INDICATIONS AND USAGE Sample Clauses

INDICATIONS AND USAGE. EXPAREL is indicated for administration into the surgical site to produce postsurgical analgesia. EXPAREL has not been studied for use in patients younger than 18 years of age.
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INDICATIONS AND USAGE. LUNESTA is indicated for the treatment of insomnia. In controlled outpatient and sleep laboratory studies, LUNESTA administered at bedtime decreased sleep latency and improved sleep maintenance. The clinical trials performed in support of efficacy were up to 6 months in duration. The final formal assessments of sleep latency and maintenance were performed at 4 weeks in the 6-week study, at the end of both 2-week studies and at the end of the 6-month study. CONTRAINDICATIONS: None known. WARNINGS: Because sleep disturbances may be the presenting manifestation of a physical and/or psychiatric disorder, symptomatic treatment of insomnia should be initiated only after a careful evaluation of the patient. The failure of insomnia to remit after 7 to 10 days of treatment may indicate the presence of a primary psychiatric and/or medical illness that should be evaluated. Worsening of insomnia or the emergence of new thinking or behavior abnormalities may be the consequence of an unrecognized psychiatric or physical disorder. Such findings have emerged during the course of treatment with sedative/hypnotic drugs, including LUNESTA. Because some of the important adverse effects of LUNESTA appear to be dose-related, it is important to use the lowest possible effective dose, especially in the elderly (see DOSAGE AND ADMINISTRATION). A variety of abnormal thinking and behavior changes have been reported to occur in association with the use of sedative/hypnotics. Some of these changes may be characterized by decreased inhibition (e.g., aggressiveness and extroversion that seem out of character), similar to effects produced by alcohol and other CNS depressants. Other reported behavioral changes have included bizarre behavior, agitation, hallucinations, and depersonalization. Complex behaviors such as “sleep-driving” (i.e., driving while not fully awake after ingestion of a sedative-hypnotic, with amnesia for the event) have been reported. These events can occur in sedative-hypnotic-naïve as well as in sedative-hypnotic-experienced persons. Although behaviors such as sleep-driving may occur with LUNESTA alone at therapeutic doses, the use of alcohol and other CNS depressants with LUNESTA appears to increase the risk of such behaviors, as does the use of LUNESTA at doses exceeding the maximum recommended dose. Due to the risk to the patient and the community, discontinuation of LUNESTA should be strongly considered for patients who report a “sleep-driving” episode. Other com...
Sample 1
INDICATIONS AND USAGE. KOVALTRY®, Antihemophilic Factor (Recombinant), is a recombinant, human DNA sequence derived, full length Factor VIII concentrate indicated for use in adults and children with hemophilia A (congenital Factor VIII deficiency) for: • On-demand treatment and control of bleeding episodes • Perioperative management of bleeding • Routine prophylaxis to reduce the frequency of bleeding episodes KOVALTRY is not indicated for the treatment of von Willebrand disease I NTR O D U C TI O N “[Bayer] is engaged in the business of developing, manufacturing and distributing human health care products and has been conducting this business for more than 70 years . . . within the City Typically, this requires a development process with an average time frame of 10–12 years and an average investment of in excess of $200 million. As a consequence, long range planning is mandatory for business, financial, and competitive reasons.” —Development Agreement, 1992, page 4 Bayer’s 30-year Development Agreement with the City of Berkeley (DA) is the product of a company acutely aware of the long-term risk it was taking in building one of the earliest biopharmaceutical manufacturing facilities—with all the long-term investment and complex processes the venture required—and a city willing to under- stand and respond to those risks. In 1992, after a year of negotiations, Bayer and the City signed this historic agreement which provides the streamlined development processes that have allowed Bayer to develop the site over time. In return, the City has received a broad array of mitigations and community benefits. 2015 was a watershed year for the DA, showing that foresight and decades of collaboration pay off for a business and its employees, a community and its citizens, and patients around the world. Since 1992, Berkeley has served as Bayer’s global hub of biotech manufacturing, producing Kogenate®, a recombinant Factor VIII protein that replaces the clotting factors missing in patients born with the devastating disease of hemophilia A. Over the years, Kogenate® has become one of Bayer’s best-selling products. The construction of the new Product Testing Facility, begun in 2015 near Xxxxx’x Xxxxxxx Street entrance, represents the most recent investment in a site development process that began seven years ago with the mission of building state-of-the-art facilities, housing the state-of-the-art equipment needed for the manufacture of new generations of Bayer’s hemophilia treatments. As Bayer’s...
Sample 1

Related to INDICATIONS AND USAGE

  • Definitions and Usage Except as otherwise specified herein or as the context may otherwise require, capitalized terms used but not otherwise defined herein are defined in Appendix A hereto, which also contains rules as to usage that shall be applicable herein.

