Package Insert: Information for the User

MeroFert Kit 900 UIpowder and solvent for injectable solution

Menotropin

Read this package insert carefully before starting to use this medication, as it contains important information for you.

• • Keep this package insert, as you may need to read it again.
  • If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.

• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package insert. See section 4.
• In this package insert, MeroFert Kit 900 UI powder and solvent for injectable solution is referred to as MeroFert Kit.

1. What is MeroFert Kit and how it is used

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

3. How to use MeroFert Kit

4. Possible adverse effects

5. Storage of MeroFert Kit

6. Contents of the package and additional information

• MeriofertKitis used to stimulate ovulation in women who do not ovulate and who have not

responded to another treatment (clomiphene citrate).

• MeriofertKitis used to induce the development of multiple follicles (and therefore multiple ova) in women undergoing fertility treatment.

Meriofert Kitis a highly purified human menopausal gonadotropin, which belongs to a group of medications called gonadotropins.

Each multi-dose vial contains lyophilized powder with 900UI of human follicle-stimulating hormone (FSH) activity and 900UI of human luteinizing hormone (LH) activity.

Human menopausal gonadotropin (HMG) is extracted from the urine of postmenopausal women. Human chorionic gonadotropin (hCG), extracted from the urine of pregnant women, is added to contribute to the total LH activity.

This medication must be used under the supervision of a doctor.

Before starting treatment, your fertility and that of your partner will be evaluated.

Do not use Meriofert Kit

• If you experience an increase in the size of your ovaries, or cysts whose cause is not a hormonal disorder (polycystic ovary syndrome)
• If you have unexplained bleeding
• If you have ovarian, uterine, or breast cancer
• If you have an abnormal swelling (tumor) of the pituitary gland or hypothalamus (brain)
• If you are allergic to menotropin or any of the other components of this medication (listed in section 6)

This medication should not be used if you suffer from premature menopause, genital organ malformation, or certain uterine tumors that would prevent a normal pregnancy.

Warnings and precautions

Although allergic reactions to Meriofert Kit have not yet been described, you should inform your doctor if you have any allergic reactions to similar medications.

This treatment increases the risk of developing a condition called ovarian hyperstimulation syndrome (OHSS) (see Possible side effects). If OHSS occurs, treatment will be suspended and pregnancies should be avoided. The first signs of OHSS are lower abdominal pain, nausea, vomiting, and weight gain. If these symptoms occur, you should see a doctor as soon as possible. In severe cases, but rare, the ovaries may become enlarged and fluid may accumulate in the abdomen or chest.

The medication used to induce the final release of mature eggs (which contains hCG) may increase the likelihood of OHSS. Therefore, hCG should not be used in cases where OHSS is occurring, and you should not have sexual intercourse for at least 4 days, even if using a barrier contraceptive method.

It is worth noting that women with fertility problems have a higher rate of miscarriage than the general population.

The frequency of pregnancies and multiple births in patients undergoing treatment to stimulate ovulation is higher than in women who conceive naturally. However, this risk can be minimized by using the recommended dose.

The risk of ectopic pregnancy is slightly higher in women with fallopian tube damage.

Multiple births and the characteristics of the parents undergoing fertility treatments (such as the mother's age or semen characteristics) may be associated with an increased risk of birth defects.

Treatment with Meriofert Kit, like pregnancy itself, may increase the likelihood of developing thrombosis. Thrombosis is the formation of a blood clot in a blood vessel, most often in the veins of the legs or lungs.

Discuss this fact with your doctor before starting treatment, especially:

• If you already know that you have a higher risk of developing thrombosis.
• If you or a close relative have ever had a thrombosis.
• If you have severe obesity.

Pediatric population

The medication is not indicated for pediatric use.

Use of Meriofert Kit with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Pregnancy, lactation, and fertility

Meriofert Kit should not be used if you are pregnant or breastfeeding.

Driving and operating machinery

The influence of Meriofert Kit on the ability to drive and operate machinery is negligible or insignificant.

Meriofert Kit contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per dose; it is essentially "sodium-free".

Dosage and duration of treatment

Follow exactly the administration instructions of this medication as indicated by your doctor. If in doubt, consult your doctor again.

Women who do not ovulate and have irregular periods or absence of menstruation:

Generally, the first injection of a vial of 75 UI ofmenotropinis administered during the first week of the cycle after spontaneous or induced menstruation.

Subsequently, the prescribed dose ofthis medicationis injected daily and treatment continues until one or more mature follicles have formed in the ovary. Your doctor will adjust the dose ofthis medicationbased on the ovarian response, which is determined by clinical examinations.

Once a follicle has reached the necessary stage of development, treatment withthis medicationwill be discontinued and ovulation will be induced with another hormone (human chorionic gonadotropin, hCG).

Ovulation usually occurs within 32 to 48 hours.

At this stage of treatment, there is a possibility of fertilization. You will be advised to have sexual intercourse every day from the day before the administration of hCG. If ovulation occurs but pregnancy is not achieved, treatment may be repeated.

