Meriofert

Meriofert 75 UI
powder and solvent for injectable solution
Meriofert 150 UI
powder and solvent for injectable solution
menotropin

Please read this leaflet carefully before using this medicine, as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• In this leaflet, Meriofert 75 UI powder and solvent for injectable solution and Meriofert 150 UI powder and solvent for injectable solution are referred to as Meriofert.

Contents of this leaflet:

1. What Meriofert is and what it is used for
2. What you need to know before using Meriofert
3. How to use Meriofert
4. Possible side effects
5. How to store Meriofert
6. Contents of the pack and other information

1. What Meriofert is and what it is used for

• Meriofert is used to stimulate ovulation in women who do not ovulate and who have not responded to other treatment (clomiphene citrate).
• Meriofert is used to induce the development of multiple follicles (and therefore multiple eggs) in women undergoing infertility treatment.

Meriofert is a highly purified human menopausal gonadotropin and belongs to a group of medicines called gonadotropins.
Each vial contains lyophilized powder with 75 IU of human follicle-stimulating hormone (FSH) activity and 75 IU of human luteinizing hormone (LH) activity.
Human Menopausal Gonadotropin (HMG) is extracted from the urine of post-menopausal women. Human Chorionic Gonadotropin (hCG), a hormone extracted from the urine of pregnant women, is added to contribute to the total LH activity.
Each vial contains lyophilized powder with 150 IU of human follicle-stimulating hormone (FSH) activity and 150 IU of human luteinizing hormone (LH) activity.
Human Menopausal Gonadotropin (HMG) is extracted from the urine of post-menopausal women. Human Chorionic Gonadotropin (hCG, human Chorionic Gonadotrophin), a hormone extracted from the urine of pregnant women, is added to contribute to the total LH activity.
This medicine must be used under medical supervision.

2. What you should know before using Meriofert

Before starting treatment, your fertility and that of your partner will be assessed.
Do not use Meriofert if you have:

• Enlarged ovaries or ovarian cysts not caused by a hormonal disorder (polycystic ovary syndrome).
• Vaginal bleeding of unknown cause.
• Malignant tumour of the ovaries, uterus, or breast.
• Abnormal swelling (tumour) of the pituitary gland or hypothalamus (brain).
• Hypersensitivity (allergy) to menotropin or any of the components of Meriofert.

This medicine must not be used in cases of premature menopause, in the presence of genital malformations, or certain uterine tumours that would make a normal pregnancy impossible.
Warnings and precautions
Although allergic reactions to Meriofert have not been reported so far, inform your doctor if you have ever experienced an allergic reaction to similar medicines.
This treatment increases the risk of developing a condition known as ovarian hyperstimulation syndrome (OHSS) (see Possible side effects). If ovarian hyperstimulation occurs, treatment will be stopped and pregnancy will be avoided. Early signs of OHSS include abdominal pain in the lower abdomen, nausea, vomiting, and weight gain. If these symptoms occur, you should see your doctor as soon as possible. In rare but serious cases, the ovaries may enlarge, with accumulation of fluid in the abdomen or chest.
The medicine used to trigger the final release of mature oocytes (containing human chorionic gonadotropin, hCG) may increase the risk of OHSS. Therefore, in cases where OHSS is developing, the use of hCG is not recommended, 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 miscarriages compared to the general population.
Among patients treated to stimulate ovulation, multiple pregnancies and multiple births occur more frequently than with natural conception. However, this risk can be minimized by using the recommended dose.
Women with fallopian tube disorders have a slightly increased risk of ectopic pregnancy.
Multiple pregnancies and parental characteristics of individuals undergoing fertility treatments (e.g. maternal age, sperm characteristics) may be associated with a higher risk of congenital abnormalities.
Like pregnancy itself, treatment with Meriofert may increase the risk of thrombosis. Thrombosis involves the formation of a blood clot, most commonly in the veins of the legs or lungs.
Talk to your doctor before starting treatment, especially:

• If you already know you are at particular risk of thrombosis.
• If you or one of your close family members has ever had thrombosis.
• If you are severely overweight.

Children
Meriofert is not intended for use in children.
Other medicines and Meriofert
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pregnancy, breastfeeding and fertility
Meriofert must not be used if you are pregnant or breastfeeding.
Driving and using machines
Meriofert does not affect or has a negligible effect on the ability to drive or operate machinery.
Meriofert contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium in the reconstituted solution, i.e. essentially ‘sodium-free’.
For those engaged in sports activities
Using this medicine without therapeutic need constitutes doping and may lead to a positive result in anti-doping tests.

3. How to use Meriofert

Dosage and duration of treatment:
Use this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor.

Women who do not ovulate and who have irregular cycles or no menstruation
As a general rule, the first injection of one 75 UI vial of Meriofert is administered during the first week of the cycle, following spontaneous or induced menstruation.
Subsequently, Meriofert is injected daily at the dose prescribed by your doctor, and treatment continues until one or more mature follicles have developed in the ovary.
Your doctor will adjust the dose of Meriofert based on the ovarian response, assessed through clinical examinations.
As soon as a follicle reaches the required stage of development, treatment with Meriofert will be suspended and ovulation will be triggered by administering another hormone (chorionic gonadotropin, hCG).
Ovulation usually occurs 32–48 hours later.
During this phase of treatment, fertilization may occur. You will be advised to have sexual intercourse daily, starting the day before hCG administration. If pregnancy does not occur despite ovulation, the treatment may be repeated.

