Application Information

This drug has been submitted to the FDA under the reference 020356/001.

Names and composition

"SULAR" is the commercial name of a drug composed of NISOLDIPINE.

Forms

ApplId/ProductId Drug name Active ingredient Form Strenght
020356/001 SULAR NISOLDIPINE TABLET, EXTENDED RELEASE/ORAL 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
020356/002 SULAR NISOLDIPINE TABLET, EXTENDED RELEASE/ORAL 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
020356/003 SULAR NISOLDIPINE TABLET, EXTENDED RELEASE/ORAL 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
020356/004 SULAR NISOLDIPINE TABLET, EXTENDED RELEASE/ORAL 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
020356/005 SULAR NISOLDIPINE TABLET, EXTENDED RELEASE/ORAL 34MG
020356/006 SULAR NISOLDIPINE TABLET, EXTENDED RELEASE/ORAL 25.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
020356/007 SULAR NISOLDIPINE TABLET, EXTENDED RELEASE/ORAL 17MG
020356/008 SULAR NISOLDIPINE TABLET, EXTENDED RELEASE/ORAL 8.5MG

Similar Active Ingredient

ApplId/ProductId Drug name Active ingredient Form Strenght
020356/001 SULAR NISOLDIPINE TABLET, EXTENDED RELEASE/ORAL 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
020356/002 SULAR NISOLDIPINE TABLET, EXTENDED RELEASE/ORAL 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
020356/003 SULAR NISOLDIPINE TABLET, EXTENDED RELEASE/ORAL 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
020356/004 SULAR NISOLDIPINE TABLET, EXTENDED RELEASE/ORAL 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
020356/005 SULAR NISOLDIPINE TABLET, EXTENDED RELEASE/ORAL 34MG
020356/006 SULAR NISOLDIPINE TABLET, EXTENDED RELEASE/ORAL 25.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
020356/007 SULAR NISOLDIPINE TABLET, EXTENDED RELEASE/ORAL 17MG
020356/008 SULAR NISOLDIPINE TABLET, EXTENDED RELEASE/ORAL 8.5MG
079051/001 NISOLDIPINE NISOLDIPINE TABLET, EXTENDED RELEASE/ORAL 20MG
079051/002 NISOLDIPINE NISOLDIPINE TABLET, EXTENDED RELEASE/ORAL 30MG
079051/003 NISOLDIPINE NISOLDIPINE TABLET, EXTENDED RELEASE/ORAL 40MG
091001/001 NISOLDIPINE NISOLDIPINE TABLET, EXTENDED RELEASE/ORAL 8.5MG
091001/002 NISOLDIPINE NISOLDIPINE TABLET, EXTENDED RELEASE/ORAL 17MG
091001/003 NISOLDIPINE NISOLDIPINE TABLET, EXTENDED RELEASE/ORAL 25.5MG
091001/004 NISOLDIPINE NISOLDIPINE TABLET, EXTENDED RELEASE/ORAL 34MG

Ask a doctor

A licensed doctor will try to answer your question for free as quickly as possible. Free of charge during the beta period.

Answered questions

Side effects of sular?
Asked by Evelyn Schweder 1 year ago.

It can cause headache and swelling of legs or arms in a small percentage of patients. If you have a more specific question or experiencing side effect go to your doctor - he can switch it to another medication Answered by Lesia Dallison 1 year ago.


Why cant you eat grapefruit with some medications?
I occasionaly take 5 mgs of diazapam for anxiety. The bottle says do not eat grapefriut when taking this medication. Why? I dont eat grapefruit but I eat oranges. Is that okay? Asked by Bok Brussell 1 year ago.

