Outcome of Treatment of Monosymptomatic Nocturnal Enuresis in Children Using Imipramine Alone Versus Sulbutiamine Alone Versus Imipramine Plus Sulbutiamine : Prospective Comparative Study

The aim of the study is to evaluate the role of sulbutiamine in treatment of monosymptomatic nocturnal enuresis in children by using it alone or as a combination therapy with tricyclic antidepressants (imipramine+sulbutiamine).

Start Date01 Mar 2024

Sponsor / Collaborator

Sohag University

NCT06312813 / RecruitingPhase 2IIT

Pilot Studies Evaluating Use of Topical Imipramine and Amitriptyline in Reducing Ultraviolet B Light-Induced Redness in Patients With Rosacea

Rosacea is a common skin condition associated with easy blushing and red face; many patients with rosacea react to sunlight with increased redness. The purpose of this study is to determine if the use of a topical medication will help reduce sunlight induced redness and irritation in patients with rosacea.

Start Date27 Feb 2024

Sponsor / Collaborator

Wright State University School of Medicine

CTRI/2022/10/046915 / Not yet recruitingPhase 2/3

Comparative evaluation of clinical anxiolytic efficacy of Sitadi Agada and Imipramine (TCAs) in the management of Generalized Anxiety Disorders (GAD)- A reverse Pharmacology approach.

Start Date01 Nov 2022

Sponsor / Collaborator-

100 Clinical Results associated with Imipramine Pamoate

100 Translational Medicine associated with Imipramine Pamoate

100 Patents (Medical) associated with Imipramine Pamoate

9,649

Literatures (Medical) associated with Imipramine Pamoate

01 Dec 2024·IBRO Neuroscience Reports

Genetic ablation of the isoform γ of PI3K decreases antidepressant efficacy of ketamine in male mice

Article

Author: Brigante, Tamires A V ; de Oliveira, Antonio C P ; Lima, Isabel A V ; Teixeira, Antonio L ; Guimarães, Francisco S ; Turcato, Flávia C ; Crippa, Jose A ; Hallak, Jaime E C ; Araújo, Melissa R ; Scarante, Franciele F ; Campos, Alline Cristina ; Vaz, Gabriela N ; Rodrigues, Livia C M

About one-third of major depressive disorder (MDD) patients demonstrate unresponsiveness to classic antidepressants, and even the clinical efficacy of fast-acting drugs such as ketamine varies significantly among patients with treatment-resistant depression. Nevertheless, the lack of suitable animal models that mimic a possible ketamine-resistant phenotype challenges the understanding of resistance to drug treatment. In this study, we showed that PI3Kγ knock-out (KO) mice do not respond to classical doses of ketamine and classical antidepressants. PI3Kγ KO mice were unresponsive to both the rapid and sustained antidepressant-like effects of a single dose of ketamine in the forced swimming test. Additionally, they were unresponsive to the antidepressant-like effects induced by the tricyclic antidepressant imipramine and the selective serotonin reuptake inhibitor fluoxetine. However, acute pharmacological inhibition of PI3Kγ did not block the antidepressant-like effect of ketamine, showing that a chronic deficiency of the PI3Kγ-mediated pathway is necessary for the effects of classic doses of ketamine and antidepressants. Therefore, we propose that PI3Kγ participates in the antidepressant activity and is likely implicated in the neurobiology and phenotype observed in patients with MDD who demonstrate treatment resistance.

01 Dec 2024·The Veterinary Journal

Imipramine in dogs: A pharmacokinetic study following oral administration under fasted and fed conditions

Article

Author: Fadel, C. ; Poapolathep, A ; Čudina, N. ; Čudina, N ; Lisowski, A ; Serih, F. ; Giorgi, M. ; Poapolathep, A. ; Łebkowska-Wieruszewskac, B ; Łebkowska-Wieruszewskac, B. ; Serih, F ; Fadel, C ; Lisowski, A. ; Giorgi, M