Women undergoing ovarian stimulation for the development of multiple follicles prior to in vitro fertilization or other assisted reproductive techniques
The aim of this method is to achieve the simultaneous development of multiple follicles. Treatment begins on day 2 or 3 of the cycle with injections of 150–300 UI of Meriofert (1–2 vials of Meriofert 150 UI). If necessary, your doctor may decide to administer higher doses. The dose of Meriofert administered is higher than that used for natural fertilization. Treatment continues with individual adjustments as determined by your doctor.
Once a sufficient number of follicles have developed, treatment with Meriofert will be suspended and ovulation will be triggered by injecting another hormone (chorionic gonadotropin, hCG).

How Meriofert should be administered
Meriofert is administered by subcutaneous injection (under the skin) or intramuscular injection (into the muscle).
Each vial must be used only once, and the injection must be performed immediately after preparation.

After adequately informing and training you, your doctor may ask you to self-inject Meriofert.
Before doing so for the first time, your doctor must:

• allow you to practice by performing a subcutaneous injection on yourself,
• show you the possible injection sites,
• demonstrate how to prepare the injectable solution,
• explain how to prepare the exact dose for injection.

Before self-injecting Meriofert, carefully read the following instructions.

How to prepare and inject 1 vial of Meriofert
Prepare the injection only when you are ready to use it, using the pre-filled syringe of solvent (a solution of 9 mg/ml sodium chloride in water for injections) included in each Meriofert package.
Prepare a clean surface and wash your hands. It is important that your hands and all materials used are as clean as possible.
Place the following items on the clean surface:

• two alcohol swabs (not provided),
• one vial containing Meriofert powder,
• one pre-filled syringe with solvent,
• one needle for reconstitution (long needle),
• one fine needle for subcutaneous injection.

WARNING: Do not remove the back-stop (white collar) from the pre-filled syringe,
as it prevents unintentional plunger withdrawal and improves grip during injection.

Reconstitution of the injectable solution.
Preparation of the injection

1. • Remove the cap from the pre-filled syringe and attach the reconstitution needle (long needle) to the syringe.
   • Carefully place the syringe on the clean surface.
   • Avoid touching the needle.

Preparation of the injectable solution

2. • Remove the colored plastic cap from the Meriofert vial (light green for 75 UI, dark green for 150 UI) by gently pushing it upward.
   • Wipe the rubber stopper at the top with an alcohol swab and allow it to dry.

3. • Take the syringe, remove the protective cap from the needle, and insert the needle through the center of the rubber stopper at the top of the Meriofert vial.
   • Firmly push the plunger to inject the entire solvent solution onto the powder.
   • WITHOUT SHAKING, gently rotate the vial until the solution becomes clear. Meriofert usually dissolves immediately.

4. • With the needle still inserted, invert the vial.
   • Ensure the needle tip is below the liquid level.
   • Gently pull back the plunger to draw all of the Meriofert solution into the syringe.
   • Check that the reconstituted solution is clear.

To reconstitute more than one vial of Meriofert, draw the reconstituted solution from the first vial into the syringe, then slowly inject it into a second vial after repeating steps 2 to 4.

Subcutaneous injection of the medicine

• When the syringe contains the prescribed dose, place the protective cap on the reconstitution needle. Remove the needle from the syringe and replace it with the fine needle for subcutaneous injection, including its protective cap.
• Firmly press the fine needle onto the syringe body, then rotate it slightly to ensure it is fully screwed on and securely attached.

• Remove the protective cap from the fine needle. Holding the syringe with the needle pointing upward, gently tap one side of the syringe to move any air bubbles to the top.
• Press the plunger until a drop of liquid appears at the needle tip.
• Do not use the solution if it contains particles or appears cloudy.

Injection site:

• Your doctor or nurse will have already instructed you on where to inject the medicine. Usual sites are the thigh or the lower abdominal area below the navel.
• Clean the injection site with an alcohol swab.

Inserting the needle:

• Firmly grasp and lift the skin. With the other hand, insert the needle with an arrow-like motion at an angle of 45° or 90°.

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 properly administer the solution without damaging tissues.

Take all the time needed to inject the prescribed volume of solution. Depending on the dose prescribed by your doctor, you may not need to use the entire volume of the solution.

Removing the needle:

• Quickly withdraw the syringe and press the injection site with an alcohol swab soaked in disinfectant. Gently massaging the site while maintaining pressure helps disperse the Meriofert solution and may relieve any discomfort.

Intramuscular injection of the medicine
For intramuscular injections, a healthcare professional will prepare and administer Meriofert into the thigh or buttock.

Disposal of all used materials
After completing the injection, place all needles, empty vials, and syringes into a sharps container. Unused solution and waste derived from this solution must be disposed of in accordance with local regulations.

If you use more Meriofert than you should
The effects of a Meriofert overdose are not known, but ovarian hyperstimulation syndrome may occur (see section on Possible side effects). If you use more Meriofert than prescribed, contact your doctor or nurse immediately.

If you forget to use Meriofert
Take it at the time of your next scheduled injection. Do not take a double dose to make up for the missed dose.

If you stop using Meriofert
Do not stop treatment on your own initiative. If you are considering stopping treatment, always consult your doctor.

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

4. Possible side effects

Like all medicines, Meriofert can cause side effects, although not everybody gets them.
The following side effect is important and requires immediate medical attention if it occurs. You must stop taking Meriofert and contact your doctor immediately if the following occurs.
Common: may affect up to 1 in 10 people

• Ovarian hyperstimulation syndrome (symptoms include formation of an ovarian cyst or enlargement of pre-existing cysts, abdominal pain, feeling thirsty, nausea, sometimes vomiting, reduced urine output and concentrated urine, and weight gain) (for further information, see section 2).

The following side effects have also been reported.
Very common: may affect more than 1 in 10 people

• Headache
• Bloating

Common: may affect up to 1 in 10 people

• Abdominal pain or discomfort
• Pelvic pain
• Back pain
• Feeling of heaviness
• Breast tenderness
• Dizziness
• Hot flushes
• Thirst
• Nausea
• Fatigue
• General feeling of malaise
• Injection site reaction, such as pain and inflammation (more frequent with intramuscular injection than with subcutaneous injection).

