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NISOLDIPINE TABLET, EXTENDED RELEASE/ORAL 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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NISOLDIPINE TABLET, EXTENDED RELEASE/ORAL 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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NISOLDIPINE TABLET, EXTENDED RELEASE/ORAL 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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NISOLDIPINE TABLET, EXTENDED RELEASE/ORAL 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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NISOLDIPINE TABLET, EXTENDED RELEASE/ORAL 25.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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NISOLDIPINE TABLET, EXTENDED RELEASE/ORAL 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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NISOLDIPINE TABLET, EXTENDED RELEASE/ORAL 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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NISOLDIPINE TABLET, EXTENDED RELEASE/ORAL 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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NISOLDIPINE TABLET, EXTENDED RELEASE/ORAL 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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NISOLDIPINE TABLET, EXTENDED RELEASE/ORAL 25.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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 2 years 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 2 years 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 2 years 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 2 years ago.

Viagra Grapefruit Answered by Alejandro Derobles 2 years 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 2 years 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 2 years ago.

grapefruit and whatever medication together can cause a stronger reaction that can hurt you Answered by Stephen Given 2 years ago.

The acid in grapefruit or its juice can lessen the effect of some meds. Answered by Madalene Zogg 2 years ago.


Side effects of sular?
Asked by Norbert Baylon 2 years 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 2 years 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 2 years 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 2 years ago.

Viagra Grapefruit Answered by Lindsay Reuhl 2 years 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 2 years 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 2 years ago.

grapefruit and whatever medication together can cause a stronger reaction that can hurt you Answered by Mirella Vigliotti 2 years ago.

The acid in grapefruit or its juice can lessen the effect of some meds. Answered by Audrie Wrinkles 2 years ago.


Side effects of sular?
Asked by Cindie Morgans 2 years 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 2 years 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 2 years 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 2 years ago.

Viagra Grapefruit Answered by Cari Tugman 2 years 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 2 years 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 2 years ago.

grapefruit and whatever medication together can cause a stronger reaction that can hurt you Answered by Ola Cowee 2 years ago.

The acid in grapefruit or its juice can lessen the effect of some meds. Answered by Mafalda Monetti 2 years ago.


Side effects of sular?
Asked by Frieda Dinehart 2 years 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 2 years 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 2 years 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 2 years ago.

Viagra Grapefruit Answered by Rana Kubas 2 years 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 2 years 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 2 years ago.

grapefruit and whatever medication together can cause a stronger reaction that can hurt you Answered by Josefine Puhr 2 years ago.

The acid in grapefruit or its juice can lessen the effect of some meds. Answered by Tom Tiburcio 2 years ago.


Side effects of sular?
Asked by Mary Turton 2 years 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 2 years 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 2 years 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 2 years ago.

Viagra Grapefruit Answered by Elsie Both 2 years 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 2 years 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 2 years ago.

grapefruit and whatever medication together can cause a stronger reaction that can hurt you Answered by Dong Cokeley 2 years ago.

The acid in grapefruit or its juice can lessen the effect of some meds. Answered by Timothy Garreh 2 years ago.


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