cannabidiol has to be dispensed with

If you are interested in this option, talk to your specialty pharmacy to find out more. laura ashley adeline duvet cover; tivo stream 4k vs firestick 4k; ba flights from gatwick today; saved by the bell actor dies in car crash; loco south boston $1 oysters Feb 2, 2021 - 4.16pm. Get tips on dosage here. Regarding imports, if it appears that an article is adulterated, misbranded, in violation of section 505 of the FD&C Act, or prohibited from introduction or delivery for introduction into interstate commerce under section 301(ll) of the FD&C Act, such article will be refused admission (see section 801(a)(3) of the FD&C Act [21 U.S.C. The contents of this site are intended for US healthcare professionals. Cannabidiol Side Effects: Common, Severe, Long Term - Drugs.com Can this product be used in patients with moderate or severe hepatic impairment? Epidiolex is an oral solution that contains cannabidiol (CBD) extracted from the cannabis plant. Resolution of. Controlled substances include poisons, compositions containing poisons . The following states have legalized medical and recreational marijuana: Alaska. 1. CANNABIDIOL (CBD) - Uses, Side Effects, and More - WebMD It is a component of some dietary supplements and cosmetics. Often such products are sold online and are therefore available throughout the country. Concomitant use of valproate and elevated transaminase levels at baseline increase this risk. Signs that your pet may be suffering adverse effects from ingesting cannabis may include lethargy, depression, heavy drooling, vomiting, agitation, tremors, and convulsions. EPIDIOLEX may affect exposure to CYP2C19 substrates (e.g., clobazam, diazepam, stiripentol), orally administered P-gp substrates, or other substrates (see full Prescribing Information). Tennessee SB2125 Controlled Substances - As enacted, excludes from the definition of marijuana, cannabis oil containing the substance cannabidiol, with less than 0.6 percent THC, including the necessary seeds and plants, when manufactured, processed, transferred, dispensed, or possessed by certain four-year institutions of higher education in this state as part of clinical research studies on . Where are EPIDIOLEX prescriptions filled? Research on CBD oil for migraine is limited, but some evidence suggests that it may help relieve chronic or acute pain. People can take these extracts on their own, usually through a dropper or add them to food and drinks themselves. cannabidiol has to be dispensed with - hazrentalcenter.com Do not start or stop other medicines . Unlike oils, edibles, and vaping solutions, topicals dont typically enter the bloodstream as long as theyre not a transdermal solution intended to do so. Under the FD&C Act, any product intended to have a therapeutic or medical use, and any product (other than a food) that is intended to affect the structure or function of the body of humans or animals, is a drug. The site is secure. Delta-9-tetrahydrocannabinol (THC) is the most famous ingredient in cannabis. Keep in mind that topical CBD, like lotions, creams, and salves, may also be an option. Concomitant use of EPIDIOLEX and valproate increases the incidence of liver enzyme elevations. What does the FDA think about making CBD available to children with epilepsy? Diabetic Retinopathy: Role of Inflammation and Potential Therapies for Anti-Inflammation. We need more research but CBD may prove to be a helpful, relatively non-toxic option for managing anxiety, insomnia, and chronic pain. yellowing of the skin or the whites of the eyes (jaundice), right upper stomach area pain or discomfort. In some cases, EPIDIOLEX treatment may need to be stopped. EFSA's scientists cannot currently establish the safety of cannabidiol (CBD) as a novel food due to data gaps and uncertainties about potential hazards related to CBD intake.. Cannabidiol is a substance that can be obtained from Cannabis sativa L. plants and be synthesised chemically as well. NIDA provides research-grade cannabis for scientific study. EPIDIOLEX may affect the way other medicines work, and other medicines may affect how EPIDIOLEX works. Biologists are working on developing marijuana strains that suppress THC content and enhance the production of cannabidiol. For more information, please see the FDAs webpage on MedWatch. Chemist Warehouse and Cannatrek do medical cannabis deal Poster presented at: American Epilepsy Society Annual Meeting; December 6-10, 2019; Baltimore, MD. Our website services, content, and products are for informational purposes only. However, CBD products containing more than 0.3% THC still fall under the legal definition of marijuana, making them illegal at the federal level. No. 2 The law provides