Horapur

PATIENT INFORMATION LEAFLET

Leaflet accompanying the packaging: patient information

CHORAPUR, 1500 IU, powder and solvent for solution for injection

CHORAPUR, 5000 IU, powder and solvent for solution for injection

Chorionic gonadotropin

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Chorapur and what is it used for
• 2. Important information before using Chorapur
• 3. How to use Chorapur
• 4. Possible side effects
• 5. How to store Chorapur
• 6. Contents of the pack and other information

1. What is Chorapur and what is it used for

Chorapur belongs to a group of medicines called gonadotropins (sex hormones). In women, it controls the release of egg cells from the ovaries, and in men, it controls the production of the male hormone - testosterone.
Chorapur contains the active substance - highly purified human chorionic gonadotropin (hCG) (a protein hormone), which is obtained from the urine of pregnant women and purified. Gonadotropins play a key role in fertility and reproduction.
In women
In female infertility, this medicine can be used to induce ovulation in women (ovulation induction). Chorapur is also used in combination with other medicines to support the production of egg cells in assisted reproduction programs (in vitro fertilization).
In men
Chorapur is used in men to treat a condition where there is a low sperm count.
Chorapur is used either alone or in combination with other gonadotropins (hMG, FSH). Chorapur is also used in men before starting stimulation treatment to assess testicular function when the reproductive organs are not working properly due to a lack of sex hormones.
In children
Chorapur is used in children to treat delayed sexual development and in children whose testes have not descended or have not fully descended into the scrotum.

2. Important information before using Chorapur

When not to use Chorapur:

• if you are allergic to chorionic gonadotropin or any of the other ingredients of this medicine (listed in section 6);
• if you have a tumor in the brain or pituitary gland;
• if you have ovarian cysts or ovarian enlargement due to other causes than polycystic ovary syndrome;
• if you have vaginal bleeding of unknown origin;
• if you have been diagnosed with ovarian, uterine, or breast cancer;
• if you have had an ectopic pregnancy in the last three months;
• if you have severe vein inflammation or blood clots in the veins (active thromboembolic disorders);
• if you have ovarian hyperstimulation syndrome (OHSS);
• if normal pregnancy development is not possible, e.g., in case of ovarian failure, genital organ developmental disorders preventing pregnancy, uterine fibroids, or if you have had early menopause;
• if you have been diagnosed with or suspected to have hormone-dependent tumors, such as prostate cancer or male breast cancer;
• if it is known that the cause of undescended testes cannot be treated with hormones (inguinal hernia, previous surgery in the groin area, abnormal testicle location).

Warnings and precautions

Before starting treatment with Chorapur, discuss it with your doctor or nurse.
Tell your doctor if you currently have or have had any of the following diseases, as they may worsen after using Chorapur:

• heart disease;
• kidney disease;
• epilepsy;
• migraine-like headaches.

Treatment with Chorapur may increase the risk of blood clots. Blood clots are the formation of blood clots in blood vessels, usually in the veins of the legs or lungs. Pregnancy itself can also increase the risk of blood clots. Before starting treatment with Chorapur, tell your doctor if:

• you know that you have an increased risk of blood clots;
• you or a close family member have had blood clots;
• you are overweight.

Before starting treatment, it is necessary to determine the causes of infertility in you or your partner and any reasons why normal pregnancy development may not be possible. You should be thoroughly examined to rule out any changes in the reproductive organs or hormonal disorders unrelated to the gonads (e.g., thyroid, adrenal, or pituitary disorders).
During treatment, close monitoring by your doctor is very important. Regular ultrasound examinations and blood tests are usually performed. This is especially important because treatment with Chorapur increases the risk of ovarian hyperstimulation syndrome (OHSS) (see also section 4 "Possible side effects"). This occurs when the ovaries respond excessively to treatment and produce too many follicles. OHSS usually resolves on its own with the onset of menstruation.
In the event of pregnancy, OHSS may have a more severe course and last longer. Therefore, patients should remain under medical supervision for at least two weeks after hCG administration.
Mild or moderate OHSS may cause symptoms such as:

