MERIOFERT 75 IU Порошок для инъекционного раствора

Содержание инструкции

1. Meriofert 75 IU
2. Meriofert 150 IU
   1. What is Meriofert and what is it 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. Package contents and other information
3. Meriofert 75 IU
4. Meriofert 150 IU
   1. What is Meriofert and what is it 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
5. MERIOFERT 900 IU
   1. What is MERIOFERT and what is it 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

Meriofert 75 IU

powder and solvent for injectable solution

Meriofert 150 IU

powder and solvent for injectable solution

menotropine
Read this leaflet carefully before you use 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 could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• Throughout this leaflet, Meriofert 75 IU powder and solvent for injectable solution and Meriofert 150 IU 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 you use 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 is Meriofert and what is it used for

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

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 activity of human follicle
stimulating hormone (FSH) and 75 IU of activity of human luteinizing hormone (LH).
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 activity of human follicle
stimulating hormone (FSH) and 150 IU of activity of human luteinizing hormone (LH).
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.
This medicine must be used under the supervision of a doctor.

2. What you need to 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).
• Bleeding of unknown cause.
• Malignant tumor of the ovaries, uterus or breast.
• Abnormal enlargement (tumor) of the pituitary gland or hypothalamus (brain).
• Hypersensitivity (allergy) to menotropins or any of the ingredients of Meriofert

This medicine should not be used in case of premature menopause, in the presence of a
malformation of the genital organs or of certain tumors of the uterus 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 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
interrupted and pregnancy will be avoided. The first signs of ovarian hyperstimulation are pain in the lower
abdomen, nausea, vomiting and weight gain. If these symptoms appear, you should
see your doctor as soon as possible. In serious, but rare cases, the ovaries may
enlarge, with an accumulation of fluid in the abdomen or chest.
The drug used to induce the final release of mature eggs (containing human chorionic
gonadotropin, hCG) may increase the probability of OHSS. In cases where OHSS is
developing, the use of hCG is therefore not recommended and for at least 4 days you should
abstain from sexual intercourse even if you use a barrier contraceptive method.
It should be emphasized that women with fertility problems have a higher percentage of abortions
compared to the general population.
Among patients treated to promote ovulation, pregnancies and multiple births occur
more frequently than with natural conception. However, this risk can be minimized
by using the recommended dose.
In women with problems with the fallopian tubes, there is a slightly higher risk of
ectopic pregnancy (or extrauterine pregnancy).
Multiple pregnancies and the characteristics of parents undergoing fertility treatments
(e.g. mother's age, sperm characteristics) may be associated with an increased
risk of birth defects.
As pregnancy itself, treatment with Meriofert may increase the likelihood of having
a thrombosis. Thrombosis consists of the formation of a blood clot, more frequently
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 developing a thrombosis.
• If you or a close family member has ever had a thrombosis.
• If you are severely overweight.

Children
The use of the medicine in children is not intended.

Other medicines and Meriofert
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.

Pregnancy, breastfeeding and fertility
Meriofert should not be used if you are pregnant or breastfeeding.

Driving and operating machinery
Meriofert does not or negligibly alters the ability to drive vehicles 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 athletes
The use of the drug without therapeutic necessity constitutes doping and may in any case
result in positive doping tests.

3. How to use Meriofert

Dosage and duration of treatment:
Use this medicine following exactly the instructions of your doctor. If you have any doubts
consult your doctor.

Women who do not ovulate and who have irregular cycles or no cycles
As a general rule, the first injection of a vial of 75 IU of Meriofert is
administered during the first week of the cycle after spontaneous or induced menstruation.
Subsequently, Meriofert is injected daily at the dose prescribed by the doctor and the
treatment will continue until one or more mature follicles have developed in the ovary.
The doctor will modify the dose of Meriofert based on the ovary's response, ascertained through
clinical examinations.
As soon as a follicle reaches the required stage of development, treatment with Meriofert
will be stopped and ovulation will be initiated by means of another hormone (human chorionic gonadotropin, hCG).
Ovulation usually occurs after 32-48 hours.
Fertilization may occur during this phase of treatment. You will be advised to have
sexual intercourse every day starting from the day before the administration
of hCG. If pregnancy does not occur despite ovulation, the treatment can be repeated.