that a New York-licensed pharmacist must be on the premises where marijuana is sold or dispensed. To date, FDA has not approved a marketing application for cannabis for the treatment of any disease or condition and thus has not determined that cannabis is safe and effective for any particular disease or condition. You may also contact Jazz Pharmaceuticals at 1-833-424-6724. CONTRAINDICATION: HYPERSENSITIVITY EPIDIOLEX (cannabidiol) oral solution is contraindicated in patients with a history of hypersensitivity to cannabidiol or any ingredients in the product. (2017). Reply STOP to 95752 to cancel, HELP for help. The most common side effects of EPIDIOLEX include increase in liver enzymes, sleepiness, decreased appetite, diarrhea, fever, vomiting, feeling very tired and weak, rash, sleep problems, and infections. Your doctor may order blood tests to check your liver before you start taking EPIDIOLEX and during treatment. Selling unapproved products with unsubstantiated therapeutic claims is not only a violation of the law, but also can put patients at risk, as these products have not been proven to be safe or effective. If an animal food contains an ingredient that is not the subject of an approved food additive petition or GRAS for its intended use in the intended species, that animal food would be adulterated under section 402(a)(2)(C)(i) of the FD&C Act [21 U.S.C. Today, the U.S. Food and Drug Administration approved Epidiolex (cannabidiol) [CBD] oral solution for the treatment of seizures associated with tuberous sclerosis complex (TSC) in patients one . Be sure to tell your doctor if you are taking any other medicines so he or she can take that into account when creating your dosing schedule. Up to 10 msg/mo. Be sure to have your insurance and prescription information handy when the pharmacy calls. Prescribing medicinal cannabis in Queensland - Home | Queensland Health There are over 100 cannabinoids in the cannabis plant. The bottom line on cannabidiol. Medical marijuana - Mayo Clinic More than 100 different cannabinoids have been found in cannabis so far, including tetrahydrocannabinol, or THC, the chemical that gets you high . A. Can hulled hemp seed, hemp seed protein powder, and hemp seed oil be used in human food? Walgreens operates 72 stores in Iowa, according to the company's website. cannabidiol has to be dispensed with - nexa.com.br Setting up and preparing to administer EPIDIOLEX. Published scientific literature reports potential adverse effects of cannabis use in pregnant women, including fetal growth restriction, low birth weight, preterm birth, small-for-gestational age, neonatal intensive care unit (NICU) admission, and stillbirth. How can patients gain access to cannabis or cannabis-derived products for medical use through expanded access? A. Cannabis sativa contains many active compounds. 342(f)(1)(B)]). Inform patients, caregivers, and families of the risk and advise to monitor and report any signs of depression, suicidal thoughts or behavior, or unusual changes in mood or behavior. 2017;13:1131-1140. How does the 2018 Farm Bill define hemp? 20. One specific form of CBD is approved as a drug in the U.S. for seizures. Cannabidiol has observed anticonvulsant, anxiolytic, anti-inflammatory, and neuroprotective properties. What is FDAs position on cannabis and cannabis-derived ingredients in cosmetics? However, all food ingredients must comply with all applicable laws and regulations. Despite the lack of a described and understood molecular mechanism of action, CBD is still the most effective cannabinoid for use in developing anti . CBD is often treated like a wonder ingredient. However, even if you take one of these medications, your doctor might be able to formulate a plan that works for you through close monitoring of medication levels in your system. Grapefruit warnings are common in several types of medications, but not all medications within a category will require the avoidance of grapefruit. WARNINGS & PRECAUTIONS Hepatocellular Injury: EPIDIOLEX can cause dose-related transaminase elevations. Ive seen cannabis products being marketed for pets. This is the first FDA-approved drug made from the cannabis plant. [2] Gunn, et al. Does the FDA have concerns about administering a cannabis product to pregnant and lactating women? The most common adverse reactions in patients receiving EPIDIOLEX (10% and greater than placebo) include transaminase elevations; somnolence; decreased appetite; diarrhea; pyrexia; vomiting; fatigue, malaise, and asthenia; rash; insomnia, sleep disorder and poor-quality sleep; and infections. ES, Setting up and preparing to administer EPIDIOLEX. As such, as CBD is not currently a scheduled substance in its own right (only as a . 