• abdominal pain or discomfort;
• abdominal swelling;
• nausea;
• vomiting;
• diarrhea;
• weight gain. In severe cases of OHSS, additional symptoms may occur, such as:
• breathing difficulties;
• decreased urine output. In very rare cases, severe OHSS may be complicated by blood clots in blood vessels (thromboembolic disease) or ovarian torsion. You should immediately inform your doctor, even if symptoms occur several days after the last dose of the medicine. These may be symptoms of excessive ovarian activity, which can be severe. If these symptoms worsen, fertility treatment should be discontinued and appropriate hospital treatment should be initiated. Following the recommended dose and carefully monitoring the treatment will reduce the risk of such symptoms. In patients with polycystic ovary syndrome, there is an increased risk of OHSS.

  After gonadotropin treatment, there is a higher likelihood of becoming pregnant with twins or multiple pregnancies than after natural conception.
  The number of miscarriages in women who do not produce enough mature egg cells or do not produce them at all, as well as in women participating in assisted reproduction programs, such as in vitro fertilization, is higher than in the general population but comparable to the number of miscarriages in women with other fertility disorders.
  Women with damaged fallopian tubes have a slightly increased risk of ectopic pregnancy.
  The frequency of congenital anomalies after fertility treatment may be slightly higher than in the case of natural conceptions. This may be related to parental characteristics (e.g., maternal age, sperm quality) and the more frequent occurrence of multiple pregnancies.
  In the case of a clinically significant disease that may worsen during pregnancy, the doctor will provide special supervision during treatment.
  Chorapur may cause a false positive pregnancy test result for up to 10 days after administration.
  Using Chorapur may result in positive doping test results. Using Chorapur for doping purposes can be hazardous to health.

  Children

  Chorapur should be used with caution in boys before puberty to avoid bone problems or premature sexual development. Bone maturity should be regularly monitored.

  Chorapur and other medicines

  Tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
  No interactions with other medicines are known.

  Pregnancy, breastfeeding, and fertility

  If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor before using this medicine.
  Chorapur is indicated for the treatment of infertility (see section "What is Chorapur and what is it used for").
  Chorapur should not be used during pregnancy and breastfeeding.

  Driving and using machines

  No studies have been conducted on the effects on the ability to drive and use machines. It is expected that Chorapur will not affect the ability to drive and use machines.

  Chorapur contains sodium

  Chorapur contains sodium, but the amount does not exceed 1 mmol (23 mg) per 1 ml of solvent, which means the medicine is considered almost "sodium-free".

  3. How to use Chorapur

  This medicine should always be used exactly as your doctor has told you. If you are not sure, ask your doctor.
  Method of administration:
  This medicine is given as an intramuscular injection by a doctor who has experience in treating fertility disorders

  Chorapur 1500 IU

  Treatment with Chorapur should be carried out by a doctor who has experience in treating fertility disorders.
  In men, the recommended dose is 1 vial twice a week (corresponding to 3000 IU per week).
  Since sperm development takes about 74 days, treatment should be continued for at least 3 months to expect any improvement. During treatment, the doctor monitors testosterone levels. It may be necessary to increase the dose of the medicine.
  If the response to treatment with Chorapur alone is insufficient, the doctor may decide to administer another medicine at the same time as Chorapur. In some cases, after improvement is achieved using a combination of these medicines, it can be maintained using only Chorapur.

  Use in children

  Treatment for undescended testes should be completed when the child is 1 year old.
  The recommended dose in infants is: 250 IU/dose (0.17 ml from a vial containing 1500 IU) twice a week for 5 weeks.