Grapefruit and Meds Don't Mix (The Washington Post, September 26, 2000) Pity the poor grapefruit. Never as popular as its sweeter sibling the orange, it also possesses a potentially dangerous flaw: When combined with certain medications, the juice of the grapefruit can dramatically boost the amount of a drug in the bloodstream and increase the chance of adverse effects. Here's why: The intestine is host to an enzyme that, under normal circumstances, breaks drugs down; recommended dosages of drugs take into account this enzyme's effect. But both grapefruit and its juice somehow inhibit the action of this enzyme, and the patient ends up absorbing a much higher dose of the drug than the doctor intended. Scientists don't know exactly which ingredient in grapefruit is responsible for this perplexing property, but it doesn't appear to be shared by oranges or any other fruit, according to Garvan C. Kane, an internist at the Mayo Clinic who co-authored a comprehensive review paper on grapefruit-drug interactions in the September issue of the Mayo Clinic Proceedings. What's worrisome is that the drugs that grapefruit interacts with are among today's most commonly prescribed. They include many of the cholesterol-lowering drugs known as statins (such as Zocor and Lipitor), some of the calcium antagonists used to treat high blood pressure (Plendil, Sular), the sedative Valium, the anti-anxiety medication BuSpar and possibly the impotence drug Viagra. Grapefruit-drug interactions were first noticed about 10 years ago. Although there have been no reports of death or even serious adverse effects associated with the phenomenon, nobody has specifically looked for them. And bad reactions have been reported in people who have combined these drugs with the antibiotic erythromycin, which blocks the same enzyme that grapefruit does. The effect is akin to an overdose of the drug itself. High doses of statins, for example, can lead to muscle pain or weakness, and in rare instances a condition called rhabdomyolysis, in which excess muscle breakdown can lead to kidney failure. Grapefruit plus calcium antagonists could cause dizziness or faintness. And a higher Valium dose means increased sedation. Some pharmacies label prescription bottles with a warning not to consume grapefruit juice within two to four hours of taking these medications. But Kane says that might not be a long enough waiting period for the drugs with more serious side effects. "The grapefruit juice effect can last up to 24 hours. Given that most medications are taken on a daily basis, I would advise that a person not take grapefruit juice at all without first discussing it with their doctor," Kane said. But suppose you wanted to boost the amount of a drug--say, Viagra--in your system. Could you combine it with grapefruit? Not a good idea. Grapefruit might indeed enhance Viagra's potency-inducing property, but at a price: Side effects such as headache, flushing, indigestion and vision changes would likely rise as well. Kane urges caution. But "I don't want people to panic. With many medications, grapefruit is perfectly safe. It's just a matter of discussing it with your physician." That view is echoed by Falco Witkamp, director of grapefruit marketing for the Florida Department of Citrus, based in Lakeland, Fla. "There are many foods that interact with medicines, including caffeine and milk. People should always discuss their diet with their doctor," he urged. And of course grapefruit does have a health upside: Studies have shown that regular consumption reduces the risk for heart disease, stroke and possibly cancer. ### Answered by Miguel Hasty 1 year ago.

Viagra Grapefruit Answered by Alejandro Derobles 1 year ago.

So what if I took less valium as I m working out at the gym 5 days a week and I suffer from panic attacks but grapefruits is part of my weight loss regiment...what about Vicodin also or is it just benzopines Answered by Beryl Rucki 1 year ago.

If it specifically says grapefruit then you're fine with oranges...there must be some chemicals in the grapefruit that dulls your medicine effectiveness Answered by Annemarie Sarcia 1 year ago.

grapefruit and whatever medication together can cause a stronger reaction that can hurt you Answered by Stephen Given 1 year ago.

The acid in grapefruit or its juice can lessen the effect of some meds. Answered by Madalene Zogg 1 year ago.


Side effects of sular?
Asked by Norbert Baylon 1 year ago.

It can cause headache and swelling of legs or arms in a small percentage of patients. If you have a more specific question or experiencing side effect go to your doctor - he can switch it to another medication Answered by June Pestronk 1 year ago.


Why cant you eat grapefruit with some medications?
I occasionaly take 5 mgs of diazapam for anxiety. The bottle says do not eat grapefriut when taking this medication. Why? I dont eat grapefruit but I eat oranges. Is that okay? Asked by Mayme Marietta 1 year ago.