2010; 56(9): 1442-1450. Sign up for a 30-minute webinar featuring a Q&A with a caregiver and an epilepsy specialist. Information about these requirements, and about FDA requirements across all product areas, can be found on FDAs website. The most commonly known compounds are . The FDA granted Priority Review designation for this application. Whether you want a product for pain or all-purpose use, here are 8 great recommendations. How does the 2018 Farm Bill define hemp? Some substances also speed up the work of the CYP450 enzyme family. A. The IND application process gives researchers a path to follow that includes regular interactions with the FDA to support efficient drug development while protecting the patients who are enrolled in the trials. The site is secure. 2. There is ongoing communication with state and local officials to answer questions about requirements under the FD&C Act, to better understand the landscape at the state level, and to otherwise engage with state/local regulatory partners. sore throat. Epidyolex is approved for adjunctive therapy of seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet . In some cases, EPIDIOLEX treatment may need to be stopped. Step-by-step instructions for taking EPIDIOLEX or giving it to a loved one. It has also approved Epidiolex for the treatment of seizures associated with tuberous sclerosis complex in patients 1 year of age or older. ES, Step-by-step instructions for taking EPIDIOLEX or giving it to a loved one. Epidyolex (cannabidiol) and Sativex (nabiximols) are the only cannabis medicines currently registered in Australia on the Australian Register of Therapeutic Goods (ARTG). Call your doctor right away if. Encourage women who are taking EPIDIOLEX during pregnancy to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry. There is an exception to section 201(ff)(3)(B) if the substance was "marketed as" a dietary supplement or as a conventional food before the drug was approved or before the new drug investigations were authorized, as applicable. Resolution of transaminase elevations occurred with discontinuation of EPIDIOLEX, reduction of EPIDIOLEX and/or concomitant valproate, or without dose reduction. Heres what comes next. Pay particular attention to Lousiana which has a 3% excise tax on cannabidiol. References: 1. Medicinal cannabis products must be dispensed in the same manner as other prescription medicines and controlled drugs. Drug-drug interaction between clobazam and cannabidiol in children with refractory epilepsy. Now that Epiodiolex has been approved by the FDA, it has a currently accepted medical use in treatment in the United States for purposes of the CSA. A. THC (dronabinol) is the active ingredient in the approved drug products, Marinol capsules (and generics) and Syndros oral solution. 2018;391(10125):1085-1096. The agency has, however, approved one cannabis-derived and three cannabis-related drug products (see Question #2). Consider dose reduction of orally administered everolimus, with appropriate therapeutic drug monitoring, when everolimus is combined with EPIDIOLEX. In coordination with state feed control officials, CVM also recognizes ingredients listed in the Official Publication (OP) of the Association of American Feed Control Officials (AAFCO) as being acceptable for use in animal food. loss of appetite. A. Messaging and data rates may apply. You may not recognize the phone number, but its important to answer the phone when the pharmacy calls to avoid delays with your EPIDIOLEX shipment. EPIDIOLEX can cause somnolence and sedation that generally occurs early in treatment and may diminish over time; these effects occur more commonly in patients using clobazam and may be potentiated by other CNS depressants. Certain cosmetic ingredients are prohibited or restricted by regulation, but currently that is not the case for any cannabis or cannabis-derived ingredients. Please enable javascript as some features and content will be inaccessible. Please certify that you are a healthcare professional by clicking the appropriate link below. Many medications inhibit CYP3A4. US-EPX-2200685 No. For some situations, your doctor may want to monitor blood plasma levels of certain medications you take. Monitor patients for somnolence and sedation and advise patients not to drive or operate machinery until they have gained sufficient experience on EPIDIOLEX, Pneumonia was observed more frequently with concomitant use of EPIDIOLEX and clobazam, Dose adjustment of EPIDIOLEX or concomitant medications may be required, EPIDIOLEX is made without sugar or carbohydrates, so it can be used with most epilepsy diets, such as the ketogenic diet. What does it mean for FDA-regulated products? We are aware that some firms are marketing CBD products to treat diseases or for other therapeutic uses , and we have issued several warning letters to such firms. 