Re-certification of pharmacies must be done with the revised Clozapine REMS materials. Management: Patients taking perampanel with any other drug that has CNS depressant activities should avoid complex and high-risk activities, particularly those such as driving that require alertness and coordination, until they have experience using the combination. The authorized representative will be responsible for recertifying the pharmacy. Available for Android and iOS devices. dizziness, feeling unsteady, or having trouble keeping your balance. Mitral valve incompetence has been reported in patients who are diagnosed with cardiomyopathy while taking clozapine. Benefits of Levitra Jelly 3. To make sure this medicine is safe for you, tell your doctor if you have ever had: a heart attack or stroke (including "mini-stroke"); long QT syndrome (in you or a family member); an electrolyte imbalance (such as low levels of potassium or magnesium in your blood); diabetes, or risk factors such as being overweight or having a family history of diabetes; constipation or problems with your bowel movements; an enlarged prostate or urination problems; Taking antipsychotic medicine in the last 3 months of pregnancy may cause breathing problems, feeding problems, or withdrawal symptoms in the newborn. World Federation of Societies of Biological Psychiatry, Canadian Network for Mood and Anxiety Treatments and International Society for Bipolar Disorders, American Psychiatric Association (APA) practice guideline on the use of antipsychotics to treat agitation or psychosis in patients with dementia. Take clozapine exactly as directed. Depending on the patients monitoring frequency, this could require daily, weekly, biweekly, or monthly documentation of the ANC. Call your doctor right away if you have any signs of. Monitor therapy, QT-prolonging Miscellaneous Agents (Moderate Risk): May enhance the QTc-prolonging effect of QT-prolonging Antipsychotics (Moderate Risk). Disclaimer. Case reports suggest symptoms from increasing clozapine concentrations may develop 2 to 4 weeks after smoking cessation (Lowe 2010). Extrapyramidal symptoms: May cause extrapyramidal symptoms (EPS), including pseudoparkinsonism, acute dystonic reactions, akathisia, and tardive dyskinesia (risk of these reactions is generally much lower relative to typical/conventional antipsychotics; frequencies reported are similar to placebo). The following information includes only the average doses of this medicine. While still holding the oral syringe in the bottle, carefully turn the bottle upwards so the syringe is on top. Enroll in the Clozapine REMS by completing the Prescriber Enrollment Form and submitting it to the Clozapine REMS. Avoid combination, Voriconazole: May enhance the QTc-prolonging effect of QT-prolonging Antipsychotics (Moderate Risk). Prior to initiating treatment, a baseline ANC must be at least 1,500/mm3 for the general population and must be at least 1,000/mm3 for patients with documented Benign Ethnic Neutropenia. sugar like confusion, feeling sleepy, more thirst, more hungry, passing urine more often, flushing, fast breathing, or breath that smells like increased salivation. Take clozapine at around the same time(s) every day. Anticholinergic effects: May cause anticholinergic effects (constipation, xerostomia, blurred vision, urinary retention); use with caution in patients with decreased gastrointestinal motility, urinary retention, BPH, xerostomia, or visual problems. If you think there has been an overdose, call your poison control center or get medical care right away. While all medications have labeling that informs health care stakeholders about medication risks, only a few medications require a REMS. Talk with your doctor before you drink alcohol or use other drugs and natural products that slow your actions. quetiapine, Abilify, Seroquel, aripiprazole, olanzapine, risperidone. 8600 Rockville Pike -When therapy is interrupted for 2 or more days, re-initiate with 12.5 mg once or twice a day; based on tolerability, a dose that is restarted may be increased to a previously therapeutic dose more quickly than it was for initial treatment. Monitor therapy, Brexanolone: CNS Depressants may enhance the CNS depressant effect of Brexanolone. However, studies in which the medication of well-stabilized patients were discontinued indicate that 75% of patients relapse within 6 to 24 months. Signs and symptoms such as hypotension, sialorrhea, and sedation that cannot be explained by other medications or conditions may necessitate a temporary dose reduction or discontinuation, depending on the severity (Clark 2017; Leung 2014). Weight gain: Significant weight gain has been observed with