Mensinorm set

Package leaflet: Information for the patient

Mensinorm Set, 900 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 the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
• In this leaflet, the medicine Mensinorm Set 900 IU powder and solvent for solution for injection is referred to as Mensinorm Set.

Leaflet contents

1. What Mensinorm Set is and what it is used for
2. What you need to know 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 eggs) in women undergoing infertility treatment.

Mensinorm Set is a highly purified human menopausal gonadotropin, belonging to a group of medicines called gonadotropins.
Each multidose vial contains a 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 enhance 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, fertility assessment of both partners will be performed.
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 cause;
• if the patient has ovarian, uterine, or breast cancer;
• if the patient has enlargement (tumour) of the pituitary gland or hypothalamus (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 reproductive organs, or certain uterine tumours 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 ovarian hyperstimulation syndrome occurs, treatment will be discontinued and pregnancy must be avoided. Early symptoms of ovarian hyperstimulation include lower abdominal pain, nausea, vomiting, and weight gain. If any of these symptoms occur, the patient should consult a doctor as soon as possible. In severe, although rare, cases, enlargement of the ovaries and accumulation of fluid in the abdominal cavity or chest cavity may occur.
This medicine, used to trigger the release of mature egg cells (containing human chorionic gonadotropin (hCG)), may also increase the likelihood of OHSS. Therefore, hCG should not be used if OHSS is developing.
Sexual intercourse should be avoided 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 multiple births is higher than with natural conception. However, this risk can be reduced by using the recommended dose of the medicine.
Women with abnormalities of the fallopian tubes have a slightly increased risk of ectopic (extrauterine) 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 involves 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:

• if the patient has previously been diagnosed with an increased risk of thrombosis;
• if the patient or a close family member has ever had 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
Inform your doctor or pharmacist about all medicines currently used or recently used, 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 operating machinery
Mensinorm Set has no effect or 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:
As a general rule, the first injection of 75 IU is administered during the first week of the menstrual cycle, following the onset of natural or induced menstrual bleeding.
Then, Mensinorm Set should be used 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 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, fertilization is possible. Sexual intercourse is recommended daily, starting from the day before hCG injection. 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 physician may prescribe higher doses if necessary.
The dose of Mensinorm Set is higher than that used in methods intended for natural fertilization. The further course of treatment is individually adjusted by the physician.
When the appropriate number of 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 as a subcutaneous injection (subcutaneous route).
Each vial of the medicine should be reconstituted only once, and each individual injection should be administered immediately after withdrawing the required dose.
After appropriate consultation and training, the physician may instruct the patient to self-administer injections of Mensinorm Set.
Before the first injection, the physician should:

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

Before self-administering Mensinorm Set, carefully read the instructions below.
Since each vial contains medicine for several days of treatment, ensure that only the amount prescribed by the physician is withdrawn. The physician prescribes the dose of Mensinorm Set in IU (International Units). To obtain the correct dose, use one of the 12 provided syringes calibrated in FSH/LH units.

These syringes are for single use only and must be discarded in an appropriate container according to local regulations after each injection.

How to prepare and inject 1 vial of Mensinorm Set
The injection solution containing 900 IU of menotropin should be prepared immediately before the first dose by adding the solvent for reconstitution from the prefilled syringe (included in each package) to the vial containing the powder.
Prepare a clean surface and wash hands thoroughly with soap and warm water. It is important that hands and materials used are as clean as possible.

Prepare the following materials:

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

REMEMBER: Before reconstitution and each subsequent injection, disinfect the rubber stopper of the vial with a cotton swab moistened with disinfectant (e.g. alcohol solution) and allow it to dry. Do not remove the backstop (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 prefilled syringe:
1.

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

Preparing the vial:
2.

• Remove the colored flip-off plastic cap from the vial by gently pushing it upward with the thumb.
• Wipe the rubber closure with a disinfectant-impregnated swab and allow it to dry.

• Pick up the syringe, remove the protective cap from the needle, and insert the needle through the center of the rubber closure of the vial.
• Press the plunger firmly to expel all the solvent onto the powder.
• A slight overpressure may develop in the vial during solvent addition. Therefore, release the plunger to allow it to rise back on its own for about 10 seconds, thereby relieving overpressure in the vial.

DO NOT SHAKE the reconstituted solution, but gently rotate until the solution becomes clear.
In nearly 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.
• Disinfect the rubber stopper of the vial with a disinfectant-impregnated swab.

Preparing the injection:
5.

• Take one of the provided single-use syringes with attached 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 until it is fully depressed.
• Invert the vial. Ensure the needle tip is below the surface of the solution and withdraw the prescribed dose of Mensinorm Set 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 move air bubbles to the top.
• Slowly push the plunger until a drop of liquid appears at the tip of the needle.

REMEMBER: Since the vial contains medicine for several days of treatment, it is essential to ensure that only the amount prescribed by the physician is withdrawn.

Administering the injection
Injection site:

• The patient should have been previously instructed by the physician or nurse on 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-impregnated swab.
• With fingers, firmly pinch a skin fold. With the other hand, insert the needle in a short, decisive motion at a 45° or 90° angle.

Injecting the solution:

• Inject the solution subcutaneously as instructed. Do not inject directly into a vein. Press the plunger slowly and steadily so that the solution is properly administered and surrounding tissues are not damaged.

Inject the prescribed volume of solution without rushing.
Remove the needle and press the injection site with a disinfectant-impregnated swab.
Gentle massage of the injection site with light pressure facilitates the dispersion of Mensinorm Set and reduces discomfort.

Subsequent injections:
Repeat steps 4 onward for subsequent injections from the prepared solution of Mensinorm Set.

Use of a higher than recommended dose of Mensinorm Set:
The effects of overdose 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 is used, consult a physician or nurse immediately.

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 use of the medicine without consulting your physician. In case of any doubts 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 may cause adverse reactions, although not everyone experiences 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 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 of thirst,
• nausea,
• feeling of fatigue,
• general malaise,
• injection site reactions such as pain and inflammation (more frequent with intramuscular administration than subcutaneous).

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

• ovarian torsion (twisting of the ovary causing severe lower abdominal pain),
• 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 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
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 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 given as
month/year, the expiry date refers to the last day of the stated month.
Before reconstitution: store at 2–8°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 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 the sewage system or household waste. 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 the medicine Mensinorm Set contains
The active substance is menotropin.
Each multidose vial contains a 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 enhance total LH activity, human chorionic gonadotropin (hCG) has been added — a hormone derived from the urine of pregnant women.

Excipients
Powder: monohydrate lactose, 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 pellet or powder
Solvent: clear, colourless solution
Mensinorm Set is supplied as a powder and solvent for solution for injection, packed in a cardboard box.
One set contains the following components:

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

Marketing Authorisation Holder and Manufacturer:
IBSA Farmaceutici Italia srl
Via Martiri di Cefalonia, 2
26900 Lodi
Italy
For further information, please contact the local representative of the Marketing Authorisation Holder:
IBSA Poland Sp. z o.o.
Al. Jana Pawła II 29
00-867 Warsaw
Tel.: +48 22 653 68 60

This medicinal product is authorised for sale in the European Economic Area countries and in the United Kingdom (Northern Ireland) under the following trade names: (strength and pharmaceutical form are identical 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