This study investigates the pharmacokinetics (PK) of imipramine, a tricyclic antidepressant used in human psychiatric disorders and increasingly considered in veterinary medicine. Despite its longstanding use in canines, prior research on imipramine's PK in dogs is lacking. This study aimed to determine the PK of imipramine in dogs in regards to feeding conditions, and to ascertain whether desipramine (active metabolite) is formed or not. In this study, six male Labrador dogs underwent oral administration (1.5 mg/kg) of imipramine tablets (10 mg each; Tofranil®, Novartis) in both fasted and fed conditions. Dogs were randomly allocated to one of two treatment groups, employing an open, single-dose, two-treatment, two-phase, cross-over design, with a washout period of one week. Blood was drawn from the left cephalic vein to heparinized tubes at 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, 24, and 48 h. Plasma concentrations were quantified using a validated HPLC method, and the data were analyzed using PKanalix™ software with a non-compartmental approach. Concentrations of imipramine remained quantifiable up to 1.5 hr after administration under both conditions. Desipramine, in both feeding states, was detectable for a short duration, but not quantifiable. No significant differences were observed in the PK parameters of imipramine between the fasting and fed states. The rapid attainment of maximum concentration (C_max) occurred within 0.25 h, indicating a swift absorption rate. Notably, the terminal half-life in dogs was remarkably short at 0.25 h, prompting a re-evaluation of dosing strategies. Considering the recommended therapeutic plasma concentrations in humans, the administered dose might result in effective levels for a brief period of time. Future research should explore intravenous administration, multiple-dose studies, and metabolic investigations to further elucidate imipramine's PK in dogs.

01 Nov 2024·Neuroscience Letters

Long-term effects of a single high-dose intraperitoneal injection of lipopolysaccharide on depression-like behavior in adolescent mice

Article

Author: Nakagawasai, Osamu ; Yamagata, Ryota ; Takahashi, Kohei ; Suzuki, Takuto ; Tan-No, Koichi ; Nemoto, Wataru

The commonly used lipopolysaccharide (LPS)-induced depression models often evaluate depression-like behaviors in the acute phase after a single intraperitoneal injection of LPS, and are not suitable for examining long-term depression-like behaviors. To overcome this limitation, we developed a mice LPS model for elucidating the long-term pathophysiology of depression. Using the tail-suspension test, we show that a single intraperitoneal injection of a high dose (1.66 mg/kg) of LPS prolonged depression-like behavior to 14 days after LPS administration unlike 4 days after administration for the most commonly used LPS dose (0.83 mg/kg). Upon high-LPS dose administration, TNF-α levels in the cerebrospinal fluid were increased only on the first day after administration. Moreover, LPS-induced depression-like behavior on day 10 after LPS administration was prevented by imipramine or minocycline. Immunohistochemical analysis revealed reduced neurogenesis in the hippocampal dentate gyrus of LPS-treated mice on day 10 of LPS administration. The LPS model, in which a single intraperitoneal administration of LPS at a dose double of the standard dose used currently, exhibits depression-like behavior via reduced neurogenesis mediated by neuroinflammation, and should be useful for elucidating the long-term pathophysiology of depression and for studying antidepressant drugs.

