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IPR2019-00451, No. 1109-113 Exhibit - Ericksson K, Kalviainen R Pharmacologic management of convulsive status epilepticus in childhood Expert Rev Neurotherapeutics 2005 5 777 783 (P.T....
ME Drugs currently used Out of hospital/nonmedical Out of hospital/medical persons (e.g., parents) personnel (e.g., paramedics) Rectal DZP None or rectal DZP only In hospital/emergency room or department In hospital/intensive care ...
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IPR2019-00451, No. 1109-113 Exhibit - Ericksson K, Kalviainen R Pharmacologic management of convulsive status epilepticus in childhood Expert Rev Neurotherapeutics 2005 5 777 783 (P.T.A.B. Jan. 28,
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IPR2019-00451, No. 1101-105 Exhibit - Lowenstein DH, Alldredge BK Status epilepticus N Eng J Med 1998 338 970 976 (P.T.A.B. Jan. 28, 2020)
Nonetheless, pa- tients should receive 100 percent oxygen by nasal cannula or a nonrebreathing mask, and airway paten- cy should be maintained by an oral or nasopharyn- geal device while the patient remains unresponsive.
Nonetheless, the results of the study suggest that treatment with lorazepam alone may be sufficient and may obviate the need for intravenous phenytoin or fosphenytoin loading when status epilepticus is caused by a rapidly reversible ...
56,57 Nonetheless, this approach has not been studied prospectively, and the relative risks and benefits re- main unknown.
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IPR2019-00451, No. 1101-105 Exhibit - Lowenstein DH, Alldredge BK Status epilepticus N Eng J Med 1998 338 970 976 (P.T.A.B. Jan. 28, 2020)
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IPR2019-00451, No. 1134-133 Exhibit - Wermeling DP, Miller JL, Archer SM, et al Bioavailability and pharmacokinetics of lorazepam after intranasal, intravenous, and intramuscular administratio...
The Journal of Clinical Pharmacology http://www.jclinpharm.org Bioavailability and pharmacokinetics of lorazepam after intranasal, intravenous, and intramuscular administration DP Wermeling, JL Miller, SM Archer, JM Manaligod and AC Rudy 2001; 41; 1225 J. Clin.
Volume of distribution at steady state and for elimination (Vss and Vz) were deter- mined by moment curves.13 Statistical Considerations Sample size was determined by clinical feasibility rather than standard calculations using alpha and power estimates.
The rela- tively small variation present in the pharmacokinetic Back pain Bad taste Blurred vision Burning/coolness in nose Burning/coolness in throat Ceiling moving Chemical smell Dazed/confused Diarrhea Disconnected/incoherent Dizziness/lightheaded Drowsiness/sleepiness Euphoria/giddiness Eyes heavy Eyes watery Floating sensation Flu/cold-like symptoms Groggy/heavy feeling Headache Hiccups Muscle tension/soreness Nausea Pain at injection site Pallor Phlegm in throat Postnasal drainage Pulse elevated Relaxed Slow response time Thirsty Warm IV, intravenous; IM, intramuscular; IN, intranasal.
However, this enzyme exists in multiple forms, only one of which was analyzed in that particular study.24 Last, as evi- denced by the second peak (Figure 2), partial oral ab- sorption of the dose could have played a role in the bioavailability, especially if nasal clearance took place.
Sev- eral of these studies found no significant pharmacokinetic differences between genders.29-31 Al- ternatively, Yonkers et al32 conducted a literature re- view and concluded that young women may require lower doses of benzodiazepines.
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IPR2019-00451, No. 1134-133 Exhibit - Wermeling DP, Miller JL, Archer SM, et al Bioavailability and pharmacokinetics of lorazepam after intranasal, intravenous, and intramuscular administration J Cli
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IPR2019-00451, No. 1118-122 Exhibit - Constantino HR, Illum L, Brandt G, et al, Intranasal delivery Physicochemical and therapeutic aspects, Intl J Pharmaceutics 2007 337 1 24 (P.T.A.B. Jan...
It was concluded that the transport of these drugs, both to the blood and the CSF, seemed to be controlled by a combination of molecular and physiological properties, none of which singu- larly determined the tissue distribution.
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IPR2019-00451, No. 1118-122 Exhibit - Constantino HR, Illum L, Brandt G, et al, Intranasal delivery Physicochemical and therapeutic aspects, Intl J Pharmaceutics 2007 337 1 24 (P.T.A.B. Jan. 28, 202
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IPR2019-00451, No. 2015-82 Exhibit - C Cole et al, ¿¿¿Community Survey of Carer¿¿¿s Individual Epilepsy Guidelines IEG for Rescue Medication,¿¿¿ Seizure 18220 224 2009 (P.T.A.B. Nov. 5, 2019...
Carers can give rectal diazepam and it may avoid the necessity of sending for medical help or preventing hospital admission.5 Other benzodiazepines, i.e. clobazam are often prescribed prophylactically for epilepsy cluster events.6 Within this Learning Disability Service (LDS) the clinicians found that in the community settings many of the support * Corresponding author.
This is important information for doctors as it aids distinguishing the preictal, ictal and postictal stages which can be difficult to detect when they co-exist with psychiatric and behavioural symptoms.14–16 Many studies have highlighted the complications of monitoring and diagnosing seizures due to the dual diagnosis in the learning disability population.17,18 The patients IEG’s were produced in consultation with carers, relatives and significant others, i.e. day/residential placements; respite care services staff and health professionals (nurses, psychiatrists, neurologists and general practitioners (GP)).