Grapefruit and Meds Don't Mix (The Washington Post, September 26, 2000) Pity the poor grapefruit. Never as popular as its sweeter sibling the orange, it also possesses a potentially dangerous flaw: When combined with certain medications, the juice of the grapefruit can dramatically boost the amount of a drug in the bloodstream and increase the chance of adverse effects. Here's why: The intestine is host to an enzyme that, under normal circumstances, breaks drugs down; recommended dosages of drugs take into account this enzyme's effect. But both grapefruit and its juice somehow inhibit the action of this enzyme, and the patient ends up absorbing a much higher dose of the drug than the doctor intended. Scientists don't know exactly which ingredient in grapefruit is responsible for this perplexing property, but it doesn't appear to be shared by oranges or any other fruit, according to Garvan C. Kane, an internist at the Mayo Clinic who co-authored a comprehensive review paper on grapefruit-drug interactions in the September issue of the Mayo Clinic Proceedings. What's worrisome is that the drugs that grapefruit interacts with are among today's most commonly prescribed. They include many of the cholesterol-lowering drugs known as statins (such as Zocor and Lipitor), some of the calcium antagonists used to treat high blood pressure (Plendil, Sular), the sedative Valium, the anti-anxiety medication BuSpar and possibly the impotence drug Viagra. Grapefruit-drug interactions were first noticed about 10 years ago. Although there have been no reports of death or even serious adverse effects associated with the phenomenon, nobody has specifically looked for them. And bad reactions have been reported in people who have combined these drugs with the antibiotic erythromycin, which blocks the same enzyme that grapefruit does. The effect is akin to an overdose of the drug itself. High doses of statins, for example, can lead to muscle pain or weakness, and in rare instances a condition called rhabdomyolysis, in which excess muscle breakdown can lead to kidney failure. Grapefruit plus calcium antagonists could cause dizziness or faintness. And a higher Valium dose means increased sedation. Some pharmacies label prescription bottles with a warning not to consume grapefruit juice within two to four hours of taking these medications. But Kane says that might not be a long enough waiting period for the drugs with more serious side effects. "The grapefruit juice effect can last up to 24 hours. Given that most medications are taken on a daily basis, I would advise that a person not take grapefruit juice at all without first discussing it with their doctor," Kane said. But suppose you wanted to boost the amount of a drug--say, Viagra--in your system. Could you combine it with grapefruit? Not a good idea. Grapefruit might indeed enhance Viagra's potency-inducing property, but at a price: Side effects such as headache, flushing, indigestion and vision changes would likely rise as well. Kane urges caution. But "I don't want people to panic. With many medications, grapefruit is perfectly safe. It's just a matter of discussing it with your physician." That view is echoed by Falco Witkamp, director of grapefruit marketing for the Florida Department of Citrus, based in Lakeland, Fla. "There are many foods that interact with medicines, including caffeine and milk. People should always discuss their diet with their doctor," he urged. And of course grapefruit does have a health upside: Studies have shown that regular consumption reduces the risk for heart disease, stroke and possibly cancer. ### Answered by Kasey Machens 1 year ago.

Viagra Grapefruit Answered by Lindsay Reuhl 1 year ago.

So what if I took less valium as I m working out at the gym 5 days a week and I suffer from panic attacks but grapefruits is part of my weight loss regiment...what about Vicodin also or is it just benzopines Answered by Renate Merlini 1 year ago.

If it specifically says grapefruit then you're fine with oranges...there must be some chemicals in the grapefruit that dulls your medicine effectiveness Answered by Chan Fierros 1 year ago.

grapefruit and whatever medication together can cause a stronger reaction that can hurt you Answered by Mirella Vigliotti 1 year ago.

The acid in grapefruit or its juice can lessen the effect of some meds. Answered by Audrie Wrinkles 1 year ago.


Side effects of sular?
Asked by Cindie Morgans 1 year ago.

It can cause headache and swelling of legs or arms in a small percentage of patients. If you have a more specific question or experiencing side effect go to your doctor - he can switch it to another medication Answered by Lasonya Wooward 1 year ago.


Why cant you eat grapefruit with some medications?
I occasionaly take 5 mgs of diazapam for anxiety. The bottle says do not eat grapefriut when taking this medication. Why? I dont eat grapefruit but I eat oranges. Is that okay? Asked by Jacquline Dealmeida 1 year ago.

