Chorapur

Package leaflet: Information for the patient

CHORAPUR, 1500 IU, powder and solvent for solution for injection
CHORAPUR, 5000 IU, powder and solvent for solution for injection
Gonadotropinum chorionicum
Please read carefully all the information in this leaflet before using this medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm others, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or nurse. See section 4.

Table of contents of the leaflet

1. What Chorapur is and what it is 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 package and other information

1. What Chorapur is and what it is used for

Chorapur belongs to a group of medicines called gonadotropins (sex hormones). In women, it controls the release of eggs from the ovaries, and in men, it regulates the production of the male hormone testosterone.
Chorapur contains the active substance human chorionic gonadotropin (hCG), a protein hormone obtained and purified from the urine of pregnant women. Gonadotropins play a key role in fertility and reproduction.

In women
In female infertility, this medicine may be used to induce ovulation (ovulation induction). Chorapur is also used in combination with other medicines to support egg development in assisted reproductive technologies (e.g. in vitro fertilization treatment).

In men
Chorapur is used in men to treat low sperm count.
Chorapur may be used alone or in combination with other gonadotropins (hMG, FSH). Chorapur is also used in men prior to initiating stimulatory treatment to assess testicular function when reproductive organs do not function properly due to lack of sex hormones.

In children
Chorapur is used in children to treat delayed puberty and in those with undescended or incompletely descended testes.

2. Important information before using Chorapur

When not to use Chorapur:

• if the patient is allergic to human chorionic gonadotropin or any of the other ingredients of this medicine (listed in section 6);
• if the patient has a brain or pituitary gland tumour;
• if the female patient has ovarian cysts or ovarian enlargement due to causes other than polycystic ovary syndrome;
• if the female patient has unexplained vaginal bleeding;
• if the female patient has been diagnosed with cancer of the ovaries, uterus or breast;
• if the female patient has had an ectopic pregnancy within the last three months;
• if the female patient has severe vein inflammation or blood clots in the veins (active thromboembolic disorders);
• if the female patient has ovarian hyperstimulation syndrome (OHSS);
• if a normal pregnancy cannot develop, e.g. due to ovarian failure, congenital abnormalities of the reproductive organs preventing pregnancy development, uterine fibroids, or if the female patient has experienced early menopause;
• if the male patient has been diagnosed with or is suspected of having hormone-dependent tumours such as prostate cancer or male breast cancer;
• if it is known that undescended testes cannot be treated with hormones (e.g. inguinal hernia, previous inguinal surgery, or abnormal testicular location).

Warnings and precautions
Before starting treatment with Chorapur, discuss this with your doctor or nurse.
Inform your doctor if you currently have or have ever had any of the following conditions, as they may worsen after using Chorapur:

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

Treatment with Chorapur may increase the risk of thrombosis. Thrombosis is the formation of blood clots in blood vessels, usually in the veins of the legs or lungs. Pregnancy itself may also increase the risk of thrombosis. Before starting treatment with Chorapur, inform your doctor if:

• the patient knows they are at increased risk of thrombosis;
• the patient or a close family member has previously experienced thrombosis;
• the patient is overweight.

Before starting treatment, it is essential to determine the cause of infertility in the female patient or her partner and any factors that may prevent a normal pregnancy. The female patient should undergo a thorough examination to rule out any abnormalities of the reproductive organs or hormonal disorders not related to the gonads (e.g. thyroid, adrenal or pituitary gland disorders).
Close medical supervision during treatment is very important. Regular ultrasound examinations and blood tests are usually performed. This is particularly important because treatment with Chorapur increases the risk of developing ovarian hyperstimulation syndrome (OHSS) (see also section 4 "Possible side effects"). This may occur when the ovaries over-respond to treatment and produce too many follicles. Usually, OHSS resolves spontaneously with the onset of menstruation. However, if pregnancy occurs, OHSS may be more severe and last longer. Therefore, female 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 bloating;
• nausea;
• vomiting;
• diarrhoea;
• weight gain.
  In severe cases of OHSS, additional symptoms may include:
• difficulty breathing;
• reduced urine output.
  In very rare cases, severe OHSS may lead to complications such as ovarian torsion or venous or arterial thrombosis. The doctor should be informed immediately, even if symptoms occur several days after the last dose of the medicine. These may be signs of excessive ovarian activity, which can be serious. If symptoms worsen, infertility treatment should be discontinued and appropriate treatment initiated in hospital. Adhering to the recommended dose and careful monitoring of treatment reduces the risk of such symptoms. Female patients with polycystic ovary syndrome have an increased risk of developing OHSS.

After treatment with gonadotropins, the likelihood of twin or multiple pregnancies is higher than with natural conception.
The rate of miscarriages in women who do not produce enough mature egg cells or do not produce them at all, and in women participating in assisted reproductive programmes such as in vitro fertilisation, is higher than in the general population, but comparable to the miscarriage rate in women with other fertility disorders.
Women with damaged fallopian tubes have a slightly increased risk of ectopic pregnancy.
The frequency of congenital abnormalities after fertility treatment may be slightly higher than after natural conception. This may be related to parental factors (e.g. maternal age, sperm quality) and the higher incidence of multiple pregnancies.
If the patient has a clinically significant medical condition that could worsen during pregnancy, the doctor will provide special monitoring during treatment.
Chorapur may cause a false positive result in pregnancy tests for up to 10 days after administration.
Use of Chorapur may lead to positive results in anti-doping tests. Using Chorapur for doping purposes may endanger health.

Children
Chorapur should be used with caution in prepubertal boys to avoid bone problems or premature sexual development. Bone maturation should be monitored regularly.

