This page is for general information. Consult a doctor for personal advice. Call emergency services if symptoms are severe.

How to use MERIOFERT 75 IU POWDER AND SOLVENT FOR INJECTABLE SOLUTION

Introduction

Package Leaflet: Information for the User

Meriofert 75 UIpowder and solvent for solution for injection

Meriofert 150 UI powder and solvent for solution for injection

menotropin

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

- Keep this leaflet, you may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
In this leaflet, Meriofert 75 UI powder and solvent for solution for injection and Meriofert 150 UI powder and solvent for solution for injection are referred to as Meriofert.

Contents of the pack

What is Meriofert and what it is used for
What you need to know before you use Meriofert
How to use Meriofert
Possible side effects
Storage of Meriofert
Contents of the pack and other information

1. What is Meriofert and what it is used for

Meriofert is used to stimulate ovulation in women who do not ovulate and have not responded to other treatment (clomifene citrate).
Meriofert is used to induce the development of multiple follicles (and therefore multiple eggs) in women undergoing fertility treatment.

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

Each vial contains lyophilized powder with 75 IU of human follicle-stimulating hormone (FSH) activity and 75 IU of human luteinizing hormone (LH) activity.

The human menopausal gonadotropin (HMG) is extracted from the urine of post-menopausal women. Human chorionic gonadotropin (hCG), a natural hormone extracted from the urine of pregnant women, is added to contribute to the total LH activity.

Each vial contains lyophilized powder with 150 IU of human follicle-stimulating hormone (FSH) activity and 150 IU of human luteinizing hormone (LH) activity.

This medicine should be used under the supervision of a doctor.

2. What you need to know before you use Meriofert

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

Do not use Meriofert

If you have enlarged ovaries or cysts of unknown cause (polycystic ovary syndrome).
If you have bleeding of unknown origin.
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 medicine.

You should not use this medicine if you have premature menopause, malformation of the genital organs, or certain uterine tumors that would prevent a normal pregnancy.

Warnings and precautions

Although allergic reactions to this medicine have not been described, you should inform your doctor if you have any allergic reactions to similar medicines.

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

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

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

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

The risk of ectopic pregnancy is slightly higher in women with damaged Fallopian tubes.

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

Treatment with this medicine, like pregnancy itself, may increase the likelihood of blood clots. Blood clots are the formation of a blood clot in a blood vessel, most often in the veins of the legs or lungs.

Discuss this with your doctor before starting treatment, especially:

If you already know you have a higher risk of blood clots.
If you or a close family member has had a blood clot.
If you have severe obesity.

Children

This medicine is not indicated for use in children.

Other medicines and Meriofert

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Pregnancy, breastfeeding, and fertility

This medicine should not be used if you are pregnant or breastfeeding.

Driving and using machines

The influence of this medicine on the ability to drive and use machines is negligible.

Meriofert contains sodium

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

3. How to use Meriofert

Dose and duration of treatment:

Follow your doctor's instructions for administering this medication exactly. If in doubt, consult your doctor again.

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

As a general rule, the first injection of a 75 IU vial of menotropin is administered during the first week of the cycle after spontaneous or induced menstruation.

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

Once a follicle reaches the necessary stage of development, treatment with this medication will 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 starting from the day before hCG administration. If pregnancy is not achieved despite ovulation, treatment may be repeated.

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

The purpose of this method is to achieve simultaneous multiple follicular development. Treatment will begin on the second or third day of the cycle with injections of 150 to 300 IU of this medication (1 or 2 vials of Meriofert 150 IU). Your doctor may opt for higher doses if necessary. The dose of this medication injected is higher than that used for natural fertilization. Your doctor will adjust the continuation of treatment on an individual basis.

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

How to administer Meriofert:

This medication is administered by subcutaneous injection (under the skin) or intramuscular injection (into the muscle).

Vials should only be used once, and the injection should be administered immediately after preparation.

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

Before the first injection, your doctor should:

Allow you to practice self-administering 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 injection.

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

How to prepare and inject 1 vial of Meriofert powder:

The solution should be prepared just before injection. Each vial is used for a single use. The medication must be reconstituted under aseptic conditions.

This medication should only be reconstituted with the solvent provided in the package.

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

Place the following items on the surface:

two cotton balls moistened with alcohol (not included in the box),
a vial of Meriofert powder,
a solvent ampoule,
a syringe (not included in the box),
a needle for preparing the injection (not included in the box),
a fine needle for subcutaneous injection (not included in the box).