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, which then detaches and travels through the bloodstream to block another vessel).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the Italian Medicines Agency (Agenzia Italiana del Farmaco) website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Meriofert

Keep this medicine out of the sight and reach of children.
Do not store above 25 °C. Keep the vial and the pre-filled syringe with the solvent in the outer packaging to protect the medicine from light.
Do not use this medicine after the expiry date stated on the outer carton, on the vial, and on the pre-filled syringe with the solvent. If the expiry date is stated as month/year, the expiry date refers to the last day of that month.
Use the medicine immediately after reconstitution.
Do not use Meriofert if you notice that the solution is not clear. After reconstitution, the solution must be clear and colourless.
Do not dispose of any medicine via wastewater. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Meriofert contains
The active substance is menotropin.
Each vial contains a lyophilized powder with 75 IU of human follicle-stimulating hormone (FSH) activity and 75 IU of human luteinizing hormone (LH) activity.
Menopausal human gonadotropin (HMG) is extracted from the urine of post-menopausal women. Human chorionic gonadotropin (hCG, human Chorionic Gonadotrophin), a hormone extracted from the urine of pregnant women, is added to contribute to the total LH activity.
Each vial contains a lyophilized powder with 150 IU of human follicle-stimulating hormone (FSH) activity and 150 IU of human luteinizing hormone (LH) activity.
Menopausal human gonadotropin (HMG) is extracted from the urine of post-menopausal women. Human chorionic gonadotropin (hCG, human Chorionic Gonadotrophin), a hormone extracted from the urine of pregnant women, is added to contribute to the total LH activity.
If multiple vials of powder are used, the amount of menotropin contained in 1 ml of reconstituted solution will be:

Meriofert 75 IU powder and solvent for injectable solution
Number of vials used	Total amount of menotropin in 1 ml of solution
1	75 IU
2	150 IU
3	225 IU
4	300 IU
5	375 IU
6	450 IU
Meriofert 150 IU powder and solvent for injectable solution
Number of vials used	Total amount of menotropin in 1 ml of solution
1	150 IU
2	300 IU
3	450 IU

Other components are
For the powder: monohydrate lactose.
For the solvent: 9 mg/ml sodium chloride solution.
Description of the appearance of Meriofert and contents of the pack
Powder: white lyophilized tablet or powder
Solvent: clear, colourless solution
Meriofert is supplied as a powder and solvent for injectable solution.
1 kit contains:

• One vial containing a white lyophilized tablet or powder
• One pre-filled syringe (1 ml) containing a clear, colourless solution
• One needle for reconstitution and intramuscular injection (long needle)
• One needle for subcutaneous injection (short needle)
  Packs of 1, 5 or 10 kits. Not all pack sizes may be marketed.

Marketing Authorization Holder
IBSA Farmaceutici Italia S.r.l.
Via Martiri di Cefalonia, 2
26900 Lodi - Italy
Manufacturer
IBSA Farmaceutici Italia S.r.l.
Via Martiri di Cefalonia, 2
26900 Lodi - Italy
For UK (NI):
Pharmasure Ltd
Units 4-6
Colonial Business Park
Colonial Way
Watford D24 4PR
United Kingdom
This medicinal product is authorized in EEA member states under the following
names: (dosage and pharmaceutical form are identical in all countries, only the brand name differs)
Austria, Bulgaria, Cyprus, Romania, United Kingdom (Northern Ireland): Meriofert PFS
Belgium: Fertinorm Kit
Denmark, Estonia, Czech Republic, Norway: Meriofert Set
Greece, Italy: Meriofert
Finland, Latvia, Lithuania, Sweden: Meriofert Set
France: Fertistartkit
Latvia: name under evaluation during national phase
Lithuania: name under evaluation during national phase
Luxembourg: Fertinorm Kit
Poland: Mensinorm Set
Netherlands: Meriofert spuit
Slovakia, Spain, Hungary: Meriofert Kit
Meriofert 75 UI
powder and solvent for solution for injection
Meriofert 150 UI
powder and solvent for solution for injection
menotropin
Read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• In this leaflet, Meriofert 75 UI powder and solvent for solution for injection and Meriofert 150 UI powder and solvent for solution for injection are referred to as Meriofert.

Contents of this leaflet:

1. What Meriofert is and what it is used for
2. What you need to know before using Meriofert
3. How to use Meriofert
4. Possible side effects
5. How to store Meriofert
6. Contents of the pack and other information

4. What Meriofert is and what it is used for

• Meriofert is used to stimulate ovulation in women who do not ovulate and who have not responded to other treatment (clomiphene citrate).
• Meriofert is used to induce the development of multiple follicles (and therefore multiple oocytes) in women undergoing infertility treatment.

Meriofert is a highly purified human menopausal gonadotropin and belongs to a group of medicines called gonadotropins.
Each vial contains a lyophilized powder with 75 IU of human follicle-stimulating hormone (FSH) activity and 75 IU of human luteinizing hormone (LH) activity.
Human Menopausal Gonadotropin (HMG) is extracted from the urine of post-menopausal women. Human Chorionic Gonadotropin (hCG), a hormone naturally extracted from the urine of pregnant women, is added to contribute to the total LH activity.
Each vial contains a lyophilized powder with 150 IU of human follicle-stimulating hormone (FSH) activity and 150 IU of human luteinizing hormone (LH) activity.
Human Menopausal Gonadotropin (HMG) is extracted from the urine of post-menopausal women.
Human Chorionic Gonadotropin (hCG, human Chorionic Gonadotrophin), a hormone naturally 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 doctor.

