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Makena 250 Mg/Ml Sdv 1 Ml Ds

  • Manufacturer Name : Covis
  • MFG # : 64011024702
  • NDC : 64011024702
  • Distributor Name : AmeriSource Bergen
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Product Properties:

Description Makena, 10 mg
DESI Drug Ind -
DESI2 Drug Ind -
Drug Category I
Drug Type Code 1
FDA Approval Date 02/03/2011
FDA Therap Equiv AP
HCPCS J1726
Market Entry Date 02/04/2011
Medical Coverage COVERED WITH CARRIER DISCRETION
Termination Date 05/31/2021
Unit ML
Units Per Pkg 1
Active Ingredients 1293 hydroxyprogesterone caproate 630568; 9870 preservative free
AHFS Class 68320000 PROGESTINS
DEA Class NC
Dose Form VIAL (ML)
Fine Line Class 850085008510 All Rx Products
Gen Code and Des 75680 hydroxyprogesterone caproat/PF INTRAMUSC VIAL 250 MG/ML
Inactive Ingredients -
OMP Family -
Product Category RX Pharmaceuticals
Strength 250MG/ML
Common Brand Name COMMON BRAND NAME(S): Makena
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 -
Case Quantity 120
Drug Form Pack Size 1
Form SINGLE DOSE VIAL
Hazard Code UN3082 ENVIRONMENTALLY HAZARDOUS SUBSTANCE, LIQUID, N.O.S.
Listed Chemical -
NIOSH Code NT2 NON-ANTINEOPLASTIC DRUGS THAT MEET 1 OR MORE OF NIOSH CRITERIA FOR HAZARDOUS DRUG INCLUDING (MSHG)
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 Not Returnable
Special Storage Cond 00 None
Temp Zone 20 Cool-Store Cont Temp
Unit EA
Unit Size 1
How to Use HOW TO USE: Read the Patient Information Leaflet if available from your pharmacist before you start using hydroxyprogesterone and each time you get a refill. If you have any questions, ask your doctor or pharmacist. This medication is given by injection as directed by your doctor, usually once a week (every 7 days). The injection is given by a health care professional, either under the skin of your upper arm or into the muscle of your buttocks. You will start receiving injections any time from the 16th week through the 20th week of your pregnancy. You will continue to receive injections once a week until week 37 of your pregnancy or when your baby is delivered, whichever comes first. Use this medication regularly to get the most benefit from it.
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.
Notes NOTES: Keep all medical and lab appointments.
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 (hye-DROX-ee-proe-JES-ter-one KAP-roe-ate)
Precautions PRECAUTIONS: Before using hydroxyprogesterone, tell your doctor or pharmacist if you are allergic to it; 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: asthma, blood clots or other blood clotting problems, cancer (especially of the breast or other female organs), depression, diabetes, severe headaches/migraines, heart problems, high blood pressure, kidney problems, liver problems, seizure disorder, unusual vaginal bleeding, yellowing eyes/skin (jaundice) during pregnancy. If you have diabetes, this medication may affect your blood sugar. Check your blood sugar regularly as directed and share the results with your doctor. Tell your doctor right away if you have symptoms of high blood sugar such as increased thirst/urination. Your doctor may need to adjust your diabetes medication, exercise program, or diet. Tell your doctor if you will be having surgery or will be confined to a chair or bed for a long time (such as a long plane flight). You may need to take special precautions. Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). This medication is used to prevent preterm birth during pregnancy. Discuss the risks and benefits with your doctor. This drug may pass into breast milk. However, it is not used after 37 weeks of pregnancy, or after delivery. Consult your doctor before breast-feeding.
Side Effects SIDE EFFECTS: Pain, swelling, itching, bruising, or a lump at the injection site may occur. Nausea or diarrhea may also 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: nausea/vomiting that doesn't stop, dark urine, mental/mood changes (such as depression, nervousness), stomach/abdominal pain, unusual vaginal bleeding, yellowing eyes/skin. This drug may rarely cause blood clots. Get medical help right away if any of these serious side effects occur: chest/jaw/left arm pain, confusion, pain/swelling/redness/warmth in the leg, trouble speaking, sudden shortness of breath, sudden vision changes (such as partial/complete blindness), weakness on one side of the body. 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: 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 in women who are pregnant with a single baby, and who have delivered a baby too early (preterm) in the past. It is used to help lower the risk of having a preterm baby again. Hydroxyprogesterone is a man-made form of a female hormone (progestin). It is not known how it works to prevent preterm births. This medication is not intended to prevent preterm birth in women pregnant with more than one baby (such as twins, triplets). It is also not intended to stop active preterm labor. This drug has been withdrawn from the US market due to problems with safety or effectiveness.

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The cost of Makena 250 Mg/Ml Sdv 1 Ml Ds is available for registerd members only .
Makena 250 Mg/Ml Sdv 1 Ml Ds is manufactured by Covis.
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