Reconstitution of the solution for injection, using 1 vial of powder

Prepare the solution for injection:

	1. The neck of the ampoule is specifically designed to break more easily below the colored point. Gently tap the top of the ampoule to dislodge any residual liquid in the tip. Hold the ampoule with the colored point facing outwards and break off the top of the ampoule as shown in the image. Using a cloth or an ampoule breaker to hold the ampoule will help protect your fingers. Carefully place the open ampoule in a vertical position on the clean surface.
	Remove the protective cap from the needle. Attach the needle for reconstitution (large needle) to the syringe. With the syringe in one hand, take the open solvent ampoule, insert the needle, and withdraw all the contents of the ampoule into the syringe. Replace the protective cap on the needle. Carefully place the syringe on the surface.
	2. Remove the colored plastic cap (light green for the 75 IU presentation and dark green for the 150 IU presentation) from the powder vial by gently pushing it upwards. Disinfect the top of the rubber stopper by rubbing it with an alcohol-moistened cotton ball and let it dry.
	3. Take the syringe, remove the protective cap from the needle, and slowly inject the solvent through the center of the rubber stopper of the powder vial. Press the plunger firmly downwards to pour all the solution over the powder. DO NOT SHAKE, but gently move the vial between your hands until the powder is completely dissolved, taking care not to create foam.
	4. Once the powder has dissolved (which usually occurs immediately), slowly withdraw the solution into the syringe. With the needle still inserted, turn the vial upside down. Make sure the tip of the needle is below the liquid level. Gently pull the plunger to load all the solution into the syringe. Check that the reconstituted solution is transparent and colorless.

Preparation of higher doses, using more than 1 vial of powder

If your doctor has recommended higher doses, you can achieve this by using more than 1 vial of powder with a solvent ampoule.

When reconstituting more than 1 vial of this medication, at the end of the phase 4 described above, introduce the reconstituted contents of the first vial back into the syringe and slowly inject it into a second vial. Repeat phases 2 to 4 for the second vial and subsequent ones until the contents of the required number of vials equivalent to the prescribed dose are dissolved (within the limit of the maximum total dose of 450 IU, corresponding to a maximum of 6 vials of Meriofert 75 IU or 3 vials of Meriofert 150 IU).

Your doctor may increase the dose by 37.5 IU, which represents half of a 75 IU vial of Meriofert.

To do this, you must reconstitute the contents of the 75 IU vial according to phases 2 to 3 described above and introduce half of this reconstituted solution (0.5 ml) into the syringe according to phase 4.

In this situation, you will have two preparations to inject: the first reconstituted preparation in 1 ml and the second containing 37.5 IU in 0.5 ml.

Both preparations must be injected with their own syringes according to the following phases.

The solution must be transparent and colorless.

Subcutaneous injection of the medication:

Hands holding a preloaded syringe vertically over a dark surface with the plunger facing upwards

	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 cylinder and then twist it slightly to ensure it is fully threaded and achieve a tight connection.
	Remove the protective cap from the needle. Hold the syringe with the needle pointing upwards and gently tap the side of the syringe to make any air bubbles rise to the top; Push the plunger until a drop of liquid appears at the tip of the needle. Do not use it if it contains particles or is turbid.

Injection site

Your doctor or nurse will have already explained where on your body to administer the medication. The usual places are the thigh or the lower abdominal wall below the navel.
Clean the injection site with an alcohol-moistened cotton ball.

Insertion of the needle:

Hand holding a syringe with the needle inserted into the arm skin showing the angle of injection

Pinch and firmly press the skin. With the other hand, insert the needle with a quick, firm motion, forming a 45° or 90° angle.

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 interruption, so the solution is injected correctly and the skin tissues are not damaged.

Take all the time you need to inject the prescribed volume of the solution. As described in the preparation of the solution, depending on the dose prescribed by your doctor, you may not need to use the entire volume of the solution.

Removal of the needle

Quickly remove the syringe and press the injection site with a disinfectant-moistened cotton ball. Gentle massage of the area (while maintaining pressure) helps to disperse the solution of this medication and alleviate any discomfort.

Intramuscular injection of the medication:

In the case of intramuscular injections, the healthcare professional will prepare and inject this medication in the lateral thigh or buttock.