Women undergoing ovarian stimulation for the development of multiple follicles before
in vitro fertilization or other assisted reproductive techniques
The purpose of this method is to obtain the simultaneous development of multiple follicles. Treatment
will begin on the 2nd or 3rd day of the cycle with injections of 150-300 IU of Meriofert (1-2 vials
of Meriofert 150 IU). If necessary, the doctor may decide to administer higher doses.
The dose of Meriofert injected is higher than the method used for natural
fertilization. The treatment continues with individual modifications decided by the doctor.
As soon as a sufficient number of follicles have developed, treatment with Meriofert
will be stopped and ovulation will be initiated by injecting another hormone (human chorionic gonadotropin, hCG).

How it should be administeredMeriofert
Meriofert is administered by injection under the skin (subcutaneous route) or into the muscle
(intramuscular 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 inject
Meriofert yourself.
For the first time, the doctor must:

• allow you to practice by giving yourself a subcutaneous injection,
• have shown you the possible areas where you can give yourself injections,
• have shown you how to prepare the injectable solution,
• have explained how to prepare the exact dose for the injection.

Before injecting Meriofert yourself, read the following instructions carefully.
How to prepare and inject 1 vial of Meriofert
You must prepare the injection when you are ready to use it, using the pre-filled syringe with
solvent (a solution of 9 mg/ml of sodium chloride in water for injectable preparations),
included in each package of Meriofert.
Prepare a clean surface and wash your hands. It is important that your hands and the objects you
use are as clean as possible.
Place the following items on the clean surface:

• two cotton swabs with alcohol (not supplied)
• a vial containing Meriofert powder,
• a pre-filled syringe with the solvent,
• a needle for preparing the injection,
• a thin needle for subcutaneous injection.

WARNING: Do not remove the back-stop (white collar) from the pre-filled syringe,
as it prevents accidental plunger extraction and improves grip on the syringe
during injection.
Reconstitution of the injectable solution.
Preparation of the injection

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

Preparation of the injectable solution

• 2. •Remove the colored plastic capsule (light green for 75 IU, dark green for 150 IU) from the Meriofert vial by gently pushing it upwards.
• Rub the rubber stopper at the top with a cotton swab soaked in alcohol and let it dry.

• 3. • Take the syringe, remove the protective cap from the needle and push the needle through the rubber stopper at the center of the top of the Meriofert vial.
• Press the plunger firmly downwards to inject all the solution onto the powder.
• WITHOUT SHAKING, gently rotate the vial until the solution is clear. Meriofert usually dissolves immediately.

• 4. •With the needle still inserted, turn the vial upside down.
• Make sure the tip of the needle is below the level of the liquid.
• Gently pull the plunger to draw all the Meriofert solution into the syringe.
• Check that the reconstituted solution is clear.

To reconstitute more than 1 vial of Meriofert, draw the reconstituted contents into the syringe
from the first vial and 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 needle. Remove the needle from the syringe and replace it with the thin needle for subcutaneous injection, with its protective cap.
• Press the thin needle firmly onto the syringe body, then rotate it slightly to ensure it is fully screwed on and securely fastened.
• Remove the protective cap from the needle. Holding the syringe with

the needle pointing upwards, gently tap the side of the syringe
to bring any air bubbles present 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 is cloudy.

The injection site:

• Your doctor or nurse will have already explained which parts of your body to inject the medicine into. The usual sites are the thigh or the surface of the lower abdomen below the navel.
• Rub the injection site with a cotton swab soaked in alcohol.

Needle insertion:

• Grasp the skin firmly, lifting it up. With the other hand, insert the needle with a dart-like movement at an angle of 45° or 90°.

Injection of the solution:

• Inject the solution under the skin as you have been shown. Do not inject directly into a vein. Press the plunger with a slow and steady movement to inject the solution correctly without damaging the tissues.

Take as much time as necessary 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.
Needle removal:

• Quickly remove the syringe and compress the injection site with a cotton swab soaked in a disinfectant. Gentle massage of the site, while maintaining compression, helps to disperse the Meriofert solution and relieve any discomfort.

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

Disposal of all used items
Once the injection is finished, put all needles, empty vials and syringes into the
sharps container. Unused solution and waste derived from that
solution must be disposed of in accordance with local regulations.