5. What you should know before using Meriofert

Before starting treatment, your fertility and that of your partner will be assessed.
Do not use Meriofert if you have:

• Enlarged ovaries or cysts not caused by a hormonal disorder (polycystic ovary syndrome).
• Unexplained vaginal bleeding.
• Malignant tumour of the ovaries, uterus, or breast.
• Abnormal swelling (tumour) of the pituitary gland or hypothalamus (in the brain).
• Hypersensitivity (allergy) to menotropin or to any of the components of Meriofert.

This medicine must not be used in cases of premature menopause, in the presence of malformations of the genital organs, or certain uterine tumours that make a normal pregnancy impossible.
Warnings and precautions
Although allergic reactions to Meriofert have not been reported so far, inform your doctor if you have ever had an allergic reaction to similar medicines.
This treatment increases the risk of developing a condition known as ovarian hyperstimulation syndrome (OHSS) (see Possible side effects). If ovarian hyperstimulation occurs, treatment will be stopped and pregnancy will be avoided. Early signs of ovarian hyperstimulation include pain in the lower abdomen, nausea (feeling unwell), vomiting, and weight gain. If these symptoms occur, you must see your doctor as soon as possible. In rare but serious cases, the ovaries may become enlarged, with accumulation of fluid in the abdomen or chest.
The medicine used to trigger the final release of mature oocytes (containing human chorionic gonadotropin, hCG) may increase the risk of OHSS. Therefore, in cases where OHSS is developing, the use of hCG is not recommended, and sexual intercourse should be avoided for at least 4 days, even if using a barrier contraceptive method.
It should be noted that women with fertility problems have a higher rate of miscarriage compared to the general population.
Among patients treated to stimulate ovulation, multiple pregnancies and multiple births occur more frequently than with natural conception. However, this risk can be minimized by using the recommended dose.
Women with fallopian tube problems have a slightly increased risk of ectopic pregnancy (pregnancy outside the uterus).
Multiple pregnancies and parental characteristics of those undergoing fertility treatments (e.g. maternal age, sperm characteristics) may be associated with an increased risk of birth defects.
Like pregnancy itself, treatment with Meriofert may increase the risk of thrombosis. Thrombosis involves the formation of a blood clot, most commonly in the veins of the legs or lungs.
Talk to your doctor before starting treatment, especially:

• If you already know you are at particular risk of thrombosis.
• If you or one of your close family members has ever had a thrombosis.
• If you are significantly overweight.

Children
This medicine is not intended for use in children.
Other medicines and Meriofert
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pregnancy, breastfeeding and fertility
Meriofert must not be used if you are pregnant or breastfeeding.
Driving and using machines
Meriofert does not affect or affects negligibly the ability to drive or use machinery.
Meriofert contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium in the reconstituted solution, i.e. essentially 'sodium-free'.
For those engaged in sports activities
Using this medicine without therapeutic need constitutes doping and may result in a positive anti-doping test.

6. How to use Meriofert

Dosage and duration of treatment:
Use this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor.

Women who do not ovulate and who have irregular cycles or no menstruation
As a general rule, the first injection of a 75 UI vial of Meriofert is administered during the first week of the cycle following spontaneous or induced menstruation.
Subsequently, Meriofert is injected daily at the dose prescribed by the doctor, and treatment continues until one or more mature follicles have developed in the ovary.
Your doctor will adjust the dose of Meriofert based on your ovarian response, assessed through clinical examinations.
As soon as a follicle reaches the required stage of development, treatment with Meriofert will be suspended and ovulation will be triggered with another hormone (chorionic gonadotropin, hCG).
Ovulation usually occurs 32–48 hours later.
During this phase of treatment, fertilization may occur. You will be advised to have sexual intercourse daily starting from the day before hCG administration. If pregnancy does not occur despite ovulation, treatment may be repeated.

Women undergoing ovarian stimulation for the development of multiple follicles prior to in vitro fertilization or other assisted reproductive techniques
The aim of this method is to achieve the simultaneous development of multiple follicles. Treatment begins on day 2 or 3 of the cycle with injections of 150–300 UI of Meriofert (1–2 vials of Meriofert 150 UI). If necessary, your doctor may decide to administer higher doses. The dose of Meriofert injected is higher than that used for natural fertilization. Treatment continues with individual adjustments as determined by your doctor.
Once a sufficient number of follicles have developed, treatment with Meriofert will be suspended and ovulation will be triggered by injecting another hormone (chorionic gonadotropin, hCG).

How Meriofert should be administered
Meriofert is administered by subcutaneous (under the skin) or intramuscular (into the muscle) injection.
Each vial must be used only once, and the injection must be performed immediately after preparation.

After adequately informing and training you, your doctor may ask you to self-inject Meriofert.
For the first time, your doctor must:

• allow you to practice by performing a subcutaneous injection on yourself,
• show you the possible injection sites,
• demonstrate how to prepare the injectable solution,
• explain how to prepare the exact dose for injection.

Before self-injecting Meriofert, read the following instructions carefully.

How to prepare and inject 1 vial of Meriofert
The solution must be prepared immediately before injection. The vial is for single use only.
The medicine must be reconstituted under aseptic conditions.
Meriofert must be reconstituted exclusively with the solvent supplied with the pack.
Prepare a clean surface and wash your hands before reconstituting the solution. It is important that your hands and all materials used are as clean as possible.
On a clean surface, prepare the following items:

• two alcohol-soaked cotton swabs (not supplied),
• one vial containing Meriofert powder,
• one ampoule of solvent,
• one syringe (not supplied),
• one needle for reconstitution (not supplied),
• one fine needle for subcutaneous injection (not supplied).

