Mensinorm Set

Leaflet accompanying the packaging: patient information

Mensinorm Set, 900 IU

Powder and solvent for solution for injection
Menotropin

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor, pharmacist, or nurse. See section 4.
• In this leaflet, Mensinorm Set 900 IU powder and solvent for solution for injection is referred to as Mensinorm Set.

Table of contents of the leaflet

• 1. What is Mensinorm Set and what is it used for
• 2. Important information before using Mensinorm Set
• 3. How to use Mensinorm Set
• 4. Possible side effects
• 5. How to store Mensinorm Set
• 6. Contents of the pack and other information

1. What is Mensinorm Set and what is it used for

• Mensinorm Set is used to stimulate ovulation in women who do not ovulate and for whom treatment with other medicines (clomiphene citrate) has not produced the expected results.
• Mensinorm Set is used to stimulate the development of multiple follicles (and thus multiple eggs) in women undergoing infertility treatment.

Mensinorm Set is a highly purified human menopausal gonadotropin, which belongs to a group of medicines called gonadotropins.
Each multidose vial contains lyophilized powder containing 900 IU of human follicle-stimulating hormone (FSH) and 900 IU of human luteinizing hormone (LH).
Human menopausal gonadotropin (HMG) is obtained from the urine of postmenopausal women. To increase the total LH activity, human chorionic gonadotropin (hCG) - a hormone obtained from the urine of pregnant women - has been added.
This medicine should be used under the supervision of a doctor.

2. Important information before using Mensinorm Set

Before starting treatment, an assessment of the fertility of both partners will be carried out.

When not to use Mensinorm Set:

• if the patient has enlarged ovaries or ovarian cysts not caused by hormonal disorders (polycystic ovary syndrome);
• if the patient has bleeding of unknown origin;
• if the patient has a tumor of the ovary, uterus, or breast;
• if the patient has a pituitary or hypothalamic tumor (parts of the brain);
• if the patient is allergic to menotropin or any of the other ingredients of this medicine (listed in section 6).

This medicine should not be used in women with early menopause, developmental abnormalities of the reproductive organs, or certain uterine tumors that prevent the development of a normal pregnancy.

Warnings and precautions

So far, no cases of allergic reactions to Mensinorm Set have been reported, but if the patient has experienced allergic reactions to similar medicines in the past, they should inform their doctor.
Taking this medicine increases the risk of a condition called ovarian hyperstimulation syndrome (OHSS) (see section 4 Possible side effects). If OHSS occurs, treatment will be discontinued and it will be necessary to avoid becoming pregnant. The first symptoms of ovarian hyperstimulation are abdominal pain, nausea (vomiting), vomiting, and weight gain. If these symptoms occur, the doctor should be consulted as soon as possible. In severe, but rare cases, it may lead to ovarian enlargement and fluid accumulation in the abdominal or chest cavity.
This medicine, used to release mature eggs (containing human chorionic gonadotropin, hCG), may also increase the likelihood of OHSS. Therefore, hCG is not recommended in the event of developing OHSS.
Sexual intercourse should not be engaged in for at least 4 days, even when using mechanical contraceptive methods.
In women with fertility problems, the risk of miscarriage is higher than in the general population.
In women undergoing treatment to induce ovulation, the risk of multiple pregnancies and births is higher than with natural conception. However, this risk can be reduced by using the recommended dose of the medicine.
In women with tubal abnormalities, there is a slightly increased risk of ectopic pregnancy.
Multiple pregnancy and characteristics of partners undergoing infertility treatment (e.g., woman's age, sperm parameters) may be associated with an increased risk of congenital anomalies.
Taking Mensinorm Set, like pregnancy itself, may increase the risk of thrombosis. Thrombosis is the formation of a blood clot in a blood vessel, most often in the veins of the legs or lungs.
Before starting treatment, the doctor should be consulted, especially in the following cases:

• if the patient has a history of increased risk of thrombosis;
• if the patient or someone in their immediate family has had a thrombosis in the past;
• if the patient has severe obesity.

Children

This medicine is not intended for use in children.

Mensinorm Set and other medicines

The doctor or pharmacist should be informed about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.

Pregnancy, breastfeeding, and fertility

Mensinorm Set should not be used during pregnancy or breastfeeding.

Driving and using machines

Mensinorm Set has no or negligible influence on the ability to drive and use machines.

Mensinorm Set contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per prepared solution, i.e., the medicine is considered "sodium-free".

3. How to use Mensinorm Set

Recommended dose and duration of treatment:

This medicine should always be used exactly as prescribed by the doctor. If you are unsure, consult your doctor.

Women who do not ovulate, with irregular periods or amenorrhea:

As a general rule, the first injection of 75 IU is given in the first week of the menstrual cycle after natural or induced menstrual bleeding.
Then, Mensinorm Set is administered daily in the dose prescribed by the doctor, and treatment is continued until at least one mature follicle has developed in the ovary. The doctor will adjust the dose of Mensinorm Set based on the ovarian response determined by diagnostic tests.
When one follicle has reached the required stage of development, the administration of Mensinorm Set will be discontinued, and ovulation will be induced with another hormone (human chorionic gonadotropin, hCG).
Ovulation usually occurs 32-48 hours later.
At this stage of treatment, fertilization is possible. It is recommended to have sexual intercourse every day, starting from the day before hCG administration. If pregnancy does not develop despite ovulation, treatment can be repeated.