Grapefruit and Meds Don't Mix (The Washington Post, September 26, 2000) Pity the poor grapefruit. Never as popular as its sweeter sibling the orange, it also possesses a potentially dangerous flaw: When combined with certain medications, the juice of the grapefruit can dramatically boost the amount of a drug in the bloodstream and increase the chance of adverse effects. Here's why: The intestine is host to an enzyme that, under normal circumstances, breaks drugs down; recommended dosages of drugs take into account this enzyme's effect. But both grapefruit and its juice somehow inhibit the action of this enzyme, and the patient ends up absorbing a much higher dose of the drug than the doctor intended. Scientists don't know exactly which ingredient in grapefruit is responsible for this perplexing property, but it doesn't appear to be shared by oranges or any other fruit, according to Garvan C. Kane, an internist at the Mayo Clinic who co-authored a comprehensive review paper on grapefruit-drug interactions in the September issue of the Mayo Clinic Proceedings. What's worrisome is that the drugs that grapefruit interacts with are among today's most commonly prescribed. They include many of the cholesterol-lowering drugs known as statins (such as Zocor and Lipitor), some of the calcium antagonists used to treat high blood pressure (Plendil, Sular), the sedative Valium, the anti-anxiety medication BuSpar and possibly the impotence drug Viagra. Grapefruit-drug interactions were first noticed about 10 years ago. Although there have been no reports of death or even serious adverse effects associated with the phenomenon, nobody has specifically looked for them. And bad reactions have been reported in people who have combined these drugs with the antibiotic erythromycin, which blocks the same enzyme that grapefruit does. The effect is akin to an overdose of the drug itself. High doses of statins, for example, can lead to muscle pain or weakness, and in rare instances a condition called rhabdomyolysis, in which excess muscle breakdown can lead to kidney failure. Grapefruit plus calcium antagonists could cause dizziness or faintness. And a higher Valium dose means increased sedation. Some pharmacies label prescription bottles with a warning not to consume grapefruit juice within two to four hours of taking these medications. But Kane says that might not be a long enough waiting period for the drugs with more serious side effects. "The grapefruit juice effect can last up to 24 hours. Given that most medications are taken on a daily basis, I would advise that a person not take grapefruit juice at all without first discussing it with their doctor," Kane said. But suppose you wanted to boost the amount of a drug--say, Viagra--in your system. Could you combine it with grapefruit? Not a good idea. Grapefruit might indeed enhance Viagra's potency-inducing property, but at a price: Side effects such as headache, flushing, indigestion and vision changes would likely rise as well. Kane urges caution. But "I don't want people to panic. With many medications, grapefruit is perfectly safe. It's just a matter of discussing it with your physician." That view is echoed by Falco Witkamp, director of grapefruit marketing for the Florida Department of Citrus, based in Lakeland, Fla. "There are many foods that interact with medicines, including caffeine and milk. People should always discuss their diet with their doctor," he urged. And of course grapefruit does have a health upside: Studies have shown that regular consumption reduces the risk for heart disease, stroke and possibly cancer. ### Answered by Jacqulyn Bloom 1 year ago.

Viagra Grapefruit Answered by Cari Tugman 1 year ago.

So what if I took less valium as I m working out at the gym 5 days a week and I suffer from panic attacks but grapefruits is part of my weight loss regiment...what about Vicodin also or is it just benzopines Answered by Alexander Bang 1 year ago.

If it specifically says grapefruit then you're fine with oranges...there must be some chemicals in the grapefruit that dulls your medicine effectiveness Answered by Ludie Guanche 1 year ago.

grapefruit and whatever medication together can cause a stronger reaction that can hurt you Answered by Ola Cowee 1 year ago.

The acid in grapefruit or its juice can lessen the effect of some meds. Answered by Mafalda Monetti 1 year ago.


Side effects of sular?
Asked by Frieda Dinehart 1 year ago.

It can cause headache and swelling of legs or arms in a small percentage of patients. If you have a more specific question or experiencing side effect go to your doctor - he can switch it to another medication Answered by Mindi Pesiri 1 year ago.


Why cant you eat grapefruit with some medications?
I occasionaly take 5 mgs of diazapam for anxiety. The bottle says do not eat grapefriut when taking this medication. Why? I dont eat grapefruit but I eat oranges. Is that okay? Asked by Janyce Weyrauch 1 year ago.