Reconstitution of the injectable solution using 1 vial of powder
Preparation of the injectable solution

1. The ampoule neck is specially designed to break more easily below the colored mark. Gently tap the top of the ampoule to dislodge any liquid remaining at the tip. Hold the ampoule with the colored mark facing away from you and break off the top as shown in the figure. Using a cloth or an ampoule breaker to hold the ampoule will help protect your fingers. Carefully place the open ampoule upright on the clean surface.

Remove the protective cap from the needle. Attach the reconstitution needle (a larger needle) to the syringe. With the syringe in one hand, take the open solvent ampoule, insert the needle into it, and draw the entire contents into the syringe. Replace the protective cap on the needle. Carefully place the syringe on the surface.

2. Remove the colored plastic cap (light green for 75 UI and dark green for 150 UI) from the powder vial by gently pushing upwards. Disinfect the top of the rubber stopper with an alcohol-soaked cotton swab and allow it to dry.

3. Take the syringe, remove the needle cap, and slowly inject

the solvent into the center of the powder vial, targeting the top of the rubber stopper.
Press the plunger firmly to inject the entire solution into the powder.
DO NOT SHAKE, but gently rotate the vial between your hands until the powder is completely dissolved, taking care not to create foam.

4. Once the powder is dissolved (which usually happens immediately), slowly draw the solution back into the syringe:
   • With the needle still inserted, turn the vial upside down.
   • Ensure the tip of the needle is below the liquid level.
   • Gently pull back the plunger to draw all the solution into the syringe.

• Check that the reconstituted solution is clear and colorless.

Preparing higher doses using more than one vial of powder
If your doctor has prescribed a higher dose, this can be achieved by using more than one vial of powder with one ampoule of solvent.
When reconstituting more than one vial of Meriofert, after completing step 4 above, draw the reconstituted contents of the first vial into the syringe and slowly inject it into a second vial. Repeat steps 2 to 4 for the second and any subsequent vials, until the contents of the required number of vials equivalent to the prescribed dose are dissolved (within the maximum total dosage limit of 450 UI, corresponding to a maximum of 6 vials of Meriofert 75 UI or 3 vials of Meriofert 150 UI).

Your doctor may increase the dose by 37.5 UI, equivalent to half a vial of Meriofert 75 UI.
To do this, reconstitute the contents of a 75 UI vial according to steps 2 to 3 described above, and draw half of this reconstituted solution (0.5 ml) into the syringe as described in step 4.
In this case, you will have two preparations to inject: the first reconstituted in 1 ml and the second containing 37.5 UI in 0.5 ml.
Both preparations will be injected using a syringe prepared according to the following steps.
The solution must be clear and colorless.

Subcutaneous injection of the medicine

• When the syringe contains the prescribed dose, place the protective cap on the needle. Remove the needle from the syringe and replace it with the fine needle for subcutaneous injection, including its protective cap.
• Firmly press the fine needle onto the syringe barrel, then slightly rotate it to ensure it is fully screwed on and securely fixed.
• Remove the protective cap from the needle. Holding the syringe with the needle pointing upwards, gently tap one side of the syringe to bring any air bubbles to the top.
• Press the plunger until a drop of liquid appears at the tip of the needle.
• Do not use the solution if it contains particles or if it is cloudy.

Injection site:

• Your doctor or nurse will have already shown you where on the body to inject the medicine. Usual injection sites are the thigh or the lower abdominal wall, below the navel.
• Wipe the injection site with an alcohol-soaked cotton swab.

Inserting the needle:

• Firmly grasp and lift the skin. With the other hand, insert the needle with an arrow-like motion at an angle of 45° or 90°.

Injecting the solution:

• Inject the solution under the skin as instructed. Do not inject directly into a vein. Press the plunger with a slow, steady motion to inject the solution correctly and without damaging tissues.

Take all the time needed to inject the prescribed volume of solution. As described for solution preparation, depending on the dose prescribed by your doctor, you may not need to use the entire volume of the solution.

Removing the needle:

• Quickly withdraw the syringe and press the injection site with an alcohol-soaked cotton swab soaked in disinfectant. Gentle massage of the site, while maintaining pressure, helps disperse the Meriofert solution and may relieve any discomfort.

Intramuscular injection of the medicine
For intramuscular injections, a healthcare professional will prepare and inject Meriofert into the thigh or buttock.

Disposal of all used materials
After completing the injection, all needles and empty syringes must be disposed of in appropriate sharps containers. Unused solution and waste materials must be disposed of in accordance with local regulations.

If you use more Meriofert than you should
The effects of a Meriofert overdose are not known, but ovarian hyperstimulation syndrome may occur (see section on Possible side effects). If you use more Meriofert than prescribed, contact your doctor or nurse immediately.

If you forget to use Meriofert
Take the next scheduled injection as planned. Do not use a double dose to make up for the missed dose.

If you stop using Meriofert
Do not stop treatment on your own initiative. If you are considering stopping treatment, always consult your doctor first.

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

4. Possible side effects

Like all medicines, Meriofert can cause side effects, although not everyone experiences them.
The following side effect is important and requires immediate medical attention if it occurs. You must stop taking Meriofert and contact your doctor immediately if the following effect occurs.
Common: may affect up to 1 in 10 people

• Ovarian hyperstimulation syndrome (symptoms include formation of an ovarian cyst or enlargement of pre-existing cysts, pain in the lower abdomen, feeling thirsty and unwell, nausea, sometimes vomiting, reduced urine output and concentrated urine, and weight gain) (for further information see section 2).

The following side effects have also been reported.
Very common: may affect more than 1 in 10 people

• Headache
• Bloating

Common: may affect up to 1 in 10 people

• Abdominal pain or discomfort
• Pelvic pain
• Back pain
• Heaviness sensation
• Breast tenderness
• Dizziness
• Hot flushes
• Thirst
• Nausea
• Fatigue
• General malaise
• Injection site reaction, such as pain and inflammation (more frequent with intramuscular injection than with subcutaneous injection).

