Meriofert Kit 150 IU powder and solvent for solution for injection

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Meriofert Kit 150 UI powder and solvent for injectable solution

menotropin

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

• • Keep this leaflet, as you may need to read it again.
  • If you have any questions, consult your doctor or pharmacist.

• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.

• If you experience any adverse effects, consult your doctor or pharmacist, even if these adverse effects are not listed in this leaflet. See section 4.

• In this leaflet, Meriofert 150 UI powder and solvent for injectable solution is referred to as Meriofert Kit.

Contents of the leaflet

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

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

• Meriofert Kit is used to stimulate ovulation in women who do not ovulate and who have not responded to other treatment (clomiphene citrate).

• Meriofert Kit is used to induce the development of multiple follicles (and therefore multiple oocytes) in women undergoing fertility treatment.

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

Each vial contains a freeze-dried 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 postmenopausal women. Human chorionic gonadotropin (hCG), extracted from the urine of pregnant women, is added to contribute to the total LH activity.

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

2. What you need to know before starting Meriofert Kit

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

Do not use Meriofert Kit

• If you have an increased size of your ovaries or cysts not caused by a hormonal disorder (e.g. polycystic ovarian disease).
• If you have unexplained vaginal bleeding.
• If you have cancer of the ovary, uterus, or breast.
• If you have an abnormal swelling (tumour) of the pituitary gland or hypothalamus (in the brain).
• If you are allergic to menotropin or to any of the other ingredients of this medicine (listed in section 6).

You should not use this medicine if you have premature menopause, genital malformations, or certain uterine tumours that would prevent a normal pregnancy.

Warnings and precautions

Talk to your doctor before starting to use Meriofert Kit.

Although allergic reactions to Meriofert Kit have not yet been reported, you should inform your doctor if you have ever had an allergic reaction to similar medicines.

This treatment increases the risk of developing a condition called ovarian hyperstimulation syndrome (OHSS) (see section 4). If ovarian hyperstimulation occurs, treatment will be stopped and pregnancy must be avoided. Early signs of OHSS include lower abdominal pain, nausea (feeling unwell), vomiting, and weight gain. If these symptoms occur, you should see a doctor as soon as possible. In rare but severe cases, the ovaries may enlarge and fluid may accumulate in the abdomen or chest.

The medicine used to trigger final egg release (containing human chorionic gonadotropin, hCG) may increase the risk of OHSS. Therefore, hCG should not be used if OHSS is occurring, and sexual intercourse should be avoided for at least 4 days, even when using a barrier contraceptive method.

It should be noted that women with fertility problems have a higher rate of miscarriage than the general population.

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

The risk of ectopic pregnancy (pregnancy outside the uterus) is slightly higher in women with damage to the Fallopian tubes.

Multiple pregnancies and parental characteristics in fertility treatments (e.g. maternal 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 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 with your doctor before starting treatment, especially:

• If you already know you have an increased risk of thrombosis.
• If you or a close family member has ever had thrombosis.
• If you have severe obesity.

Paediatric population

This medicine is not intended for use in children.

Using Meriofert Kit with other medicines

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

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, consult your doctor before using this medicine.

Driving and using machines

The effect of Meriofert Kit on the ability to drive and use machines is negligible or non-existent.

Meriofert Kit contains sodium

This medicine contains less than 23 mg (1 mmol) of sodium per dose and is therefore considered essentially "sodium-free".

3. How to use Meriofert Kit

Follow exactly the administration instructions for this medicine as given by your doctor. If in doubt, consult your doctor again.

Dosage and duration of treatment

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

Generally, the first injection of a 75 IU vial of menotropin is administered during the first week of the cycle following spontaneous or induced menstruation.

Subsequently, the daily dose of this medicine prescribed by your doctor should be injected, and treatment should continue until one or more mature follicles have developed in the ovary. Your doctor will adjust the dose of this medicine depending on the ovarian response, which is determined through clinical examinations.

Once a follicle has reached the necessary stage of development, treatment with this medicine will be stopped and ovulation will be triggered with another hormone (chorionic gonadotropin, hCG).

Ovulation usually occurs within 32 to 48 hours.

During this phase of treatment, fertilization is possible. You will be advised to have sexual intercourse daily starting from the day before hCG administration. If pregnancy does not occur despite ovulation, the treatment may be repeated.

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

The aim of this method is to achieve simultaneous multiple follicular development. Treatment will begin on day 2 or 3 of the cycle with injections of 150 to 300 IU of this medicine (1 or 2 vials of Meriofert Kit 150 IU). Your doctor may choose to administer higher doses if necessary. The dose of this medicine injected is higher than that used for natural fertilization. Your doctor will individually adjust the continuation of treatment.

Once a sufficient number of follicles have developed, treatment with this medicine will be stopped and ovulation will be triggered by injection of another hormone (chorionic gonadotropin, hCG).

How to administer Meriofert Kit

This medicine is administered as an injection under the skin (subcutaneously) or into the muscle (intramuscularly).

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

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

The first time you do this, your doctor should:

• allow you to practice self-administering a subcutaneous injection,
• indicate the sites where you may administer the injection,
• teach you how to prepare the injectable solution,
• explain how to prepare the correct dose for injection.

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

How to prepare and inject 1 vial of Meriofert Kit

The injection should be prepared immediately before you are ready to use it, using the pre-filled syringe of solvent (a solution of sodium chloride 9 mg/ml in water for injections) included in each Meriofert Kit pack.

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

Place the following items on the surface:

• two alcohol swabs (not included),
• one vial of Meriofert Kit powder,
• one pre-filled syringe with solvent,
• one needle for preparing the injection,
• one fine needle for subcutaneous injection.

