Contraindications Sample Clauses

Contraindications. This is a general description of the disease or condition and the patient population for which the medical device should not be used for the purpose of diagnosing, treating, curing or mitigating. Contraindications are conditions under which the medical device should not be used because the risk of use clearly outweighs any possible benefit.
Sample 1
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Contraindications. Advanced arteriosclerosis; agitated states; hyperthyroidism; moderate hypertension; severe hypertension; symptomatic cardiovascular disease Adverse effects Common or Very Common Abdominal cramps, aggression, agitation, anxiety, constipation, decreased appetite, depression, diarrhea, dizziness, dry mouth, dyspnoea, growth restriction, headache, irritability, labile mood, nausea, palpitations, pyrexia, rash, restlessness, sleep disturbances, somnolence, tachycardia, tics, vomiting and weight loss Uncommon Agitation, bruxism, cardiomyopathy, chest pain, dermatillomania, dysgeusia, dyskinesia, dysphoria, euphoria, hallucinations, hypertension, logorrhea, mania, mydriasis, psychomotor hyperactivity, Raynaud’s Syndrome, sexual dysfunction, sweating, urticarial, visual disturbances Frequency not known Psychotic episodes and seizures. Drug interactions - Refer to current Summary of Product Characteristics (SPC): xxx.xxxxxxxxx.xxx.xx Lisdexamfetamine Shared Care Agreement I have read the Lisdexamfetamine Shared Care Agreement Please circle a response A) I am willing to prescribe Lisdexamfetamine and adhere to the terms in this Shared Care Agreement B) I am not willing to prescribe Lisdexamfetamine as per this Shared Care Agreement Name (Print)
Sample 1
Contraindications. General contraindications for coronary stenting and for the use of this device are: · Unprotected left main coronary artery disease; · Coronary artery spasm; · Lesions involving a bifurcation; · Cardiogenic shock; · Any patients judged to have a lesion which may prevent proper stent deployment; · Vessel trauma requiring surgical repair or reintervention · Total occlusion of target lesion · Ejection fraction <30%; · Allergies to required procedural medications; · Lesions involving arterial segments with highly tortuous anatomy; · Severe reaction to contrast agents; · Contraindication for anti-platelets and/or anti-coagulation therapy; · Known allergies to Stainless Steel or Polyethelyne Theraphalate. · Cardiac Tamponade · Emboli, distal (air, tissue or thrombotic emboli) · Emergent Coronary Artery Bypass Surgery (CABG) · Pericardial effusion · Pseudoaneurysm, femoral · Respiratory Failure · Shock/Pulmonary edema
Sample 1
Contraindications. Budenofalk® 2mg rectal foam must not be used in: - hypersensitivity to budesonide or any of the ingredients - hepatic cirrhosis with signs of portal hypertension, e.g. late-stage primary biliary cirrhosis
Sample 1
Contraindications. Advanced arteriosclerosis; agitated states; hyperthyroidism; moderate hypertension; severe hypertension; symptomatic cardiovascular disease Cautions Bipolar disorder; history of cardiovascular disease; history of substance abuse; may lower seizure threshold (discontinue if seizures occur); psychotic disorders; susceptibility to angle-closure glaucoma; tics; Tourette syndrome. Adverse effects Common or very common Abdominal cramps, aggression, agitation, anxiety, constipation, decreased appetite, depression, diarrhea, dizziness, dry mouth, dyspnoea, growth restriction, headache, irritability, labile mood, nausea, palpitations, pyrexia, rash, restlessness, sleep disturbances, somnolence, tachycardia, tics, vomiting and weight loss Uncommon Agitation, bruxism, cardiomyopathy, chest pain, dermatillomania, dysgeusia, dyskinesia, dysphoria, euphoria, hallucinations, hypertension, logorrhea, mania, mydriasis, psychomotor hyperactivity, Raynaud’s Syndrome, sexual dysfunction, sweating, urticarial, visual disturbances Frequency not known Psychotic episodes and seizures. For other adverse effects refer to current Summary of Product Characteristics (SPC): xxx.xxxxxxxxx.xxx.xx or British National Formulary for Children (BNFC), available at xxx.xxx.xxx, Drug interactions Refer to current Summary of Product Characteristics (SPC): xxx.xxxxxxxxx.xxx.xx or British National Formulary for Children (BNFC), available at xxx.xxx.xxx,
Sample 1
Contraindications. Do not use Whole Body Cryotherapy if you have any of the following conditions: • Uncontrolled high blood pressure • Cold Allergy • Prior heart attack • Open sores • Unstable chest pain • Nerve pain in feet or legs • Disease of blood vessels • Pregnancy • History of blood clots You may have other conditions that make whole body cryotherapy inappropriate. Consult with your physician or medical advisor if you have questions as to whether whole body cryotherapy is right for you.
Sample 1
Contraindications. “In all paediatric patients (0-18 years of age) who undergo tonsillectomy and/or adenoidectomy for obstructive sleep apnoea syndrome due to an increased risk of developing serious and life-threatening adverse reactions (see section 4.4)” “In women during breastfeeding (see section 4.6)” “In patients for whom it is known they are CYP2D6 ultra-rapid metabolisers”
Sample 1
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Related to Contraindications

  • Studies The clinical, pre-clinical and other studies and tests conducted by or on behalf of or sponsored by the Company or its subsidiaries that are described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus were and, if still pending, are being conducted in accordance in all material respects with all statutes, laws, rules and regulations, as applicable (including, without limitation, those administered by the FDA or by any foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA). The descriptions of the results of such studies and tests that are described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus are accurate and complete in all material respects and fairly present the published data derived from such studies and tests, and each of the Company and its subsidiaries has no knowledge of other studies or tests the results of which are materially inconsistent with or otherwise call into question the results described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus. Except as described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, neither the Company nor its subsidiaries has received any notices or other correspondence from the FDA or any other foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA with respect to any ongoing clinical or pre-clinical studies or tests requiring the termination or suspension of such studies or tests. For the avoidance of doubt, the Company makes no representation or warranty that the results of any studies, tests or preclinical or clinical trials conducted by or on behalf of the Company will be sufficient to obtain governmental approval from the FDA or any foreign, state or local governmental body exercising comparable authority.