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, which then detaches and travels through the bloodstream to block another vessel).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist.
You may also report side effects directly via the Italian Medicines Agency (Agenzia Italiana del Farmaco) website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Meriofert

Keep this medicine out of the sight and reach of children.
Do not store above 25 °C. Keep the vial and the solvent vial in the outer packaging to protect the medicine from light.
Do not use this medicine after the expiry date stated on the outer carton, on the vial, and on the solvent vial. If the expiry date is stated as month/year, the expiry date refers to the last day of that month.
Use the medicine immediately after reconstitution.
Do not use Meriofert if you notice that the solution is not clear. After reconstitution, the solution must be clear and colourless.
Do not dispose of any medicine via wastewater. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Meriofert contains
The active substance is menotropin.
Each vial contains a lyophilized powder with 75 IU of human follicle-stimulating hormone (FSH) activity and 75 IU of human luteinizing hormone (LH) activity.
Menopausal human gonadotropin (HMG) is extracted from the urine of postmenopausal women.
Human chorionic gonadotropin (hCG, human Chorionic Gonadotrophin), a hormone extracted from the urine of pregnant women, is added to contribute to the total LH activity.
Each vial contains a lyophilized powder with 150 IU of human follicle-stimulating hormone (FSH) activity and 150 IU of human luteinizing hormone (LH) activity.
Menopausal human gonadotropin (HMG) is extracted from the urine of postmenopausal women.
Human chorionic gonadotropin (hCG, human Chorionic Gonadotrophin), a hormone extracted from the urine of pregnant women, is added to contribute to the total LH activity.
If multiple vials of powder are used, the amount of menotropin contained in 1 ml of reconstituted solution will be:

Meriofert 75 IU powder and solvent for injectable solution
Number of vials used	Total amount of menotropin in 1 ml of solution
1	75 IU
2	150 IU
3	225 IU
4	300 IU
5	375 IU
6	450 IU
Meriofert 150 IU powder and solvent for injectable solution
Number of vials used	Total amount of menotropin in 1 ml of solution
1	150 IU
2	300 IU
3	450 IU

The other components are
For the powder: monohydrate lactose.
For the solvent: 9 mg/ml sodium chloride and water for injections.

Description of the appearance of Meriofert and contents of the pack
Powder: white lyophilisate or powder
Solvent: clear, colourless solution
Meriofert is supplied as a powder and solvent for injectable solution.
1 kit contains:

• One vial containing a white lyophilisate or powder
• One ampoule (1 ml) containing a clear, colourless solution

Pack sizes of 1, 5 or 10 kits. Not all pack sizes may be marketed.

Marketing Authorization Holder
IBSA Farmaceutici Italia S.r.l.
Via Martiri di Cefalonia, 2
26900 Lodi - Italy

Manufacturer
IBSA Farmaceutici Italia S.r.l.
Via Martiri di Cefalonia, 2
26900 Lodi - Italy

This medicinal product is authorized in EEA member states under the following
brand names: (dosage and pharmaceutical form are identical in all countries; only the brand name differs)
Austria, Bulgaria, Cyprus, Denmark, Estonia, Finland, Greece, Italy, Latvia, Lithuania,
Norway, Netherlands, Poland, Czech Republic, United Kingdom, Romania, Slovakia,
Spain, Sweden, Hungary: Meriofert
Belgium, Luxembourg: Fertinorm
France: Fertistart

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
MERIOFERT 900 IU
powder and solvent for solution for injection
menotropin
Read this leaflet carefully before using this medicine because it contains important information for you.

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

Contents of this leaflet:

1. What MERIOFERT is and what it is used for
2. What you need to know before using MERIOFERT
3. How to use MERIOFERT
4. Possible side effects
5. How to store MERIOFERT
6. Contents of the pack and other information

1. What MERIOFERT is and what it is used for

• MERIOFERT is used to stimulate ovulation in women who do not ovulate and who have not responded to other treatment (clomiphene citrate).
• MERIOFERT is used to induce the development of multiple follicles (and therefore multiple oocytes) in women undergoing infertility treatment.

MERIOFERT is a highly purified human menopausal gonadotropin and belongs 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), a hormone extracted from the urine of pregnant women, is added to contribute to the total LH activity.
This medicine must be used under medical supervision.

2. What you should know before using MERIOFERT

Before starting treatment, your fertility and that of your partner will be assessed.
Do not use MERIOFERT if you have:

• Enlarged ovaries or cysts not caused by a hormonal disorder (polycystic ovary syndrome).
• Unexplained vaginal bleeding.
• Malignant tumour of the ovaries, uterus or breast.
• Abnormal swelling (tumour) of the pituitary gland or hypothalamus (in the brain).
• Allergy to menotropin or to any of the ingredients of this medicine (listed in section 6).

This medicine must not be used in cases of premature menopause, in the presence of malformations of the reproductive organs, or certain uterine tumours that would make a normal pregnancy impossible.
Warnings and precautions
Although allergic reactions to MERIOFERT have not been reported so far, inform your doctor if you have ever had an allergic reaction to similar medicines.
This treatment increases the risk of developing a condition known as ovarian hyperstimulation syndrome (OHSS) (see Possible side effects). If ovarian hyperstimulation occurs, treatment will be stopped and pregnancy will be avoided. Early signs of ovarian hyperstimulation include abdominal pain in the lower abdomen, nausea, vomiting and weight gain. If these symptoms occur, you should see your doctor as soon as possible. In rare but serious cases, the ovaries may enlarge, with accumulation of fluid in the abdomen or chest.
The medicine used to trigger the final release of mature eggs (containing hCG) may increase the risk of OHSS. Therefore, in cases where OHSS is developing, the use of hCG is not recommended 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 compared to the general population.
Among patients treated to stimulate ovulation, multiple pregnancies and multiple births occur more frequently than with natural conception. However, this risk can be minimised by using the recommended dose.
Women with fallopian tube problems have a slightly increased risk of ectopic pregnancy.
Multiple pregnancies and parental characteristics of individuals undergoing fertility treatments (e.g. maternal age, sperm characteristics) may be associated with a higher risk of birth defects.
Like pregnancy itself, treatment with MERIOFERT may increase the risk of thrombosis. Thrombosis involves the formation of a blood clot, most commonly in the veins of the legs or lungs.
Talk to your doctor before starting treatment, especially:

• If you already know you are particularly at risk of thrombosis.
• If you or a close family member has ever had thrombosis.
• If you are significantly overweight.