  • Limitations and Exclusions The limitation and exclusion in this Section 8 shall not apply: (i) to the extent that liability cannot be limited or excluded according to the Applicable Law; (ii) in cases of our willful misconduct and gross negligence; (iii) in cases of bodily injuries or death caused by our negligence; and (iv) in cases of our fraud or fraudulent misrepresentation.

  • Amounts and Terms of Commitments and Loans 2.1 Commitments; Making of Loans; the Register; Notes.

  • CONDITIONS TO ALL BORROWINGS The obligations of the Lenders to make any Loan or issue any Letter of Credit, whether on or after the Closing Date, shall also be subject to the satisfaction of the following conditions precedent:

  • Conditions and Limitations The admission of any Person as a Substituted Member or an Additional Member shall be conditioned upon (i) such Person’s written acceptance and adoption of all the terms and provisions of this Agreement, either by (A) execution and delivery of a counterpart signature page to this Agreement countersigned by the Managing Member on behalf of the Company or (B) any other writing evidencing the intent of such Person to become a Substituted Member or an Additional Member and such writing is accepted by the Managing Member on behalf of the Company.

  • Exceptions and Limitations For the avoidance of doubt, where Exceptions and Limitations apply to Your use, this Public License does not apply, and You do not need to comply with its terms and conditions.

  • Promotions and Transfers Professional staff are eligible for a promotion which occurs when there is a vacancy at a higher level for which they are qualified. The announcement of the position vacancy will include a description of the position, a detailed outline of expected educational and professional requirements and the salary range for the position. Staff members may bid online on any open position for which they qualify provided those positions are not being reserved for staff members affected by a layoff or intradepartmental postings. All regular vacant negotiations unit positions will be posted on the University Hospital website. The announcement of the position vacancy will be posted daily online. Interested internal candidates are to apply online. Computer Kiosks for the purpose of accessing job vacancies will be available at each Human Resources Office. Beginning thirty (30) days after ratification of this agreement, each internal applicant within a department who applies during the first five (5) days of posting for a higher classification within the same department, as identified on the position posting, shall be interviewed. Each internal candidate will be notified in writing of the decision with respect to his or her candidacy on a timely basis. This decision will indicate: 1.) that the applicant has been offered the position, or 2.) that the applicant has not been offered the position, including a reason for such decision. The Hospital agrees that seniority and all other relevant criteria will be taken into consideration in the selection of internal applicants for a position. Any dispute regarding this paragraph shall be grievable to Step Two of the grievance procedure with the decision at Step Two being final and binding. Transfer in status or classification shall not delay the use of entitled benefits. At the time of promotion, a staff member shall be provided the opportunity to negotiate his/her salary increase and shall receive written notice of final salary offer. Acceptance of the position constitutes acceptance of the salary, and the amount of the promoted staff member’s salary shall not be subject to the grievance procedure. This provision shall not result in any promoted staff member being placed off guide. Voluntarily transferred and promoted staff members shall serve a ninety (90) calendar day probationary period, subject to a ninety (90) calendar day extension. Time spent on an authorized leave shall not count towards the probationary period. Reclassifications and Involuntary transfers within a Department do not serve a probationary period. Such staff member shall retain all benefits and rights pertaining to negotiations unit members, including access to the grievance procedure, except for the decision concerning the outcome and disposition of their probation period. At any time prior to the end of probation, the staff member may return to his/her former position, provided that it is still available. If an employee opts to return to his or her former position, the employee may not bid on another position for six months. Should the staff member fail probation, the Hospital shall return the staff member to his/her former position if it is still available. Should the staff member’s position not be available, the employee may be offered a vacant position to the classification of the former title held by the employee before the promotion, if one exists at University Hospital. If the vacant position is in a different department, the employee must serve a 90 calendar day probation period. If not, the employee will be placed on the recall list for one year.

