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 further questions, please consult your doctor or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, 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 pack 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 egg cells 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), 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 may be used to induce ovulation (ovulation induction). Chorapur is also used together with other medicines to support egg cell development in assisted reproductive technology programs (in vitro fertilization treatment).

In men
Chorapur is used in men for the treatment of 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 stimulation therapy 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 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 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 enlarged ovaries due to causes other than polycystic ovary syndrome;
• if the female patient has vaginal bleeding of unknown cause;
• if the female patient has been diagnosed with ovarian, uterine or breast cancer;
• if the female patient has had an ectopic pregnancy within the last three months;
• if the female patient has severe inflammation of the veins or blood clots in the veins (active thromboembolic disorders);
• if the female patient has ovarian hyperstimulation syndrome (OHSS);
• if normal pregnancy development is not possible, e.g. in cases of 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-like 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 have an 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 patient or her partner and any factors that might prevent a normal pregnancy. The female patient should undergo a thorough examination to rule out any abnormalities of the reproductive organs or hormonal disorders unrelated 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 observation for at least two weeks after hCG administration.
Mild or moderate OHSS may cause the following symptoms:

• 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. Inform your doctor immediately, even if symptoms appear 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 a 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 multiple pregnancy (twins or more) is higher than with natural conception.
The rate of miscarriage among women who do not produce enough mature oocytes or do not produce them at all, and among women participating in assisted reproductive programmes such as in vitro fertilisation, is higher than in the general population, but comparable to the miscarriage rate among 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 in naturally conceived pregnancies. This may be related to parental factors (e.g. maternal age, sperm quality) and the higher frequency 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 pregnancy test result 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 baby, 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 operating machinery
No studies have been conducted on the effect of Chorapur on the ability to drive or operate machinery. It is expected that Chorapur has no or negligible influence on the ability to drive and operate machinery.

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

3. How to use Chorapur

This medicine should always be used as directed by the physician. 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 conducted by a physician experienced
in the treatment of fertility disorders.
The recommended dose for men is 1 vial twice a week (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, the physician monitors
testosterone levels. An increase in the dose of the medicine may be necessary.
If the response to treatment with Chorapur alone is insufficient, the physician may
decide to administer another medicine simultaneously with Chorapur. In some cases,
after achieving improvement using a combination of these medicines, maintenance 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 for infants is: 250 IU/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 conducted by a physician experienced
in the treatment of 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 following follicular stimulation,
the patient is advised to have sexual intercourse on the day of injection and the day following
the injection.
To evaluate 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 unilateral or bilateral undescended testes:
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
physician.
Discontinuation of Chorapur
Consult your physician.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Hormonal medicines used in fertility treatment, such as Chorapur, may cause excessive ovarian activity, leading to a condition called 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, causing difficulty in 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 advice must be sought, even if symptoms appear several days after the last dose of the medicine.

Allergic (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 advice 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 1000 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 men (gynaecomastia)
• Headache
• Injection site reactions and pain

Common:

• Nausea, abdominal pain, vomiting
• Mild to moderate ovarian hyperstimulation syndrome (OHSS), breast swelling, testicular pain
• Hot flushes (observed in men only)
• Skin rash, inflammation of sebaceous glands (acne)

Uncommon:

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

Frequency not known:

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

An increase in penis size and erections, as well as prostate gland enlargement, may also be observed.

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

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 Drug Reactions at 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: [email protected]
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Chorapur

Keep this medicine out of 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 stated month.
No special temperature storage requirements. 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 you see solid particles 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 the sewage system 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 countries of the European Economic Area under the following names:

Belgium CHORAPUR 1500 IU poeder en oplosmiddel voor oplossing voor injectie
CHORAPUR 5000 IU poeder en oplosmiddel voor oplossing voor injectie
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 further 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 from the solvent ampoule and inject all of it 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 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.