15. If you then take CBD while on these medications, your body cant work to process the CBD as effectively. For example, in one study of 25 children with hard-to-treat epilepsy, 13 kids were given both clobazam and CBD. In making the two previous determinations about THC, why did FDA conclude that THC is an active ingredient in a drug product that has been approved under section 505 of the FD&C Act? Thiele EA, Marsh ED, French JA, et al. It is not known if EPIDIOLEX is safe and effective in children under 1 year of age. Medical marijuana is a term for derivatives of the Cannabis sativa plant that are used to ease symptoms caused by certain medical conditions. (See Sativex Commences US Phase II/III Clinical Trial in Cancer Pain ). Starting on Epidiolex | EPIDIOLEX (cannabidiol) We understand that parents are trying to find treatments for their childrens medical conditions. DOI: McDonnell AM, et al. Frequently Asked Questions | EPIDIOLEX (cannabidiol) How can patients gain access to cannabis or cannabis-derived products for medical use through expanded access? The GRAS conclusions can apply to ingredients for human food marketed by other companies, if they are manufactured in a way that is consistent with the notices and they meet the listed specifications. Register now. Apple and the Apple logo are trademarks of Apple Inc., registered in the U.S. and other countries and regions. Some of the intended uses for these ingredients include adding them as source of protein, carbohydrates, oil, and other nutrients to beverages (juices, smoothies, protein drinks, plant-based alternatives to dairy products), soups, dips, spreads, sauces, dressings, plant-based alternatives to meat products, desserts, baked goods, cereals, snacks and nutrition bars. This paradigm ensures new therapies are safe, effective, and manufactured to a high quality that provides uniform and reliable dosing for patients, said Douglas Throckmorton, M.D., deputy center director for regulatory programs in the FDAs Center for Drug Evaluation and Research. Nabiximols (Sativex) for multiple sclerosis (MS) Nabiximols (Sativex) is a cannabis-based medicine that is sprayed into the mouth. BMJ Open. It has low affinity for cannabinoid type 1 and cannabinoid type 2 receptors and is thought to exert its effects via other mechanisms. Find out, and get product recommendations. The CBD doses were increased every 2 weeks. 2016;1(1):10-14. Your doctor and staff will submit your prescription. Under FDAs regulations (21 CFR 312.2), unless a clinical investigation meets the limited criteria in that regulation, an IND is required for all clinical investigations of products that are subject to section 505 of the FD&C Act. CBD was not an ingredient considered under the OTC drug review. [5] Trezza, et al. Has FDA approved any medical products containing cannabis or cannabis-derived compounds such as CBD? Consumers can report adverse events associated with cosmetic products via the FDAs MedWatch reporting system, either online or by phone at 1-800-FDA-1088, or by contacting your nearest FDA district office consumer complaint coordinator. A controlled substance is any anabolic steroid, narcotic, hallucinogenic, stimulant, or depressant drug identified in Schedules I through V of the Controlled Substances Act in 21 U.S.C. Specialty pharmacies have expertise in preparing and filling medicines like EPIDIOLEX. Will my patients test positive for marijuana? Under the careful supervision of your doctor, you might still be able to safely use CBD with medications, even those that have a grapefruit warning. The major pharmacy chain Walgreens has informed Iowa Attorney General Brenna Bird that the company will not dispense a drug commonly used for medication abortions and miscarriage care in the state. Prescribing medicinal cannabis. For example, two such substantial clinical investigations include GW Pharmaceuticals investigations regarding Sativex. FDAs December 2016 Guidance for Industry: Botanical Drug Developmentprovides specific recommendations on submitting INDs for botanical drug products, such as those derived from cannabis, in support of future marketing applications for these products. Cannabidiol Attenuates Cardiac Dysfunction, Oxidative Stress, Fibrosis, and Inflammatory and Cell Death Signaling Pathways in Diabetic Cardiomyopathy. (2018). Find out what this means for your patients and your practice. Are there long-term safety data for patients using EPIDIOLEX? Unlike drugs approved by FDA, products that have not been subject to FDA review as part of the drug approval process have not been