Women undergoing ovarian stimulation to induce the development of multiple follicles before in vitro fertilization or other assisted reproduction techniques:

The goal of this method is to achieve the simultaneous development of multiple follicles. Treatment starts on the 2nd or 3rd day of the menstrual cycle with an injection of 150-300 IU of Mensinorm Set. The doctor may recommend higher doses if necessary.
The dose of Mensinorm Set is higher than that used for natural conception. The course of further treatment is individually adjusted by the doctor.
When the required number of follicles has reached the desired stage of development, the administration of Mensinorm Set will be discontinued, and ovulation will be induced with an injection of another hormone (human chorionic gonadotropin, hCG).

How to use Mensinorm Set:

Mensinorm Set is administered as a subcutaneous injection.
Each vial should be reconstituted only once, and each single injection should be given immediately after drawing up the required dose.

After proper consultation and training of the patient, the doctor may recommend that the patient administer the injections of Mensinorm Set herself.

Before the first injection of the medicine, the doctor should:

• allow the patient to practice self-administering a subcutaneous injection;
• indicate the areas of the body where self-injections can be given;
• demonstrate how to prepare the solution for injection;
• explain how to prepare the correct dose of the medicine for injection.

BEFORE SELF-ADMINISTERING THE INJECTION, READ THE FOLLOWING INSTRUCTIONS CAREFULLY.

Since the vial contains enough medicine for several days of treatment, make sure to only draw up the dose prescribed by the doctor. The doctor prescribes the dose of Mensinorm Set in IU (International Units). To obtain the correct dose, use one of the 12 syringes with a scale in FSH/LH IU.

These syringes are for single use only and should be discarded after each injection, in accordance with local requirements.

How to prepare and inject 1 vial of Mensinorm Set

The solution for injection containing 900 IU of menotropin should be prepared just before taking the first dose, by adding the solvent for reconstitution from the ampoule-syringe (contained in each package) to the vial containing the powder.
Prepare a clean surface and wash your hands with soap and warm water. It is essential to keep your hands and the objects you use as clean as possible.

Prepare the following materials:

• vial containing Mensinorm Set powder;
• ampoule-syringe containing solvent for reconstitution;
• needle for reconstitution;
• one single-use syringe with a pre-attached needle for subcutaneous administration with a scale in FSH/LH IU;
• one alcohol swab;
• swab and disinfectant solution (not included in the package).

REMEMBER: Before reconstitution and each subsequent administration, disinfect the rubber stopper of the vial containing the solution using a swab and disinfectant (e.g., alcohol solution) and let it dry. Do not remove the backstop-type protector (white ring) from the ampoule-syringe, as it prevents accidental removal of the cap and facilitates handling of the syringe during injection.

Reconstitution of the solution for injection:

• 1.
• Remove the cap from the ampoule-syringe containing the solvent; attach the reconstitution needle with a protective cap to the syringe.
• Carefully place the syringe on a clean surface.

Preparing the vial:

• 2.
• Remove the colored plastic flip-off cap from the vial by gently pushing it upwards with your thumb.
• Wipe the rubber stopper with an alcohol swab and let it dry.
• 3.
• Pick up the syringe, remove the protective cap from the needle, and insert the needle through the center of the rubber stopper of the vial.
• Press the plunger firmly to empty the entire solvent into the vial.
• During the addition of the solvent, a slight overpressure is created in the vial. Therefore, release the syringe plunger, allowing it to rise for about 10 seconds, which will relieve the overpressure in the vial.

DO NOT SHAKE the reconstituted solution, but gently rotate it until the solution is clear.
In almost all cases, Mensinorm Set dissolves immediately.
Check that the resulting solution is clear.

Before injection:

• 4.
• Check that the resulting solution is clear, colorless, and free from visible particles. DO NOT USE if the solution contains visible particles, is cloudy, or is not colorless.
• Clean the rubber stopper of the vial with an alcohol swab.

Preparing the injection:

• 5.
• Take one of the provided single-use 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.
• Press the plunger until it is fully pressed.
• Turn the vial upside down. Make sure the needle is below the surface of the medicine and draw up the prescribed dose of Mensinorm Set into the syringe for administration.
• Remove the needle from the vial. Hold the syringe with the needle pointing upwards and gently tap the side of the syringe to bring any air bubbles to the top.
• Slowly press the plunger until a drop of liquid appears at the tip of the needle.

REMEMBER: Since the vial contains enough medicine for several days of treatment, make sure to only draw up the dose prescribed by the doctor.