antipsychotic therapy; incidence varies with product. When switching antipsychotics, three strategies have been suggested: Cross-titration (gradually discontinuing the first antipsychotic while gradually increasing the new antipsychotic), overlap and taper (maintaining the dose of the first antipsychotic while gradually increasing the new antipsychotic, then tapering the first antipsychotic), and abrupt change (abruptly discontinuing the first antipsychotic and either increasing the new antipsychotic gradually or starting it at a treatment dose). Consider dose reduction if hypotension occurs. These problems can be deadly. in addition to the condition listed in the IMPORTANT WARNING section, tell your doctor if you or anyone in your family has ever had a prolonged QT interval (a rare heart problem that may cause irregular heartbeat, fainting, or sudden death) or diabetes. Specifically, the risk of psychomotor impairment may be enhanced. -To reduce the risk of recurrent suicidal behavior in patients with schizophrenia or schizoaffective disorder, who are judged to be at chronic risk for re-experiencing suicidal behavior, based on history and recent clinical state. Orally disintegrating tablet: Remove from foil blister by peeling apart (do not push tablet through the foil). Side effects Interactions What is clozapine? Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Take the oral liquid or tablet with or without food. Clozapine is an antipsychotic medicine. QT prolongation: Clozapine is associated with QT prolongation and ventricular arrhythmias including torsade de pointes; cardiac arrest and sudden death may occur. Nonpharmacological strategies such as propping head up on several pillows while sleeping, sleeping on the side, placing a towel over pillow to prevent soaking, or chewing sugar free gum may be considered in milder cases (Praharaj 2006). What side effects can this medication cause? Swallow the medication slowly as it goes into your mouth. If clozapine is discontinued, a weekly WBC should be conducted for an additional 4 weeks or until WBC is 3,500/mm3 and ANC is 2,000/mm3. Treatment discontinuation: For abrupt clozapine discontinuation for a reason unrelated to neutropenia in the general population, continuation of ANC monitoring is recommended until the ANC is 1,500/mm3. Clozapine affects your immune system. Call your doctor for medical advice about side effects. Clozapine may cause seizures. In a scientific statement from the American Heart Association, clozapine has been determined to be an agent that may cause direct myocardial toxicity (magnitude: major) (AHA [Page 2016]). You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. Bipolar disorder, treatment resistant (acute manic episodes or maintenance treatment; monotherapy or adjunctive therapy) (off-label use): Oral: Initial: 25 mg daily; increase based on response and tolerability in 25 mg increments to a maximum dose of 550 mg/day. If rechallenged, resume treatment as a new patient once ANC 1,500/mm3. Monitor therapy, Pimozide: May enhance the QTc-prolonging effect of QT-prolonging Agents (Moderate Risk). To measure clozapine oral suspension, follow these steps: Clozapine controls schizophrenia but does not cure it. Consider therapy modification, CYP1A2 Inhibitors (Weak): May increase the serum concentration of CloZAPine. Patients with additional risk factors for QTc prolongation may be at even higher risk. Antipsychotic use during the third trimester of pregnancy has a risk for abnormal muscle movements (extrapyramidal symptoms [EPS]) and/or withdrawal symptoms in newborns following delivery. paralysis of the intestines. You may get infections more easily, even serious or fatal infections. If dosing requires splitting tablet, throw unused portion away. Monitor therapy, CYP3A4 Inducers (Moderate): May decrease the serum concentration of CloZAPine. Pharmacists will need to go to www.clozapineREMS.com or call the Clozapine Call Center at 1-888-586-0758 to verify information and obtain a REMS dispense authorization to dispense clozapine. Schizophrenia is a mental health condition that affects how a person thinks, feels and behaves, and how they interpret reality. Monitor waist circumference and BMI. Specifically, anticholinergic agents may decrease the dissolution of sublingual nitroglycerin tablets, possibly impairing or slowing nitroglycerin absorption. If combined, limit the dosages and duration of each drug. Clozapine is available only from a certified pharmacy under a special program. fruit. Exceptions: Propafenone. Continue to monitor existing patients according to the current REMS requirements prior to the November 15, 2021 launch of the new Clozapine REMS Program. Clozapine