Brevactid 1500 I.E.

Each vial with powder of Brevactid 1500 I.E. contains human Brevactid 1500 I.E. 5,000 IU as the active ingredient and lactose as further ingredient.

Each ampoule with 1 mL solvent of Brevactid 1500 I.E. contains isotonic sodium chloride solution and dilute hydrochloric acid for pH adjustment.

this medicine PreFilled Syringe (choriogonadotropin alfa injection) is indicated for the induction of final follicular maturation and early luteinization in infertile women who have undergone pituitary desensitization and who have been appropriately pretreated with follicle stimulating hormones as part of an Assisted Reproductive Technology (ART) program such as in vitro fertilization and embryo transfer. this medicine PreFilled Syringe is also indicated for the induction of ovulation (OI) and pregnancy in anovulatory infertile patients in whom the cause of infertility is functional and not due to primary ovarian failure.

Selection of Patients

1.

Before treatment with gonadotropins is instituted, a thorough gynecologic and endocrinologic evaluation must be performed. This should include an assessment of pelvic anatomy. Patients with tubal obstruction should receive this medicine PreFilled Syringe only if enrolled in an in vitro fertilization program.

2.

Primary ovarian failure should be excluded by the determination of gonadotropin levels.

3.

Appropriate evaluation should be performed to exclude pregnancy.

4.

Patients in later reproductive life have a greater predisposition to endometrial carcinoma as well as a higher incidence of anovulatory disorders. A thorough diagnostic evaluation should always be performed in patients who demonstrate abnormal uterine bleeding or other signs of endometrial abnormalities before starting FSH and this medicine PreFilled Syringe therapy.

5.

Evaluation of the partner

Brevactid 1500 I.E. is a drug whose actions are almost the same as those of luteinizing hormone (LH), which is produced by the pituitary gland. It is a hormone also normally produced by the placenta in pregnancy. Brevactid 1500 I.E. has different uses for females and males.

In females, Brevactid 1500 I.E. is used to help conception occur. It is usually given in combination with other drugs such as menotropins and urofollitropin. Many women being treated with these drugs usually have already tried clomiphene alone (e.g., Serophene) and have not been able to conceive yet. Brevactid 1500 I.E. is also used in in vitro fertilization (IVF) programs.

In males, LH and Brevactid 1500 I.E. stimulate the testes to produce male hormones such as testosterone. Testosterone causes the enlargement of the penis and testes and the growth of pubic and underarm hair. It also increases the production of sperm.

Although Brevactid 1500 I.E. has been prescribed to help some patients lose weight, it should never be used this way. When used improperly, Brevactid 1500 I.E. can cause serious problems.

Brevactid 1500 I.E. is to be administered only by or under the immediate supervision of your doctor.

Female: To Induce Ovulation: 5,000 or 10,000 IU injected once IM.

To Maintain Corpus Luteum Function: 1,500-5,000 IU to be injected IM on the 3rd, 6th and 9th day following ovulation. If desired, Brevactid 1500 I.E. 1500 can be used.

Male: To Induce Puberty in Boys with Pubertas Tarda: 3,000-5,000 IU IM once a week over a period of 3 months. If desired, Brevactid 1500 I.E. 1500 can be used.

Hypogonadotrophic Hypogonadism (together with HMG): 1,500-6,000 IU IM per week. If desired, Brevactid 1500 I.E. 1500 can be used.

As a Diagnostic Agent: For Differential Diagnosis in Boys with Undescended Testicle and to Assess the Function of the Testes in Patients with Hypogonadotrophic Hypogonadism: One (1) time injection of 5,000 IU IM.

Administration: Brevactid 1500 I.E. is to be injected IM.

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What is the most important information I should know about Brevactid 1500 I.E.?

PROMETRIUM Capsules should not be used in women with any of the following conditions:

1. PROMETRIUM Capsules should not be used in patients with known hypersensitivity to its ingredients. PROMETRIUM Capsules contain peanut oil and should never be used by patients allergic to peanuts.

Use Brevactid 1500 I.E. as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Brevactid 1500 I.E. is usually administered as an injection at your doctor's office, hospital, or clinic. If you are using Brevactid 1500 I.E. at home, carefully follow the injection procedures taught to you by your health care provider.
• If Brevactid 1500 I.E. contains particles or is discolored, or if the vial is cracked or damaged in any way, do not use it.
• Using the technique described to you by your doctor, add the diluent to the vial that contains the medicine. Mix the solution by gently rotating the vial. DO NOT SHAKE. The solution should be clear and free of particles.
• Wipe the rubber stopper of the vial with an alcohol swab. Insert the needle straight through the center circle of the rubber stopper. Draw up the solution for injection. After drawing up the solution, switch needles. Be sure all air bubbles are tapped out of the syringe.
• Wipe the appropriate injection site (usually the upper thigh or buttocks) with an alcohol swab, then insert the syringe. To be sure that the needle is not in a vein, pull back on the plunger of the syringe while holding the syringe in place. If the syringe begins to fill with blood, the needle is in a vein. If this happens, remove the needle from the skin, throw the syringe away, and start the procedure again using new materials (drugs, syringes, etc.).
• After giving the injection, cover the injection site with a small bandage if necessary.
• Keep this product, as well as syringes and needles, out of the reach of children. Do not reuse needles, syringes, or other materials. Dispose of properly after use. Ask your doctor or pharmacist to explain local regulations for proper disposal.
• If you miss a dose of Brevactid 1500 I.E., contact your doctor right away.

