Mensinorm set

Package leaflet: Information for the patient

Mensinorm Set, 75 IU
Mensinorm Set, 150 IU
powder and solvent for solution for injection
Menotropinum
Please read all of this leaflet carefully before 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 further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• In this leaflet, the medicine Mensinorm Set 75 IU powder and solvent for solution for injection and the medicine Mensinorm Set 150 IU powder and solvent for solution for injection are referred to as Mensinorm Set.

Contents of the leaflet:

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

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

Mensinorm Set is a highly purified human menopausal gonadotropin belonging to a group of medicines called gonadotropins.
Each vial contains a lyophilized powder containing 75 IU of human follicle-stimulating hormone (FSH) and 75 IU of human luteinizing hormone (LH).
Human menopausal gonadotropin (hMG) is obtained from the urine of postmenopausal women.
To increase total LH activity, human chorionic gonadotropin (hCG) — a hormone obtained from the urine of pregnant women — has been added.
Each vial contains a lyophilized powder containing 150 IU of human follicle-stimulating hormone (FSH) and 150 IU of human luteinizing hormone (LH).
Human menopausal gonadotropin (hMG) is obtained from the urine of postmenopausal women.
To increase total LH activity, human chorionic gonadotropin (hCG) — a hormone obtained from the urine of pregnant women — has been added.
This medicine should be taken under the supervision of a doctor.

2. Important information before using Mensinorm Set

Before starting treatment, fertility will be assessed in both partners.
Do not use Mensinorm Set if the patient has any of the following conditions:

• hypersensitivity (allergy) to menotropin or any of the other components of Mensinorm Set (listed in section 6);
• enlarged ovaries or ovarian cysts not caused by hormonal disorders (polycystic ovary syndrome);
• unexplained vaginal bleeding;
• ovarian, uterine or breast cancer;
• pituitary or hypothalamic tumour (a part of the brain);

This medicine should not be used in women with early menopause, reproductive organ malformations, or certain uterine tumours that prevent normal pregnancy development.
Warnings and precautions
To date, no cases of allergic reactions to Mensinorm Set have been reported. However, if the patient has previously experienced allergic reactions to similar medicines, this should be reported to the doctor.
Use of this medicine increases the risk of a condition called ovarian hyperstimulation syndrome (OHSS) (see section 4 Possible side effects). If ovarian hyperstimulation syndrome occurs, treatment will be stopped and fertilisation must be avoided. Early symptoms of ovarian hyperstimulation include lower abdominal pain, nausea, vomiting and weight gain. If any of these symptoms occur, consult a doctor as soon as possible. In severe, although rare, cases, ovarian enlargement and accumulation of fluid in the abdominal cavity or chest cavity may occur.
The medicine used to trigger the release of mature oocytes (containing human chorionic gonadotropin (hCG)) may increase the risk of OHSS. Therefore, hCG should not be administered if OHSS is developing. Sexual intercourse should be avoided, even when using mechanical contraceptive methods, for at least 4 days.
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 multiple births is higher than with natural conception. However, this risk can be reduced by using the recommended dose of the medicine.
Women with blocked fallopian tubes have a slightly increased risk of ectopic pregnancy.
Multiple pregnancy and characteristics of infertility treatment patients (e.g. female age, semen parameters) may be associated with an increased risk of congenital abnormalities.
Use of Mensinorm Set, as well as pregnancy itself, may increase the risk of thrombosis. Thrombosis refers to the formation of a blood clot in a blood vessel, most commonly in the veins of the lower limbs or in the lungs.
Before starting treatment, discuss this with your doctor, especially in the following cases:

• the patient has previously been diagnosed with an increased risk of thrombosis;
• the patient or a close family member has previously experienced thrombosis;
• the patient has severe obesity.

Children
This medicine is not intended for use in children.
Interaction of Mensinorm Set with other medicines
Tell your doctor or pharmacist 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 effects on fertility
Mensinorm Set must not be used during pregnancy or while breastfeeding.
Driving and operating machinery
Mensinorm Set has no effect or has a negligible effect on the ability to drive and operate machinery.
Mensinorm Set contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium in the prepared solution, meaning the medicine is considered "sodium-free".

3. How to use Mensinorm Set

Recommended dose and duration of treatment:
This medicine should always be used as directed by the physician. If in doubt, consult your doctor.

Women who do not ovulate, have irregular menstruation or absence of menstruation:
The first injection of the contents of one vial of Mensinorm Set 75 IU is usually administered during the first week of the menstrual cycle, following the onset of natural or induced menstruation.
Then, Mensinorm Set should be administered daily at the dose prescribed by the physician, and treatment continues until at least one mature ovarian follicle has developed in the ovary. The physician will adjust the dose of Mensinorm Set according to the ovarian response, as determined by diagnostic tests.
When one follicle reaches the required stage of development, administration of Mensinorm Set will be discontinued and ovulation will be triggered using another hormone (chorionic gonadotropin, hCG).
Ovulation usually occurs 32–48 hours after hCG administration.
At this stage of treatment, conception is possible. Sexual intercourse is recommended daily, starting from the day before hCG administration. If pregnancy does not occur despite ovulation, treatment may be repeated.

