Prospect: information for the user

Meriofert Kit 75 UIpowder and solvent for injectable solution

menotropin

Read this prospect carefully before starting to use this medication, because 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 medication has been prescribed only to you, and you must 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 not listed in this prospect. See section 4.
• In this prospect, Meriofert 75 UI powder and solvent for injectable solution is referred to as Meriofert Kit.

1. What is Meriofert Kit and how it is used

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

3. How to use Meriofert Kit

4. Possible adverse effects

5. Storage of Meriofert 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

eggs) in women undergoing fertility treatment.

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

Each vial containslyophilized powder with75 IU of human follicle-stimulating hormone (FSH) activity and 75 IU of human luteinizing hormone (LH) activity.

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

You should not use this medication if you are experiencing premature menopause, genital organ malformation, or certain uterine tumors that would prevent a normal pregnancy.

Warnings and precautions

Consult your doctor before starting to use Meriofert Kit.

Although allergic reactions toMeriofert Kithave 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 calledovarian hyperstimulation syndrome (OHSS)(see section 4). If OHSS occurs, treatment will be suspended and pregnancies should be avoided. The first signs of OHSS are lower abdominal pain, nausea (discomfort), vomiting, and weight gain. If these symptoms occur, you should have a doctor examine you 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 (containing human chorionic gonadotropin, 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 miscarriages 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 (ectopic pregnancy) is slightly higher in women with fallopian tube damage.

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

Treatment withMeriofert 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 ofMeriofert Kit with other medications

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

Pregnancy, lactation, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medication.

Driving and operating machinery

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

Meriofert Kit contains sodium

This medication contains less than 23 mg (1 mmol) of sodium, making it essentially “sodium-free”

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

Dose and duration of treatment

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

Generally, the first injection of a 75 UI vial 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 interrupted 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 hCG administration. 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 ofthis medication(1 or 2 vials of Meriofert Kit 150 UI). 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 interrupted and ovulation will be induced with another hormone (human chorionic gonadotropin, hCG).

How to administer Meriofert Kit

This medicationis administered in the form of an injection under the skin (subcutaneously) or into a muscle (intramuscularly).

The vials should only be used once and the injection should be administered as soon as it is prepared.

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

The first time you do it, the doctor must

• allow you to practice self-administration of a subcutaneous injection,
• indicate the places 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.

How to prepare and inject 1 vial of Meriofert Kit

The injection must be prepared just before you are ready to use it, using the pre-loaded syringe with diluent (a 9 mg/ml sodium chloride solution in injectable water) included in each Meriofert Kit package.

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

Place the following items on the clean surface:

• two alcohol wipes (not included),
• a vial of Meriofert Kit powder,
• a pre-loaded syringe with diluent,
• a needle for preparing the injection,
• a fine needle for subcutaneous injection.

REMEMBER: do not remove the support plug (white piece) from the pre-loaded syringe, as it prevents accidental piston extraction and improves syringe handling during injection.

Solution reconstitution

Preparation of the injection

1.• Remove the syringe cap; insert the reconstitution needle (long needle) into the syringe.

• Place the syringe carefully on the clean surface.

• Avoid touching the needle.

Prepare the solution for the injection

2.•Remove the colored plastic capsule (greenish in the 75 UI presentation and dark green in the 150 UI presentation) from the Meriofert Kit vial by gently pushing it upwards.

•Clean the top rubber stopper with an alcohol wipe and wait for it to dry.

3.•Take the syringe, remove the protective cap from the needle, and insert the needle through the center of the rubber stopper on the top of the Meriofert Kit vial.

•Push the plunger firmly down to spray the entire solution over the powder.

•DO NOT SHAKE THE VIAL; gently move it in circles until a clear solution is obtained.

Generally, the medication dissolves immediately.

4.•With the needle still inserted, turn the vial over.

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

•Pull the plunger gently to introduce the entire Meriofert Kit solution into the syringe.

•Check that the reconstituted solution is clear.

When reconstituting more than 1 vial of Meriofert Kit, introduce the contents of the first vial into the syringe and inject it slowly into a second vial after repeating steps 2 to 4.

