Gonasi Kit 5,000 IU powder and solvent for solution for injection

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Gonasi Kit 5,000 IU powder and solvent for solution for injection

human chorionic gonadotropin

? This medicinal product is subject to additional monitoring, which will allow quicker detection of new safety information. You can help by reporting any side effects you may experience. Information on how to report side effects is provided at the end of section 4.

Read this leaflet carefully before you start using this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only; do not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this leaflet. See section 4.
• In this leaflet, Gonasi Kit 5,000 IU powder and solvent for solution for injection is referred to as Gonasi Kit.

Contents of this leaflet

1. What Gonasi Kit is and what it is used for
2. What you need to know before using Gonasi Kit
3. How to use Gonasi Kit
4. Possible side effects
5. How to store Gonasi Kit
6. Contents of the pack and other information

1. What Gonasi Kit is and what it is used for

What is Gonasi Kit**

This medicine contains highly purified human chorionic gonadotropin, a hormone derived from human urine and belonging to the family of "gonadotropins", which are natural hormones related to reproduction and fertility.

What Gonasi Kit is used for:

This medicine is used:

• To help several follicles (each containing an egg) develop and mature in women undergoing assisted reproductive techniques (procedures that may help you become pregnant), such as in vitro fertilization (IVF)
• To help release an egg from the ovary (induction of ovulation) in women who do not produce eggs ("anovulation") or produce very few eggs ("oligoovulation").

This medicine should be used under the supervision of your doctor, unless your doctor gives you other instructions.

2. What you need to know before using Gonasi Kit

Do not use Gonasi Kit:

• if you are allergic to human chorionic gonadotropin or to any of the other ingredients of this medicine (listed in section 6)
• if you have untreated diseases affecting the thyroid, pituitary, or adrenal glands
• if you have ovarian, uterine, or breast cancer
• if you have any condition that makes a normal pregnancy impossible, such as ovarian insufficiency, absence of the uterus, premature menopause, blocked fallopian tubes, uterine fibroids, or other abnormalities of the reproductive organs
• if you have recently experienced vaginal bleeding of unknown cause.

Consult your doctor or pharmacist if any of the above conditions apply to you, as this medicine may not be suitable for you.

Warnings and precautions

Your doctor must check before treatment that your reproductive organs are normal.

Consult your doctor before using this medicine if you have or have had any of the following conditions:

• abnormalities of the reproductive organs
• chronic illness (such as diabetes, cardiovascular disorders, etc.)
• vascular complications (i.e., increased risk of blood clots, personal or family history of blood clots, overweight).

Medical examinations

For up to ten days after administration of this medicine, a pregnancy test may give a false positive result.

The following may occur during treatment with this medicine:

Ovarian hyperstimulation syndrome (OHSS)

Treatment with gonadotrophic hormones such as this medicine may cause ovarian hyperstimulation syndrome (OHSS). This is a serious condition in which the ovaries become overstimulated and the growing follicles become larger than normal. In rare cases, severe OHSS can be potentially life-threatening. Therefore, close medical supervision is very important. To monitor the effects of treatment, your doctor will perform ultrasound examinations of your ovaries. Your doctor may also check hormone levels in your blood. (See also section 4, "Possible side effects.")

OHSS may cause sudden accumulation of fluid in the abdominal (stomach) and chest areas, potentially leading to blood clot formation. Inform your doctor immediately if you experience:

• severe swelling and pain in the abdomen (stomach)
• dizziness (nausea)
• vomiting
• sudden weight gain due to fluid retention
• diarrhea
• decreased urine output
• difficulty breathing.

Ovarian torsion

Ovarian torsion is the twisting of an ovary. Twisting of the ovary may cut off blood flow to the ovary.

Before starting to use this medicine, it is important to inform your doctor if:

• you have ever had OHSS
• you are pregnant or think you might be pregnant
• you have ever had abdominal surgery
• you have ever had ovarian torsion
• you have cysts or have had cysts in your ovary or ovaries.