REMEMBER: Do not remove the support tab (white piece) from the pre-filled syringe, as it prevents the plunger from being accidentally withdrawn and improves syringe handling during injection.

Reconstitution of the injectable solution

Preparation of the injection

1. • Remove the cap from the pre-filled syringe; insert the reconstitution needle (long needle) into the syringe.
   • Carefully place the syringe on the clean surface.
   • Avoid touching the needle.

Prepare the solution for injection

1. • Remove the colored plastic cap (light green for the 75 IU presentation and dark green for the 150 IU presentation) from the Meriofert Kit vial by gently pushing it upward.

• Clean the rubber top with an alcohol-impregnated swab and wait for it to dry.

1. • Pick up the syringe, remove the protective cap from the needle, and insert the needle through the center of the rubber top of the Meriofert Kit vial.

• Firmly push the plunger down to spray all the solution onto the powder.
• DO NOT SHAKE THE VIAL; gently swirl it in circles until a clear solution is obtained.
  The medicine usually dissolves immediately.

1. • With the needle still inserted, turn the vial upside down.

• Ensure the tip of the needle is below the liquid level.
• Carefully pull the plunger to draw all the Meriofert Kit solution into the syringe.

• Check that the reconstituted solution is clear.

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

Subcutaneous injection of the medicine

• When the syringe contains the prescribed dose, place the protective needle cap on. Remove the reconstitution needle from the syringe and replace it with the fine subcutaneous injection needle with its protective cap.
• Firmly insert the fine needle into the syringe barrel and then slightly twist it to ensure it is fully screwed on and forms a tight seal.
• Remove the protective cap from the needle. Hold the syringe with the needle pointing upward and gently tap the side of the syringe to allow air bubbles to rise to the top;
• Push the plunger until a drop of liquid appears at the tip of the needle.
• Do not use if the solution contains particles or appears cloudy.

Injection site

• Your doctor or nurse will have already explained to you where on your body the medicine should be administered. Common sites are the thigh or the lower abdominal wall below the navel.

• Clean the injection site with an alcohol swab.

Insertion of the needle

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

Injection of the solution

• Inject the syringe under the skin as instructed. Do not inject directly into a vein. Push the plunger slowly and steadily so that the solution is properly injected 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 alcohol-impregnated swab. Gentle massage of the area (while maintaining pressure) helps to disperse the Meriofert Kit solution and relieve any discomfort.

Intramuscular injection of the medicine

For intramuscular injections, a healthcare professional will prepare and administer this medicine into the outer thigh or buttock.

Dispose of all used items

After completing the injection, place all needles, empty vials, and syringes into a sharps 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 Meriofert Kit than you should

The effects of an overdose of this medicine are unknown; however, ovarian hyperstimulation syndrome would be expected (see section 4). If you use more medicine than you should, consult your doctor or nurse.

If you forget to use Meriofert Kit

Use it as soon as you remember, within the time of your next scheduled injection. Do not take a double dose to compensate for missed doses.

If you stop using Meriofert Kit

Do not stop treatment on your own initiative.

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.

The following adverse effect is important and will require immediate intervention if it occurs. You must stop taking this medicine and contact your doctor immediately if the following occurs:

Frequent: may affect up to 1 in 10 people

• Ovarian hyperstimulation syndrome (symptoms include formation of ovarian cysts or increase in size of existing cysts, pain in the lower abdomen, feeling thirsty and nauseous with occasional vomiting, passage of small amounts of concentrated urine, and weight gain) (see section 2 for additional information).

The following adverse effects have also been reported:

Very common: may affect more than 1 in 10 people

• Headache
• Stomach swelling or flatulence

Common: may affect up to 1 in 10 people

• Abdominal pain or discomfort
• Pelvic pain
• Back pain
• Feeling of heaviness
• Breast discomfort
• Dizziness
• Hot flushes
• Thirst
• Feeling unwell
• Fatigue
• Malaise
• Reactions at the injection site, such as pain and inflammation (more common with IM injection than 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 which detaches and travels through the bloodstream to block another vessel).

Reporting of 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 leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Meriofert Kit

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

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

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

Use immediately after reconstitution.

Do not use this medicine if you notice that the solution is not clear. After reconstitution, the solution must be clear and colourless.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE 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 container and additional information

Composition of Meriofert Kit

The active substance is menotropin.

Each vial contains a 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 postmenopausal women.

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

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

Meriofert Kit 150UI powder and solvent for injectable solution
Number of vials used	Total amount of menotropin in 1 ml of solution
1	150 IU
2	300 IU
3	450 IU

The other components are

Vial of powder: monohydrate lactose

Pre-filled syringe with solvent: 9 mg/ml sodium chloride solution

Appearance of the product and contents of the pack

Powder: white lyophilized cake or powder

Solvent: clear, colourless solution

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

1 pack contains the following:

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

Supplied in packs of 1, 5 or 10 kits.

Only certain 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

or (for the United Kingdom)

IBSA Pharma Limited

Units 4-6

Colonial Business Park

Colonial Way

Watford WD24 4PR

United Kingdom

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

Instituto Bioquímico Ibérico IBSA S.L.

Avenida Diagonal 605,

8th Floor, Local 1,

08028 Barcelona (Spain)

This medicinal product is authorized in the Member States of the European Economic Area under the following names (concentrations and pharmaceutical forms are identical in all countries; only the brand names differ):

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: 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: Meriofert Set

Date of the most recent review of this leaflet: May 2024

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