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Chorionic Gonadotropin for Injection, USP

Chorionic gonadotropin for injection (hCG) acts very similarly to luteinizing hormone.

Chorionic Gonadotropin may cause serious side effects.

  • Chorionic Gonadotropin can sometimes stimulate the ovaries too much. This is called ovarian hyperstimulation syndrome (OHSS) and can be a serious medical problem. OHSS may cause pelvic pain or breathing problems, or it may make you urinate less. In rare cases, patients with this problem have had serious lung problems.
  • Chorionic Gonadotropin may also cause blood clots and strokes.
  • Call your doctor or get medical help right away if you have: severe abdominal or pelvic pain, nausea, vomiting, diarrhea, sudden weight gain, trouble breathing, or decreased or no urination.
  • Chorionic Gonadotropin may cause you to be pregnant with twins or more than two babies at the same time.
  • Anaphylaxis and other allergic reactions have occurred with urinary-derived human chorionic gonadotropin (hCG) products.

Before taking Chorionic Gonadotropin for Injection, USP, tell your doctor about all of your medical conditions, including if you:

  • have heart or kidney disease, epilepsy, migraine, or asthma.
  • are pregnant or breastfeeding. Chorionic gonadotropin may cause harm to an unborn baby when given to a pregnant woman. It is not known whether chorionic gonadotropin is excreted in human milk.

Tell your doctor about all the medicines you are taking, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Chorionic Gonadotropin for Injection, USP may affect the way some medicines work and some medicines may affect the way Chorionic Gonadotropin for Injection, USP works.

Side effects of Chorionic Gonadotropin may include: headache, irritability, restlessness, depression, fatigue, swelling, and pain at the injection site.

These are not all the possible side effects of Chorionic Gonadotropin. Tell your doctor about any side effect that bothers you or does not go away.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

INDICATIONS AND USAGE
Chorionic Gonadotropin for Injection, USP is a prescription medicine that contains a hormone to help stimulate healthy ovaries to make eggs. Chorionic Gonadotropin for Injection, USP is used for women who need medical help in becoming pregnant. Your doctor may prescribe more than one medicine as part of a pregnancy plan.

Chorionic Gonadotropin for Injection, USP has not been shown to be effective as an additional therapy for treating obesity. Chorionic Gonadotropin for Injection, USP has not been proven to help with weight loss, cause a more attractive or “normal” distribution of fat, or decrease hunger and discomfort related to caloric-restricted diets.

This Important Safety Information does not include all the information needed to use Chorionic Gonadotropin for Injection, USP safely and effectively. To learn more about Chorionic Gonadotropin for Injection, USP, talk to your doctor or pharmacist. Please see the full prescribing information for Chorionic Gonadotropin for Injection, USP.

Cetrorelix Acetate for Injection

Cetrorelix Acetate for Injection is a prescription fertility medicine.

Before starting Cetrorelix Acetate for Injection, tell your healthcare professional about all your medical conditions. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Consult your doctor before taking Cetrorelix Acetate for Injection if you have had severe allergic reactions.

What is the most important information I should know before starting Cetrorelix Acetate for Injection?

Your doctor will confirm you are not pregnant.

How should you use Cetrorelix Acetate for Injection?
You may self-inject Cetrorelix Acetate for Injection after special instruction from your doctor.

What do you do if you have used too much Cetrorelix Acetate for Injection?
Contact your doctor in case of overdosage immediately to check whether an adjustment of the further ovarian stimulation procedure is required.

What are the possible side effects of Cetrorelix Acetate for Injection?
Allergic reactions including anaphylactic reaction with the first dose. Treatment with Cetrorelix Acetate for Injection is not advised in women with severe allergic conditions.

Mild and short-lasting reactions may occur at the injection site like reddening, itching, and swelling. Nausea and headache have also been reported.

Call your doctor if you have any side effect not mentioned here or if you are unsure about the effect of this medicine. 

These are not all of the possible side effects of Cetrorelix Acetate for Injection. Tell your healthcare provider if you have any side effect that bothers you or that does not go away. You are encouraged to report negative side effects of Cetrorelix Acetate for Injection, contact the FDA at: 1-800-FDA-1088 or www.fda.gov/medwatch.

What is Cetrorelix Acetate for Injection used for?
Cetrorelix Acetate for Injection is a prescription medicine used to block the effects of a natural hormone, called gonadotropin releasing hormone (GnRH). GnRH controls the secretion of another hormone, called luteinizing hormone (LH), which induces ovulation during the menstrual cycle. During hormone treatment for ovarian stimulation, premature ovulation may lead to eggs that are not suitable for fertilization. Cetrorelix Acetate for Injection blocks such undesirable premature ovulation during controlled ovarian stimulation.

This Important Safety Information does not include all the information needed to use Cetrorelix Acetate for Injection safely and effectively. To learn more about Cetrorelix Acetate for Injection, talk to your doctor or pharmacist. Please see full prescribing information for Cetrorelix Acetate for Injection.

Ganirelix Acetate Injection

Ganirelix Acetate Injection is used as a fertility medicine.

Before taking Ganirelix Acetate Injection, tell your doctor about all of your medical conditions, including if you:

  • Are already pregnant. Although this medicine is used as a part of a program to achieve pregnancy, receiving it while pregnant can harm your unborn baby. Carefully follow any instructions your doctor gives you regarding birth control or pregnancy testing during your treatment.
  • Are breastfeeding.

Tell your doctor about all the medicines you are taking, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Ganirelix Acetate Injection may affect the way some medicines work and some medicines may affect the way Ganirelix Acetate Injection works.