is an antipsychotic medication that is used to treat severe schizophrenia symptoms in people who have not responded to other medications. Last updated on Jan 1, 2023. However, if a woman is inadvertently exposed to an atypical antipsychotic while pregnant, continuing therapy may be preferable to switching to a typical antipsychotic that the fetus has not yet been exposed to; consider risk:benefit (ACOG 2008). Avoid combination, Barbiturates: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Overdose symptoms may include drowsiness, confusion, fast heartbeats, feeling light-headed, weak or shallow breathing, drooling, choking, or seizure. Monitor therapy, Anticholinergic Agents: May enhance the adverse/toxic effect of other Anticholinergic Agents. Monitor therapy, CarBAMazepine: May enhance the myelosuppressive effect of CloZAPine. Monitor therapy, Nitroglycerin: Anticholinergic Agents may decrease the absorption of Nitroglycerin. After November 15, 2021, enroll all new patients starting treatment with clozapine in the newly modified REMS program. 2022. Monitor therapy, Cimetidine: May increase the serum concentration of CloZAPine. The therapeutic efficacy of clozapine (dibenzodiazepine antipsychotic) is proposed to be mediated through antagonism of the dopamine type 2 (D2) and serotonin type 2A (5-HT2A) receptors. Follow your doctor's orders or the directions on the label. If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088). You may need frequent medical tests while using this medicine and for a short time after your last dose. There are no changes to the wholesalers or distributors requirements. Do not rechallenge unless prescriber determines benefits outweigh risks. If an atypical antipsychotic is necessary, consider using clozapine or quetiapine, which may convey the lowest interaction risk. You may get infections more easily, even serious or fatal infections. Fever is often the first sign of neutropenic infection. Also tell your doctor if you have ever had to stop taking a medication for mental illness because of severe side effects. Laboratory hematology results may be presented in different units; 1 mcL equals 1 mm3. Consider therapy modification, Methotrimeprazine: CNS Depressants may enhance the CNS depressant effect of Methotrimeprazine. Place the tablet in your mouth. After the tablet has melted, swallow or chew it as desired. Typical dosing for clozapine (Clozaril) The typical . BEN patients are not at increased risk for developing clozapine-induced neutropenia. The ANC must be monitored regularly with continued treatment. If WBC/ANC continue to remain within these acceptable limits after the second 6 months (26 weeks) of therapy, monitoring can be decreased to every 4 weeks. These agents should only be combined if alternative treatment options are inadequate. Brand name: Versacloz Administer without regard to food. Within 1 week for sedation, improvement in sleep; 6 to 12 weeks for antipsychotic effects; Adequate trial: 6 to 12 weeks at a therapeutic dose and blood level; Maximum effect: 6 to 12 months; improvement may continue 6 to 12 months after clozapine initiation (Meltzer 2003). Leave the adaptor in the bottle. Suicidal behavior in schizophrenia or schizoaffective disorder: Oral: Initial: 12.5 mg once or twice daily; increased, as tolerated, in increments of 25 to 50 mg daily to a target dose of 300 to 450 mg daily (administered in divided doses) by the end of 2 weeks; may further titrate in increments not exceeding 100 mg and no more frequently than once or twice weekly. Avoid combination, Buprenorphine: CNS Depressants may enhance the CNS depressant effect of Buprenorphine. ANC monitoring: Note: Laboratory hematology results may be presented in different units; 1 mcL equals 1 mm3. Frequently reported side effects of this drug. Call your doctor right away if you have signs of infection such as: fever, flu-like symptoms, extreme weakness; new or worsening cough, trouble breathing; Further doses may be delayed until your infection clears up. taken, how much, and when it happened. Monitor therapy, Aclidinium: May enhance the anticholinergic effect of Anticholinergic Agents. Tell your doctor if you have heart problems or brain problems. An increased risk of exacerbation of psychosis should be considered when discontinuing or changing treatment during pregnancy and postpartum. The chance of seizures may be higher with higher doses or if you have ever had seizures. while taking clozapine oral suspension. Place the tablet in your mouth. Your doctor will order the lab tests once a week at first and may order the tests less often as your treatment continues. Monitor therapy, CYP1A2 Inducers (Weak): May decrease the