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Medroxyprogesterone Acetate (Depo-Subq Provera)

Trade Name : Depo-SubQ Provera

Pharmacia and Upjohn Company LLC

INJECTION, SUSPENSION

Strength 104 mg/.65mL

MEDROXYPROGESTERONE ACETATE Progesterone Congeners [CS],Progestin [EPC]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Medroxyprogesterone Acetate (Depo-Subq Provera) which is also known as Depo-SubQ Provera and Manufactured by Pharmacia and Upjohn Company LLC. It is available in strength of 104 mg/.65mL per ml. Read more

Medroxyprogesterone Acetate (Depo-Subq Provera) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • WARNING: LOSS OF BONE MINERAL DENSITY
  • See full prescribing information for complete boxed warning
  • Women who use depo-subQ provera 104 may lose significant bone mineral density. Bone loss is greater with increasing duration of use and may not be completely reversible. ()
  • It is unknown if use of depo-subQ provera 104 during adolescence or early adulthood, a critical period of bone accretion, will reduce peak bone mass and increase the risk for osteoporotic fracture in later life. ()
  • Depo-subQ provera 104 is not recommended as a long-term (i.e., longer than 2 years) birth control method or medical therapy for endometriosis-associated pain unless other options are considered inadequate. (, )
  • Depo-subQ provera 104 is indicated in females of reproductive age for:
  • Limitations of Use
  • The use of depo-subQ provera 104 is not recommended as a long-term (i.e., longer than 2 years) birth control method or medical therapy for endometriosis-associated pain unless other options are considered inadequate n
  • Depo-subQ provera 104 is a progestin that is indicated in females of reproductive age for:
  • Limitations of Use
  • Use of depo-subQ provera 104 is not recommended as a long-term (i.e., longer than 2 years) birth control method or medical therapy for endometriosis-associated pain unless other options are considered inadequate. (, )
  • Prevention of pregnancy. ()
  • Management of endometriosis-associated pain. ()
  • No data
  • Only for healthcare professional administration. ()
  • Prior to first injection confirm the patient is not pregnant. ()
  • Administer 104 mg of depo-subQ provera 104 by subcutaneous injection into the anterior thigh or abdomen, once every 12 to 14 weeks. ()
  • See Full Prescribing Information for recommendations on switching from another contraceptive method to depo-subQ provera 104. ()
  • See Full Prescribing Information for important preparation and administration instructions. ()
  • Injectable suspension (104 mg/0.65 mL) in a single-dose pre-filled syringe, packaged with a 26-gauge u00d7 3/8-inch Terumo SurGuard needle.
  • Injectable suspension: 104 mg/0.65 mL ()
  • The use of depo-subQ provera 104 is contraindicated in the following conditions:
  • Active thrombophlebitis, or current or history of thromboembolic disorders, or cerebral vascular disease. ()
  • Known, suspected, or past malignancy of the breast. ()
  • Significant liver disease. ()
  • Known hypersensitivity to medroxyprogesterone acetate or any of the ingredients of depo-subQ provera 104. ()
  • Undiagnosed vaginal bleeding. ()
  • No data
  • Thromboembolic disorders: Discontinue depo-subQ provera 104 in patients who develop arterial or venous thrombosis. ()
  • Breast cancer risks: Monitor women with a family history of breast cancer or a significant risk of breast cancer carefully. ()
  • Ectopic pregnancy: Consider ectopic pregnancy if a woman becomes pregnant or complains of severe abdominal pain. ()
  • Anaphylaxis: Provide emergency medical treatment. ()
  • Injection site reactions (e.g., persistent atrophy, dimpling/indentation, and lump/nodule) have been reported. ()
  • Diabetics may be at greater risk of hyperglycemia. ()
  • Jaundice and elevated transaminase: Discontinue depo-subQ provera 104 if jaundice or elevated transaminase levels develop. ()
  • The following important adverse reactions are described in more detail in other sections of the prescribing information:
  • Most common adverse reactions (incidence >5%) are dysfunctional uterine bleeding, headache, increased weight, amenorrhea, and injection site reactions. ()
  • To report SUSPECTED ADVERSE REACTIONS, contact Pfizer, Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or n
  • Strong CYP3A inhibitors and inducers: Avoid concomitant use. ()
  • No data
  • Nursing mothers: Detectable amounts of drug have been identified in the milk of mothers receiving depot-medroxyprogesterone acetate. ()
  • Pediatric patients (after menarche): Bone loss is a particular concern. ()
  • Depo-subQ provera 104 contains medroxyprogesterone acetate (MPA), a derivative of progesterone, as its active ingredient. MPA is a white to off-white, odorless crystalline powder that is stable in air and that melts between 205u00b0C and 209u00b0C. It is freely soluble in chloroform, soluble in acetone and dioxane, sparingly soluble in alcohol and methanol, slightly soluble in ether, and insoluble in water.