When using Ganirelix Acetate Injection, you should:

  • Use Ganirelix Acetate Injection exactly as your doctor tells you to. Your doctor will prescribe your exact dose and tell you how often it should be given. This medicine is given as a shot under your skin. Talk with your doctor if you have any questions about the schedule for your treatment or how your progress will be checked. A nurse or other health provider may give you this medicine.
  • Make sure you understand all the instructions before giving yourself an injection. You may be taught how to give your medicine at home. Do not use more medicine or use it more often than your doctor tells you to.
  • Use a different body area each time you give yourself a shot. You will be shown the body areas where this shot can be given. Keep track of where you give each shot to make sure you rotate body areas.
  • Use this medicine on a fixed schedule. Call your doctor or pharmacist if you miss a dose.
  • Keep all appointments. Your doctor will check your progress and the effects of this medicine at regular visits.
  • Keep all medicine out of the reach of children. Never share your medicine with anyone.

Ganirelix Acetate Injection may cause serious side effects, including:

  • Rapid weight gain or bloating
  • Severe or ongoing nausea, vomiting, diarrhea
  • Severe stomach or pelvic pain
  • Fetal death 

Side effects of Ganirelix Acetate Injection may include: headache, mild nausea or stomach pain, pain, redness, or swelling where the shot was given, unusual vaginal bleeding.

These are not all the possible side effects of Ganirelix Acetate Injection. Tell your doctor about any side effect that bothers you or does not go away.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

INDICATIONS AND USAGE
Ganirelix Acetate Injection is a prescription medicine that keeps a woman from ovulating too soon when undergoing infertility treatment.

This Important Safety Information does not include all the information needed to use Ganirelix Acetate Injection safely and effectively. To learn more about Ganirelix Acetate Injection, talk to your doctor or pharmacist. Please see the full prescribing information for Ganirelix Acetate Injection.

Progesterone Injection, USP

Progesterone injection contains the natural female hormone progesterone.

Progesterone Injection may cause serious side effects including:

  • Abnormal blood clotting. Blood clots have been reported with the use of estrogens and progestational drugs (alone or in combination). If blood clots do form in your bloodstream, they can cut off the blood supply to vital organs, causing serious problems. These problems may include a stroke (by cutting off blood to part of the brain), a heart attack (by cutting off blood to part of the heart), a pulmonary embolus (by cutting off blood to part of the lungs), or other problems. Any of these conditions may cause death or serious long-term disability. Call your doctor immediately if you suspect you have any of these conditions. He or she may advise you to stop using this drug. 
  • Be alert for unusual signs and symptoms. If any of these warning signals (or any other unusual symptoms) happen while you are using Progesterone Injection, call your doctor immediately: 
    • Abnormal bleeding from the vagina. 
    • Pains in the calves or chest, a sudden shortness of breath or coughing blood indicating possible clots in the legs, heart, or lungs. 
    • Severe headache or vomiting, dizziness, faintness, or changes in vision or speech, weakness or numbness of an arm or leg indicating possible clots in the brain or eye. 
    • Breast lumps, which could be associated with fibrocystic disorders, fibroadenoma, or breast cancer. (Ask your doctor or healthcare provider to show you how to examine your breasts monthly.) 
    • Yellowing of the skin and/or white of the eyes indicating possible liver problems. 

Before taking Progesterone Injection, tell your doctor about all of your medical conditions, including if you: 

  • are pregnant, planning to become pregnant, or become pregnant while taking Progesterone Injection. 
  • are breastfeeding or planning to breastfeed. Small amounts of drug have been found in the milk of nursing mothers. The effect on a nursing infant is not known.

Tell your doctor about all the medicines you are taking, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Progesterone Injection may affect the way some medicines work and some medicines may affect the way Progesterone Injection works.

Side effects of Progesterone Injection may include: The following side effects have been reported with Progesterone Injection. Consult your doctor if you experience any of the side effects mentioned below, or other side effects.

  • breakthrough bleeding 
  • amenorrhea 
  • general swelling 
  • breast tenderness, discharge from the nipple 
  • hair loss or growth of new hair 
  • insomnia or sleepiness* 
  • nausea 
  • spotting 
  • change in weight (increase or decrease) 
  • vaginal discharge 
  • skin reactions including rash, hives, itching, and swelling 
  • mental depression 
  • changes in menstrual flow 
  • pain, irritation, swelling, and/or redness at the injection area 
  • yellow discoloration of skin or white of eyes 
  • acne 
  • fever 
  • anaphylactoid (life-threatening allergic) reaction with symptoms that may include a sense of uneasiness or apprehension; flushing; fast, throbbing heartbeat; itching; hives; difficult breathing; swelling of the throat; fainting; nausea; vomiting; or convulsions.

* If you experience sleepiness, do not drive or operate machinery.

These are not all the possible side effects of Progesterone Injection. Tell your doctor about any side effect that bothers you or does not go away.  

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

INDICATIONS AND USAGE
Progesterone Injection, USP is a sterile injectable solution containing the natural female hormone called progesterone. Progesterone Injection is a prescription medicine used for the treatment of amenorrhea (absence of menses in women who have previously had a menstrual period) and abnormal uterine bleeding due to progesterone deficiency.

This Important Safety Information does not include all the information needed to use Progesterone Injection safely and effectively. To learn more about Progesterone Injection, talk to your doctor or pharmacist. Please see the full prescribing information for Progesterone Injection and Patient Information.

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Cetrorelix Acetate for Injection