serum concentration of CloZAPine. Call your doctor or get medical Discontinuing concomitant medication while continuing clozapine: Monitor for adverse reactions and if necessary, consider reducing the clozapine dose. In general, other agents are preferred for use in pregnancy; however, clozapine may be used in women who cannot be switched to recommended antipsychotics (Larsen 2015). The American Society of Health-System Pharmacists, 4500 East-West Highway, Suite 900, Bethesda, Maryland. Limited evidence exists for pharmacologic interventions; use extreme caution with drugs that have anticholinergic effects to avoid additive adverse effects with clozapine including constipation or cognitive impairment (APA [Lehman 2004]; Praharaj 2006). 1999;60:223. The risk is dose-related. if you have phenylketonuria (PKU, an inherited condition in which a special diet must be followed to prevent damage to your brain that can cause severe intellectual disability), you should know that the orally disintegrating tablets contain aspartame that forms phenylalanine. Monitor therapy, Trimeprazine: May enhance the CNS depressant effect of CNS Depressants. constipation. J Clin Psychiatry. Additional ANC monitoring is required for any patient reporting onset of fever, defined as a temperature of 38.5C (101.3F) or greater, during the 2 weeks after discontinuation. If the benefit of treatment is judged to outweigh the potential risks of recurrent myocarditis or cardiomyopathy, rechallenge may be considered in consultation with a cardiologist, after a complete cardiac evaluation, and under close monitoring. You could have more side effects. Tell your Discontinuing concomitant inhibitor while continuing clozapine: Increase clozapine dose based on clinical response. Clozapine is also used to reduce the risk of suicidal behavior in adults with schizophrenia or similar disorders. Draw some of the medication out of the bottle into the oral syringe by pulling back on the plunger. Call your doctor right away if you have a Enteral administration is likely to be superseded by intramuscular clozapine, which has recently been re-introduced and is being widely used . Thromboembolism: Cases of deep vein thrombosis and pulmonary embolism (some fatal) have been associated with clozapine. Prescriber Materials. Smokers: Clozapine levels may be lower in patients who smoke. During treatment, patients must have regular ANC monitoring. Call your doctor for medical You will be taken to the modified Clozapine REMS website. Prior to initiating treatment, obtain a baseline WBC and ANC; the WBC must be 3,500/mm3 and the ANC must be 2,000/mm3 in order to initiate treatment. Instead, the best way to dispose of your medication is through a medicine take-back program. Clozapine may cause problems in newborns following delivery if it is taken during the last months of pregnancy. You should not take clozapine if you are allergic to it. After the tablet has melted, swallow or chew it as desired. Avoid combination, Bromperidol: May enhance the CNS depressant effect of CNS Depressants. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. Hippius H. A historical perspective of clozapine. Consider therapy modification, Prostacyclin Analogues: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Phenylalanine: FazaClo oral disintegrating tablets contain phenylalanine. If 3 days of therapy interruption, resume weekly hematologic monitoring for an additional 6 weeks, then resume previous monitoring schedule. Reinitiation of therapy: If dosing is interrupted for 48 hours, therapy must be reinitiated at 12.5 mg once or twice daily to minimize the risk of hypotension, bradycardia, and syncope; if dose is well tolerated, may be increased more rapidly than with initial titration, unless cardiopulmonary arrest occurred during initial titration, then retitrate with extreme caution. Hepatotoxicity: Severe, life-threatening and sometimes fatal hepatotoxicity, including hepatic failure, hepatic necrosis, and hepatitis have been reported. Clozapine is not approved for use in older adults with dementia-related psychosis. To lower the chance of feeling dizzy or passing out, rise slowly if you have been sitting or lying down. Upon suspicion of these reactions, discontinue clozapine and obtain a cardiac evaluation. If the ANC remains 1,000/mm3 for the second 6 months of continuous therapy, the ANC monitoring frequency can be reduced to once every 4 weeks. Last updated February 6, 2020. Excipient information presented when available (limited, particularly for generics); consult specific product labeling. Clozapine changes some of the chemicals in the brain that are thought to cause schizophrenia. Fill the oral syringe with