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

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

If you stop using Meriofert
Do not stop it on your own initiative, if you are thinking of stopping the treatment always consult
your doctor.
If you have any further questions on 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 taking Meriofert and see your doctor immediately if you
experience the following effect.

Common:may affect up to 1 in 10 people

• Ovarian hyperstimulation syndrome (symptoms including the formation of an ovarian cyst or enlargement of pre-existing cysts, abdominal pain, feeling thirsty, nausea, sometimes vomiting, decreased 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
• Bloated stomach

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 feeling of unwellness
• Reaction at the injection site, 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 breaks off and is carried by the bloodstream to block another vessel).

Reporting of side effects
If you get any side effects, even those not listed in this
leaflet, tell your doctor or pharmacist.
You can also report side effects directly through the Italian Medicines Agency 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 at a temperature 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 which is stated on the outer pack, 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 in waste water. Ask your pharmacist how to eliminate the
medicines that you no longer use. This will help protect the environment.

6. Package contents and other information

What Meriofert contains
The active ingredient is menotropin.
Each vial contains 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), 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.
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 more than one vial of powder is used, the amount of menotropin contained in 1 ml of reconstituted solution will be:

Other ingredients are
For the powder: lactose monohydrate.
For the solvent: 9 mg/ml of sodium chloride solution.

Description of the appearance of Meriofert and contents of the pack
Powder: a cake or lyophilized powder of white color
Solvent: clear and colorless solution
Meriofert is supplied as powder and solvent for solution for injection.
1 kit contains:

• One vial containing a cake or lyophilized powder of white color
• One pre-filled syringe (1 ml) containing a clear and colorless 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 authorised in the member states of the EEA under the following
denominations:(dosage and pharmaceutical form are identical in all countries, only the trade name is different)
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 the national phase
Lithuania: name under evaluation during the national phase
Luxembourg: Fertinorm Kit
Poland: Mensinorm Set
Netherlands: Meriofert spuit
Slovakia, Spain, Hungary: Meriofert Kit

Meriofert 75 IU

powder and solvent for injectable solution

Meriofert 150 IU

powder and solvent for injectable solution

menotropine
Read this leaflet carefully before you use 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 could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• Throughout this leaflet, Meriofert 75 IU powder and solvent for injectable solution and Meriofert 150 IU 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 you use 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 is Meriofert and what is it used for

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

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 activity of human follicle
stimulating hormone (FSH) and 75 IU of activity of human luteinizing hormone (LH).
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 lyophilized powder with 150 IU of activity of human follicle
stimulating hormone (FSH) and 150 IU of activity of human luteinizing hormone (LH).
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.
This medicine must be used under the supervision of a doctor.

5. What you need to 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).
• Bleeding of unknown cause.
• Malignant tumor of the ovaries, uterus or breast.
• Abnormal enlargement (tumor) of the pituitary gland or hypothalamus (brain).
• Hypersensitivity (allergy) to menotropins or any of the ingredients of Meriofert

This medicine should not be used in case of premature menopause, in the presence of a
malformation of the genital organs or of certain tumors of the uterus 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 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 discontinued and
pregnancy will be avoided. The first signs of ovarian hyperstimulation are pain in the lower
abdomen, nausea (feeling unwell), vomiting and weight gain. If
these symptoms appear, you should see your doctor as soon as possible. In serious,
but rare, cases, the ovaries may enlarge, with an accumulation of fluid in the abdomen or chest.
The drug used to induce the final release of mature eggs (containing human chorionic gonadotropin, hCG) may increase the probability of OHSS. In cases where
OHSS is developing, the use of hCG is therefore not recommended and for at least 4 days you should
abstain from sexual intercourse even if you use a barrier contraceptive method.
It should be emphasized that women with fertility problems have a higher percentage of miscarriages
compared to the normal population.
In patients treated to promote ovulation, multiple pregnancies and births occur
more often than with natural conception. However, this risk can be minimized
by using the recommended dose.
In women with problems with the fallopian tubes there is a slightly increased risk of
ectopic pregnancy (pregnancy outside the uterus).
Multiple pregnancies and the characteristics of parents undergoing fertility treatments (e.g. mother’s age, sperm characteristics) may be associated with an
increased risk of birth defects.
Like pregnancy itself, treatment with Meriofert may increase the likelihood of having
a thrombosis. Thrombosis is the formation of a blood clot, more frequently
in the veins of the legs or lungs.
Consult your doctor before starting treatment, especially:

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

Children
The use of the medicine in children is not intended.

