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 use, as it contains information important for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any questions, please consult 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 the patient experiences any adverse reactions, including any not listed in this leaflet, she should inform her doctor or pharmacist. See section 4.
• In this leaflet, Mensinorm Set 75 IU powder and solvent for solution for injection and Mensinorm Set 150 IU powder and solvent for solution for injection are collectively referred to as Mensinorm Set.

Leaflet contents:

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 (clomiphene citrate) has not been successful.
• Mensinorm Set is used to stimulate the development of multiple ovarian follicles (and thus multiple oocytes) 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) 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.
This medicine should be used under the supervision of a doctor.

2. Important information before using Mensinorm Set

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

• hypersensitivity (allergy) to menotropin or any of the other ingredients of Mensinorm Set (listed in section 6);
• enlarged ovaries or ovarian cysts not caused by hormonal disorders (polycystic ovary syndrome);
• vaginal bleeding of unknown cause;
• ovarian, uterine, or breast cancer;
• enlargement (tumor) of the pituitary gland or hypothalamus (a part of the brain);

This medicine should not be used in women with early menopause, malformations of the reproductive organs, or certain uterine tumors that prevent normal pregnancy development.
Warnings and precautions

Allergic reactions to Mensinorm Set have not been reported so far; 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 OHSS occurs, treatment will be discontinued and fertilization must be avoided. Early symptoms of ovarian hyperstimulation include lower abdominal pain, nausea, vomiting, and weight gain. If any of these symptoms occur, medical advice should be sought immediately. In severe, although rare, cases, enlargement of the ovaries and accumulation of fluid in the abdominal cavity or chest cavity may occur.
Medicines used to trigger the release of mature oocytes (containing human chorionic gonadotropin, hCG) may increase the risk of OHSS. Therefore, hCG should not be used 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. 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 infertile couples undergoing treatment (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 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 had thrombosis in the past;
• the patient has morbid obesity.

Children
This medicine is not intended for use in children.
Mensinorm Set and other medicines
Inform 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 effect on fertility
Mensinorm Set must not be used during pregnancy or breastfeeding.
Driving and operating machinery
Mensinorm Set has no effect or negligible effect on the ability to drive and operate machinery.
Mensinorm Set contains sodium
The reconstituted solution contains less than 1 mmol (23 mg) of sodium, 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. In case of doubt, consult your
doctor.
Women who do not ovulate, with 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.
Mensinorm Set is then 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 determined by diagnostic
examinations.
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, fertilization is possible. Sexual intercourse is recommended daily, starting
from the day preceding 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 prescribe 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 the appropriate number of ovarian follicles reaches 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 of the medicine may 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 sites on the body where self-injections may be performed;
• demonstrate the method of preparing the injection solution;
• explain how to prepare the appropriate dose of the medicine for injection.

Before self-administering a Mensinorm Set injection, carefully read the instructions below.
Instructions for preparing and administering the contents of one vial of Mensinorm Set:
The injection solution must be prepared immediately before injection using a prefilled syringe
containing solvent (9 mg/ml sodium chloride solution in water for injections) supplied in each
Mensinorm Set package.
Prepare a clean surface and wash your hands. It is essential to maintain maximum cleanliness of the
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;
• one fine 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 by gently lifting it upward.
   • Wipe the rubber stopper of the vial with an alcohol swab and wait for it to dry.
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 surface of the liquid.
   • Gently pull the plunger to withdraw the entire Mensinorm Set solution into the syringe.
   • Ensure 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 a subcutaneous injection of the medicine:

• After drawing up 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 fine needle for subcutaneous injection, including its protective cap.
• Firmly push the fine needle onto the prefilled syringe, then slightly twist it 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 of the syringe 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 injection sites on the body. The usual injection sites are the thigh or the lower abdominal wall below the navel.
• Clean the injection site with an alcohol swab.

Inserting the needle:

• Firmly pinch a fold of skin with your fingers. 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 vein. 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 volume.
Removing the needle:

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

Performing an intramuscular injection of the medicine:
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 the 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 treatment with the medicine on your own. In case of 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, stop using Mensinorm Set and consult a doctor immediately:

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

• Ovarian hyperstimulation syndrome (symptoms include formation of ovarian cysts or enlargement of existing cysts, lower abdominal pain, feeling of thirst, nausea, vomiting, passing reduced amounts of concentrated urine, and weight gain) (additional information – see section 2, Important information before using 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, 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 a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the 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 must not be disposed of via wastewater. Ask your pharmacist how to dispose of medicines no longer required. Such measures 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 tablet or powder
Solvent: clear and colourless solution
Mensinorm Set is available as a powder and solvent for solution for injection.
One set contains the following components:

• one vial containing a white lyophilized tablet or powder;
• one ampoule-syringe (1 ml) with clear, colourless solution;
• one (long) needle for reconstitution of the solution and intramuscular injection;
• one (short) needle for subcutaneous injection.
  The medicine 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 member states 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