Disposal of all used utensils:

After the injection, all needles and empty syringes must be disposed of in an appropriate container. Any unused product or waste material must be eliminated according to local requirements.

If you use more Meriofert than you should:

The effects of an overdose of this medication are unknown; however, it is likely that an ovarian hyperstimulation syndrome (see Possible side effects) would occur. If you use more Meriofert than you should, consult your doctor or nurse.

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

If you forget to use Meriofert:

Use it at the next scheduled injection time. Do not take a double dose to make up for forgotten doses.

If you stop treatment with Meriofert:

Do not stop treatment on your own initiative. Always consult your doctor before stopping this medication.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

The following side effect is important and will require immediate attention if you experience it. You must stop taking this medication and consult your doctor immediately if you experience:

Frequent:may affect up to 1 in 10 people

Ovarian hyperstimulation syndrome (symptoms include the formation of ovarian cysts or the enlargement of existing cysts, pain in the lower abdomen, feeling of thirst, and nausea with occasional vomiting, passing small amounts of concentrated urine, and weight gain) (see section 2 for additional information).

The following side effects have also been reported:

Very frequent:may affect more than 1 in 10 people

Headache
Abdominal bloating

Frequent:may affect up to 1 in 10 people

Abdominal pain or discomfort

Pelvic pain
Back pain
Feeling of heaviness
Breast tenderness
Dizziness
Hot flashes
Thirst
Feeling of illness
Fatigue
General malaise
Reactions at the injection site, such as pain and inflammation (more common with IM than SC injections).

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 is carried by the bloodstream to block another vessel).

Reporting of side effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are possible side effects not listed in this leaflet.

You can also report them directly through the Spanish Medicines Monitoring System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Meriofert

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

Do not store above 25°C. Keep the vial and solvent ampoule in the outer packaging to protect them from light.

Do not use this medication after the expiration date stated on the carton, vial, and solvent ampoule after "EXP". 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.

Medications should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medications in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medications. This will help protect the environment.

6. Container Content and Additional Information

Meriofert Composition

The active ingredient is menotropin.

Each vial contains lyophilized powder with 75 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 post-menopausal women.

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

Each vial contains lyophilized powder with 150 IU of human follicle-stimulating hormone (FSH) activity and 150 IU of human luteinizing hormone (LH) activity.

Human menopausal gonadotropin (HMG) is extracted from the urine of post-menopausal 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:

Meriofert 75 IU powder and solvent for injectable solution		Meriofert 150 IU powder and solvent for injectable solution
Number of vials used	Total amount of menotropin in 1 ml of solution	Number of vials used	Total amount of menotropin in 1 ml of solution
1	75 IU	1	150 IU
2	150 IU	2	300 IU
3	225 IU	3	450 IU
4	300 IU
5	375 IU
6	450 IU

The other components (excipients) are

Powder: lactose monohydrate.

Solvent: 9 mg/ml of sodium chloride and water for injectable preparations.

Appearance of the product and container content

Powder: white cake or lyophilized powder.

Solvent: clear and colorless solution.

Meriofert is presented as powder and solvent for injectable solution.

A carton contains:

1 vial with white cake or lyophilized powder
1 ampoule (1 ml) of clear and colorless solution

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

Only some pack sizes may be marketed.

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

You can request more information about this medicinal product by contacting the local representative of the marketing authorization holder:

Instituto Bioquimico Iberico IBSA S.L.

Avenida Diagonal 605,

Planta 8, Local 1,

08028 Barcelona

Spain

This medicinal product is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names (concentrations and pharmaceutical forms are identical in all countries, only the trade names differ):

Austria: Meriofert

Belgium: Fertinorm

Bulgaria: Meriofert

Cyprus: Meriofert

Czech Republic: Meriofert

Denmark: Meriofert

Estonia: Meriofert

Finland: Meriofert

France: Fertistart

Greece: Meriofert

Hungary: Meriofert

Italy: Meriofert

Latvia: Meriofert

Lithuania: Meriotert

Luxembourg: Fertinorm

Norway: Meriofert

Poland: Mensinorm

Romania: Meriofert

Slovakia: Meriofert

Spain: Meriofert

Sweden: Meriofert

Netherlands: Meriofert

United Kingdom: Meriofert

Date of the last revision of this leaflet: November 2023

Detailed 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)

MERIOFERT 75 IU POWDER AND SOLVENT FOR INJECTABLE SOLUTION