evaluated as to whether they work, what the proper dosage may be if they do work, how they could interact with other drugs, or whether they have dangerous side effects or other safety concerns. If you or your loved one are on a dietary therapy, talk to your doctor before taking EPIDIOLEX, Also note: EPIDIOLEX does not contain any artificial dyes or coloring, EPIDIOLEX should be taken consistently with respect to meals to reduce variability in cannabidiol plasma exposure, Caffeine: In vivo data showed EPIDIOLEX increases exposure to caffeine by 15% for C, Alcohol: Coadministration of EPIDIOLEX with alcohol increased exposure to cannabidiol, with 93% increased C, Concomitant use of EPIDIOLEX with other CNS depressants (including alcohol) may increase the risk of sedation and somnolence, EPIDIOLEX is an oral solution of cannabidiol (100 mg/mL) in sesame seed oil, It is important to note that sesame is a seed, not a nut, and an allergy to a nut does not necessarily generalize to seeds, EPIDIOLEX should be avoided in patients with a known or suspected sesame seed allergy, Sesame seed allergies may affect 0.1% of the general population in the United States, EPIDIOLEX is dispensed by licensed pharmacists at the specialty pharmacies currently in the Epidiolex Engage, Due to the weight-based dosing and titration for EPIDIOLEX, most patients will require a partial bottle fill, which the specialty pharmacy partners are equipped to handle, Trained staff at specialty pharmacies can assist with patient- and caregiver-specific questions throughout the patient journey on EPIDIOLEX, Copay assistance is available for eligible commercially insured patients who reside in the United States. Some CBD manufacturers have come under government scrutiny for wild, indefensible claims, such that CBD is a cure-all for cancer or COVID-19, which it is not. It is not known if EPIDIOLEX is safe and effective in children under 1 year of age. However, based on available evidence, FDA has concluded that this is not the case for THC or CBD. For example, by statute, any substance intentionally added to food is a food additive, and therefore subject to premarket review and approval by FDA, unless the substance is generally recognized as safe (GRAS) by qualified experts under the conditions of its intended use, or the use of the substance is otherwise excepted from the definition of a food additive (sections 201(s) and 409 of the FD&C Act [21 U.S.C. If a product is intended to affect the structure or function of the body, or to diagnose, cure, mitigate, treat or prevent disease, it is a drug, or possibly both a cosmetic and a drug, even if it affects the appearance. What is EPIDIOLEX (cannabidiol)? 26. [7] ACOG Committee Opinion: Marijuana Use During Pregnancy and Lactation, An official website of the United States government, Recalls, Market Withdrawals and Safety Alerts, Accelerating Access to Critical Therapies for ALS Act ACT for ALS, Infant Formula Information and Ongoing FDA Efforts to Increase Supply, Informacin sobre la frmula infantil y los esfuerzos continuos de la FDA para aumentar su suministro, FDA Regulation of Cannabis and Cannabis-Derived Products, Including Cannabidiol (CBD), FDA Concludes that Existing Regulatory Frameworks for Foods and Supplements are Not Appropriate for Cannabidiol, Will Work with Congress on a New Way Forward, FDA Issues Response to Three Citizen Petitions related to CBD and Dietary Supplements, FDA Warns Companies for Illegally Selling Food and Beverage Products that Contain CBD, FDA Warns Four Companies for Illegally Selling CBD Products Intended for Use in Food-Producing Animals, FDA Issues Warning Letters to Companies Illegally Selling CBD and Delta-8 THC Products, FDA Warns Companies Illegally Selling Over-the-Counter CBD Products for Pain Relief, FDA Warns Companies Illegally Selling CBD Products, FDA Approves New Indication for Drug Containing an Active Ingredient Derived from Cannabis to Treat Seizures in Rare Genetic Disease, FDA Warns Companies Illegally Selling CBD Products to Treat Medical Conditions, Opioid Addiction, FDA Advances Work Related to Cannabidiol Products with Focus on Protecting Public Health, Providing Market Clarity, FDA warns 15 companies for illegally selling various products containing cannabidiol as agency details safety concerns, FDA, FTC warn company marketing unapproved cannabidiol products with unsubstantiated claims to treat teething and ear pain in infants, autism, ADHD, Parkinsons and Alzheimers disease, FDA warns company marketing unapproved cannabidiol products with unsubstantiated claims to treat cancer, Alzheimer's disease, opioid withdrawal, pain and pet anxiety, FDA is Committed to Sound, Science-based Policy on CBD, Statement