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Ganirelix Acet 250 Mcg Pfs 0.5 Ml

  • Manufacturer Name : Amphastar
  • MFG # : 00548500100
  • NDC : 00548500100
  • Distributor Name : AmeriSource Bergen
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Product Properties:

Description -
DESI Drug Ind -
DESI2 Drug Ind AP
Drug Category -
Drug Type Code N
FDA Approval Date 06/20/2022
FDA Therap Equiv ML
HCPCS -
Market Entry Date -
Medical Coverage -
Termination Date 1
Unit -
Units Per Pkg 04/07/2022
Active Ingredients 8056 ganirelix acetate 129311553
AHFS Class 68180400 ANTIGONADTROPINS
DEA Class NC
Dose Form SYRINGE (ML)
Fine Line Class 850085008510 All Rx Products
Gen Code and Des 47336 ganirelix acetate SUBCUT SYRINGE 250MCG/0.5
Inactive Ingredients 2272 mannitol 69658
OMP Family -
Product Category RX Pharmaceuticals
Strength 250MCG
Common Brand Name COMMON BRAND NAME(S): Antagon
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 (such as 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 -
Case Quantity 20
Drug Form Pack Size -
Form PRE-FILLED SYRINGE
Hazard Code -
Listed Chemical -
NIOSH Code NT3 NON-ANTINEOPLASTIC DRUGS THAT PRIMARILY HAVE ADVERSE REPRODUCTIVE EFFECTS
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
Returnable Status Returnable
Special Storage Cond 00 None
Temp Zone 10 Room Temperature
Unit EA
Unit Size 0.5
How to Use HOW TO USE: Read the Patient Information Leaflet if available from your pharmacist before you start using ganirelix and each time you get a refill. If you have any questions, ask your doctor or pharmacist. Learn all preparation and usage instructions from your health care professional and the product package. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. Inject this medication under the skin as directed by your doctor, usually once a day for several days. Carefully follow your doctor's instructions on when to start and stop this medication. Before injecting each dose, clean the injection site with rubbing alcohol. Change the injection site each time to lessen injury under the skin. Use this medication exactly as directed by your doctor to get the most benefit from it. Do not increase your dose or use this drug more often or for longer than prescribed. Learn how to store and discard medical supplies safely.
Missed Dose MISSED DOSE: 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: Do not share this medication with others. Lab and/or medical tests (such as vaginal ultrasound, hormone levels, liver tests) may 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.
Phonetic Pronunciation (GAN-i-REL-ix AS-e-tate)
Precautions PRECAUTIONS: Before using ganirelix, tell your doctor or pharmacist if you are allergic to it; or to other products containing gonadotropin releasing hormone (GnRH); or if you have any other allergies. This product may contain inactive ingredients (such as latex), 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. Before having surgery, tell your doctor or dentist about all the products you use (such as prescription drugs, nonprescription drugs, and herbal products). Multiple births may occur as a result of this treatment. Consult your doctor for more details. Stop using this medication when you become pregnant. This medication must not be used during pregnancy. If you think you may be pregnant, tell your doctor right away. It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.
Side Effects SIDE EFFECTS: Redness or pain at the injection site, headache, mild nausea/stomach pain, or tiredness 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, such as: unusual vaginal bleeding. This medication may cause a condition known as ovarian hyperstimulation syndrome (OHSS). This condition may occur during or after treatment. Rarely, serious OHSS causes fluid to suddenly build up in the stomach, chest, and heart area. Get medical help right away if you develop the following side effects: severe pain or swelling in the lower abdominal (pelvic) area, severe nausea/vomiting, sudden/rapid weight gain, or decreased urination. 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, such as: 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: Store at room temperature away from light and moisture. Do not store in the bathroom. 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 by women having certain fertility treatments (controlled ovarian stimulation). Ganirelix is usually used in combination with other hormones (FSH and hCG). It works by blocking the release of a certain hormone (luteinizing hormone). Ganirelix stops eggs from being released too early and gives the eggs time to grow properly.

Frequently Asked Questions(FAQs)

The cost of Ganirelix Acet 250 Mcg Pfs 0.5 Ml is available for registerd members only .
Ganirelix Acet 250 Mcg Pfs 0.5 Ml is manufactured by Amphastar.
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