Meriofert Kit 900 IU powder and solvent for solution for injection

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Meriofert Kit 900 UI powder and solvent for solution for injection

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, pharmacist or nurse.

• 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, pharmacist or nurse, even if these effects are not listed in this leaflet. See section 4.

• In this leaflet, Meriofert Kit 900 UI powder and solvent for solution for injection 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 multidose vial contains lyophilized powder with 900 IU of human follicle-stimulating hormone (FSH) activity and 900 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 must be used under the supervision of a physician.

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

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

Do not use Meriofert Kit

• If you have enlarged ovaries or cysts not caused by a hormonal disorder (polycystic ovarian disease)
• 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 (listed in section 6).

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

Warnings and precautions

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 Possible side effects). If ovarian hyperstimulation occurs, treatment will be stopped and pregnancy must be avoided. Early signs of ovarian hyperstimulation include lower abdominal pain, nausea (feeling unwell), vomiting, and weight gain. If these symptoms occur, you should be examined by 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 medication used to trigger the final release of mature eggs (containing hCG) may increase the likelihood of developing 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-stimulating 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 tubal damage.

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, as with pregnancy itself, may increase the likelihood of thrombosis. Thrombosis is the formation of a blood clot in a blood vessel, most commonly 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.

Use of 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, breastfeeding and fertility

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

Driving and using machines

The effect of Meriofert Kit on the ability to drive and use machines is negligible or none.

Meriofert Kit contains sodium

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

3. How to use Meriofert Kit

Dosage and duration of treatment

Follow exactly the instructions for administration of this medicine given 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 75 IU vial of menotropin is administered during the first week of the cycle following spontaneous or induced menstruation.

Subsequently, inject the dose of this medicine prescribed by your doctor every day, continuing treatment 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 by 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 the day before hCG administration. If pregnancy does not occur despite ovulation, 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 the second or third day of the cycle with injections of 150 to 300 IU of Meriofert Kit. 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).

Vials should only be reconstituted once, and each single injection should be administered as soon as the required dose has been drawn up.

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

Before your first injection, your doctor should:

• Allow you to practice self-administration of 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, read the following instructions carefully.

Since this vial contains medication for several days of treatment, you must ensure that you only withdraw the amount of medication prescribed by your doctor. Your doctor has prescribed a dose of Meriofert Kit in IU (units). To obtain the correct dose, use one of the 12 disposable syringes graduated in FSH/LH IU units supplied in the package.

These disposable syringes are for single use only and must be discarded after administration according to local regulations into an appropriate container.

How to prepare and inject 1 vial of Meriofert Kit:

The injectable solution containing 900 IU of menotropin must be prepared just before the first dose is administered. To do this, add the solvent from the pre-filled 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 important that your hands and the items you use are as clean as possible.

Place the following items on the surface:

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

REMEMBER:

• Disinfect the rubber stopper of the vial containing the reconstituted solution with cotton and disinfectant (i.e., alcoholic solution) and allow it to dry before reconstitution and before each administration.
• Do not remove the support tab (white piece) from the pre-filled syringe, as it prevents unintentional plunger withdrawal and improves syringe handling during injection.

Reconstitution of the injectable solution

Preparation of the pre-filled syringe:

1.

• Remove the cap from the pre-filled syringe with solvent; attach the reconstitution needle with the protective cap still on the syringe.
  • Carefully place the syringe on a clean surface.

Preparation of the vial:

2.

• Remove the colored plastic flip-off cap from the vial by gently pushing it upward with your thumb.

• Clean the area of the rubber stopper with cotton and disinfectant solution and let it dry.

• Take the syringe, remove the protective cap from the needle, and press the needle through the center of the rubber stopper of the vial.
• Firmly push the plunger to empty all the solution onto the powder.
• Adding the solvent creates slight overpressure in the vial. Therefore, release the syringe plunger so it rises by itself for about 10 seconds. This will eliminate overpressure in the vial.

DO NOT SHAKE the reconstituted solution; gently swirl until a clear solution is obtained. The medicine usually dissolves immediately.

Check that the reconstituted solution is clear.

Before injection:

• Check that the reconstituted solution is clear, colorless, and free of particles. DO NOT USE if the solution contains particles, is cloudy, or not colorless.
• Clean the area of the rubber stopper with cotton and disinfectant solution.

Preparation of the injection:

4.

• Take one of the disposable syringes with fixed 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 fully down.
• Invert the vial. Make sure the needle is below the surface of the medicine and withdraw the prescribed dose of medicine into the administration syringe.
• Remove the needle from the vial. Hold the syringe with the needle pointing upward and gently tap the side of the syringe to force any air bubbles to rise.
• Slowly push the plunger 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 withdraw the amount of medication prescribed by your doctor.

Administration of the injection

Injection site:

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

• Clean the injection site with an alcohol-impregnated cotton swab.

• 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 continuously so the solution is properly injected and skin tissues are not damaged.

Take the time needed to inject the volume of solution prescribed.

Quickly withdraw the needle and press the injection site with a cotton swab soaked in disinfectant. Gently massage the area (while maintaining pressure), which helps disperse the medicine and relieve possible discomfort.

Subsequent injections:

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

If you use more Meriofert Kit than you should

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

If you forget to use Meriofert Kit

Use it at the time when your next injection is normally due. Do not take a double dose to make up for missed doses.

If you stop using Meriofert Kit

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

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 serious and requires 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 the size of existing cysts, pain in the lower abdomen, feeling of thirst, nausea 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
• General malaise
• Reactions at the injection site, such as pain and inflammation

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

• Ovarian torsion (twisting of the ovary causing severe pain in the lower abdomen)
• Thromboembolism (formation of a blood clot in a blood vessel that 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 use this medicine after the expiry date stated on the outer packaging, the vial, and the pre-filled solvent syringe after EXP. If the expiry date is stated as month/year, the expiry date refers to the last day of the specified month.

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

After reconstitution, the solution may be stored for up to 28 days at a temperature not exceeding 25°C.

Do not freeze, either before or after reconstitution.

Do not use this medicine if the solution is not clear. After reconstitution, the solution should be clear and colourless.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Meriofert Kit

The active substance is menotropin.

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

Other components are

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

Solvent: metacresol and water for injections.

Appearance of Meriofert Kit and contents of the pack

Powder: white lyophilized cake or powder.

Solvent: clear, colourless solution.

Meriofert Kit is supplied as a powder and solvent for injectable solution.

One pack contains:

• 1 vial of Meriofert Kit powder
• 1 pre-filled syringe with solvent for reconstitution
• 1 needle for reconstitution
• 12 alcohol swabs for multiple injections
• 12 disposable syringes with fixed needles for multiple injections

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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 United Kingdom/Northern Ireland)
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 Authorisation Holder:

Instituto Bioquimico Iberico IBSA S.L.
Avenida Diagonal 605,
8th Floor, Premises 1,
08028 Barcelona (Spain)

This medicinal product is authorised 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 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

Date of the most recent revision 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