  • The chemical name for MPA is 17-hydroxy-6u03b1-methylpregn-4-ene-3,20-dione 17-acetate. The structural formula is as follows:
  • Depo-subQ provera 104 for subcutaneous use is available in pre-filled syringes, each containing 0.65 mL (104 mg) of sterile medroxyprogesterone acetate injectable suspension.
  • Each 0.65 mL contains the following inactive ingredients:
  • When necessary, the pH is adjusted with sodium hydroxide or hydrochloric acid, or both.
  • No data
  • [See , ])
  • No data
  • No data
  • No data
  • Advise the patient to read the FDA-approved patient labeling (Patient Information)n
  • This product's labeling may have been updated. To see the current prescribing information, please visit www.pfizer.com.
  • LAB-0295-15.0
  • PATIENT INFORMATIONDEPO-SUBQ PROVERA 104n n n- (medroxyprogesterone acetate injectable suspension)for subcutaneous use
  • WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT depo-subQ provera 104?
  • Use of depo-subQ provera 104 may cause you to lose calcium stored in your bones.
  • Loss of calcium may cause weak, porous bones (osteoporosis) that could increase the risk that your bones might break, especially after menopause. It is not known whether your risk of developing osteoporosis may be greater if you are a teenager when you start to use depo-subQ provera 104.
  • You should use depo-subQ provera 104 long-term (for example, more than 2 years) only if other methods of birth control or other treatments for endometriosis pain are not right for you.
  • Depo-subQ provera 104 does not protect you from HIV (AIDS) and other infections spread through sex (STIs).
  • WHAT IS depo-subQ provera 104?
  • Depo-subQ provera 104 is a drug for birth control. It also helps relieve pain related to endometriosis . Symptoms of endometriosis arise when cells normally inside your uterus grow outside the uterus. The cells respond to menstrual cycle hormones, and may cause painful periods, pelvic pain, and painful sex.
  • Depo-subQ provera 104 contains a hormone called medroxyprogesterone acetate (MPA). It is given as a shot (injection) every 3 months. Three months is the same as 12 to 14 weeks.
  • HOW WELL DOES depo-subQ provera 104 WORK FOR PREVENTING PREGNANCY?
  • When you use depo-subQ provera 104 correctly, the chance of getting pregnant is very low. In studies, no women became pregnant during the year they used depo-subQ provera 104 injection.
  • The list below estimates the chances of getting pregnant using different types of birth control. The numbers are based on typical use. Typical use includes people who use the method correctly and people who use the method incorrectly. The list shows the number of women out of 100 women who will likely get pregnant if they use the method for 1 year.
  • HOW WILL I GET depo-subQ provera 104?
  • Depo-subQ provera 104 is given as a shot just under the skin on your thigh or belly. You get it once every 3 months.
  • For Birth Control
  • First shot:
  • Your healthcare professional will want to be sure that you are not pregnant before you get your first shot. Normally, you get the shot by the 5th day from the START of your menstrual period. You get it whether or not you are still bleeding.
  • If you are breast-feeding, you may have your first shot as early as 6 weeks after you deliver your baby.
  • After the first shot:
  • It is very important to keep getting depo-subQ provera 104 every 3 months. If you wait more than 14 weeks between shots, you could become pregnant. Your healthcare professional must make sure you are not pregnant before you get your next shot.
  • When you get your shot, make an appointment for your next shot. Mark it on your calendar.
  • If you need a birth control method for more than two years, your healthcare professional may ask you to have a test of your bones or ask you to switch to another birth control method before continuing depo-subQ provera 104, especially if you have other risks for weak bones.
  • For Endometriosis
  • If you have regular periods, you will get depo-subQ provera 104 the same way as described above for birth control. If your periods have stopped or are not regular, your healthcare professional must test to make sure you are not pregnant before you get your first shot.
  • It is not recommended that you receive depo-subQ provera 104 for treatment of endometriosis for longer than 2 years. If your painful symptoms return after stopping treatment, your healthcare professional should ask you to have a test of your bones before restarting treatment.
  • WHAT IF I MISS A SHOT?
  • If you miss a shot, or wait longer than 14 weeks between shots, you could get pregnant. The longer you wait, the greater the risk of getting pregnant.Talk with your healthcare professional to find out when to restart depo-subQ provera 104. You should be tested to be sure you are not pregnant.Use another kind of non-hormonal birth control, such as condoms, until you start depo-subQ provera 104 again.