Other medicines and Meriofert
Tell 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 alter or alters negligibly the ability to drive vehicles 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 who play sports
The use of the drug without therapeutic necessity constitutes doping and may still
result in a positive doping test.

6. How to use Meriofert

Dose and duration of treatment:
Use this medicine following exactly the instructions of your doctor. If you have any doubts
consult your doctor.

Women who do not ovulate and who have irregular cycles or do not have a cycle
As a general rule, the first injection of a vial of 75 IU of Meriofert is
administered during the first week of the cycle after spontaneous or induced menstruation.
Subsequently, Meriofert is injected daily at the dose prescribed by the doctor and the
treatment will continue until one or more mature follicles have developed in the ovary.
The doctor will modify the dose of Meriofert based on the ovary's response, ascertained through
clinical examinations.
As soon as a follicle reaches the required stage of development, treatment with Meriofert
will be stopped and ovulation will be induced with another hormone (chorionic gonadotropin,
hCG).
Ovulation usually occurs after 32-48 hours.
In this phase of treatment, fertilization can occur. You will be advised to have
sexual intercourse every day starting from the day before the administration
of hCG. If pregnancy does not occur despite ovulation, the
treatment can be repeated.

Women undergoing ovarian stimulation for the development of multiple follicles before
in vitro fertilization or other assisted reproductive techniques
The purpose of this method is to obtain the simultaneous development of multiple follicles. Treatment
will begin on the 2nd or 3rd day of the cycle with injections of 150-300 IU of Meriofert (1-2 vials
of Meriofert 150 IU). If necessary, the doctor may decide to administer higher doses.
The dose of Meriofert injected is higher than the method used for
natural fertilization. The treatment continues with individual modifications decided by the doctor.
As soon as the development of a sufficient number of follicles is reached, treatment with Meriofert
will be stopped and ovulation will be induced by injecting another hormone (chorionic gonadotropin,
hCG).

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

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

• allow you to practice by giving yourself a subcutaneous injection alone,
• have shown you the possible areas where you can give yourself injections,
• have shown you how to prepare the injectable solution,
• have explained how to prepare the exact dose for injection.

Before injecting Meriofert alone, read the following instructions carefully.
How to prepare and inject 1 vial of Meriofert
The solution must be prepared immediately before the injection. The vial is for single use.
The medicine must be reconstituted under aseptic conditions.
Meriofert must be reconstituted exclusively with the solvent provided with the package.
Prepare a clean surface and wash your hands before reconstituting the solution. It is important
that your hands and the objects you use are as clean as possible.
Prepare the following items on a clean surface:

• two cotton swabs soaked in alcohol (not provided)
• a vial containing Meriofert powder,
• a vial with the solvent,
• a syringe (not provided)
• a needle for preparing the injection (not provided),
• a thin needle for subcutaneous injection (not provided).

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

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

Remove the protective cap from the needle. Attach the needle for
reconstitution (larger needle) to the syringe. With the syringe in one hand,
take the open vial of solvent, insert the needle and withdraw the entire
contents of the vial into the syringe. Replace the needle cap
of the needle. Carefully place the syringe on the surface.
. 2. Remove the colored plastic cap (light green for 75 IU and dark green
for 150 IU) from the powder vial by pressing gently
upwards. Disinfect the top of the rubber stopper with a cotton ball
soaked in alcohol and let it dry.

• 3. Take the syringe, remove the cap from the needle and slowly inject the solvent into the powder vial in the center of the top of the rubber stopper. Press the plunger firmly to inject all the solution into the

powder.

DO NOT SHAKE, but slowly rotate the vial between your hands until the
powder is completely dissolved, being careful not to form
foam.

• 4. Once the powder is dissolved (which usually happens immediately),

slowly draw the solution into the syringe:

• With the needle still inserted, turn the vial upside down.
• Make sure the tip of the needle is below the level of the liquid.
• Gently pull back the plunger to draw all the solution into the syringe.
• Check that the reconstituted solution is clear and colorless.