Subcutaneous injection of the medication

• When the syringe contains the prescribed dose, place the protective cap on the needle. Remove the needle from the syringe and replace it with the fine needle for subcutaneous injection with its protective cap.
• Insert the fine needle firmly into the syringe barrel and, then, rotate it slightly to ensure it is fully seated and provides a tight seal.
• Remove the protective cap from the needle. Hold the syringe with the needle pointing upwards and gently tap the syringe sides to bring air bubbles to the top;
• Push the plunger until a drop of liquid appears at the needle tip.
• Do not use it if it contains particles or is cloudy.

Injection site

• Your doctor or nurse will have already explained where you should administer the medication. Common sites are the thigh or the lower abdominal wall below the navel.

• Clean the injection site with an alcohol wipe.

Insertion of the needle

?Pinch and firmly grasp the skin. With the other hand, insert the needle quickly and firmly, 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 continuously, ensuring the solution is injected correctly and the skin tissues are not damaged.

Take the time you need to inject the prescribed volume of solution. Depending on the dose prescribed by your doctor, you may not use the entire volume of the solution.

Removal of the needle

• Quickly remove the syringe and press the injection site with an antiseptic wipe. Gentle massages in the area (while maintaining pressure) help to disperse the Meriofert Kit solution and alleviate any discomfort.

Intramuscular injection of the medication

In the case of intramuscular injections, the healthcare professional will prepare and administerthis medicationin the lateral thigh or gluteal area.

Dispose of all used items

After the injection, place all needles, vials, and syringes in the sharps container.The disposal of unused solution and all items that have come into contact with it will be carried out in accordance with local regulations.

If you use more Meriofert Kit than you should

The effects of an overdose ofthis medicationare unknown, but it could be expected to produce a hyperstimulation syndrome (see section 4). If you use more medication than prescribed, consult your doctor or nurse.

If you forget to use Meriofert Kit

Use it in the time frame when your next injection would normally be due. Do not take a double dose to compensate for missed doses.

If you interrupt treatment with Meriofert Kit

Do not stop treatment on your own initiative.

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

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

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

Frequent, may affect up to 1 in 10 people

• Ovarian Hyperstimulation Syndrome (symptoms include ovarian cyst formation 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 (more common with IM injection than with SC).

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

• Ovarian torsion (rotation of the ovary causing severe pain in the lower abdomen)
• Thromboembolism (formation of a blood clot in a blood vessel that breaks loose and travels 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 store at a temperature above 25°C. Store the vial and preloaded syringe with solvent in the outer packaging to protect them from light.

Do not use this medication after the expiration date that appearson 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.

Use immediately 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 unused medicines at the SIGRE pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of containers and unused medicines. By doing so, you will help protect the environment.

Composition of Meriofert Kit

The active principle ismenotropin.

Each vial containslyophilized powder with75 UI of follicle-stimulating hormone (FSH) human activity and 75 UI of human luteinizing hormone (LH) activity.

Human menopausal gonadotropin (HMG) is extracted from the urine of postmenopausal women.

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

If several vials of powder are used, the amount of menotropin in 1 ml of reconstituted solution will be as follows:

Theadditional components are

Vial of powder: lactose monohydrate

Pre-filled syringe with solvent: solutionof 9 mg/mlof sodium chloride

Appearance of the product and contents of the package

Powder: white lyophilized cake or powder

Solvent: transparent and colorless solution

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

1 pack contains the following:

• One vial with white lyophilized cake or powder
• One pre-filled syringe (1 ml) with transparent and colorless solution
• One needle for reconstitution and intramuscular injection (long needle)
• One needle for subcutaneous injection (short needle)

It is supplied in boxes of 1, 5 or 10 packs.

Only some package sizes may be commercially available.

Marketing authorization holder and manufacturer

Marketing authorization 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

or (for the United Kingdom)

IBSA PharmaLimited

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 with the following names (the concentrations and pharmaceutical forms are identical in all countries, only the trade 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: MeriofertSet

France: Fertistartkit

Greece: Meriofert

Hungary: Meriofert Kit

Italy: Meriofert

Latvia: Meriofert Set

Lithuania:Meriofert Set

Luxembourg: Fertinorm Kit

Norway: Meriofert Set

Poland: Mensinorm Set

Romania: Meriofert PFS

Slovakia: Meriofert Kit

Spain: Meriofert Kit

Netherlands: Meriofert spuit

United Kingdom: Meriofert PFS

Sweden: MeriofertSet

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