Fortunately the advantages compensate for this as it increases patient/carers satisfaction as affirmed by the results of this survey, prevents hospital admissions, and enables the person to receive emergency treatment by familiar people.
The plan is in the future for adult learning disability patients to use buccal midazolam medication (an alternative to rectal diazepam which is less intrusive) and develop guidelines using this process.30 Acknowledgements Thanks to Dr M Shah, Dr Bhandarkar, and Laura Findlay for their support during this project, and thanks also to the anonymous reviewers at Seizure Journal for their helpful comments.
McIntyre S, Robertson S, Norris E, Appleton R, Whitehouse WP, Phillips B, et al. Safety and efficacy of buccal midazolam versus rectal diazepam for emergency treatment of seizures in children: a randomised controlled trial.
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IPR2019-00451, No. 2015-82 Exhibit - C Cole et al, ¿¿¿Community Survey of Carer¿¿¿s Individual Epilepsy Guidelines IEG for Rescue Medication,¿¿¿ Seizure 18220 224 2009 (P.T.A.B. Nov. 5, 2019)
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IPR2019-00451, No. 2021-88 Exhibit - ¿¿¿How does the nose work The nasal mucosa,¿¿¿ httpswwwfitonasal2actcomhow does the nose workthe nasal mucosa Accessed November 5, 2019 (P.T.A....
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IPR2019-00451, No. 2021-88 Exhibit - ¿¿¿How does the nose work The nasal mucosa,¿¿¿ httpswwwfitonasal2actcomhow does the nose workthe nasal mucosa Accessed November 5, 2019 (P.T.A.B. Nov. 5, 2019)
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IPR2019-00451, No. 2012-93 Exhibit - Declaration of Dr Sveinbjorn Gizurarson, PhD (P.T.A.B. Nov. 5, 2019)
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IPR2019-00451, No. 2012-93 Exhibit - Declaration of Dr Sveinbjorn Gizurarson, PhD (P.T.A.B. Nov. 5, 2019)
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IPR2019-00451, No. 2023-90 Exhibit - ¿¿¿Neurelis Files New Drug Application With The FDA For VALTOCO¿¿¿ Diazepam Nasal Spray, An Investigational Treatment For Pediatric, Adolescent And A...
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IPR2019-00451, No. 2023-90 Exhibit - ¿¿¿Neurelis Files New Drug Application With The FDA For VALTOCO¿¿¿ Diazepam Nasal Spray, An Investigational Treatment For Pediatric, Adolescent And Adult Epilepsy
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IPR2019-00451, No. 2024-91 Exhibit - ¿¿¿Neurelis Receives FDA Orphan Drug Designation for NRL 1 in the Treatment of Acute Repetitive Seizures,¿¿¿ httpswwwneureliscomneurelis newsfda orph...
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IPR2019-00451, No. 2024-91 Exhibit - ¿¿¿Neurelis Receives FDA Orphan Drug Designation for NRL 1 in the Treatment of Acute Repetitive Seizures,¿¿¿ httpswwwneureliscomneurelis newsfda orphan drug design
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IPR2019-00451, No. 2019-86 Exhibit - J French and T Pedley, ¿¿¿Initial Management of Epilepsy,¿¿¿ New England Journal of Medicine 359166 176 2008 (P.T.A.B. Nov. 5, 2019)
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IPR2019-00451, No. 2019-86 Exhibit - J French and T Pedley, ¿¿¿Initial Management of Epilepsy,¿¿¿ New England Journal of Medicine 359166 176 2008 (P.T.A.B. Nov. 5, 2019)
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IPR2019-00451, No. 2007-76 Exhibit - E Bechgaard et al, ¿¿¿Solubilization of Various Benzodiazepines for Intranasal Administration, A Pilot Study,¿¿¿ Pharmaceutical Development and Technolog...
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IPR2019-00451, No. 2007-76 Exhibit - E Bechgaard et al, ¿¿¿Solubilization of Various Benzodiazepines for Intranasal Administration, A Pilot Study,¿¿¿ Pharmaceutical Development and Technology 2293 296
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IPR2019-00451, No. 3001-75 Exhibit - Ex 3001 (P.T.A.B. Oct. 2, 2019)
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IPR2019-00451, No. 3001-75 Exhibit - Ex 3001 (P.T.A.B. Oct. 2, 2019)
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IPR2019-00451, No. 2006-74 Exhibit - SIGMA Chemical Company Catalog 1988 (P.T.A.B. May. 21, 2019)
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IPR2019-00451, No. 2006-74 Exhibit - SIGMA Chemical Company Catalog 1988 (P.T.A.B. May. 21, 2019)
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IPR2019-00451, No. 2001-69 Exhibit - Epilepsy Fast Facts, CDC Center for Disease Control and Preventions, CDC 247 Saving Lives, Protection People¿¿¿, Apr, 9, 2019, pp 1 2 (P.T.A.B. May. 21,...
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IPR2019-00451, No. 2001-69 Exhibit - Epilepsy Fast Facts, CDC Center for Disease Control and Preventions, CDC 247 Saving Lives, Protection People¿¿¿, Apr, 9, 2019, pp 1 2 (P.T.A.B. May. 21, 2019)
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IPR2019-00451, No. 1025-41 Exhibit - Lindhardt et al, Electroencephalographic effects and serum concentrations after intranasal and intravenous administration of diazepam to healthy voluntee...
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IPR2019-00451, No. 1025-41 Exhibit - Lindhardt et al, Electroencephalographic effects and serum concentrations after intranasal and intravenous administration of diazepam to healthy volunteers, Blackw
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