on new steps to advance agencys continued evaluation of potential regulatory pathways for cannabis-containing and cannabis-derived products, Statement on signing of the Agriculture Improvement Act and the agencys regulation of products containing cannabis and cannabis-derived compounds, Statement on the importance of conducting proper research to prove safe and effective medical uses for the active chemicals in marijuana and its components, FDA approves first drug comprised of an active ingredient derived from marijuana to treat rare, severe forms of epilepsy, FDA warns companies marketing unproven products, derived from marijuana, that claim to treat or cure cancer, What the FDA is Doing to Protect Consumers from Cannabidiol (CBD) in Foods, FDA Warns Consumers About the Accidental Ingestion by Children of Food Products Containing THC, 5 Things to Know about Delta-8 Tetrahydrocannabinol -- Delta-8 THC, What You Need to Know (And What Were Working to Find Out) About Products Containing Cannabis or Cannabis-derived Compounds, Including CBD, What You Should Know About Using Cannabis, Including CBD, When Pregnant or Breastfeeding, Remarks at the Council forFederal Cannabis Regulation Webinar: Understanding FDAs Approach to Cannabis Science, Policy, and Regulation, Remarks at the Council for Responsible Nutrition Conference, Remarks at the National Industrial Hemp Council 2019 Hemp Business Summit, Congressional Testimony: Hemp Production and the 2018 Farm Bill, Congressional Testimony: Cannabis Policies for the New Decade, Remarks at the FDA Public Hearing on Scientific Data and Information about Products Containing Cannabis or Cannabis-Derived Compounds, Science Board to the FDA 2022: Challenges in evaluating the safety of dietary supplement and food ingredients with predicted pharmacological activity, Safety of CBD in Humans A Literature Review, Public Hearing, May 2019: Scientific Data and Information about Products Containing Cannabis or Cannabis-Derived Compounds, Reopening of the Comment Period (uncertainties and data gaps), Information on CBD Data Collection and Submission, Scientific Conference on November 19, 2020: CBD and Other Cannabinoids: Sex and Gender Differences in Use and Responses, Warning Letters for Cannabidiol-Related Products, Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research, Draft Guidance for Industry, FDA and Cannabis: Research and Drug Approval Process, FDA Regulation of Dietary Supplement & Conventional Food Products Containing Cannabis and Cannabis-Derived Compounds. 22. While the agency is aware of reports of pets consuming various forms of cannabis, to date, FDA has not directly received any reports of adverse events associated with animals given cannabis products. There are no other FDA-approved drug products that contain CBD. By checking this box, you confirm that you are 18 years of age or older and a resident of the US. REVIEW DOSING CONSIDERATIONS FOR PATIENTS WITH HEPATIC IMPAIRMENT, REVIEW MONITORING CONSIDERATIONS FOR PATIENTS WITH HEPATIC IMPAIRMENT, EPIDIOLEX is the first and only FDA-approved prescription cannabidiol and the only cannabidiol formulation demonstrated in well-controlled clinical trials to be effective in reducing seizures associated with TSC, LGS, and Dravet syndrome, EPIDIOLEX was studied in over 900 patients with LGS, Dravet syndrome, and TSCmaking up the largest controlled clinical trial program for an AED in these conditions to date, EPIDIOLEX has a known and well-characterized safety profile, EPIDIOLEX manufacturing has been inspected by and is in accordance with FDA standards, resulting in highly controlled and consistent cannabidiol concentrations of 100 mg/mL, free from contaminants, EPIDIOLEX is federally legal and eligible for insurance coverage for appropriate patients, EPIDIOLEX oral solution contains highly purified, plant-derived cannabidiol, EPIDIOLEX is manufactured in accordance with FDA standards, resulting in highly controlled and consistent cannabidiol concentrations of 100 mg/mL, Synthetic cannabinoids are produced in laboratories through a chemical reaction to structurally or functionally mimic the effects of endocannabinoids or phytocannabinoids, There are no synthetic cannabinoid products that have been evaluated in Phase 3 controlled trials for the treatment of seizures associated with LGS, Dravet syndrome, or TSC, Patients on other cannabinoid products were excluded from the EPIDIOLEX clinical trials, Jazz Pharmaceuticals, Inc. cannot provide advice on converting from a cannabidiol/cannabinoid product to EPIDIOLEX, As stated in the Prescribing Information, patients taking EPIDIOLEX may test positive on urine cannabinoid screens.

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