  • Specific Exclusions Apart from the exclusions common to all covers, the following are also excluded. We do not intervene for:  Travel taken for the purpose of diagnosis and/or treatment,  Medical and hospitalisation expenses in the country of residence,  Drunkenness, suicide or attempted suicide and their consequences,  Any voluntary mutilation of the insured,  Ailments or benign injuries which can be treated on site and/or which do not prevent the Beneficiary/Insured from continuing his trip,  The states of pregnancy, unless there are unforeseeable complications, and in all cases, the states of pregnancy beyond the 36th week, voluntary termination, the aftermath of childbirth,  Convalescence and ailments during treatment, not yet consolidated and involving a risk of sudden aggravation,  Illnesses diagnosed previously that have resulted in hospitalisation in the 6 months preceding the date of departure on the trip,  Events related to medical treatment or surgery that are not unforeseen, fortuitous or accidental,  Prosthesis costs: optical, dental, acoustic, functional, etc.  The consequences of infectious risk situations in an epidemic context that are subject to quarantine or preventive measures or specific surveillance by the international health authorities and/or local health authorities of the country where you are staying and/or national authorities of your country of origin, unless otherwise specified in the cover.  The costs of spa treatment, cosmetic treatment, vaccination and resultant costs,  Stays in a rest home and the resultant costs,  Rehabilitation, physiotherapy, chiropractic and resultant costs,  Scheduled hospitalisations. In the event of significant trauma following your quarantine related to a context of epidemic or pandemic, we can, at your request, put you in contact with a psychologist by telephone, within the limit indicated in the Schedule of Cover. These sessions are strictly confidential. This listening work is not to be confused with the psychotherapeutic work done by licensed practitioners. Under no circumstances can this service be a substitute for psychotherapy, due to the physical absence of the caller. EMERGENCY SUITCASE In the event that you no longer have enough usable personal effects at your disposal due to your quarantine or your hospitalisation following an epidemic or pandemic, we pay, on presentation of supporting documents, for basic necessities, up to the amount indicated in the Schedule of Cover. DOMESTIC HELP Following your repatriation by us following an illness linked to an epidemic or a pandemic, if you cannot perform your usual household chores, we look for, arrange and pay for domestic help assistance, within the limit indicated in the Schedule of Cover. DELIVERY OF HOUSEHOLD SHOPPING Following your repatriation by us following an illness linked to an epidemic or a pandemic, if you are not able to leave your home, we organize and cover, within the limit of local availability, the costs of delivery of your shopping within the limit set in the Schedule of Cover. PSYCHOLOGICAL SUPPORT UPON YOUR RETURN HOME In the event of significant trauma following an event related to a context of epidemic or pandemic, we can, at your request, put you in contact with a psychologist by telephone after you return home, within the limit indicated in the Schedule of Cover. These sessions are strictly confidential. This listening work is not to be confused with the psychotherapeutic work done by licensed practitioners. Under no circumstances can this service be a substitute for psychotherapy, due to the physical absence of the caller. NEED ASSISTANCE? Contact us, 7 days/week and 24 hours/day By ‘phone from France: By e-mail +00 0 00 00 00 00 (Call not surcharged, cost according to operator, call may be recorded) xxxxxxxxxx@xxxxxxxx.xx To allow us to intervene under the best conditions, remember to prepare the following information that will be requested when you call: › Your policy number, › Your last and first names, › Your home address, › The country, city or town where you are at the time of the call, › Specify the exact address (no., street, hotel possibly, etc.), › The phone number where we can reach you, › The nature of your problem. When you call initially, you will be given an assistance file number. State it systematically during any subsequent contacts with our Assistance Service.  General Provisions - the policy came with the purchase of goods or a service sold by a supplier; - you can show that you are already covered for one of the risks covered by this new policy; - the policy you wish to cancel has not been fully established; - you have not declared any loss covered by this policy. In this situation, you can exercise your right to cancel this policy by letter or in any lasting medium sent to the insurer of the new policy, together with documentary proof that you already have cover for one of the risks covered by this new policy. The insurer must reimburse you the premium paid within thirty days of your cancellation. If you wish to cancel your policy but do not meet all the above conditions, please check the cancellation procedure stipulated in your policy. Like any insurance policy, this one comprises mutual rights and obligations. It is governed by the French Insurance Code. These rights and obligations are set forth in the following pages. This is a collective damage insurance policy taken out by Gritchen Affinity with MUTUAIDE ASSISTANCE with optional membership.

  • Specific Limitations No Member shall have the right or power to: (a) withdraw or reduce such Member’s Capital Contribution except as a result of the dissolution of the Company or as otherwise provided by law or in this Agreement; (b) make voluntary Capital Contributions or to contribute any property to the Company other than cash; (c) bring an action for partition against the Company or any Company assets; (d) cause the termination and dissolution of the Company, except as set forth in this Agreement; or (e) upon the Distribution of its Capital Contribution require that property other than cash be distributed in return for its Capital Contribution. Each Member hereby irrevocably waives any such rights.

  • Availability of Types of Advances If any Lender determines that maintenance of its Eurodollar Loans at a suitable Lending Installation would violate any applicable law, rule, regulation, or directive, whether or not having the force of law, or if the Required Lenders determine that (i) deposits of a type and maturity appropriate to match fund Eurodollar Advances are not available or (ii) the interest rate applicable to Eurodollar Advances does not accurately reflect the cost of making or maintaining Eurodollar Advances, then the Agent shall suspend the availability of Eurodollar Advances and require any affected Eurodollar Advances to be repaid or converted to Floating Rate Advances, subject to the payment of any funding indemnification amounts required by Section 3.4.

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