Women undergoing ovarian stimulation for multiple follicular development before in vitro fertilization or other assisted reproductive techniques:

The purpose of this method is to obtain simultaneous multiple follicular development. Treatment will begin on the second or third day of the cycle with injections of 150 to 300 UI of Meriofert Kit. Your doctor may choose to administer higher doses if necessary. The dose ofthis medicationinjected is higher than that used for natural fertility. Your doctor will adjust the continuation of treatment on an individual basis.

Once a sufficient number of follicles have developed, treatment withthis medicationwill be discontinued and ovulation will be induced with another hormone (human chorionic gonadotropin, hCG).

How to administer Meriofert Kit:

This medicationis administered in the form of a subcutaneous injection.

The vials should only be reconstituted once and each single injection should be administered as soon as the required dose has been extracted.

After advising and instructing you, your doctor may ask you to administer the Meriofert Kit injection yourself.

Before the first injection, your doctor must:

• Allow you to practice self-administration of a subcutaneous injection
• Indicate the areas where the injection can be administered
• Teach you how to prepare the injectable solution
• Explain how to prepare the correct dose for the injection.

Before administering the Meriofert Kit injection, read the following instructions carefully.

Since this vial contains medication for several days of treatment, you must be sure that you only extract the amount of medication prescribed by your doctor. Your doctor has prescribed a dose of Meriofert Kit in UI (units). To obtain the correct dose, you must use one of the 12 graduated syringes for administration provided in the package.

These disposable syringes are intended for single use and should be disposed of after administration in accordance with local regulations in an appropriate container.

How to prepare and inject 1 vial of Meriofert Kit:

The injectable solution containing 900 UI of menotropin must be prepared just before it is ready to be administered for the first dose. To do this, add the reconstitution solvent from the pre-loaded syringe (included in the package) to the vial containing the powder.

Prepare a clean surface and wash your hands with soap and warm water. It is essential that your hands and the items you use are as clean as possible.

Place the following items on the clean surface:

• the vial of Meriofert Kit powder
• the pre-loaded syringe with reconstitution solvent
• the reconstitution needle
• a disposable syringe for subcutaneous administration with a pre-attached needle graduated in units FSH/LH
• a cotton swab with alcohol
• cotton and disinfectant solution (not included in the package)

REMEMBER:

- Disinfect the rubber stopper of the vial containing the reconstituted solution with a cotton swab and disinfectant (alcohol solution) and let it dry before reconstitution and each administration.

-Do not remove the white support plug (plunger) from the pre-loaded syringe, as it prevents accidental extraction of the piston and improves handling of the syringe during injection.

Reconstitution of the injectable solution

Preparation of the pre-loaded syringe:

1.

• Remove the cap from the pre-loaded syringe with solvent; attach the reconstitution needle with the protective cap still on the syringe.
• • Place the syringe carefully on a clean surface.

Preparation of the vial:

2.

• Clean the area around the rubber stopper with a cotton swab and disinfectant solution and let it dry.

3.

• Take the syringe, remove the protective cap from the needle, and push the needle through the center of the rubber stopper of the vial.
• Push the plunger firmly to empty the solution onto the powder.
• When adding the solvent, a slight overpressure is created in the vial. Therefore, release the plunger of the syringe to allow it to rise on its own for 10 seconds. This will eliminate the overpressure in the vial.

DO NOT SHAKE the reconstituted solution, gently rotate it until a transparent solution is obtained. The medication usually dissolves immediately.

Check that the reconstituted solution is transparent.

Before injection:

• Check that the reconstituted solution is transparent, colorless, and particle-free. DO NOT USE if the solution contains particles, is turbid, or is not colorless.
• Clean the area around the rubber stopper with a cotton swab and disinfectant solution.

Preparation of the injection:

4.

• Take one of the disposable syringes with a pre-attached needle, remove the protective cap from the needle, and insert the needle vertically into the center of the top of the vial.
• Push the plunger until it is fully pressed.
• Invert the vial. Make sure the needle is below the surface of the medication and extract the prescribed dose of medication in the administration syringe.
• Remove the needle from the vial. Hold the syringe with the needle pointing upwards and gently tap the side of the syringe to force any air bubbles upwards.
• Push the plunger slowly until a drop of liquid appears at the tip of the needle.

REMEMBER: since the vial contains medication for several days of treatment, you must ensure that you only extract the amount of medication prescribed by your doctor.

Administration of the injection

Injection site:

• Your doctor or nurse has already explained to you where you should inject the medication. The usual areas are the thigh or the lower abdominal wall below the navel.

• Clean the injection site with a cotton swab with alcohol.
• Pinch and firmly press the skin. With the other hand, insert the needle with a dry and quick motion, forming an angle of 45° or 90°.

Injection of the solution:

• Inject the syringe under the skin as instructed. Do not inject it directly into a vein. Push the plunger slowly and without interruptions, so that the solution is injected correctly and the skin tissues are not damaged.

Take the time you need to inject the volume of solution prescribed.