  Chorapur 5000 IU

  Treatment with Chorapur should be carried out by a doctor who has experience in treating fertility disorders.
  To induce ovulation and stimulate the ovaries:
  The recommended dose is 1 vial (5000 IU) or 2 vials (10,000 IU). The medicine should be administered 24 to 48 hours after optimal follicular growth stimulation has been achieved.
  If Chorapur is used to induce ovulation after follicular growth stimulation, the patient is advised to have sexual intercourse on the day of injection and the next day after injection.
  To assess testicular function in cases where the reproductive organs are not working properly due to a lack of sex hormones:
  The recommended dose is 1 vial (5000 IU) as a single dose.

  Use in children

  In boys with delayed sexual development:
  The recommended dose is 1 vial (5000 IU) once a week for 3 months.
  In case of undescended testes:
  The recommended dose is 1 vial (5000 IU) as a single dose.

  Using a higher dose of Chorapur than recommended

  No cases of overdose have been reported. However, there is a possibility that an overdose may cause ovarian hyperstimulation syndrome (OHSS), see section 2 "Important information before using Chorapur").

  Missing a dose of Chorapur

  Do not take a double dose to make up for a forgotten dose. Consult your doctor.

  Stopping treatment with Chorapur

  Consult your doctor.

  4. Possible side effects

  Like all medicines, Chorapur can cause side effects, although not everybody gets them.
  Hormonal medicines used to treat infertility, such as Chorapur, can cause excessive ovarian activity, leading to a condition called ovarian hyperstimulation syndrome (OHSS). Symptoms may include: abdominal pain, abdominal swelling, nausea, vomiting, diarrhea, and weight gain. In severe cases of OHSS, fluid may accumulate in the abdominal cavity, pelvic cavity, and (or) pleural cavity, breathing difficulties, and decreased urine output may occur. Rare complications reported in severe OHSS are the formation of blood clots in blood vessels (thromboembolic disease) and ovarian torsion. If you experience any of these symptoms, you should immediately consult your doctor, even if the symptoms occur several days after the last dose of the medicine.
  When using Chorapur, allergic reactions (hypersensitivity) may occur. Symptoms include: rash, itching, throat swelling, and breathing difficulties. If you experience any of these symptoms, you should immediately consult your doctor.
  The assessment of side effects is based on the following frequency classification:
  Very common: may affect more than 1 in 10 people
  Common: may affect up to 1 in 10 people
  Uncommon: may affect up to 1 in 100 people
  Rare: may affect up to 1 in 1,000 people
  Very rare: may affect up to 1 in 10,000 people
  Unknown (frequency cannot be estimated from available data).
  Very common:

  • Breast enlargement in men (gynecomastia)
  • Headache
  • Reactions and pain at the injection site

  Common

  • Nausea, abdominal pain, vomiting
  • Mild and moderate ovarian hyperstimulation syndrome (OHSS), breast swelling, testicular pain
  • Hot flashes (observed only in men)
  • Rash (skin eruptions), acne

  Uncommon:

  • Diarrhea;
  • Disorders of salt and water excretion
  • Severe ovarian hyperstimulation syndrome (OHSS)
  • Depression, irritability, anxiety

  Frequency unknown:

  • Hypersensitivity reactions (allergic)
  • Blood clots in blood vessels
  • Abdominal swelling
  • Rash, hives, itching
  • Breast tenderness and pain
  • Fever, fatigue, weakness

  Also, an increase in penis size and erections, as well as an enlarged prostate, have been observed.

  Additional side effects in children

  In boys, minor emotional changes similar to those that occur at the beginning of puberty may occasionally occur during treatment.

  Reporting side effects

  If you experience any side effects, including any not listed in this leaflet, please tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
  Aleje Jerozolimskie 181C, 02-222 Warsaw, Tel: +48 22 49 21 301, Fax: +48 22 49 21 309, e-mail:
  ndl@urpl.gov.pl
  Side effects can also be reported to the marketing authorization holder.
  By reporting side effects, you can help provide more information on the safety of this medicine.