Preparation of higher doses, using more than 1 vial of powder
If your doctor has recommended higher doses, these can be obtained by using
more than one vial of powder with one vial of solvent.
When reconstituting more than 1 vial of Meriofert, at the end of step 4 above
reported, draw the reconstituted contents of the first vial into the syringe and inject it
slowly into a second vial. Repeat steps 2 to 4 for the second vial and for
subsequent vials, until the contents of the required number of vials equivalent to the
prescribed dose is dissolved (within the maximum total dosage limit of 450 IU,
corresponding to a maximum of 6 vials of Meriofert 75 IU or 3 vials of Meriofert
150 IU).
The doctor may increase the dose by 37.5 IU, equivalent to half a vial of Meriofert 75 IU.
To do this, reconstitute the contents of the 75 IU vial according to steps 2
to 3 described above and draw half of this reconstituted solution (0.5 ml) into the syringe according to
step 4.
In this case you will have two preparations to inject: the first preparation reconstituted in 1 ml and
the second containing 37.5 IU in 0.5 ml.
Both preparations will be injected with a syringe prepared according to the steps
following.
The solution must be clear and colorless.

Subcutaneous injection of the medicine

• When the syringe contains the prescribed dose, insert the protective cap on the needle. Remove the needle from the syringe and replace it with the thin needle for subcutaneous injection, with its protective cap.
• Press firmly on the needle on the body of the syringe, then rotate it slightly to make sure it is completely screwed in and to secure it firmly.
• Remove the protective cap from the needle. Holding the syringe with the needle pointing upwards, gently tap the side of the syringe to bring any air bubbles present to the top.
• Press the plunger until a drop of liquid appears on the tip of the needle.
• Do not use the solution if it contains particles or if it is cloudy.

The injection site:

• Your doctor or nurse will have already explained which parts of your body to inject the medicine into. The usual sites are the thigh or the lower part of the abdomen, below the navel.
• Rub the injection site with a cotton swab soaked in alcohol.

Needle insertion:

• Grasp the skin firmly lifting it up. With the other hand, insert the needle with a dart-like movement, at an angle of 45° or 90°.

Injection of the solution:

• Inject the solution under the skin as you have been shown. Do not inject it directly into a vein. Press the plunger with a slow and steady movement to inject the solution correctly without damaging the tissues.

Take as much time as necessary to inject the prescribed volume of solution. As
described for the preparation of the solution, depending on the dose that your doctor has
prescribed, you may not have to use the entire volume of the solution.
Needle removal:

• Quickly withdraw the syringe and compress the injection site with a cotton swab soaked in a disinfectant. Gently massaging the site, always maintaining compression, helps to disperse the Meriofert solution and to relieve any discomfort.

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

Disposal of all used items
Once the injection is finished, all needles and empty syringes must be disposed of in
special 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 an overdose of Meriofert are not known, however, ovarian hyperstimulation syndrome may occur (see Possible side effects). If you use more
Meriofert than you should, contact your doctor or nurse.

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

If you stop using Meriofert
Do not stop it on your own initiative, if you are thinking of stopping the treatment always consult
your doctor.
If you have any further questions on 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 taking Meriofert and go to your doctor immediately if you
experience the following effect.

Common: may affect up to 1 in 10 people

• Ovarian hyperstimulation syndrome (symptoms including the formation of an ovarian cyst or enlargement of pre-existing cysts, lower abdominal pain, feeling thirsty and unwell, nausea, sometimes vomiting, reduced urine flow 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
• Bloated stomach

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 feeling of being unwell
• Reaction at the injection site, 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 breaks off and is carried by the bloodstream to block another vessel).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist.
You can also report side effects directly through the Italian Medicines Agency 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 at a temperature 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 which is stated on the outer pack, 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 in wastewater. Ask your pharmacist how to dispose of the
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Meriofert contains
The active ingredient is menotropin.
Each vial contains lyophilized powder with 75 IU of activity of human follicle
stimulating hormone (FSH) and 75 IU of activity of human luteinizing hormone (LH).
Menopausal human 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 activity
of LH.
Each vial contains lyophilized powder with 150 IU of activity of human follicle
stimulating hormone (FSH) and 150 IU of activity of human luteinizing hormone (LH).
Menopausal human 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 activity
of LH.
If more than one vial of powder is used, the amount of menotropin contained in 1 ml of
reconstituted solution will be:

