appropriate). NJR Home Services disclaims any responsibility for consequential damages to the generator or building loads. This contract covers only items listed. Check-ups do not include any repair work. Services requested but not covered under this contract will be ...
Important Safety Information. Do not exceed the maximum recommended daily dose of acetaminophen. Administration of acetaminophen by any route in doses higher than recommended may result in hepatic injury, including the risk of severe hepatotoxicity and death. OFIRMEV is contraindicated in patients with severe hepatic impairment, severe active liver disease or with known hypersensitivity to acetaminophen or to any of the excipients in the formulation. Acetaminophen should be used with caution in patients with the following conditions: hepatic impairment or active hepatic disease, alcoholism, chronic malnutrition, severe hypovolemia, or severe renal impairment. OFIRMEV should be administered only as a 15-minute intravenous infusion. Discontinue OFIRMEV immediately if symptoms associated with allergy or hypersensitivity occur. Do not use in patients with acetaminophen allergy. The most common adverse reactions in patients treated with OFIRMEV were nausea, vomiting, headache, and insomnia in adult patients and nausea, vomiting, constipation, pruritus, agitation, and atelectasis in pediatric patients. The antipyretic effects of OFIRMEV may mask fever in patients treated for post-surgical pain.
Important Safety Information. Hemorrhage: Severe hemorrhage occurred with CABOMETYX. The incidence of Grade ≥3 hemorrhagic events was 2.1% in CABOMETYX-treated patients and 1.6% in everolimus-treated patients. Fatal hemorrhages also occurred in the cabozantinib clinical program. Do not administer CABOMETYX to patients that have or are at risk for severe hemorrhage.
Important Safety Information. Before using your Navigation System, be sure to read and fully understand the following safety information: • Read the manual before operating this Navigation System. • This Navigation System is intended solely as an aid to you in the operation of your vehicle. It is not a substitute for your attentiveness, judgement, and care when driving. • Do not operate this Navigation System if doing so in any way will divert your attention from the safe operation of your vehicle. Always observe safe driving rules and follow all existing traffic regulations. • Never allow others to use the system unless they have read and understood the operating instructions. • Never use this Navigation System to route to hospitals, police stations, or similar facilities in an emergency. The map data may not include a comprehensive list of emergency service facilities. • Route and guidance information displayed by this equipment is for reference purposes only. It may not accurately reflect the latest permissible routes, road conditions, or traffic restrictions. • Traffic restrictions and advisories currently in force should always take precedence over guidance given by this product. Always obey current traffic restrictions, even if this product provides contrary advice. • Failure to input correct information about the local time may result in the product provid- ing improper routing and guidance instructions. • Never set the volume of your Navigation System so high that you cannot hear outside traf- fic and emergency vehicles. • Keep your password secure and confidential. Knowledge of your password can give some- one else access to personal information stored by the system, such as the history of destina- tions you have been to and your home address. • To promote safety, certain functions are disabled unless the handbrake is on. • The data encoded in the disc provided with this product is the intellectual property of the provider, and the provider is responsible for such content. • As with any accessory in your vehicle’s interior, you should not allow this Navigation Sys- tem to divert your attention from the safe operation of your vehicle. If you experience diffi- culty in operating the system or reading the display, please make adjustments while safely parked.
Important Safety Information. Warnings and Precautions FOLOTYN may suppress bone marrow function, manifested by thrombocytopenia, neutropenia, and anemia. Monitor blood counts and omit or modify dose for hematologic toxicities. Mucositis may occur. If ³ Grade 2 mucositis is observed, omit or modify dose. Patients should be instructed to take folic acid and receive vitamin B12 to potentially reduce treatment-related hematological toxicity and mucositis. Fatal dermatologic reactions may occur. Dermatologic reactions may be progressive and increase in severity with further treatment. Patients with dermatologic reactions [ * ] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. should be monitored closely, and if severe, FOLOTYN should be withheld or discontinued. Tumor lysis syndrome may occur. Monitor patients and treat if needed. FOLOTYN can cause fetal harm. Women should avoid becoming pregnant while being treated with FOLOTYN and pregnant women should be informed of the potential harm to the fetus. Use caution and monitor patients when administering FOLOTYN to patients with moderate to severe renal function impairment. Elevated liver function test abnormalities may occur and require monitoring. If liver function test abnormalities are ³ Grade 3, omit or modify dose. Adverse Reactions The most common adverse reactions were mucositis (70%), thrombocytopenia (41%), nausea (40%), and fatigue (36%). The most common serious adverse events are pyrexia, mucositis, sepsis, febrile neutropenia, dehydration, dyspnea, and thrombocytopenia. Use in Specific Patient Population Nursing mothers should be advised to discontinue nursing or the drug, taking into consideration the importance of the drug to the mother. Drug Interactions Co-administration of drugs subject to renal clearance (e.g., probenecid, NSAIDs, and trimethoprim/sulfamethoxazole) may result in delayed renal clearance. Please see FOLOTYN Full Prescribing Information at xxx.XXXXXXX.xxx.