Children
The use of this medicine in children is not intended.
Other medicines and MERIOFERT
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pregnancy, breastfeeding and fertility
MERIOFERT must not be used if you are pregnant or breastfeeding.
Driving and using machines
MERIOFERT does not affect or affects negligibly the ability to drive or operate machinery.
MERIOFERT contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium in the reconstituted solution, i.e. essentially 'sodium-free'.
For those engaged in sports activities
Using this medicine without therapeutic need constitutes doping and may lead to a positive result in anti-doping tests.

3. How to use MERIOFERT

Dosage and duration of treatment:
Always use this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor.
Women who do not ovulate and who have irregular cycles or no menstruation:
As a general rule, the first injection of 75 IU of menotropin is administered during the first week of the cycle, following spontaneous or induced menstruation.
Thereafter, MERIOFERT is injected daily at the dose prescribed by your doctor, and treatment continues until one or more mature follicles have developed in the ovary. Your doctor will adjust the dose of MERIOFERT based on your ovarian response, assessed through clinical examinations.
As soon as a follicle reaches the required stage of development, treatment with MERIOFERT will be suspended, and ovulation will be triggered by administering another hormone (chorionic gonadotropin, hCG).
Ovulation usually occurs 32–48 hours after hCG administration.
During this phase of treatment, fertilization may occur. You will be advised to have sexual intercourse daily, starting the day before hCG administration. If pregnancy does not occur despite ovulation, the treatment may be repeated.
Women undergoing ovarian stimulation for the development of multiple follicles prior to in vitro fertilization or other assisted reproductive techniques:
The aim of this method is to achieve the simultaneous development of multiple follicles. Treatment begins on day 2 or 3 of the cycle with daily injections of 150–300 IU of MERIOFERT. If necessary, your doctor may decide to administer higher doses. The dose of MERIOFERT used is higher than that used for natural fertilization. Treatment continues with individual dose adjustments as determined by your doctor.
Once a sufficient number of follicles have developed, treatment with MERIOFERT will be suspended, and ovulation will be triggered by injecting another hormone (chorionic gonadotropin, hCG).

How MERIOFERT should be administered:
MERIOFERT is administered by subcutaneous injection (injected under the skin).
Each vial must be reconstituted only once, and each individual injection must be performed immediately after the required dose has been withdrawn.
After adequately informing and training you, your doctor may ask you to self-administer MERIOFERT injections.
Before your first injection, your doctor must:

• allow you to practice by performing a subcutaneous injection on yourself,
• show you the possible injection sites,
• demonstrate how to prepare the injectable solution,
• explain how to draw up the exact dose for injection.

Before self-injecting MERIOFERT, carefully read the following instructions.
Since this vial contains medication for several days of treatment, you must ensure that you withdraw only the amount of medication prescribed by your doctor. Your doctor has prescribed a dose of MERIOFERT in (units) IU. To obtain the correct dose, you must use one of the 12 syringes provided for administration, graduated in FSH/LH IU units.
These syringes are for single use only and must be disposed of after each administration according to local regulations and in an appropriate container.

How to prepare and inject 1 vial of MERIOFERT:
The injectable solution containing 900 IU of menotropin must be prepared immediately before you take your first dose, by adding the solvent for reconstitution from the pre-filled syringe (included in each package) to the vial containing the powder.
Prepare a clean surface and wash your hands thoroughly with soap and warm water. It is important that your hands and all materials used are as clean as possible.
Gather the following materials:

• the vial containing MERIOFERT powder,
• the pre-filled syringe containing the solvent for reconstitution,
• the needle for reconstitution,
• a single-use syringe graduated in FSH/LH IU units with attached needle, for subcutaneous administration,
• an alcohol swab,
• cotton and disinfectant solution (not provided in the package).

WARNING:

• Before reconstitution and before each administration, disinfect the rubber stopper of the vial containing the reconstituted solution with cotton and disinfectant (e.g., alcohol solution) and allow it to dry.
• Do not remove the back-stop (white collar) from the pre-filled syringe, as it prevents accidental plunger withdrawal and improves grip during injection.

Reconstitution of the injectable solution
Preparation of the pre-filled syringe:
1.

• Remove the cap from the pre-filled syringe containing the solvent; attach the reconstitution needle, keeping the protective cap on the needle.
• Carefully place the syringe on the clean surface.

Preparation of the vial:
2.

• Remove the colored plastic cap from the vial by gently pushing it upward with your thumb.
• Wipe the rubber stopper with cotton and disinfectant and allow it to dry.
• Take the syringe, remove the protective cap from the needle, and insert the needle through the rubber stopper at the center of the vial’s top.
• Firmly push the plunger down to inject the entire solvent solution onto the powder.
• During solvent addition, slight overpressure builds up inside the vial. Therefore, release the plunger and allow it to rise back on its own for about 10 seconds. This will remove the overpressure from the vial. DO NOT SHAKE the reconstituted solution; instead, gently rotate the vial until the solution becomes clear. MERIOFERT usually dissolves immediately. Check that the reconstituted solution is clear.