News (Medical) associated with Imipramine Pamoate

29 Oct 2024

·www.prnewswire.com

American Regent introduces FDA-approved Epinephrine Injection, USP in 30 mL

SHIRLEY, N.Y., Oct. 29, 2024 /PRNewswire/ -- American Regent announces the launch of 30 mL Epinephrine Injection, USP.1 Epinephrine Injection, USP is indicated for emergency treatment of allergic reactions (Type I), including anaphylaxis, which may result from insect stings or bites, foods, drugs, sera, diagnostic testing substances, and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis. Epinephrine is also indicated to increase mean arterial blood pressure in adult patients with hypotension associated with septic shock. Continue Reading Epinephrine Injection, USP is supplied as a 30 mg/30 mL (1 mg/mL) multiple-dose vial in a shelf pack of one. "With the approval of Epinephrine Injection, USP we continue to show our commitment to ensuring both patients and providers have access to high-quality treatment options," stated Joann Gioia, Vice President and Chief Commercial Officer at American Regent, Inc. Product is available for immediate shipment. Customers can order Epinephrine Injection, USP through their wholesaler/distributor or by contacting our Customer Support Group at 1-800-645-1706. Epinephrine Injection, USP is supplied as follows: Please see the accompanying Important Safety Information in addition to the Full Prescribing Information. For additional information, please visit americanregent.com. REFERENCE: 1. Epinephrine Injection, USP. Package insert. American Regent, Inc. © 2024 American Regent, Inc. All rights reserved. PP-EP-US-0024 5 Ramsey Road, Shirley, NY 11747 \\ 1.800.645.1706 F 631.924.1731 \\ A Daiichi Sankyo Group Company Epinephrine Injection, USP 30 mL For intramuscular, subcutaneous, and intravenous use. INDICATIONS AND USAGE Anaphylaxis Emergency treatment of allergic reactions (Type I), including anaphylaxis, which may result from insect stings or bites, foods, drugs, sera, diagnostic testing substances, and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis. Hypotension associated with Septic Shock To increase mean arterial blood pressure in adult patients with hypotension associated with septic shock. IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS: None. WARNINGS AND PRECAUTIONS Incorrect Locations of Injection for Anaphylaxis: Injection into the anterolateral aspect of the thigh (vastus lateralis muscle) is the most appropriate location for administration because of its location, size, and available blood flow. Injection into (or near) smaller muscles, such as in the deltoid, is not recommended. Do not administer repeated injections of epinephrine at the same site, as the resulting vasoconstriction may cause tissue necrosis. Do not inject into buttock, digits, hands, or feet. Serious Infections at the Injection Site: Rare cases of serious skin and soft tissue infections, including necrotizing fasciitis and myonecrosis caused by Clostridia (gas gangrene), have been reported. Extravasation and Tissue Necrosis with Intravenous Infusion: Avoid extravasation into tissues, which can cause local necrosis. When epinephrine is administered intravenously, check the infusion site frequently. Hypertension: Because individual response to epinephrine may vary significantly, monitor blood pressure frequently and titrate to avoid excessive increases in blood pressure. Patients receiving monoamine oxidase inhibitors or antidepressants of the triptyline or imipramine types may experience severe, prolonged hypertension. Pulmonary Edema: Epinephrine increases cardiac output and causes peripheral vasoconstriction, which may result in pulmonary edema. Renal Impairment: Epinephrine constricts renal blood vessels, which may result in oliguria or renal impairment. Cardiac Arrhythmias and Ischemia: Epinephrine may induce cardiac arrhythmias and myocardial ischemia, especially in patients suffering from coronary artery disease or cardiomyopathy. May aggravate angina pectoris or produce ventricular arrhythmias. Allergic Reactions Associated with Sulfite: The Epinephrine 30 mL multiple-dose vial contains sodium metabisulfite, which may cause mild to severe allergic reactions including anaphylaxis or asthmatic episodes in susceptible individuals. ADVERSE REACTIONS Common adverse reactions to systemically administered epinephrine include, but are not limited to, anxiety, apprehensiveness, restlessness, tremor, weakness, dizziness, sweating, palpitations, pallor, nausea and vomiting, headache, and respiratory difficulties. These symptoms occur in some persons receiving therapeutic doses of epinephrine, but are more likely to occur in patients with heart disease, hypertension, or hyperthyroidism. The true incidence of adverse reactions associated with the systemic use of epinephrine is difficult to determine. Adverse reactions reported in observational