Grapefruit and Meds Don't Mix (The Washington Post, September 26, 2000) Pity the poor grapefruit. Never as popular as its sweeter sibling the orange, it also possesses a potentially dangerous flaw: When combined with certain medications, the juice of the grapefruit can dramatically boost the amount of a drug in the bloodstream and increase the chance of adverse effects. Here's why: The intestine is host to an enzyme that, under normal circumstances, breaks drugs down; recommended dosages of drugs take into account this enzyme's effect. But both grapefruit and its juice somehow inhibit the action of this enzyme, and the patient ends up absorbing a much higher dose of the drug than the doctor intended. Scientists don't know exactly which ingredient in grapefruit is responsible for this perplexing property, but it doesn't appear to be shared by oranges or any other fruit, according to Garvan C. Kane, an internist at the Mayo Clinic who co-authored a comprehensive review paper on grapefruit-drug interactions in the September issue of the Mayo Clinic Proceedings. What's worrisome is that the drugs that grapefruit interacts with are among today's most commonly prescribed. They include many of the cholesterol-lowering drugs known as statins (such as Zocor and Lipitor), some of the calcium antagonists used to treat high blood pressure (Plendil, Sular), the sedative Valium, the anti-anxiety medication BuSpar and possibly the impotence drug Viagra. Grapefruit-drug interactions were first noticed about 10 years ago. Although there have been no reports of death or even serious adverse effects associated with the phenomenon, nobody has specifically looked for them. And bad reactions have been reported in people who have combined these drugs with the antibiotic erythromycin, which blocks the same enzyme that grapefruit does. The effect is akin to an overdose of the drug itself. High doses of statins, for example, can lead to muscle pain or weakness, and in rare instances a condition called rhabdomyolysis, in which excess muscle breakdown can lead to kidney failure. Grapefruit plus calcium antagonists could cause dizziness or faintness. And a higher Valium dose means increased sedation. Some pharmacies label prescription bottles with a warning not to consume grapefruit juice within two to four hours of taking these medications. But Kane says that might not be a long enough waiting period for the drugs with more serious side effects. "The grapefruit juice effect can last up to 24 hours. Given that most medications are taken on a daily basis, I would advise that a person not take grapefruit juice at all without first discussing it with their doctor," Kane said. But suppose you wanted to boost the amount of a drug--say, Viagra--in your system. Could you combine it with grapefruit? Not a good idea. Grapefruit might indeed enhance Viagra's potency-inducing property, but at a price: Side effects such as headache, flushing, indigestion and vision changes would likely rise as well. Kane urges caution. But "I don't want people to panic. With many medications, grapefruit is perfectly safe. It's just a matter of discussing it with your physician." That view is echoed by Falco Witkamp, director of grapefruit marketing for the Florida Department of Citrus, based in Lakeland, Fla. "There are many foods that interact with medicines, including caffeine and milk. People should always discuss their diet with their doctor," he urged. And of course grapefruit does have a health upside: Studies have shown that regular consumption reduces the risk for heart disease, stroke and possibly cancer. ### Answered by Delpha Sagendorf 1 year ago.

Viagra Grapefruit Answered by Rana Kubas 1 year ago.

So what if I took less valium as I m working out at the gym 5 days a week and I suffer from panic attacks but grapefruits is part of my weight loss regiment...what about Vicodin also or is it just benzopines Answered by Yuki Kokocinski 1 year ago.

If it specifically says grapefruit then you're fine with oranges...there must be some chemicals in the grapefruit that dulls your medicine effectiveness Answered by Caterina Hawksley 1 year ago.

grapefruit and whatever medication together can cause a stronger reaction that can hurt you Answered by Josefine Puhr 1 year ago.

The acid in grapefruit or its juice can lessen the effect of some meds. Answered by Tom Tiburcio 1 year ago.


Side effects of sular?
Asked by Mary Turton 1 year ago.

It can cause headache and swelling of legs or arms in a small percentage of patients. If you have a more specific question or experiencing side effect go to your doctor - he can switch it to another medication Answered by Curt Derossett 1 year ago.