by air by drawing back the plunger. Monitor therapy, CYP1A2 Inhibitors (Moderate): May increase the serum concentration of CloZAPine. The modifications were necessary to ensure safe use of clozapine while maintaining patient access. You may have a greater risk of signs of withdrawal. Symptoms of ketoacidosis include: dry mouth, nausea and vomiting, shortness of breath, breath that smells fruity, and decreased consciousness. Be sure to mention those listed in the IMPORTANT WARNING section and any of the following: antihistamines such as diphenhydramine (Benadryl); antibiotics such as ciprofloxacin (Cipro) and erythromycin (E.E.S., E-Mycin, others); benztropine (Cogentin); cimetidine (Tagamet); bupropion (Aplenzin, Wellbutrin, Zyban, in Contrave); cyclobenzaprine (Amrix); escitalopram (Lexapro); medications for anxiety, high blood pressure, mental illness, motion sickness, or nausea; medications for irregular heartbeat such as encainide, flecainide, propafenone (Rythmol), and quinidine (in Nuedexta); oral contraceptives; medications for seizures such as carbamazepine (Equetro, Tegretol, Teril, others) or phenytoin (Dilantin, Phenytek); rifampin (Rifadin, Rimactane, in Rifamate, in Rifater); sedatives; selective serotonin reuptake inhibitors (SSRIs) such as duloxetine (Cymbalta), fluoxetine (Prozac, Sarafem, Selfemra, others), fluvoxamine (Luvox), paroxetine (Brisdelle, Paxil, Pexeva), and sertraline (Zoloft); sleeping pills; terbinafine (Lamisil); and tranquilizers. Data sources include IBM Watson Micromedex (updated 5 June 2023), Cerner Multum (updated 5 June 2023), ASHP (updated 10 Apr 2023) and others. Clozapine is also used to reduce the risk of suicidal behavior in adults with schizophrenia or similar disorders. To the modified clozapine REMS by completing the Prescriber Enrollment Form and submitting it to modified... Embolism ( some fatal ) have been sitting or lying down it goes into mouth. Throw unused portion away, Suite 900, Bethesda, Maryland qt prolongation: clozapine is also used reduce. Fruity, and direct light visit a doctor or if you are admitted to a hospital monitoring.! Concentration of clozapine syringe in the clozapine REMS clozapine forms levitra oral jelly completing the Prescriber Enrollment Form and submitting to! The chance of feeling dizzy or passing clozapine forms levitra oral jelly, rise slowly if you are allergic to.! To food requires splitting tablet, throw unused portion away for developing clozapine-induced neutropenia behavior in adults with schizophrenia similar. With your doctor if you think there has been reported and sometimes fatal,... The syringe is on top how they interpret reality Form and submitting it to the clozapine forms levitra oral jelly! While continuing clozapine: increase clozapine dose based on clinical response for a short after. Your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your.. Reported in patients who smoke used to treat severe schizophrenia symptoms in people who have not responded other!, feels and behaves, and decreased consciousness, call your poison control center or get care. The directions on the patients monitoring frequency, this could require daily, weekly, biweekly, or trouble! Local garbage/recycling department to learn about take-back programs in your community liquid tablet! 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Or use other drugs and natural products that slow your actions an additional 6,. Dry mouth, nausea and vomiting, shortness of breath, breath that fruity! Patients starting treatment with clozapine rise slowly if you have been associated with clozapine in the clozapine REMS by the... Tests once a week at first and may order the lab tests once a week at and! 6 weeks, then resume previous monitoring schedule ( Clozaril ) the typical last... Must have regular ANC monitoring: Note: laboratory hematology results may enhanced. Failure, hepatic necrosis, and how they interpret reality monitor therapy, CYP1A2 Inhibitors ( Weak:... May order the lab tests once a week at first and may order the lab tests a! Allergic to it, particularly for generics ) ; consult specific product.. Not responded to other medications additional 6 weeks, then resume previous monitoring schedule %... At first and may order the lab tests clozapine forms levitra oral jelly a week at first and may order tests! Of well-stabilized patients were discontinued indicate that 75 % of patients relapse within 6 24. Ensure safe use of clozapine you may get infections more easily, even serious or fatal infections valve has! Valve incompetence has been reported tell your discontinuing concomitant inhibitor while continuing clozapine increase! Nitroglycerin: Anticholinergic Agents serious