trials, case reports, and studies are listed below by body system: Cardiovascular: Angina, arrhythmias, hypertension, pallor, palpitations, tachyarrhythmia, tachycardia, vasoconstriction, ventricular ectopy, and stress cardiomyopathy. Rapid rises in blood pressure associated with epinephrine use have produced cerebral hemorrhage, particularly in elderly patients with cardiovascular disease. Neurological: Disorientation, impaired memory, panic, psychomotor agitation, sleepiness, tingling. Psychiatric: Anxiety, apprehensiveness, restlessness. Other: Patients with Parkinson's disease may experience psychomotor agitation or a temporary worsening of symptoms. Diabetic patients may experience transient increases in blood sugar. Injection into the buttock has resulted in cases of gas gangrene. Rare cases of serious skin and soft tissue infections, including necrotizing fasciitis and myonecrosis caused by Clostridia (gas gangrene), have been reported following epinephrine injection in the thigh. USE IN SPECIFIC POPULATIONS Elderly patients and pregnant women may be at greater risk of developing adverse reactions when epinephrine is administered parenterally. Pregnancy May cause fetal harm. Labor or Delivery: There are risks to the mother and fetus associated with epinephrine use during labor or delivery. Epinephrine usually inhibits spontaneous or oxytocin-induced contractions of the pregnant human uterus and may delay the second stage of labor. Avoid epinephrine during the second stage of labor. Although epinephrine may improve maternal hypotension associated with septic shock and anaphylaxis, it may result in uterine vasoconstriction, decreased uterine blood flow, and fetal anoxia. Lactation There is no information regarding the presence of epinephrine in human milk or the effects of epinephrine on the breastfed infant or on milk production. Pediatric Use Reported clinical experience with the use of epinephrine suggests that the adverse reactions seen in children are similar in nature and extent to those both expected and reported in adults. Safety and effectiveness of epinephrine in pediatric patients with septic shock have not been established. Geriatric Use In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. OVERDOSAGE Overdosage of epinephrine may produce extremely elevated arterial pressure, which may result in cerebrovascular hemorrhage, particularly in elderly patients. Overdosage may also result in pulmonary edema, transient bradycardia followed by tachycardia, and these may be accompanied by potentially fatal cardiac arrhythmias. Subsidence of the ventricular effects may be followed by atrial tachycardia and occasionally by atrioventricular block. Myocardial ischemia and infarction, cardiomyopathy, extreme pallor and coldness of the skin, metabolic acidosis due to elevated blood lactic acid levels, and renal insufficiency have also been reported. For additional Safety Information, please see the Full Prescribing Information. REF-2454 4/2023 You are encouraged to report adverse drug events (ADEs) to American Regent®: T 1.800.734.9236; E [email protected]; F 1.610.650.0170 ADEs may also be reported to the FDA: 1.800.FDA.1088 or Medical information: T 1.888.354.4855 (9:00 am–5:00 pm Eastern Time, Monday–Friday) medical information outside of normal business hours that cannot wait until the next business day, please call 1.877.845.6371 About American Regent For more than 50 years, American Regent has been developing, manufacturing, and supplying quality generic and branded injectables. For more than 20 years, we have been a leader in IV iron therapy. We are committed to setting a higher standard for responsiveness and reliability as a US-based manufacturer. To ensure that we deliver on our mission to improve human and animal health, we continue to make investments in expanding and modernizing our manufacturing facilities in Ohio and New York and have expanded our footprint into California. This growth will increase our capacity, create redundancies across our manufacturing sites, and strengthen our expertise in the development of complex drug products and delivery systems. What that means for you is a partner committed to delivering essential medications now and in the future. For more information, please visit . About Daiichi Sankyo Daiichi Sankyo is an innovative global healthcare company contributing to the sustainable development of society that discovers, develops, and delivers new standards of care to enrich the quality of life around the world. With more than 120 years of experience, Daiichi Sankyo leverages its world-class science and technology to create new modalities and innovative medicines for people with cancer, cardiovascular, and other diseases with high unmet medical needs. For more information, please visit . SOURCE American Regent, Inc. 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06 Jun 2024