Chorapur with other medicines
Inform your doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
No interactions with other medicines are known.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor before using this medicine.
Chorapur is indicated for the treatment of infertility (see section "What Chorapur is and what it is used for").
Chorapur must not be used during pregnancy or breastfeeding.

Driving and using machines
No studies on the effect on the ability to drive and use machines have been conducted. It is expected that Chorapur has no influence on the ability to drive and use machines.

Chorapur contains sodium
Chorapur contains sodium, but less than 1 mmol (23 mg) of sodium per 1 ml of solvent, meaning the medicine is considered nearly "sodium-free".

3. How to use Chorapur

This medicine should always be used as directed by your doctor. If in doubt, consult your doctor.
Method of administration:
This medicine is administered as an intramuscular injection by a physician experienced in the treatment of fertility disorders.

Chorapur 1500 IU
Treatment with Chorapur should be supervised by a physician experienced in the treatment of fertility disorders.
In men, the recommended dose is 1 vial twice weekly (corresponding to 3000 IU per week).
Since spermatogenesis takes approximately 74 days, treatment should be continued for at least 3 months to expect any improvement. During treatment, your doctor will monitor testosterone levels. An increase in the dose of the medicine may be necessary.
If the response to treatment with Chorapur alone is insufficient, your doctor may decide to administer another medicine concomitantly with Chorapur. In some cases, after achieving improvement with a combination of these medicines, maintenance therapy may be continued using Chorapur alone.

Use in children
Treatment for undescended testes should be completed by the time the child reaches 1 year of age.
The recommended dose in infants is: 250 IU per dose (0.17 ml from a vial containing 1500 IU) twice weekly for a period of five weeks.

Chorapur 5000 IU
Treatment with Chorapur should be supervised by a physician experienced in the treatment of fertility disorders.

To induce ovulation and ovarian stimulation:
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 following follicular stimulation, the patient is advised to have sexual intercourse on the day of injection and the following day.

To assess testicular function in cases where reproductive organs do not function properly due to lack of sex hormones:
The recommended dose is 1 vial (5000 IU) as a single dose.

Use in children
In boys with delayed puberty:
The recommended dose is 1 vial (5000 IU) once weekly for a period of 3 months.
In cases of undescended testes (unilateral or bilateral):
The recommended dose is 1 vial (5000 IU) as a single dose.

Use of a higher than recommended dose of Chorapur
Cases of overdose have not been reported. However, overdose may potentially cause ovarian hyperstimulation syndrome (OHSS); see section 2. "Important information before using Chorapur".

Missed dose of Chorapur
Do not administer a double dose to make up for a missed dose. Consult your doctor.

Stopping Chorapur treatment
Consult your doctor.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Hormonal medicines used in the treatment of infertility, such as Chorapur, may cause excessive ovarian activity, leading to a condition known as ovarian hyperstimulation syndrome (OHSS). Symptoms may include: abdominal pain, abdominal distension, nausea, vomiting, diarrhoea, and weight gain. In severe cases of OHSS, fluid may accumulate in the abdominal cavity, pelvic cavity, and/or pleural cavity, leading to difficulty breathing and reduced urine output. Rare complications reported in severe cases of OHSS include formation of blood clots in blood vessels (thromboembolic disease) and ovarian torsion. If any of these symptoms occur, immediate medical attention must be sought, even if symptoms appear several days after the last dose of the medicine.

Hypersensitivity reactions may occur during treatment with Chorapur. Symptoms include: rash, itching, throat swelling, and difficulty breathing. If any of these symptoms occur, immediate medical attention must be sought.

Assessment of adverse reactions 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
Not known (frequency cannot be estimated from available data).

Very common:

• Breast enlargement in males (gynaecomastia)
• Headache
• Injection site reactions and pain

Common:

• Nausea, abdominal pain, vomiting
• Mild and moderate forms of ovarian hyperstimulation syndrome (OHSS), breast swelling, testicular pain
• Hot flushes (observed in males only)
• Skin rash, seborrhoeic dermatitis (acne)

Uncommon:

• Diarrhoea
• Disturbances in water and salt excretion
• Severe form of ovarian hyperstimulation syndrome (OHSS)
• Depression, irritability, anxiety

Frequency not known:

• Hypersensitivity reactions (allergic)
• Formation of blood clots in blood vessels
• Abdominal distension
• Rash, urticaria, itching
• Breast tenderness and pain
• Fever, fatigue, weakness

An increase in penile size and erection, as well as prostatic hypertrophy, may also be observed.

Additional adverse reactions in children
During treatment, boys may occasionally experience minor emotional changes similar to those occurring at the beginning of puberty.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Aleje Jerozolimskie 181C, 02-222 Warsaw, Phone: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported directly to the marketing authorisation holder.
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Chorapur

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after the word EXP.
The expiry date refers to the last day of the specified month.
No special temperature storage instructions apply. Do not freeze.
Store in the original packaging to protect from light.
The powder must be dissolved only in the solvent provided in the package.
The injection solution must be used immediately after preparation.
Do not use this medicine if visible particles are present in the solution or if the solution is not clear.
The solution must not be mixed with other medicines.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This 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: monohydrate lactose 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 solid mass.
Appearance of the solvent: clear, colourless 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 Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Ferring GmbH
Wittland 11, D-24109 Kiel, Germany
Manufacturer:
Ferring GmbH
Wittland 11, D-24109 Kiel, Germany

This medicinal product is authorised 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 5000 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

For additional information about this medicine, please contact the representative of the Marketing Authorisation Holder:
Ferring Pharmaceuticals Poland Sp. z o.o.
ul. Szamocka 8, 01-748 Warsaw
Tel.: +48 22 246 06 80, Fax: +48 22 246 06 81

Information intended exclusively for healthcare professionals:

Administration method

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