Blood clots (thrombosis)

Pregnancy increases the likelihood of blood clot formation.

If you have risk factors for blood clot formation (e.g., overweight, or personal or family history of blood clots), the risk of developing a blood clot in a blood vessel may increase during IVF treatment.

Blood clots can lead to serious conditions such as:

• blockage in your lungs (pulmonary embolism)
• stroke
• heart attack
• reduced blood flow to vital organs, which may cause organ damage
• reduced blood flow (deep vein thrombosis) in your arm or leg, which may lead to loss of the limb.

Multiple births, birth defects, miscarriages, or pregnancy complications

If treatment with this medicine results in pregnancy, there is an increased chance of twins or multiple births. Multiple pregnancies carry increased health risks for both mother and babies before and after birth. In women undergoing fertility treatment, there is a slightly higher risk of miscarriage or ectopic pregnancy (a pregnancy outside the uterus). Therefore, your doctor should perform an ultrasound early on to rule out ectopic pregnancy. Multiple births are more likely if you are taking other medications that stimulate ovulation (e.g., hMG).

It is unknown whether IVF treatment causes congenital malformations or certain cancers of the reproductive organs.

Children and adolescents

This medicine must not be used in children or adolescents.

Other medicines and Gonasi Kit

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription. This is especially important if you are taking medicines that:

• stimulate ovulation (e.g., hMG)
• contain cortisone, particularly at high doses.

Pregnancy and breastfeeding

Do not use this medicine if you are pregnant or breastfeeding. If you think you might be pregnant, consult your doctor before using this medicine.

Driving and using machines

This medicine does not affect your ability to drive or operate machinery.

Gonasi Kit contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per reconstituted solution; i.e., essentially "sodium-free".

3. How to use Gonasi Kit

Gonasi Kit is a powder that must be dissolved with a liquid (solvent) before use; it is administered by injection under the skin (subcutaneously) or into a muscle (intramuscularly). The solution is obtained by combining the solvent with the powder and must be used immediately after preparation.

Always follow exactly the instructions for administering the medicine as given by your doctor. If in doubt, consult your doctor or pharmacist.

How Gonasi Kit should be administered:

This medicine is administered by injection under your skin (subcutaneously) or into your muscle (intramuscularly).

Each vial must be used only once, and the injection should be used as soon as it is prepared.

The recommended dose of this medicine is 5,000 IU or 10,000 IU to be administered 24–48 hours after achieving optimal follicular development stimulation.

After appropriate counseling and training, your doctor may instruct you to self-inject the medicine.

For the first time, your doctor should:

• have explained to you how to prepare the correct dose for injection;
• have instructed you on how to prepare the injectable solution;
• have indicated the areas where you may inject yourself;
• have allowed you to practice administering a subcutaneous injection on yourself.

Before self-injecting this medicine, read the following instructions carefully.

How to prepare Gonasi Kit using 1 vial of powder

The solution must be prepared immediately before injection. Each vial is for single use only.

This medicine must only be reconstituted with the solvent supplied in the package, following the instructions below step by step:

Step 1

Wash your hands before preparing the solution. Use a clean surface for preparation. It is important that your hands and materials used are as clean as possible.

Step 2

Place the following materials on the clean surface:

• two alcohol-impregnated swabs (not supplied in the package);
• one vial containing Gonasi Kit powder;
• one pre-filled syringe containing solvent;
• one long needle for reconstitution and intramuscular injection;
• one short needle for subcutaneous injection.

Step 3

• Remove only the cap from the pre-filled syringe;
• Attach the reconstitution needle (long needle) to the syringe, keeping its protective cap in place, and check that the needle is securely attached to avoid loss of solution. If solution is lost, try securing the needle more firmly with a slight twist.
• Carefully place the syringe on the clean surface.
• Avoid touching the needle.