Women undergoing ovarian stimulation to induce development of multiple ovarian follicles prior to in vitro fertilization or other assisted reproductive techniques:
The aim of this method is to achieve simultaneous development of multiple ovarian follicles. Treatment begins on day 2 or 3 of the menstrual cycle with an injection of 150–300 IU of Mensinorm Set (the contents of 1–2 vials of Mensinorm Set 150 IU). The physician may recommend higher doses if necessary. The dose of Mensinorm Set is higher than that used for natural conception. The further course of treatment is individually adjusted by the physician.
When a sufficient number of follicles have reached the required stage of development, administration of Mensinorm Set will be discontinued and ovulation will be triggered by injection of another hormone (chorionic gonadotropin, hCG).

How to use Mensinorm Set:
Mensinorm Set is administered by subcutaneous injection (subcutaneous administration - sc.) or intramuscular injection (intramuscular administration - im.).
Each vial must be used only once, and the injection should be performed as soon as possible after preparing the solution for injection.

After appropriate consultation and training, the physician may recommend self-administration of Mensinorm Set injections.
When first using the medicine, the physician should:

• provide training in self-administration of subcutaneous injections;
• indicate the body sites where self-injection may be performed;
• demonstrate how to prepare the solution for injection;
• explain how to prepare the correct dose of the medicine for injection.

Before self-administering Mensinorm Set, carefully read the instructions below.

Instructions for preparing and injecting the contents of one vial of Mensinorm Set:
The injection solution must be prepared immediately before injection using the prefilled syringe containing solvent (9 mg/ml sodium chloride solution in water for injections) provided in each package of Mensinorm Set.
Prepare a clean surface and wash hands thoroughly. It is essential to maintain maximum cleanliness of hands and equipment used.
On the surface, place the following items:

• two alcohol swabs (not included in the package);
• one vial of Mensinorm Set powder;
• one prefilled syringe with solvent;
• one needle for preparing the injection solution;
• a thin needle for subcutaneous injection.
  Do not remove the backstop safety feature (white collar) from the prefilled syringe, as it prevents accidental plunger removal and facilitates syringe handling during injection.

Reconstitution of the injection solution
Preparing the injection solution:

1. • Remove the cap from the prefilled syringe; attach the (long) needle for reconstitution to the prefilled syringe.
   • Carefully place the prefilled syringe on a clean surface.
   • Do not touch the needle.

Preparing the injection solution:

2. • Remove the colored plastic cap (light green for the 75 IU dose, dark green for the 150 IU dose) from the Mensinorm Set vial, gently lifting it upward.
   • Wipe the rubber stopper of the vial with an alcohol swab and wait until it dries.
3. • Hold the prefilled syringe, remove the protective needle cap, and insert the needle into the center

of the rubber stopper of the Mensinorm Set vial.

• Firmly press the plunger of the prefilled syringe to inject the entire solvent solution into the powder.
• DO NOT SHAKE, but gently swirl the vial until a clear solution is obtained. Mensinorm Set usually dissolves immediately.

4. • Without removing the needle from the vial, turn the vial upside down.
   • Ensure the needle tip is below the liquid surface.
   • Gently pull back the plunger to withdraw the entire Mensinorm Set solution into the syringe.
   • Confirm that the reconstituted solution is clear.

If reconstituting more than one vial of Mensinorm Set, withdraw the reconstituted contents of the first vial into the syringe, then, after repeating steps 2–4, slowly inject it into the second vial.

Performing subcutaneous injection:

• After withdrawing the prescribed dose of the medicine into the prefilled syringe, attach the protective needle cap. Remove the reconstitution needle from the prefilled syringe and replace it with a thin needle for subcutaneous injection, including its protective cap.

• Firmly press the thin needle onto the prefilled syringe, then slightly twist to ensure it is fully and securely attached.

• Remove the protective needle cap. Holding the prefilled syringe with the needle pointing upward, gently tap the side to move all air bubbles to the top.

• Press the plunger until a drop of liquid appears at the needle tip.

• Do not use if the solution contains any particles or appears cloudy.

Injection site:

• The patient should have previously been instructed by the physician or nurse regarding suitable body sites for injection. Usually, the injection site is the thigh or the lower abdominal wall, below the navel.
• Clean the injection site with an alcohol swab.

Inserting the needle:

• With fingers, firmly pinch a skin fold. With the other hand, insert the needle quickly and decisively at a 45° or 90° angle.