  5. How to store Chorapur

  Keep this medicine out of the sight and reach of children.
  Do not use this medicine after the expiry date which is stated on the packaging after EXP.
  The expiry date refers to the last day of that month
  There are no special storage instructions for this medicine. Do not freeze.
  Store in the original package to protect from light.
  The powder should only be reconstituted with the solvent provided with the pack.
  The solution for injection must be used immediately after preparation.
  Do not use this medicine if the solution contains visible particles or is not clear.
  The solution must not be mixed with other medicines.
  Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

  6. Contents of the pack and other information

  What Chorapur contains

  • The active substance is highly purified human chorionic gonadotropin (hCG).
  • The other ingredients are:
  • Powder: lactose monohydrate and sodium hydroxide,
  • Solvent: sodium chloride, hydrochloric acid 10% and water for injections.

  What Chorapur looks like and contents of the pack

  Chorapur is a powder and solvent for solution for injection, 1500 IU and 5000 IU.
  Appearance of the powder: white, lyophilized, compact mass.
  Appearance of the solvent: clear, colorless solution.
  Chorapur 1500 IU and 5000 IU are supplied in packs containing 1, 3, or 5 vials of powder and a corresponding number of ampoules of solvent.
  Not all pack sizes may be marketed.

  Marketing authorization holder and manufacturer

  Marketing authorization holder:
  Ferring GmbH
  Wittland 11, D-24109 Kiel, Germany
  Manufacturer:
  Ferring GmbH
  Wittland 11, D-24109 Kiel, Germany

  This medicinal product is authorized in the Member States of the European Economic Area under the following names:

  Belgium
  CHORAPUR 1500 IU powder and solvent for solution for injection
  CHORAPUR 5000 IU powder and solvent for solution for injection
  CHORAPUR 1500 IU poudre et solvant pour solution injectable
  CHORAPUR 5000 IU poudre et solvant pour solution injectable
  CHORAPUR 1500 IU Pulver und Lösungsmittel zur Herstellung einer Injektionslösung
  CHORAPUR 5000 IU Pulver und Lösungsmittel zur Herstellung einer Injektionslösung
  Malta
  CHORAPUR 1500 IU powder and solvent for solution for injection
  CHORAPUR 5000 IU powder and solvent for solution for injection
  Germany
  CHORAPUR 1500 I.E. Pulver und Lösungsmittel zur Herstellung einer Injektionslösung
  CHORAPUR 1500 I.E. Pulver und Lösungsmittel zur Herstellung einer Injektionslösung
  Poland
  CHORAPUR
  Slovakia
  CHORAPUR 1500 IU prášok a rozpúšťadlo na injekčný roztok
  CHORAPUR 5000 IU prášok a rozpúšťadlo na injekčný roztok
  Hungary
  CHORAPUR 1500 IU powder and solvent for solution for injection
  CHORAPUR 5000 IU powder and solvent for solution for injection
  United Kingdom
  CHORAPUR 1500 IU powder and solvent for solution for injection
  CHORAPUR 5000 IU powder and solvent for solution for injection

  Date of last revision of the leaflet:

  To obtain further information on this medicine, please contact the representative of the marketing authorization holder:
  Ferring Pharmaceuticals Poland Sp. z o.o.
  Szamocka 8, 01-748 Warsaw
  Tel.: +48 22 246 06 80, Fax: +48 22 246 06 81
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  Information intended for healthcare professionals only:
  Method of administration

  • Chorapur must be administered intramuscularly immediately after reconstitution.
  • Attach the reconstitution needle to the syringe.
  • Draw the entire contents of the solvent ampoule and inject the entire contents into the vial containing the powder. The powder should dissolve quickly, forming a clear solution. If not, gently swirl the vial until the solution becomes clear. Avoid shaking the vial.
  • After reconstitution, the solution contains 1500 IU or 5000 IU in 1 ml.
  • Depending on the prescribed dose, draw the appropriate amount of solution from the vial into the syringe, change the needle to an injection needle, and administer immediately.