  • Product Changes Vocera shall have the right, in its absolute discretion, without liability to End User, to update to provide new functionality or otherwise change the design of any Product or to discontinue the manufacture or sale of any Product. Vocera shall notify End User at least 90 days prior to the delivery of any Product which incorporates a change that adversely affects form, fit or function (“Material Change”). Vocera shall also notify End User at least 90 days prior to the discontinuance of manufacture of any Product. Notification will be made as soon as reasonably practical for changes associated with regulatory or health and safety issues.

  • Adverse Events Subsequent to the date hereof, there shall not have occurred any of the following: (i) a suspension or material limitation in trading in securities generally on the New York Stock Exchange, the NASDAQ National Market or the NASDAQ Global Market, (ii) a general moratorium on commercial banking activities in the People’s Republic of China or New York, (iii) the outbreak or escalation of hostilities involving the United States or the People’s Republic of China or the declaration by the United States or the People’s Republic of China of a national emergency or war if the effect of any such event specified in this clause (iii) in your reasonable judgment makes it impracticable or inadvisable to proceed with the public offering or the delivery of the Shares on the terms and in the manner contemplated in the Prospectus, or (iv) such a material adverse change in general economic, political, financial or international conditions affecting financial markets in the United States or the People’s Republic of China having a material adverse impact on trading prices of securities in general, as, in your reasonable judgment, makes it impracticable or inadvisable to proceed with the public offering of the Shares or the delivery of the Shares on the terms and in the manner contemplated in the Prospectus.

  • Product ACCEPTANCE Unless otherwise provided by mutual agreement of the Authorized User and the Contractor, Authorized User(s) shall have thirty (30) days from the date of delivery to accept hardware products and sixty (60) days from the date of delivery to accept all other Product. Where the Contractor is responsible for installation, acceptance shall be from completion of installation. Failure to provide notice of acceptance or rejection or a deficiency statement to the Contractor by the end of the period provided for under this clause constitutes acceptance by the Authorized User(s) as of the expiration of that period. The License Term shall be extended by the time periods allowed for trial use, testing and acceptance unless the Commissioner or Authorized User agrees to accept the Product at completion of trial use. Unless otherwise provided by mutual agreement of the Authorized User and the Contractor, Authorized User shall have the option to run testing on the Product prior to acceptance, such tests and data sets to be specified by User. Where using its own data or tests, Authorized User must have the tests or representative set of data available upon delivery. This demonstration will take the form of a documented installation test, capable of observation by the Authorized User, and shall be made part of the Contractor’s standard documentation. The test data shall remain accessible to the Authorized User after completion of the test. In the event that the documented installation test cannot be completed successfully within the specified acceptance period, and the Contractor or Product is responsible for the delay, Authorized User shall have the option to cancel the order in whole or in part, or to extend the testing period for an additional thirty (30) day increment. Authorized User shall notify Contractor of acceptance upon successful completion of the documented installation test. Such cancellation shall not give rise to any cause of action against the Authorized User for damages, loss of profits, expenses, or other remuneration of any kind. If the Authorized User elects to provide a deficiency statement specifying how the Product fails to meet the specifications within the testing period, Contractor shall have thirty (30) days to correct the deficiency, and the Authorized User shall have an additional sixty (60) days to evaluate the Product as provided herein. If the Product does not meet the specifications at the end of the extended testing period, Authorized User, upon prior written notice to Contractor, may then reject the Product and return all defective Product to Contractor, and Contractor shall refund any monies paid by the Authorized User to Contractor therefor. Costs and liabilities associated with a failure of the Product to perform in accordance with the functionality tests or product specifications during the acceptance period shall be borne fully by Contractor to the extent that said costs or liabilities shall not have been caused by negligent or willful acts or omissions of the Authorized User’s agents or employees. Said costs shall be limited to the amounts set forth in the Limitation of Liability Clause for any liability for costs incurred at the direction or recommendation of Contractor.

  • Field The term “

  • Marking of Licensed Products To the extent commercially feasible and consistent with prevailing business practices, Company shall xxxx, and shall cause its Affiliates and Sublicensees to xxxx, all Licensed Products that are manufactured or sold under this Agreement with the number of each issued patent under the Patent Rights that applies to such Licensed Product.

  • Deviations Deviations from the drawings and the dimensions therein given, whether or not error is believed to exist, shall be made only after written authority is obtained from the County, and shall be documented within the Detailed Scope of Work for the specific Job Order.

  • Product Documentation You should review the policy documents carefully to ensure they accurately reflect the cover, conditions, limits, and other terms that you require. Particular attention should be paid to policy conditions and warranties as failure to comply with these could invalidate your policy. It is important that you retain and keep safely all documents associated with your policy so that you can refer to them in the event of a claim.

  • Commercialization Intrexon shall have the right to develop and Commercialize the Reverted Products itself or with one or more Third Parties, and shall have the right, without obligation to Fibrocell, to take any such actions in connection with such activities as Intrexon (or its designee), at its discretion, deems appropriate.

  • Markings 4.8.1. Every hose shall bear, at intervals of not greater than 0.5 m, the following clearly legible and indelible identification markings consisting of characters, figures or symbols.

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