Step 4

• Gently press upwards to remove the colored plastic closure cap from the Gonasi Kit vial.
• Clean the rubber stopper with an alcohol-impregnated swab and wait for it to dry.

Step 5

• Pick up the syringe, remove the protective cap from the needle, and insert the needle firmly through the center of the rubber stopper of the Gonasi Kit vial.
• Firmly press the plunger down and slowly inject the solvent into the vial containing the powder through the rubber stopper, ensuring all the solution is delivered into the vial.

• DO NOT SHAKE. Gently roll the vial between your hands until the powder is completely dissolved, taking care not to create foam.

Step 6

Once the powder is dissolved (which generally happens immediately), slowly draw the solution into the syringe as described below:

• With the needle still inserted, turn the vial upside down.
• Ensure the tip of the needle is below the liquid level.
• Gently pull back on the plunger to draw all the solution into the syringe.
• Check that the reconstituted solution is clear and colorless.

Preparation of higher doses using more than one vial of powder

If your doctor has prescribed the higher dose of 10,000 IU, this can be obtained by using two vials of powder with one pre-filled syringe of solvent.

When preparing two vials of the medicine, after completing step 3 above, draw the reconstituted contents of the first vial into the syringe and slowly inject it into a second vial. Then repeat steps 4–6 with the second vial.

The solution must be clear and colorless.

Administering your medicine by intramuscular injection

For intramuscular injections, your doctor or nurse will prepare and then inject this medicine into your thigh or buttock.

Administering your medicine by subcutaneous injection

• When the syringe contains your correct dose, place the protective cap back onto the long needle. Remove the long needle from the syringe and replace it with the short needle for subcutaneous injection, with its protective cap in place. Please note that the needle must be properly attached; firmly press the short needle into the syringe barrel and then gently twist it to ensure it is fully screwed on, creating a secure seal to prevent loss of solution.
• Remove the protective cap from the needle. Hold the syringe with the needle pointing upwards and gently tap the side of the syringe to force air bubbles to rise to the top.
• Press the plunger until a drop of liquid appears at the tip of the needle.
• DO NOT USE the solution if it contains particles or appears cloudy.

Injection site:

• Your doctor or nurse will have advised you on which area of your body to inject the medicine. Common sites are the thigh or lower abdominal wall (stomach area), below the navel.
• Clean the injection site with an alcohol-impregnated swab.
• Pinch and firmly press the skin. With the other hand, insert the needle with a dart-like motion at a 45° or 90° angle.

Injecting the solution:

• Inject under the skin as instructed by your doctor.
• Do not inject directly into a vein.
• Press the plunger slowly and steadily to properly inject the solution and avoid damaging skin tissue.

Take as much time as needed to inject the prescribed volume of solution.

Removing the needle:

• Quickly withdraw the syringe and apply pressure to the injection site.
• Gently massaging the area—while maintaining pressure—helps disperse the medication solution and relieve any discomfort.

Dispose of all used materials:

After completing the injection, all used needles and empty syringes must be disposed of in an appropriate container. Disposal of unused solution and all materials that have come into contact with it must be carried out in accordance with local regulations.

If you use more Gonasi Kit than you should:

The effects of an overdose of this medicine are unknown, but ovarian hyperstimulation syndrome may be expected (see "Possible side effects"). If you use more medicine than you should, consult your doctor or pharmacist.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, stating the medicine and the amount ingested.

If you forget to use Gonasi Kit:

If you forget to use the medicine, consult your doctor immediately.

If you stop using Gonasi Kit:

Consult your doctor if you are considering discontinuing this medicine.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.

