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Drug Info > P > Puregon
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DIN (Drug Identification Number)


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ABCDEFGHIJKLMNOPQRSTUVWXYZ

Brand Name

Puregon

Common Name
follitropin beta


In this drug factsheet:



DIN (Drug Identification Number)

02242441 PUREGON 100 UNIT/ 0.5ML
02243948 PUREGON 833 UNIT/ ML
02242439 PUREGON 50 UNIT / 0.5ML

How does this medication work? What will it do for me?

Follitropin beta belongs to the class of medications called gonadotropins. Follitropin beta contains a hormone similar to the human hormone called follicle stimulating hormone (FSH). Follitropin beta is used as a fertility medication in both women and men.

In women, it is used when FSH levels are low or as part of assisted reproductive technology (ART) procedures such as in-vitro fertilization. Follitropin beta causes eggs to become mature and ready for release by the ovary. In men, follitropin beta helps increase sperm production.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are being given this medication, speak to your doctor. Do not stop using this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to use this medication if their doctor has not prescribed it.

How should I use this medication?

The dose of this medication varies according to individual response.

To help induce ovulation, the recommended initial dose of follitropin beta is 50 IU given daily, usually for 7 to 14 days. The dose may be adjusted according to response, which is measured by an ultrasound or by a blood test. When an adequate response is achieved, this medication is stopped and another medication, human chorionic gonadotropin (hCG), is given to induce ovulation.

For ART procedures, the usual initial dose is 150 IU to 225 IU daily for 4 days. The dose is then adjusted according to response and is usually continued for 6 to 12 days. When an adequate response is achieved, this medication is stopped and another medication, hCG, is given to induce ovulation.

In men, the usual dose is 150 IU given 3 times a week or 225 IU twice a week. Treatment is usually given for at least 3 to 4 months. It is usually given along with another medication, hCG.

The injections can be given under the skin (subcutaneous) or into a muscle (intramuscular). The best place for subcutaneous injections is around the navel or the upper thigh. The place of injection should be varied for each injection. The best place for intramuscular injections is the upper outer part of the buttock muscle.

A health care professional will show you how to use this medication properly. Read the enclosed patient information carefully and ask your doctor any question you might have.

Many things can affect the dose of a medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are using the medication without consulting your doctor.

It is very important to use this medication on a regular schedule as prescribed by the doctor. If you miss a dose of this medication, check with your health care professional. Do not administer a double dose to make up for a missed dose.

Store this medication in the refrigerator at 2°C to 8°C (do not freeze). It can also be stored at room temperature (below 25°C) for a maximum of 3 months. Protect it from light, and keep it out of the reach of children. Once the cartridges have been punctured by a needle, store for a maximum of 28 days.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.





What form(s) does this medication come in?

Solution for injection in cartridges

Solution for injection in cartridges contain 833 IU/mL. Cartridges contain a minimum of 400 IU FSH activity in 0.48 mL aqueous solution, which is sufficient for a net deliverable dose of 300 IU; a minimum of 700 IU FSH activity in 0.84 mL aqueous solution, which is sufficient for a net deliverable dose of 600 IU; or a minimum of 1,025 IU FSH activity in 1.23 mL, which is sufficient for a net dose of 900 IU. Nonmedicinal ingredients: benzyl alcohol, L-methionine, polysorbate 20, sodium citrate, and sucrose. Hydrochloric acid 0.1 N and sodium hydroxide 0.1 N (trace amounts for pH adjustment to pH 7.0).

The net deliverable dose of 300 IU, 600 IU, and 900 IU are based upon a maximum of six 50 IU injections, six 100 IU injections and nine 100 IU injections respectively. When more injections are given the net total dose may be lowered, because each injection has to be preceded by an air shot.

Solution for injection

Each vial of sterile solution for injection contains follitropin beta (recombinant FSH) 50 IU or 100 IU. Nonmedicinal ingredients: L-methionine, polysorbate 20, sodium citrate, and sucrose. Hydrochloric acid 0.1 N and sodium hydroxide 0.1 N (trace amounts for pH adjustment to pH 7.0).

Who should NOT take this medication?

This medication should not be used by women who:

  • are allergic to follitropin beta or to any of the ingredients of the medication
  • are pregnant or breast-feeding
  • have conditions where pregnancy can or should not occur (e.g., malformation of sexual organs or fibroid tumours of the uterus)
  • have heavy or irregular vaginal bleeding of unknown cause
  • have high levels of the hormone FSH in the blood
  • have ovarian cysts or enlargement not due to polycystic ovary syndrome (PCOD)
  • have tumours of the ovary, breast, uterus, hypothalamus, or pituitary gland
  • have uncontrolled thyroid or adrenal dysfunction

This medication should not be used by men who:

  • are allergic to follitropin beta or to any of the ingredients of the medication
  • have tumours of the testicles, pituitary gland, or hypothalamus
  • have primary testicular failure


 

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