Prospect: information for the patient

Gonasi Kit 5.000 UIpowder and solvent for injectable solution

human chorionic gonadotropin

?This medicine is subject to additional monitoring, which will facilitate the detection of new information about its safety. You can contribute by reporting any adverse effects you may experience. The final part of section 4 includes information on how to report these adverse effects.

Read this prospect carefully before starting to use this medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you should not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects that do not appear in this prospect. See section 4.
• In this prospect, Gonasi Kit 5.000 UI powder and solvent for injectable solution is referred to as Gonasi Kit.

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

2. What you need to know before starting to use Gonasi Kit

3. How to use Gonasi Kit

4. Possible adverse effects

5. Conservation of Gonasi Kit

6. Contents of the package and additional information

What isGonasi Kit

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

How is Gonasi Kit used:

This medicationis used:

•to help develop and mature several follicles (each containing an egg) in women undergoing assisted reproductive techniques (a procedure that may help you become pregnant), such as in vitro fertilization (IVF)

•to help release an egg from the ovary (ovulation induction) in women who cannot produce eggs ("anovulation") or produce very few ("oligovulation").

This medication should be used under the supervision of your doctor, unless you receive other instructions from your doctor.

Do not use Gonasi Kit:

• if you are allergic to human chorionic gonadotropin or any of the other components of this medicine (listed in section 6)
• if you have untreated diseases that affect 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, for example, ovarian insufficiency, absence of the uterus, premature menopause, blockage of the fallopian tubes, uterine fibroids, or other reproductive organ abnormalities
• 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:

• reproductive organ abnormalities
• long-term diseases (such as diabetes, cardiovascular disorders, etc.).
• vascular complications (i.e., increased risk of blood clots, family or previous history of blood clots, obesity).

Medical examinations

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

During treatment with this medicine, the following may occur:

Ovarian Hyperstimulation Syndrome (OHSS)

Treatment with gonadotropin hormones like this medicine may cause ovarian hyperstimulation syndrome (OHSS). This is a serious condition in which the ovaries are overstimulated and the growing follicles become abnormally large. In rare cases, severe OHSS can be potentially fatal. Therefore, it is very important to have close monitoring by your doctor. To check 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 causes sudden fluid accumulation in the abdominal (stomach) and chest areas, which can cause blood clots. Inform your doctor immediately if you have:

• intense swelling and pain in the abdominal area
• dizziness (nausea)
• vomiting
• sudden weight gain due to fluid accumulation
• diarrhea
• decreased urine volume
• difficulty breathing.

Ovarian torsion

Ovarian torsion is the twisting of an ovary. Twisting of the ovary could cause blood flow to the ovary to be cut off.

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

• you have ever had OHSS
• you are pregnant or think you may 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 clots forming.

If you have risk factors for blood clots (e.g., obesity, or if you have a family history of blood clots), the likelihood of a blood clot forming in a blood vessel may increase during FIV treatment.

Blood clots can cause serious conditions, such as:

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

Multiple births, birth defects, spontaneous abortions, or complications during pregnancy

If treatment with this medicine leads to pregnancy, there is a higher likelihood of having twins or multiple births. Multiple births pose an increased risk to the health of both the mother and the children in the days leading up to and following birth. In women undergoing fertility treatment, there is a slightly increased risk of spontaneous abortion or ectopic pregnancy. Therefore, your doctor should perform an ultrasound at the beginning to rule out the possibility of ectopic pregnancy. Multiple births are more likely if you are taking other medications that promote ovulation (e.g., hMG).

The effects of FIV treatment on congenital malformations or some cancers of the reproductive organs are unknown.

Children and Adolescents

This medicine should not be used in children or adolescents.

Other medicines and Gonasi Kit

Inform your doctor or pharmacist if you are taking or have taken any other medicine, even without a prescription. This is especially important if you are taking medicines that:

• stimulate ovulation (e.g., hMG);
• contain cortisone, especially in high doses.

Pregnancy and breastfeeding

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

Driving and operating machinery

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

Gonasi Kit contains sodium

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

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.

Follow exactly the administration instructions of the medication indicated by your doctor. In case of doubt, ask your doctor or pharmacist.

How to administerGonasi Kit:

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

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

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

After proper advice and training, your doctor may ask you to inject the medication yourself.