Ask your health care provider any questions you may have about how to use Brevactid 1500 I.E..

This medication is a hormone used in boys (before puberty) to cause the normal dropping of the testicles into the scrotum. It is also used in certain boys to help with normal sexual development. It works by causing the testes to release male sex hormones (e.g., testosterone).

This medication is also used in women to treat fertility problems. It is given after finishing another medication (menotropins) to cause the release of an egg (ovulation). It should not be used in women whose ovaries no longer make eggs properly (primary ovarian failure).

This medication has not been shown to be effective for weight loss and should not be used for this purpose.

How to use HCG intramuscular

This medication is given by injection into a muscle by a health care professional. If you are giving this medication at home, learn all preparation and usage instructions for this product. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. If you have any questions about the use of this medication, ask your doctor or pharmacist.

The dosage is based on your age, weight, medical condition, and response to treatment.

For boys, use this medication usually 3 times a week or as directed by your doctor. For women, use this medication usually for 1 dose after finishing your menotropins treatment.

Use this medication regularly to get the most benefit from it. To help you remember, mark the day(s) on the calendar when you need to receive the medication.

Learn how to store and discard needles and medical supplies safely. Consult your pharmacist for more details.

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Drug/Laboratory Test Interactions

The following laboratory results may be altered by the use of estrogen-progestin combination drugs:

• Increased sulfobromophthalein retention and other hepatic function tests.
• Coagulation tests: increase in prothrombin factors VII, VIII, IX and X.
• Metyrapone test.
• Pregnanediol determination.
• Thyroid function: increase in PBI, and butanol extractable protein bound iodine and decrease in T3 uptake values.

Fasting and 2-hour plasma insulin and glucose levels following an oral glucose tolerance test (OGTT) and figrinogen levels were measured in patients receiving PROMETRIUM® Capsules at a dose of 200 mg/day for 12 days per 28 day cycle in combination with conjugated estrogens 0.625 mg/day (n-120). Table 6 summarizes this data. Plasma insulin levels 2 hours post-OGTT were decreased from baseline. The fasting plasma glucose and fasting plasma insulin levels were also decreased from baseline. Glucose levels 2 hours post-OGTT were increased slightly. There was no effect on fibrinogen levels.

For information on changes in lipid profile, see the CLINICAL PHARMACOLOGY, Clinical Studies subsection, Table 5.

Table 6

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What are the possible side effects of Brevactid 1500 I.E.?

Applies to Brevactid 1500 I.E. (hcg): powder for solution, solution

In addition to its needed effects, some unwanted effects may be caused by Brevactid 1500 I.E. (hcg). In the event that any of these side effects do occur, they may require medical attention.

Severity: Moderate

If any of the following side effects occur while taking Brevactid 1500 I.E. (hcg), check with your doctor or nurse as soon as possible:

For females onlyMore common:

• Bloating (mild)
• stomach or pelvic pain

• Abdominal or stomach pain (severe)
• bloating (moderate to severe)
• decreased amount of urine
• feeling of indigestion
• nausea, vomiting, or diarrhea (continuing or severe)
• pelvic pain (severe)
• shortness of breath
• swelling of feet or lower legs
• weight gain (rapid)

• Acne
• enlargement of penis and testes
• growth of pubic hair
• increase in height (rapid)

• difficult or labored breathing
• difficulty breathing
• flushing of skin
• hives or welts
• itching of skin
• large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, sex organs
• pain in chest, groin, or legs, especially the calves
• redness of skin
• severe, sudden headache
• skin rash
• slurred speech
• sudden loss of coordination
• sudden, severe weakness or numbness in arm or leg
• sudden, unexplained shortness of breath
• tightness in chest
• unusually warm skin
• vision changes
• wheezing

Minor Side Effects

Some of the side effects that can occur with Brevactid 1500 I.E. (hcg) may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

Less common:

• Discouragement
• enlargement of breasts
• feeling sad or empty
• headache
• irritability
• lack of appetite
• loss of interest or pleasure
• pain at place of injection
• trouble concentrating
• trouble sleeping
• tiredness

Side Effects: Post Treatment

After you stop taking this drug, it is possible that you may still experience side effects that need medical attention. If you notice any of the following side effects check with your doctor immediately:

For females onlyLess common or rare:

• Abdominal or stomach pain (severe)
• bloating (moderate to severe)
• decreased amount of urine
• feeling of indigestion
• nausea, vomiting, or diarrhea (continuing or severe)
• pelvic pain (severe)
• shortness of breath
• weight gain (rapid)