Why cant you eat grapefruit with some medications?
I occasionaly take 5 mgs of diazapam for anxiety. The bottle says do not eat grapefriut when taking this medication. Why? I dont eat grapefruit but I eat oranges. Is that okay? Asked by Timmy Decoster 1 year ago.

Grapefruit and Meds Don't Mix (The Washington Post, September 26, 2000) Pity the poor grapefruit. Never as popular as its sweeter sibling the orange, it also possesses a potentially dangerous flaw: When combined with certain medications, the juice of the grapefruit can dramatically boost the amount of a drug in the bloodstream and increase the chance of adverse effects. Here's why: The intestine is host to an enzyme that, under normal circumstances, breaks drugs down; recommended dosages of drugs take into account this enzyme's effect. But both grapefruit and its juice somehow inhibit the action of this enzyme, and the patient ends up absorbing a much higher dose of the drug than the doctor intended. Scientists don't know exactly which ingredient in grapefruit is responsible for this perplexing property, but it doesn't appear to be shared by oranges or any other fruit, according to Garvan C. Kane, an internist at the Mayo Clinic who co-authored a comprehensive review paper on grapefruit-drug interactions in the September issue of the Mayo Clinic Proceedings. What's worrisome is that the drugs that grapefruit interacts with are among today's most commonly prescribed. They include many of the cholesterol-lowering drugs known as statins (such as Zocor and Lipitor), some of the calcium antagonists used to treat high blood pressure (Plendil, Sular), the sedative Valium, the anti-anxiety medication BuSpar and possibly the impotence drug Viagra. Grapefruit-drug interactions were first noticed about 10 years ago. Although there have been no reports of death or even serious adverse effects associated with the phenomenon, nobody has specifically looked for them. And bad reactions have been reported in people who have combined these drugs with the antibiotic erythromycin, which blocks the same enzyme that grapefruit does. The effect is akin to an overdose of the drug itself. High doses of statins, for example, can lead to muscle pain or weakness, and in rare instances a condition called rhabdomyolysis, in which excess muscle breakdown can lead to kidney failure. Grapefruit plus calcium antagonists could cause dizziness or faintness. And a higher Valium dose means increased sedation. Some pharmacies label prescription bottles with a warning not to consume grapefruit juice within two to four hours of taking these medications. But Kane says that might not be a long enough waiting period for the drugs with more serious side effects. "The grapefruit juice effect can last up to 24 hours. Given that most medications are taken on a daily basis, I would advise that a person not take grapefruit juice at all without first discussing it with their doctor," Kane said. But suppose you wanted to boost the amount of a drug--say, Viagra--in your system. Could you combine it with grapefruit? Not a good idea. Grapefruit might indeed enhance Viagra's potency-inducing property, but at a price: Side effects such as headache, flushing, indigestion and vision changes would likely rise as well. Kane urges caution. But "I don't want people to panic. With many medications, grapefruit is perfectly safe. It's just a matter of discussing it with your physician." That view is echoed by Falco Witkamp, director of grapefruit marketing for the Florida Department of Citrus, based in Lakeland, Fla. "There are many foods that interact with medicines, including caffeine and milk. People should always discuss their diet with their doctor," he urged. And of course grapefruit does have a health upside: Studies have shown that regular consumption reduces the risk for heart disease, stroke and possibly cancer. ### Answered by Arcelia Michelin 1 year ago.

Viagra Grapefruit Answered by Elsie Both 1 year ago.

So what if I took less valium as I m working out at the gym 5 days a week and I suffer from panic attacks but grapefruits is part of my weight loss regiment...what about Vicodin also or is it just benzopines Answered by Karine Stohs 1 year ago.

If it specifically says grapefruit then you're fine with oranges...there must be some chemicals in the grapefruit that dulls your medicine effectiveness Answered by Tanika Milum 1 year ago.

grapefruit and whatever medication together can cause a stronger reaction that can hurt you Answered by Dong Cokeley 1 year ago.

The acid in grapefruit or its juice can lessen the effect of some meds. Answered by Timothy Garreh 1 year ago.


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