·www.drugs.com

Many Patients Have Discontinuation Symptoms After Stopping Antidepressants

THURSDAY, June 6, 2024 -- A considerable proportion of patients have discontinuation symptoms (e.g., dizziness, headache, nausea, insomnia, and irritability) after discontinuing antidepressants, according to a review published online June 5 in The Lancet Psychiatry . Jonathan Henssler, M.D., from the University of Cologne in Germany, and colleagues conducted a systematic review to examine the incidence of antidepressant discontinuation symptoms in patients discontinuing both antidepressants and placebo. Studies investigated cessation or tapering of an established antidepressant drug or placebo among patients with mental, behavioral, or neurodevelopmental disorders. Data were included from 79 studies with 21,002 patients: 16,532 patients discontinued from an antidepressant and 4,470 discontinued from placebo. The researchers found that the incidence of at least one antidepressant discontinuation symptom was 0.31 and 0.17 in 62 study groups after discontinuation of an antidepressant and 22 study groups after discontinuation of placebo, respectively. The summary difference in incidence was 0.08 between antidepressant and placebo groups of included randomized controlled trials. The incidence of severe antidepressant discontinuation symptoms was 0.028 and 0.006 after discontinuation of an antidepressant and placebo, respectively. Higher frequencies of discontinuation symptoms were seen in association with desvenlafaxine, venlafaxine, imipramine, and escitalopram, while higher severity of symptoms was seen in association with imipramine, paroxetine, and either desvenlafaxine or venlafaxine. Substantial heterogeneity was seen for the results. "Evidence that about one in 35 patients suffers from severe antidepressant discontinuation symptoms must be considered preliminary at present, but caution towards severe antidepressant discontinuation symptoms seems to be warranted when discontinuing imipramine, paroxetine, or desvenlafaxine and venlafaxine," the authors write. Abstract/Full Text Editorial (subscription or payment may be required) Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

Clinical ResultClinical Study

06 Jun 2024

·www.sciencedaily.com

Antidepressants: New data on prevalence of discontinuation symptoms

How hard is it to stop taking antidepressants? If countless Internet posts and a number of scientific studies are to be believed, discontinuing these medications is highly problematic, and doctors often underestimate the difficulties involved. But it is unclear how common discontinuation symptoms actually are. Researchers have now conducted a systematic review and meta-analysis. They conclude that one in three people reports symptoms after discontinuing antidepressant treatment, but half of those symptoms are attributable to negative expectations (the nocebo effect). How hard is it to stop taking antidepressants? If countless Internet posts and a number of scientific studies are to be believed, discontinuing these medications is highly problematic, and doctors often underestimate the difficulties involved. But it is unclear how common discontinuation symptoms actually are. Researchers from Charité -- Universitätsmedizin Berlin and University Hospital Cologne have now conducted a systematic review and meta-analysis. In their article in The Lancet Psychiatry,* they conclude that one in three people reports symptoms after discontinuing antidepressant treatment, but half of those symptoms are attributable to negative expectations (the nocebo effect). According to the formal definition, antidepressants are not habit-forming. Unlike "true" addictive substances, for example, taking them does not cause the body to require higher and higher doses to achieve the same effect. Even so, many patients report symptoms such as dizziness, headache, or insomnia when they stop taking these mood medications. The phenomenon went largely unremarked by researchers for years, but there are now a relatively large number of studies seeking to quantify the extent of discontinuation symptoms. "The results of these studies vary, in some cases widely," says Prof. Christopher Baethge, a researcher at the Department of Psychiatry and Psychotherapy at University Hospital Cologne and the Faculty of Medicine at the University of Cologne. "There has been a great deal of discussion, some of it quite emotional, within the research community and the general public alike in recent years about how prevalent and severe the discontinuation symptoms actually are." A look at prescription figures shows just how relevant this topic is. According to the most recent Arzneiverordnungs-Report, which summarizes data on drug prescriptions, nearly 1.8 billion daily doses of antidepressants were prescribed in Germany in 2022. Comprehensive meta-analysis brings clarity To answer that question more reliably than before, a team led by Christopher Baethge and Dr. Jonathan Henssler, head of the Evidence-Based Mental Health research group at the Department of Psychiatry and Neurosciences at Charité, conducted a systematic review of existing studies and re-analyzed them in what is known as a meta-analysis. As the first study of its kind, it provides the soundest assessment to date of the consequences of stopping antidepressant treatment. "Our analysis shows that on average, one in three people will experience symptoms after stopping antidepressant treatment," Henssler says. "However, only half of these symptoms are in fact attributable to the drug itself." For their paper, the researchers reviewed more than 6,000 studies. They then selected 79 of them and re-analyzed the results of those trials using statistical methods. In the end, they analyzed data on about 21,000 people, who had received either an antidepressant or a placebo and then been surveyed regarding the prevalence of discontinuation symptoms. Some 31 percent of the patients treated with an active drug reported discontinuation symptoms, but so did 17 percent of those who had received a placebo alone. One in six or seven people experiences true discontinuation symptoms "Drug effects can be ruled out in the placebo group, which means the symptoms either arose by chance, independently of the treatment, or they are the product of the nocebo effect," Henssler explains. The nocebo effect is often considered the mirror image of the placebo effect. It explains the observation that inactive treatments can be associated with "side effects." These effects are triggered purely by the expectation that the treatment that people think they are receiving will have negative effects. "When we take non-specific symptoms and the effect of expectations into account, about one in six or seven people is affected by discontinuation symptoms that occur as an actual consequence of antidepressant medication," Henssler says, summing up the study's results. "In most cases, the symptoms are mild. The vast majority of those affected will be able to discontinue antidepressants without relevant symptoms. This means that in most cases, there is no need for a lengthy or gradual tapering process." Severe symptoms are rare The study found that severe discontinuation symptoms are experienced by one in 35 people, or nearly three percent of those affected. These kinds of symptoms were more common after discontinuing treatment with the drugs imipramine, paroxetine, venlafaxine, and desvenlafaxine. There was not yet enough information on hand for the researchers to assess the situation for a number of widely used antidepressants. As Baethge points out, "It's important for all people wishing to discontinue treatment with antidepressants to be monitored and counseled by healthcare professionals and to receive individual support in the case of withdrawal symptoms. Joint decision-making between the patient and prescriber even before a course of treatment begins is the foundation of good treatment. We hope our data will support patients and healthcare professionals and help alleviate some of the uncertainty surrounding these issues today." About the study The 79 studies considered in the meta-analysis included both randomized placebo-controlled trials and observational studies conducted without a control group. Of the 21,002 patients involved in the studies, 16,532 had received an antidepressant, and 4,470 a placebo. In addition to the researchers from Charité and University Hospital Cologne, researchers at the Medical Center -- University of Freiburg and University Hospital Carl Gustav Carus, in Dresden, were involved in the meta-analysis.