Quickly remove the needle and press the injection site with a cotton swab with disinfectant. Gently massage the area (while maintaining pressure), which helps to disperse the medication and alleviates any discomfort.

Subsequent injections:

Repeat from step 4 onwards for subsequent injections with the reconstituted solution of Meriofert Kit.

If you use more Meriofert Kit than you should:

The effects of an overdose ofthis medicationare unknown, but it could be expected that a syndrome of hyperstimulation of the ovaries (see Possible adverse effects) would occur. If you use moremedicationthan you should, consult your doctor or nurse.

If you forget to use Meriofert Kit:

Use it at the time when you would normally take the next injection. Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Meriofert Kit:

Do not stop it on your own initiative. Consult your doctor before stopping this medication.

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

Like all medications,this medicationcan produce adverse effects, although not everyone will experience them.

The following adverse effect is serious and will require immediate medical attention if it occurs. You should stop takingthis medicationand seek medical attention immediately if you experience the following:

Frequent (may affect up to 1 in 10 people):

• Ovarian Hyperstimulation Syndrome (symptoms include the formation of ovarian cysts or enlargement of existing cysts, lower abdominal pain, feeling thirsty and nausea with occasional vomiting, small amounts of concentrated urine, and weight gain) (see section 2 for additional information).

The following adverse effects have also been reported:

Very frequent (may affect more than 1 in 10 people):

• Headache
• Abdominal distension or flatulence

Frequent (may affect up to 1 in 10 people):

• Abdominal pain or discomfort

• Lower pelvic pain
• Back pain
• Heaviness
• Mammary discomfort
• Dizziness
• Hot flashes
• Thirst
• Sensation of illness
• Fatigue
• General malaise
• Reactions at the injection site, such as pain and inflammation

Rare (may affect up to 1 in 1,000 people):

• Ovarian torsion (rotation of the ovary causing severe pain in thelower abdomen)
• Thromboembolism (formation of a blood clot in a blood vessel that breaks loose and is transported through the bloodstream to block another vessel).

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight andreach of children.

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

Before reconstitution: Store in the refrigerator (between 2°C and 8°C).

After reconstitution, the solution can be stored for a maximum of 28 days at no more than 25°C.

Do not freeze before or after reconstitution.

Do not use this medication if you observe that the solution is not transparent. After reconstitution, the solution must be transparent and colorless.

Medicines 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.This will help protect the environment.

Composition of Meriofert Kit

The active principle ismenotropin.

Each multidose vial contains lyophilized powder with 900 UI of human follicle-stimulating hormone (FSH) activity and 900 UI of human luteinizing hormone (LH) activity.

Human menopausal gonadotropin (HMG) is extracted from the urine of postmenopausal women. Gonadotropin chorionic human (hCG), extracted from the urine of pregnant women, is added to contribute to the total LH activity.

Theadditional components are

Powder: lactose monohydrate, polisorbate 20, sodium dihydrogen phosphate dihydrate, phosphoric acid and sodium hydroxide.

Dissolvent: metacresol and water for injectable preparations.

Appearance of Meriofert Kit and contents of the package

Powder: white lyophilized powder or powder.

Dissolvent: transparent and colorless solution.

Meriofert Kit is presented as powder and dissolvent for injectable solution.

A case contains:

• 1 vial of Meriofert Kit powder
• 1 preloaded syringe with dissolvent for reconstitution
• 1 syringe for reconstitution
• 12 cotton swabs with alcohol for multiple injections
• 12 disposable syringes with prefixed needles for multiple injections

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

IBSA FARMACEUTICI ITALIA SRL

Via Martiri di Cefalonia 2

26900 Lodi, Italy

Responsible manufacturer

IBSA Farmaceutici Italia srl

Via Martiri di Cefalonia, 2

26900 Lodi – Italy

or (for United Kingdom/Northern Ireland)

IBSA Pharma Limited

Units 4-6

Colonial Business Park

Colonial Way

Watford WD24 4PR

United Kingdom

You can request more information about this medicine by contacting the local representative of the marketing 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 and in the United Kingdom (Northern Ireland) with the following names (the concentrations and pharmaceutical forms are identical in all countries, only the commercial names change):

Austria: Meriofert PFS

Belgium: Fertinorm Kit

Bulgaria: Meriofert PFS

Cyprus: Meriofert PFS

Czech Republic: Meriofert Set

Denmark: Meriofert Set

Estonia: Meriofert Set

Finland: Meriofert Set

France: Fertistartkit

Greece: Meriofert

Hungary: Meriofert Kit

Italy: Meriofert

Latvia: Meriofert Set

Lithuania: Meriotert Set

Luxembourg: Fertinorm Kit

Norway: Meriofert Set

Poland: Mensinorm Set

Romania: Meriofert PFS

Slovakia: Meriofert Kit

Spain: Meriofert Kit

Sweden: Meriofert Set

Netherlands: Meriofert spuit

United Kingdom: Meriofert PFS

Last review date of this leaflet:May 2024

Detailed and updated information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es