Before injection:
4.

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

Preparation of the injection:
5.

• Take one of the single-use syringes provided, with attached needle, remove the protective cap from the needle, and insert the needle vertically into the center of the vial’s stopper.
• Push the plunger fully down.
• Invert the vial. Ensure that the needle tip is below the level of the medication, and withdraw the prescribed dose of MERIOFERT into the administration syringe.
• Remove the needle from the vial. Hold the syringe with the needle pointing upward and gently tap one side of the syringe to bring any air bubbles to the top.
• Slowly press the plunger until a drop of liquid appears at the needle tip.

WARNING: Since this vial contains medication for several days of treatment, you must ensure that you withdraw only the dose prescribed by your doctor.

Administration of the injection
Injection site:

• Your doctor or nurse will have already shown you the body areas where you can inject the medication. Usual sites are the thigh or the lower abdominal area below the navel.

• Wipe the injection site with an alcohol swab. Firmly grasp and lift the skin. With the other hand, insert the needle with a dart-like motion at an angle of 45° or 90°.

Injection of the solution:

• Inject the solution under the skin as instructed. Do not inject directly into a vein. Press the plunger with a slow and steady motion to correctly administer the solution without damaging tissues.

Take all the time needed to inject the prescribed volume of solution.
Quickly withdraw the needle and press the injection site with cotton and disinfectant.
Gently massage the site while maintaining pressure; this will help disperse the medication and reduce any discomfort.

Subsequent injections:
For subsequent injections with the reconstituted MERIOFERT solution, repeat steps from point 4 onwards.

If you use more MERIOFERT than you should
The effects of an overdose of MERIOFERT are not known, but ovarian hyperstimulation syndrome may occur (see Possible side effects). If you use more MERIOFERT than prescribed, contact your doctor or nurse immediately.

If you forget to use MERIOFERT
Take it at the time of your next scheduled injection. Do not take a double dose to make up for the missed dose.

If you stop treatment with MERIOFERT:
Do not stop treatment on your own initiative. Always consult your doctor before stopping treatment.

If you have any questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, MERIOFERT can cause side effects, although not everybody gets them.
The following side effect is important and requires immediate medical attention if it occurs. You must stop using MERIOFERT and contact your doctor immediately if the following effect occurs:
Common: (may affect up to 1 in 10 people)

• Ovarian hyperstimulation syndrome (symptoms include formation of an ovarian cyst or enlargement of pre-existing cysts, abdominal pain, feeling thirsty, nausea, sometimes vomiting, reduced urine output and concentrated urine, and weight gain) (for further information see section 2).
  The following side effects have also been reported:
  Very common (may affect more than 1 in 10 people):

• Headache

• Bloating

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

• Abdominal pain or discomfort
• Pelvic pain
• Back pain
• Feeling of heaviness
• Breast pain
• Dizziness
• Hot flushes
• Thirst
• Nausea
• Fatigue
• General malaise
• Injection site reaction, 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, which then detaches and is carried by the bloodstream to block another vessel).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist.
You can also report side effects directly via the Italian Medicines Agency (Agenzia Italiana del Farmaco) website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store MERIOFERT

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the outer carton,
on the vial, and on the pre-filled solvent syringe. If the expiry date is stated as
month/year, the expiry date refers to the last day of that month.
Before reconstitution: store at 2-8°C.
After reconstitution, the solution can 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 MERIOFERT if you notice that the solution is not clear. After reconstitution, the
solution must be clear and colourless.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What MERIOFERT contains
The active substance is menotropin.
Each multidose vial contains a lyophilized powder with 900 IU of follicle-stimulating hormone (FSH) activity and 900 IU of luteinizing hormone (LH) activity.
Human menopausal gonadotropin (HMG) is extracted from the urine of post-menopausal women. Human chorionic gonadotropin (hCG, human Chorionic Gonadotrophin), a hormone extracted from the urine of pregnant women, is added to contribute to the total LH activity.
Other components are
Powder: monohydrate lactose, polysorbate 20, disodium phosphate dihydrate, phosphoric acid and sodium hydroxide.
Solvent: metacresol and water for injections.
Description of the appearance of MERIOFERT and package contents
Powder: white lyophilized cake or powder
Solvent: clear, colourless solution
MERIOFERT is supplied as a powder and solvent for solution for injection.
1 kit contains:

• 1 vial containing MERIOFERT powder
• 1 pre-filled syringe containing solvent for reconstitution
• 1 needle for reconstitution
• 12 alcohol swabs for multiple injections
• 12 single-use syringes with attached needle for multiple injections

Marketing Authorization Holder
IBSA Farmaceutici Italia S.r.l.
Via Martiri di Cefalonia, 2
26900 Lodi - Italy
Manufacturer
IBSA Farmaceutici Italia S.r.l.
Via Martiri di Cefalonia, 2
26900 Lodi - Italy
For UK (NI):
IBSA Pharma Limited
Units 4-6
Colonial Business Park
Colonial Way
Watford WD24 4PR
UK
This medicinal product is authorized in EEA Member States and in the United Kingdom (Northern Ireland) under the following trade names: (dosage and pharmaceutical form are identical in all countries, only the brand name differs)
Austria, Bulgaria, Cyprus, Romania, United Kingdom (Northern Ireland): Meriofert PFS
Belgium: Fertinorm Kit
Denmark, Estonia, Czech Republic, Finland, Latvia, Lithuania, Norway, Sweden: Meriofert Set
Greece, Italy: Meriofert
France: Fertistartkit
Luxembourg: Fertinorm Kit
Poland: Mensinorm Set
Netherlands: Meriofert spuit
Slovakia, Spain, Hungary: Meriofert Kit