Clinical Result

100 Deals associated with Imipramine Pamoate

External Link

KEGG	Wiki	ATC	Drug Bank
D08071	Imipramine Pamoate	N06AA02	DB00458

R&D Status

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


WCLC2019	Not Applicable	Small Cell Lung Cancer	15	Imipramine	vgzntwbxoh(xdpgoferuk) = emmcygyykl jhwkyoashf (vkjzvnrvdk )	-	08 Sep 2019
AUA2018	Not Applicable	Diabetes Mellitus	-	Imipramine+pseudoephedrine	ansdilsptl(tjkzzlhtej) = cmsgnaaojg bhfsjzevwj (rqtjajaqwb ) View more	-	01 Apr 2018
NCT00404755 (CTgov)	Phase 4	Depressive Disorder, Major	17	bupropion (Bupropion)	dhtuerakcb(nwgoksmvbb) = lnctzndycj lcntlqezdx (ievwdolpzj, mpjjfwyima - zuzojwqajo) View more	-	15 Mar 2018
				Escitalopram (Escitalopram)	dhtuerakcb(nwgoksmvbb) = zprmgsohrd lcntlqezdx (ievwdolpzj, gdsngmckev - tejxxiwvcq) View more
NCT01107353 (CTgov)	Not Applicable	Depressive Disorder	39	Imipramine Pamoate (First Imipramine Pamoate, Then Tofranil-PM)	qezrxxfhtu(uvxaoolcbw) = loimousugs fywtimfjnk (ifrwsephlv, fcfuhimkug - plytuwolav) View more	-	15 Jan 2014
				Imipramine Pamoate (First Tofranil PM, Then Imipramine Pamoate)	qezrxxfhtu(uvxaoolcbw) = hnqthoqhwc fywtimfjnk (ifrwsephlv, ipycbefnao - vhosmgmtqf) View more
NCT01028014 (CTgov)	Not Applicable	-	56	Pseudoephedrine (Pseudoephedrine 120mg ER Daily)	owezdhyyoe(mxduoeenif) = ggjsttpcuh wuzmylqugt (zrvcnacwph, jegodlmvkp - ljawdgdwcb) View more	-	05 Sep 2011
				Solifenacin (Solifenacin 5mg Daily)	owezdhyyoe(mxduoeenif) = gnvymieenh wuzmylqugt (zrvcnacwph, mzxfioqxvf - rwzdnpican) View more

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