Administering the injection

Injection site:

• The patient should have been previously instructed by the doctor or nurse on the choice of injection site. Usually, the injection is given in the thigh or the lower abdomen, below the navel.
• Wipe the injection site with an alcohol swab.
• Hold the skin fold firmly between your fingers. With your other hand, insert the needle at a 45° or 90° angle with a quick, firm motion.

Injecting the solution:

• Inject the solution under the skin, following the instructions. Do not inject the solution directly into a vein. Press the plunger slowly and at a steady rate, so that the solution is administered correctly and the skin tissues are not damaged.

Inject the prescribed volume of the solution without rushing.

Remove the needle and press the injection site with an alcohol swab.
Gentle massage of the injection site while pressing helps to distribute Mensinorm Set and reduce discomfort.
Subsequent injections:
Subsequent injections from the prepared solution of Mensinorm Set should be repeated from step 4.

Using a higher dose of Mensinorm Set than recommended:

The effects of an overdose of Mensinorm Set are unknown, but it is likely to cause ovarian hyperstimulation syndrome (OHSS) (see section 4 Possible side effects). If a higher dose of Mensinorm Set is used than recommended, consult a doctor or nurse.

Missing a dose of Mensinorm Set:

The next dose should be taken at the planned time. Do not take a double dose to make up for a missed dose.

Stopping treatment with Mensinorm Set:

Do not stop treatment on your own. If you have any doubts about continuing treatment, always consult your doctor.
If you have any further questions about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Mensinorm Set can cause side effects, although not everybody gets them.
The following side effect is serious and requires immediate action if it occurs. If you experience the following side effect, stop using Mensinorm Set and consult your doctor immediately.
Common (may affect up to 1 in 10 people):

• Ovarian hyperstimulation syndrome (symptoms include the formation of cysts on the ovaries or enlargement of existing cysts, abdominal pain, thirst, nausea, vomiting, reduced amounts of concentrated urine, and weight gain) (see also section 2 Important information before using Mensinorm Set).

The following side effects have also been reported:

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

• headache,
• swollen or bloated abdomen.

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

• abdominal pain or discomfort,
• pelvic pain,
• back pain,
• feeling of heaviness,
• breast discomfort,
• dizziness,
• hot flashes,
• thirst,
• nausea,
• fatigue,
• general feeling of being unwell,
• reaction at the injection site, such as pain and inflammation (more common with intramuscular injections than subcutaneous injections).

Rare (may affect up to 1 in 1000 people):

• ovarian torsion (twisting of the ovary causing severe abdominal pain),
• thromboembolic disease (formation of a blood clot in a blood vessel, which breaks loose and travels with the blood, and then blocks another blood vessel).

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Mensinorm Set

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the outer packaging, vial, and ampoule-syringe with solvent after: EXP. If the expiry date is stated as a month and year, the expiry date refers to the last day of the stated month.
Before reconstitution: store in a refrigerator (2-8°C).
After reconstitution, the solution can be stored for a maximum of 28 days at a temperature not exceeding 25°C.
Do not freeze before or after dissolution.
Do not use Mensinorm Set if you notice that the solution has become cloudy. After reconstitution, the solution should be clear and colorless.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Mensinorm Set contains

The active substance is menotropin.
Each multidose vial contains lyophilized powder containing 900 IU of human follicle-stimulating hormone (FSH) and 900 IU of human luteinizing hormone (LH).
Human menopausal gonadotropin (HMG) is obtained from the urine of postmenopausal women. To increase the total LH activity, human chorionic gonadotropin (hCG) - a hormone obtained from the urine of pregnant women - has been added.

Excipients

Powder: lactose monohydrate, polysorbate 20, disodium phosphate dihydrate, phosphoric acid, sodium hydroxide.
Solvent: m-cresol, water for injections.

What Mensinorm Set looks like and contents of the pack

Powder: white lyophilized disc or powder
Solvent: clear and colorless solution
Mensinorm Set is a powder and solvent for solution for injection, packaged in a cardboard box.
1 set contains the following:

• one vial containing Mensinorm Set powder;
• one ampoule-syringe containing solvent for reconstitution;
• one reconstitution needle;
• 12 alcohol swabs for injections;
• 12 single-use syringes with pre-attached needles for injections.

Marketing authorization holder and manufacturer:

IBSA Farmaceutici Italia srl
Via Martiri di Cefalonia, 2
26900 Lodi
Italy
To obtain more detailed information, contact the local representative of the marketing authorization holder:
IBSA Poland Sp. z o.o.
Al. Jana Pawła II 29
00-867 Warsaw
phone: +48 22 653 68 60
This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names: (the strength and pharmaceutical form are the same in all countries, only the trade name differs)
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
Spain: Meriofert Kit
Netherlands: Meriofert spuit
Lithuania: Meriofert Set
Luxembourg: Fertinorm Kit
Latvia: Meriofert Set
Norway: Meriofert Set
Poland: Mensinorm Set
Romania: Meriofert PFS
Slovakia: Meriofert Kit
Sweden: Meriofert Set
Hungary: Meriofert Kit
United Kingdom (Northern Ireland): Meriofert PFS
Italy: Meriofert
Date of last revision of the leaflet:May 2024