Important Safety Information. The most frequent adverse events reported with Xenazine® include sedation/somnolence, fatigue, insomnia, depression, akathisia and nausea. Xenazine® can increase the risk of depression and suicidal thoughts and behavior (suicidality) in patients with Huntington’s disease and the drug is therefore contraindicated in patients who are actively suicidal, and in patients with untreated or inadequately treated depression. Xenazine® is also contraindicated in patients with impaired hepatic function and in patients taking monoamine oxidase inhibitors or reserpine. Xenazine® was approved with a required Risk Evaluation and Mitigation Strategy (REMS) to ensure that the benefits of the drug outweigh its risks, particularly the risks of depression and suicidal thoughts and actions. REMS is a strategy to manage a known or potential serious risk associated with a drug or biological product. Caution Regarding Forward-Looking Information and “Safe Harbor” Statement To the extent any statements made in this release contain information that is not historical, these statements are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and may be forward-looking information under applicable Canadian provincial securities legislation (collectively, “forward-looking statements”). These forward-looking statements relate to, among other things, our objectives, goals, targets, strategies, intentions, plans, beliefs, estimates and outlook, including, without limitation, statements concerning the terms of the transaction, including the Company’s proposed plans for the supply and promotion of Xenazine® in the U.S. and Canada and the terms for such supply and promotion, the anticipated launch of Xenazine® and the anticipated impact of the transaction on Biovail, and rights associated with future development or products, and can generally be identified by the use of words such as “believe,” “anticipate,” “expect,” “intend,” “plan,” “will,” “may” and other similar expressions. In addition, any statements that refer to expectations, projections or other characterizations of future events or circumstances are forward-looking statements. Although Biovail believes that the expectations reflected in such forward-looking statements are reasonable, such statements involve risks and uncertainties, and undue reliance should not be placed on such statements. Certain material factor...
Important Safety Information. To avoid muscle, joint, or eye strain during your use of the products offered through THE STORE Service, you should always take frequent breaks, and take a longer rest if you experience any soreness, fatigue, or discomfort. INTELLECTUAL PROPERTY You agree that THE STORE Service, including but not limited to THE STORE Products, graphics, user interface, audio clips, video clips, editorial content, and the scripts and software used to implement THE STORE, contains proprietary information and material that is owned by the XXXXXXX SCHOOL OF MUSIC and/or its licensors, and is protected by applicable intellectual property and other laws, including but not limited to copyright. You agree that you will not use such proprietary information or materials in any way whatsoever except for use of THE STORE Service in compliance with this Agreement. No portion of THE STORE Service may be reproduced in any form or by any means, except as expressly permitted in these terms. You agree not to modify, rent, lease, loan, sell, distribute, or create derivative works based on THE STORE Service in any manner, and you shall not exploit THE STORE Service in any unauthorized way whatsoever, including, but not limited to, by trespass or burdening network capacity. Notwithstanding any other provision of this Agreement, THE STORE and its licensors reserve the right to change, suspend, remove, or disable access to any THE STORE Products, content, or other materials comprising a part of THE STORE Service at any time without notice. In no event will THE STORE be liable for making these changes. THE STORE may also impose limits on the use of or access to certain features or portions of THE STORE Service, in any case and without notice or liability. All copyrights in and to THE STORE Service (including the compilation of content, postings, links to other Internet resources, and descriptions of those resources) and related software are owned by THE STORE and/or its licensors, who reserve all their rights in law and equity. THE USE OF THE SOFTWARE OR ANY PART OF THE STORE SERVICE, EXCEPT FOR USE OF THE STORE SERVICE AS PERMITTED IN THIS AGREEMENT, IS STRICTLY PROHIBITED AND INFRINGES ON THE INTELLECTUAL PROPERTY RIGHTS OF OTHERS AND MAY SUBJECT YOU TO CIVIL AND CRIMINAL PENALTIES, INCLUDING POSSIBLE MONETARY DAMAGES, FOR COPYRIGHT INFRINGEMENT. The Xxxxxxx School of Music, the Xxxxxxx School name, THE STORE, and other Xxxxxxx School of Music trademarks, service marks, graphics, and logos used...