  • DO NOT TAKE depo-subQ provera 104 IF YOUu2026
  • BEFORE TAKING depo-subQ provera 104
  • Your healthcare professional may do a physical examination and check your blood and urine.
  • Tell your healthcare professional about all your medical conditions.
  • Most importantly, tell your healthcare professional if you:
  • It is important to see your healthcare professional regularly if you have any of these conditions.
  • Some medicines may make depo-subQ provera 104 less effective at preventing pregnancy, including those listed below:
  • Tell your healthcare professional about all the medicines you take. This includes prescription and over-the-counter medicines, vitamins, and herbal products.
  • WHAT ELSE SHOULD I KNOW ABOUT TAKING depo-subQ provera 104?
  • Other Birth Control.
  • Pregnancy.
  • You should not use depo-subQ provera 104 if you are pregnant. However, depo-subQ provera 104 taken by accident during pregnancy does not seem to cause birth defects.
  • Pregnancy in your fallopian tubes (Ectopic Pregnancy).
  • Nursing a baby. Wait at least 6 weeks after your baby is born to start depo-subQ provera 104. You can use depo-subQ provera 104 if you are nursing.
  • It does not lower the amount of milk you can make. It can pass through breast milk into your baby, but it is not harmful.
  • Blood or urine tests.
  • Liver problems.
  • WHAT ARE THE MOST SERIOUS RISKS OF depo-subQ provera 104?
  • Losing calcium from your bones.
  • Calcium is generally added to the bones during teenage years. The decrease of calcium in your bones is of most concern if you are a teenager or have the following risk factors:
  • If you need a birth control method for more than 2 years, your healthcare professional may ask you to have a test of your bones or ask you to switch to another birth control method before continuing depo-subQ provera 104, especially if you have other risks for weak bones. When depo-subQ provera 104 is stopped, the calcium in your bones begins to come back. The lost calcium may not return completely once you stop using depo-subQ provera 104.
  • Abnormal or very heavy bleeding.
  • Allergic reaction.
  • Serious blood clots.
  • Depression.
  • WHAT ARE COMMON SIDE EFFECTS OF depo-subQ provera 104?
  • The most common side effects are:
  • Women using depo-subQ provera 104 for birth control or endometriosis had these less common side effects: Vaginal inflammation, vaginal thrush, abdominal pain, urinary tract infections, acne, depression, less sex drive, nausea, back pain, breast pain/tenderness, fatigue, anxiety, being irritable, dizziness, hot flushes and fluid retention.
  • If you feel you are having other side effects, talk with your healthcare professional.
  • DOES depo-subQ provera 104 CAUSE CANCER?
  • There have been several studies of women who use birth control like depo-subQ provera 104.
  • WHAT IF I WANT TO BECOME PREGNANT?
  • Plan ahead. The effect of depo-subQ provera 104 can last for a long time after you stop getting shots. Although you may be able to get pregnant quickly, it is more likely to take a year or longer after your last shot before you get pregnant.
  • It's best to see your healthcare professional for a pre-pregnancy check-up. Your healthcare professional may also tell you to take a vitamin called folic acid every day if you are planning to become pregnant.
  • GENERAL ADVICE ABOUT depo-subQ provera 104
  • For more information about depo-subQ provera 104, ask your healthcare professional or pharmacist. You can also visit www.depo-subQprovera104.com or call 1-866-554 DEPO (3376). A nurse can answer questions in Spanish or English 24 hours-a-day, 7 days a week.
  • WHAT IS IN depo-subQ provera 104?
  • Active ingredient: medroxyprogesterone acetate.Inactive ingredients: methylparaben, propylparaben, sodium chloride, polyethylene glycol, polysorbate 80, monobasic sodium phosphateu2219H2O, dibasic sodium phosphateu221912H2O, methionine, povidone, water for shot. When necessary, the pH is adjusted with sodium hydroxide or hydrochloric acid, or both.
  • This product's labeling may have been updated. For current full prescribing information, please visit www.pfizer.com.
  • LAB-0298-8.0Revised December 2019
  • depo-subQ provera 104u2122medroxyprogesterone acetate injectablesuspension (104 mg/0.65 mL for subcutaneous use)
  • ttttttt104 mg/0.65 mL tttttt
  • 0.65 mL Single Use SyringetttttttStore at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F). tttttttShake vigorously before use.
  • Pfizer
  • Pharmacia & Upjohn Co
  • LOT/EXP: PAA091484
  • NDC 0009-4709-13
  • tttttttSingle Use 0.65 mL Prefilled Syringe tttttt
  • tttttttdepo-subQ provera 104u2122tttttttmedroxyprogesterone acetate injectable suspension tttttttttttttt(104 mg/0.65 mL for subcutaneous use) tttttt
  • tttttt104 mg/0.65 mL tttttt
  • tttttttPfizer tttttt
  • tttttttDistributed by ttttttttttttttPharmacia & Upjohn Co tttttttDivision of Pfizer Inc, NY, NY 10017n
  • Rx only

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