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MICAFUNGIN 100 MG SDV 10

  • Manufacturer Name : Apotex
  • MFG # : 60505612006
  • NDC : 60505612006
  • Distributor Name : AmeriSource Bergen
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Product Properties:

Description -
Description -
DESI Drug Ind -
DESI Drug Ind -
DESI2 Drug Ind AP
DESI2 Drug Ind AP
Drug Category -
Drug Category -
Drug Type Code N
Drug Type Code N
FDA Approval Date 02/12/2021
FDA Approval Date 02/12/2021
FDA Therap Equiv ML
FDA Therap Equiv ML
HCPCS Micafungin sodium inj, 1 MG
HCPCS Micafungin sodium inj, 1 MG
Market Entry Date -
Market Entry Date -
Medical Coverage J2248
Medical Coverage J2248
Termination Date 1
Termination Date 1
Unit 10
Unit 10
Units Per Pkg 11/05/2020
Units Per Pkg 11/05/2020
Active Ingredients 10715 micafungin sodium 208538732
Active Ingredients 10715 micafungin sodium 208538732
AHFS Class 8141600 ECHINOCANDIN ANTIFUNGALS
AHFS Class 8141600 ECHINOCANDIN ANTIFUNGALS
DEA Class NC
DEA Class NC
Dose Form VIAL (EA)
Dose Form VIAL (EA)
Fine Line Class 850085008510 All Rx Products
Fine Line Class 850085008510 All Rx Products
Gen Code and Des 61686 micafungin sodium INTRAVEN VIAL 100 MG
Gen Code and Des 61686 micafungin sodium INTRAVEN VIAL 100 MG
Inactive Ingredients 2432 lactose 64044515
Inactive Ingredients 2432 lactose 64044515
OMP Family -
OMP Family -
Product Category RX Pharmaceuticals
Product Category RX Pharmaceuticals
Strength 100MG
Strength 100MG
Common Brand Name COMMON BRAND NAME(S): Mycamine
Common Brand Name COMMON BRAND NAME(S): Mycamine
Drug Interaction DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.
Drug Interaction DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.
Allocation Period -
Allocation Period -
Case Quantity 24
Case Quantity 24
Drug Form Pack Size 10
Drug Form Pack Size 10
Form SINGLE DOSE VIAL
Form SINGLE DOSE VIAL
Hazard Code -
Hazard Code -
Listed Chemical -
Listed Chemical -
NIOSH Code -
NIOSH Code -
Orange Book AP Injectable aqueous solutions including dry powders, concentrated solutions or ready-to-use solutions are considered pharmaceutically and therapeutically equivalent if they produce the same concentration and are labeled similarly.
Orange Book AP Injectable aqueous solutions including dry powders, concentrated solutions or ready-to-use solutions are considered pharmaceutically and therapeutically equivalent if they produce the same concentration and are labeled similarly.
Retail Pack Quantity 1
Retail Pack Quantity 1
Returnable Status Returnable
Returnable Status Returnable
Special Storage Cond 00 None
Special Storage Cond 00 None
Temp Zone 10 Room Temperature
Temp Zone 10 Room Temperature
Unit EA
Unit EA
Unit Size 10
Unit Size 10
How to Use HOW TO USE: This medication is given by injection into a vein as directed by your doctor, usually once a day over 1 hour. The dosage and length of treatment are based on your medical condition and response to treatment. In children, the dosage is also based on weight. If you are using this medication at home, learn all preparation and usage instructions from your health care professional. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. Learn how to store and discard medical supplies safely. Infusion reactions may happen while you are receiving the drug. Tell your doctor right away if you have symptoms such as flushing or dizziness. Continue to use this medication until the full prescribed amount is finished, even if symptoms disappear after a few days. Stopping the medication too early may result in a return of the infection. Tell your doctor if your condition does not get better or if it gets worse.
How to Use HOW TO USE: This medication is given by injection into a vein as directed by your doctor, usually once a day over 1 hour. The dosage and length of treatment are based on your medical condition and response to treatment. In children, the dosage is also based on weight. If you are using this medication at home, learn all preparation and usage instructions from your health care professional. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. Learn how to store and discard medical supplies safely. Infusion reactions may happen while you are receiving the drug. Tell your doctor right away if you have symptoms such as flushing or dizziness. Continue to use this medication until the full prescribed amount is finished, even if symptoms disappear after a few days. Stopping the medication too early may result in a return of the infection. Tell your doctor if your condition does not get better or if it gets worse.
Missed Dose MISSED DOSE: It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule. Do not double the dose to catch up.
Missed Dose MISSED DOSE: It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule. Do not double the dose to catch up.
Notes NOTES: Lab and/or medical tests (such as liver/kidney function, complete blood count) should be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.
Notes NOTES: Lab and/or medical tests (such as liver/kidney function, complete blood count) should be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.
Overdose OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
Overdose OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
Phonetic Pronunciation (MYE-ka-FUN-jin)
Phonetic Pronunciation (MYE-ka-FUN-jin)
Precautions PRECAUTIONS: Before using micafungin, tell your doctor or pharmacist if you are allergic to it; or to other echinocandin antifungal drugs (such as anidulafungin, caspofungin); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, kidney disease. Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.
Precautions PRECAUTIONS: Before using micafungin, tell your doctor or pharmacist if you are allergic to it; or to other echinocandin antifungal drugs (such as anidulafungin, caspofungin); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, kidney disease. Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.
Side Effects SIDE EFFECTS: Swelling/redness/irritation at the injection site, nausea/vomiting, diarrhea, headache, or trouble sleeping may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly. Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Tell your doctor right away if you have any serious side effects, including: signs of liver disease (such as nausea/vomiting that doesn't stop, loss of appetite, dark urine, stomach/abdominal pain, yellowing eyes/skin), signs of kidney problems (such as change in the amount of urine), unusual tiredness, shortness of breath, signs of infection (such as fever, chills), easy bleeding/bruising, mental/mood changes (such as anxiety), fast/irregular heartbeat. A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Side Effects SIDE EFFECTS: Swelling/redness/irritation at the injection site, nausea/vomiting, diarrhea, headache, or trouble sleeping may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly. Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Tell your doctor right away if you have any serious side effects, including: signs of liver disease (such as nausea/vomiting that doesn't stop, loss of appetite, dark urine, stomach/abdominal pain, yellowing eyes/skin), signs of kidney problems (such as change in the amount of urine), unusual tiredness, shortness of breath, signs of infection (such as fever, chills), easy bleeding/bruising, mental/mood changes (such as anxiety), fast/irregular heartbeat. A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Storage STORAGE: Consult the product instructions and your pharmacist for storage details. Keep all medications away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Storage STORAGE: Consult the product instructions and your pharmacist for storage details. Keep all medications away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Uses USES: This medication is used to treat a variety of fungal infections. It is also used to prevent fungal infections in patients who are having a stem cell transplant. Micafungin belongs to a class of drugs known as echinocandins. It works by stopping the growth of fungi.
Uses USES: This medication is used to treat a variety of fungal infections. It is also used to prevent fungal infections in patients who are having a stem cell transplant. Micafungin belongs to a class of drugs known as echinocandins. It works by stopping the growth of fungi.

Frequently Asked Questions(FAQs)

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MICAFUNGIN 100 MG SDV 10 is manufactured by Apotex.
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