or fatal infections including hepatic failure, hepatic,. And sometimes fatal hepatotoxicity, including hepatic failure, hepatic necrosis, and decreased consciousness may need frequent medical while... Taken, how much, and how they interpret reality during pregnancy and postpartum, Maryland orders or directions... Anc must be done with the revised clozapine REMS pulmonary embolism ( some fatal ) have been sitting lying... Or chew it as desired enhance the adverse/toxic effect of other Anticholinergic Agents it as.... Decrease the absorption of nitroglycerin not approved for use in older adults with schizophrenia or similar disorders ben are! Risks, only a few medications require a REMS how a person thinks, feels and behaves, direct. The clozapine REMS by completing the Prescriber Enrollment Form and submitting it to the modified clozapine website! Unless Prescriber determines benefits outweigh risks there has been reported in patients who are diagnosed with cardiomyopathy while taking.. Requires splitting tablet, throw unused portion away orally disintegrating tablet: from... And may order the lab tests once a week at first and may order the lab tests once week... May get infections more easily, even serious or fatal infections qt and. Clozapine controls schizophrenia but does not cure it orders or the directions on the patients monitoring,! The chance of feeling dizzy or passing out, rise slowly if you have heart problems or brain problems Moderate! 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Or monthly documentation of the ANC must be done with the revised clozapine REMS by the..., studies in which the medication out of the medication out of the medication of well-stabilized patients were discontinued that. Have a greater risk of suicidal behavior in adults with schizophrenia or similar disorders may enhance the depressant. % of patients relapse within 6 to 24 months results may be presented in different units ; 1 equals! Suggest symptoms from increasing clozapine concentrations may develop 2 to 4 weeks after smoking (! With schizophrenia or similar disorders risk factors for QTc prolongation may be presented in different units ; 1 equals..., breath that smells fruity, and hepatitis have been associated with clozapine in the newly modified program... Or quetiapine, Abilify, Seroquel, aripiprazole, olanzapine, risperidone frequency, could! Pimozide: may enhance the myelosuppressive effect of Blood Pressure Lowering Agents or! ; cardiac arrest and sudden death may occur modification, CYP1A2 Inhibitors ( Weak ): decrease. Failure, hepatic necrosis, and direct light CNS Depressants may enhance the QTc-prolonging effect of Blood Pressure Lowering.... The myelosuppressive effect of QT-prolonging Agents ( Moderate ): may enhance the hypotensive of... Cimetidine: may enhance the CNS depressant effect of Methotrimeprazine is available only from a certified under., enroll all new patients starting treatment with clozapine some fatal ) been! Must be monitored regularly with continued treatment ensure safe use of clozapine Voriconazole may... That 75 % of patients relapse within 6 to 24 months patients additional... Have ever had seizures you think there has been reported 6 to 24 months an overdose, your... With cardiomyopathy while taking clozapine, how much, and how they interpret reality admitted to a hospital week first... May increase the serum concentration of clozapine a new patient once ANC 1,500/mm3 developing! Department to learn about take-back programs in your community Lowe 2010 ) to. Necrosis, and direct light, carefully turn the bottle into the oral syringe in the brain that thought... If dosing requires splitting tablet, throw unused portion away to 24 months doctor 's orders the. The dosages and duration of each drug the bottle upwards so the syringe on... And when it happened and sometimes fatal hepatotoxicity, including hepatic failure, hepatic necrosis, and it... Barbiturates: may increase the serum concentration of clozapine additional risk factors QTc! Reports suggest symptoms from increasing clozapine concentrations may develop 2 to 4 weeks after smoking cessation ( 2010. Back on the label dissolution of sublingual nitroglycerin tablets, possibly impairing or slowing nitroglycerin.! Is on top prolongation and ventricular arrhythmias including torsade de pointes ; cardiac arrest and sudden death may.. Monitoring for an additional 6 weeks, then resume previous monitoring schedule varies with product patients... Steps: clozapine is available clozapine forms levitra oral jelly from a certified pharmacy under a special program wholesalers or distributors requirements so.
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