On the first occasion, your doctor must:

• have explained to you how to prepare the appropriate dose for injection
• have indicated how to prepare the injectable solution
• have indicated the areas where you can inject
• have allowed you to practice the application of a subcutaneous injection to yourself.

Before injecting yourself with this medication, read the following instructions carefully.

How to prepare Gonasi Kit using 1 vial of powder

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

This medicationmust only be reconstituted with the solvent provided in the package using the following step-by-step instructions:

Step 1

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

Step 2

Place the following materials on the clean surface:

• two cotton balls soaked in alcohol (not provided in the package)
• a vial containing Gonasi Kit powder
• a solvent in a pre-loaded syringe
• a long needle for reconstitution and intramuscular injection.
• a short needle for subcutaneous injection.

Step 3

• Remove only the syringe cap;

• Insert the reconstitution needle (long needle) into the syringe with its protective cap on and check that the needle is properly seated to avoid solution loss. In case of solution loss, try to secure the needle better with a slight rotation.

• Place the syringe carefully on the clean surface.

• Avoid touching the needle.

Step 4

•Remove the plastic closure cap from the Gonasi Kit vial by pressing it upwards gently.

• Clean the rubber stopper with a cotton ball soaked in alcohol and wait for it to dry.

Step 5

• Take the syringe, remove the protective cap from the needle, and push the needle through the center of the rubber stopper of the Gonasi Kit vial.

• Press the plunger down firmly and inject the solvent slowly into the vial with powder through the rubber stopper, to pour all the solution into the vial containing the powder.

•DO NOT SHAKE, gently roll the vial between your hands until the powder is completely dissolved, being careful not to form foam.

Step 6

Once the powder is dissolved (which usually occurs immediately), load the solution slowly into the syringe as follows:

•With the needle still inserted, place the vial upside down.

•Make sure the needle tip is below the liquid level.

•Slowly pull the plunger to load all the solution into the syringe.

•Check that the reconstituted solution is transparent and colorless.

Preparing larger doses, using more than 1 vial of powder

If your doctor has recommended the higher dose of 10,000 IU, it can be obtained using two vials of powder with a pre-loaded syringe of solvent.

When preparing 2 vials of the medication, at the end of step 3 above, load the reconstituted content of the first vial into the syringe and inject it slowly into a second vial. Repeat steps 4-6 with the other vial.

The solution must be transparent and colorless.

Injection of your medication by intramuscular route

For intramuscular injections, your doctor or nurse will prepare and then inject this medication into the side of your thigh or buttock.

Injection of your medication by subcutaneous route

• When the syringe contains the correct dose for you, place the protective cap on the long needle. Remove the long needle from the syringe and replace it with the short needle for subcutaneous injection with its protective cap on. Please note that the needle must be properly seated and press the short needle firmly onto the syringe cylinder, then rotate it slightly to ensure it is securely locked in place to prevent solution loss.
• Remove the protective cap from the needle. Take the syringe with the needle pointing upwards and gently tap the side of the syringe to force the air bubbles upwards;
• Press the plunger until a drop of liquid appears at the needle tip.
• DO NOT USE the solution if it contains particles or is turbid.

The injection site:

Injecting the solution:

• Inject under the skin, as indicated by your doctor.
• Do not inject directly into a vein.
• Press the plunger slowly and constantly to inject the solution correctly and not damage the skin tissues.

Use all the time you need to inject the prescribed volume of solution.

Removing the needle:

• Remove the syringe quickly and press on the injection site
• A gentle massage in the area – keeping the pressure – helps to disperse the medication solution and alleviate any discomfort.

Dispose of all used materials:

Once the injection is complete, all needles and empty syringes must be disposed of in an appropriate container. The disposal of unused solution and all materials that have come into contact with it will be carried out in accordance with local regulations.

If you use more Gonasi Kit than you should:

The effects of an overdose of this medication are unknown, however, it may be expected to produce a hyperstimulation syndrome (see "Possible side effects"). If you use more of the medication than you should, consult your doctor or pharmacist.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to use Gonasi Kit:

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

If you interrupt treatment with Gonasi Kit:

Consult your doctor if you are considering not using this medication.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

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

•Mild to moderate ovarian hyperstimulation (ovarian hyperstimulation syndrome), which is characterized by an increase in the size of the ovaries, ovarian cysts, abdominal pain with vomiting and nausea (see also section 2. in "Ovarian Hyperstimulation Syndrome"). This is a common side effect (can affect up to 1 in 10 people).