If you notice any of the following serious adverse effects, stop using Gonasi Kit and consult a doctor immediately; you may require urgent medical treatment:

• mild to moderate ovarian hyperstimulation (ovarian hyperstimulation syndrome), manifested by an increase in ovary size, ovarian cysts, abdominal pain with vomiting and nausea (see also section 2, "Ovarian hyperstimulation syndrome"). This is a common adverse effect (may affect up to 1 in 10 people).
• severe ovarian hyperstimulation (ovarian hyperstimulation syndrome) characterized by pain in the lower abdomen (pelvis), nausea, vomiting, weight gain, accumulation of fluid in the abdomen (ascites) or in the chest (pleural effusion). This event is uncommon (may affect up to 1 in 100 people).
• rupture of ovarian cyst (a rare consequence of severe OHSS, may affect up to 1 in 1,000 people)
• formation of blood clots in blood vessels (thromboembolic events), as a complication of ovarian hyperstimulation syndrome. This event is rare (may affect up to 1 in 1,000 people)
• severe generalized allergic reactions which may include: swelling of the face, eyes, lips, throat or tongue, breathing difficulties, wheezing, skin rash—this is a rare adverse effect (may affect up to 1 in 1,000 people)

Other adverse effects

Common adverse effects: may affect up to 1 in 10 people

• Reaction at the injection site which may include redness, bruising, swelling, itching, or pain at the injection site
• swelling (edema)
• mood changes
• headache
• chest pain

Uncommon adverse effects: may affect up to 1 in 100 people

• restlessness (agitation), fatigue

Rare adverse effects: may affect up to 1 in 1,000 people

• swelling of the deeper layers of the skin, often observed with hives (wheals)
• generalized skin rashes

If you experience any of the rare adverse effects listed above, consult your doctor immediately. Your doctor will assess whether you should discontinue treatment with this medicine or go immediately to the nearest hospital emergency service.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Gonasi Kit

Keep this medicine out of the sight and reach of children.

Do not store above 25°C. Keep the vial and the solvent pre-filled syringe in the outer packaging to protect from light.

Use immediately after preparing the solution.

Do not use this medicine after the expiry date stated after “EXP” on the outer packaging, vial, and solvent pre-filled syringe. If the expiry date is expressed as month/year, the expiry date refers to the last day of the stated month.

Do not use this medicine if the solution does not appear clear (if cloudy or contains visible particles). The solution should be clear and colourless after reconstitution.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Gonasi Kit

The active substance is: human chorionic gonadotropin.

The excipients are:

• in the powder vial: lactose monohydrate
• in the pre-filled syringe with solvent (0.9% sodium chloride): water for injections, sodium chloride.

Each vial contains: 5,000 IU of human chorionic gonadotropin, produced from human urine.

Appearance of the product and contents of the container

Gonasi Kit is presented as:

Powder in vial: white to almost white lyophilized powder

Solvent in pre-filled syringe (0.9% sodium chloride): clear, colourless solution

A single pack contains:

A plastic tray containing a vial of powder (Type I glass), sealed with a rubber stopper and secured with a flip-off cap.

1 ml of solvent in a pre-filled syringe (Type I glass), 1 long needle for reconstitution and intramuscular injection, and 1 short needle for subcutaneous injection.

Multiple pack containing 10 plastic trays as described above.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder:

IBSA Farmaceutici Italia srl
Via Martiri di Cefalonia 2
26900 Lodi (Italy)

Manufacturer:

IBSA Farmaceutici Italia srl
Via Martiri di Cefalonia, 2
26900 Lodi – Italy

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

Instituto Bioquímico Ibérico IBSA S.L.
Avenida Diagonal 605,
8th floor, Local 1,
08028 Barcelona (Spain)

This medicinal product is authorised in the Member States of the European Economic Area under the following names: (The dose and pharmaceutical form are identical in all countries; only the trade name differs)

Denmark: Gonasi Set
Czech Republic: Zivafert
Spain: Gonasi Kit
Finland: Gonasi Set
France: GONADOTROPHINE CHORIONIQUE IBSA
Hungary: Zivafert Kit
Netherlands: Gonasi
Norway: Gonasi Set
Poland: Zivafert
Sweden: Gonasi Set
Slovak Republic: Gonasi Kit

Date of latest review of this leaflet: January 2025

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es.