Injecting the solution:

• Inject the solution under the skin as instructed. Do not inject directly into a blood vessel. Press the plunger slowly and steadily to ensure proper injection and to avoid tissue damage.

Inject the prescribed volume slowly. Depending on the dose prescribed by the physician, it may not be necessary to inject the entire solution volume.

Removing the needle:

• Quickly withdraw the syringe, pulling out the needle, then press the injection site with an alcohol swab. Gentle massage while applying pressure helps distribute Mensinorm Set and reduces discomfort.

Performing intramuscular injection:
For intramuscular injections, a healthcare professional will prepare Mensinorm Set and then administer the injection into the patient’s thigh or buttock.

Disposal of all used materials:
After injection, place all needles, empty vials, and prefilled syringes into a sharps container. Any unused solution or waste must be disposed of in accordance with local regulations.

Use of a higher than recommended dose of Mensinorm Set:
The effects of overdosage with Mensinorm Set are not known, but ovarian hyperstimulation syndrome is likely (see section 4 Possible side effects). If a higher than recommended dose of Mensinorm Set has been administered, consult a physician or nurse.

Missed dose of Mensinorm Set:
Take the next dose at the scheduled time. Do not use a double dose to make up for a missed dose.

Stopping treatment with Mensinorm Set:
Do not discontinue the medicine on your own. If in doubt about continuing treatment, always consult your physician.

If you have any further questions about the use of this medicine, consult your physician or pharmacist.

4. Possible adverse reactions

Like all medicines, Mensinorm Set can cause adverse reactions, although not everyone will experience them.
The adverse reaction described below is serious and requires immediate action if it occurs. If the following adverse reaction occurs, discontinue use of Mensinorm Set and consult a doctor immediately:

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

• Ovarian hyperstimulation syndrome (symptoms include formation of cysts on the ovaries or enlargement of existing cysts, lower abdominal pain, feeling of thirst, nausea, vomiting, passing smaller amounts of concentrated urine, and weight gain) (additional information – see section 2, Important information before use of Mensinorm Set).

The following adverse reactions 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 flushes,
• feeling thirsty,
• nausea,
• feeling tired,
• general feeling of malaise,
• injection site reactions such as pain and inflammation (more frequent with intramuscular than subcutaneous administration).

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

• ovarian torsion (twisting of the ovary causing severe lower abdominal pain).

Very rare (may affect up to 1 in 10,000 people):

• thromboembolic disease (formation of a blood clot in a blood vessel, detachment of the clot, its movement with the bloodstream, and subsequent blockage of another blood vessel by the clot).

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warszawa
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to 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 store above 25°C. Store the vial and the solvent pre-filled syringe in the cardboard box to protect from light.
Do not use this medicine after the expiry date stated on the outer packaging, vial, and solvent pre-filled syringe following EXP. If the expiry date is stated as month/year, the expiry date refers to the last day of the stated month.
Use immediately after reconstitution.
Do not use Mensinorm Set if cloudiness of the solution is observed. After reconstitution, the solution should be clear and colourless.
Medicines should not be disposed of via wastewater. 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 vial contains a lyophilized powder containing 75 IU of human follicle-stimulating hormone (FSH) and 75 IU of human luteinizing hormone (LH).
Human menopausal gonadotropin (HMG) is obtained from the urine of postmenopausal women.
To increase total LH activity, human chorionic gonadotropin (hCG) has been added — a hormone obtained from the urine of pregnant women.
Each vial contains a lyophilized powder containing 150 IU of human follicle-stimulating hormone (FSH) and 150 IU of human luteinizing hormone (LH).
Human menopausal gonadotropin (HMG) is obtained from the urine of postmenopausal women.
To increase total LH activity, human chorionic gonadotropin (hCG) has been added — a hormone obtained from the urine of pregnant women.
When multiple vials of powder are used, the amount of menotropin contained in 1 ml of reconstituted solution will be as follows:

Excipients:
In the case of powder: monohydrate lactose.
In the case of solvent: 9 mg/ml sodium chloride solution.
What Mensinorm Set looks like and contents of the pack
Powder: white lyophilized disc or powder
Solvent: clear, colourless solution
Mensinorm Set is available as a powder and solvent for solution for injection.
One set contains the following components:

• one vial with a white lyophilized disc or powder;
• one ampoule-syringe (1 ml) with a clear, colourless solution;
• one (long) needle for reconstitution of the solution and intramuscular injection;
• one (short) needle for subcutaneous injection.
  The medicinal product is available in packs containing 1, 5 or 10 sets. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:
IBSA Farmaceutici Italia srl
Via Martiri di Cefalonia, 2
26900 Lodi – Italy
[email protected]
This medicinal product is authorised in the European Economic Area countries under the following names:
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
Lithuania: Meriofert Set
Latvia: Meriofert 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