•Severe ovarian hyperstimulation (ovarian hyperstimulation syndrome) characterized by lower abdominal pain (pelvis), nausea, vomiting, weight gain, accumulation of fluid in the abdomen (ascitis) or in the chest (pleural effusion). This episode is rare (can affect up to 1 in 100 people).

•Ovarian cyst rupture (as a rare consequence of severe OHSS, can affect up to 1 in 1,000 people)

•Formation of blood clots in blood vessels (thromboembolic episodes), as a complication of ovarian hyperstimulation syndrome. This episode is rare (can affect up to 1 in 1,000 people)

•Severe generalized allergic reactions that may include: facial swelling, eye swelling, lip swelling, throat swelling, or tongue swelling, breathing difficulties, wheezing, skin rash, side effect rare (can affect up to 1 in 1,000 people)

Other side effects

Frequent side effects:can affect up to 1 in 10 people

• Reaction at the injection site that may include redness, bruising, swelling, itching, or pain at the injection site
• Swelling (edema)
• Mood changes
• Headache
• Chest pain

Rare side effects:can affect up to 1 in 100 people

• Inquietude (agitation), fatigue

Very rare side effects:can affect up to 1 in 1,000 people

• Deep skin swelling, often observed with urticaria (hives)
• Generalized skin rash

If you experience any of the rare side effects mentioned above, consult your doctor immediately, who will assess whether you should stop treatment with this medicine or go to the nearest hospital emergency department immediately.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through theSpanish System for the Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of sight andreach of children.

Do not store at a temperature above 25°C. Store the vial and preloaded syringe with solvent in the outer packaging to protect them from light.

Use immediately after preparing the solution.

Do not use this medication after the expiration date that appears“after CAD” on the outer packaging, the vial, and the preloaded syringe with solvent.If the expiration date is expressed as month/year,the expiration date is the last day of the month indicated.

Do not use this medication if you observe that the solution does not have a transparent appearance (turbid or with visible particles). The solution must be transparent and colorless after reconstitution.

Medications should not be disposed of through drains or in the trash. Dispose of containers and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medications you no longer need. By doing so, you will help protect the environment.

Composition ofGonasi Kit

The active ingredient is: human chorionic gonadotropin.

The excipients are:

• in the vial of powder: lactose monohydrate
• in the preloaded syringe with solvent (sodium chloride 0.9%): water for injection, sodium chloride.

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

Appearance of theproductand contents of the packaging

Gonasi Kitis presented as:

Powder in vial: lyophilized powder of white to almost white color

Solvent in preloaded syringe (sodium chloride 0.9%): transparent and colorless solution

A single pack contains:

Plastic tray including powder in a vial (type I glass), sealed with a rubber stopper and held in place with a easy-open lid.

1 ml of solvent in a preloaded 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 some package sizes may be commercially available.

Marketing Authorization Holder:

IBSA Farmaceutici Italia srl

Via Martiri di Cefalonia 2

26900 Lodi (Italy)

Responsible for manufacturing:

IBSA Farmaceutici Italia srl

Via Martiri di Cefalonia, 2

26900 Lodi – Italy

You can request more information about this medicine by contacting the local representative of themarketing authorization holder:

Instituto Bioquimico Iberico IBSA S.L.

Avenida Diagonal 605,

8th floor, Local 1,

08028 Barcelona (Spain)

This medicine is authorized in the member states of the European Economic Area with the following trade names:: (The dosage and pharmaceutical form are identical in all countries, only the trade name changes)

Denmark: Gonasi Set

Czech Republic: Zivafert

Spain: Gonasi Kit

Finland: Gonasi Set

France: HUMAN CHORIONIC GONADOTROPHIN IBSA

Hungary: Zivafert Kit

Netherlands: Gonasi

Norway: Gonasi Set

Poland: Zivafert

Sweden: Gonasi Set

Slovak Republic:Gonasi Kit

Last review date of this leaflet:January 2025

For detailed and updated information about this medicine, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es.