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

Description of the appearance of Meriofert and contents of the pack
Powder: cake or lyophilized powder of white color
Solvent: clear and colorless solution
Meriofert is supplied as powder and solvent for solution for injection.
1 kit contains:

• One vial containing a cake or lyophilized powder of white color
• One vial (1 ml) containing a clear and colorless solution Packs of 1, 5 or 10 kits. Not all pack sizes may be marketed.

Marketing Authorisation 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 authorised in the member states of the EEA under the following
names:(dosage and pharmaceutical form are identical in all countries, only the trade
name is different)
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

MERIOFERT 900 IU

powder and solvent for injectable solution

menotropine
Read this leaflet carefully before you start to use 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, 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 get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.
• Throughout this leaflet, MERIOFERT 900 IU powder and solvent for injectable solution 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 you use 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 is MERIOFERT and what is it used for

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

MERIOFERT is a highly purified human menopausal gonadotropin and belongs to a
group of medicines called gonadotropins.
Each multi-dose vial contains lyophilized powder with 900 IU of activity of human
follicle-stimulating hormone (FSH) and 900 IU of activity of human luteinizing hormone (LH).
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.
This medicine must be used under the supervision of a doctor.

2. What you need to 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).
• Bleeding of unknown cause.
• Malignant tumor of the ovaries, uterus or breast.
• Abnormal enlargement (tumor) of the pituitary gland or hypothalamus (brain).
• Allergy to menotropins or any of the ingredients of this medicine (listed in section 6)

This medicine should not be used in cases of premature menopause, in the presence of a
malformation of the genital organs or certain tumors of the uterus that would make
normal pregnancy impossible.

Warnings and precautions
Although allergic reactions to MERIOFERT have not been reported so far, inform your doctor
if you have 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. The first signs of ovarian hyperstimulation are pain in the
lower abdomen, nausea, vomiting and weight gain. If you experience these symptoms, you should
see your doctor as soon as possible. In serious, but rare cases, the ovaries may
enlarge, with an accumulation of fluid in the abdomen or chest.
The drug used to induce the final release of mature eggs (containing hCG) may increase
the probability of OHSS. In cases where OHSS is developing, the use of
hCG is therefore not recommended and you should abstain from sexual intercourse for at least 4 days,
even if you are using a barrier method of contraception.
It should be emphasized that women with fertility problems have a higher percentage of miscarriages
compared to the general population.
In patients treated to promote ovulation, multiple pregnancies and births occur
more often than with natural conception. However, this risk can be minimized
by using the recommended dose.
In women with problems with the fallopian tubes, there is a slightly increased risk of
ectopic pregnancy (or extrauterine pregnancy).
Multiple pregnancies and the characteristics of parents undergoing fertility treatments
(e.g. mother's age, sperm characteristics) may be associated with an increased
risk of birth defects.
As with pregnancy itself, treatment with MERIOFERT may increase the likelihood of
having a thrombosis. Thrombosis is the formation of a blood clot, more
frequently 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 developing a thrombosis.
• If you or a close family member has ever had a thrombosis.
• If you are severely overweight.

Children
The use of the medicine in children is not intended.

Other medicines and MERIOFERT
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.

Pregnancy, breastfeeding and fertility
MERIOFERT should not be used if you are pregnant or breastfeeding.

Driving and operating machinery
MERIOFERT does not or negligibly alters the ability to drive vehicles 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 athletes
The use of the drug without therapeutic necessity constitutes doping and may still
result in positive doping tests.

3. How to use MERIOFERT

Dosage and duration of treatment:
Use this medicine following exactly the instructions of your doctor. If you have any doubts
consult your doctor.

Women who do not ovulate and who have irregular cycles or do not have a period:
As a general rule, the first injection of 75 IU of menotropine is administered during
the first week of the cycle after spontaneous or induced menstruation.
Subsequently, MERIOFERT is injected daily at the dose prescribed by the doctor and
the treatment will continue until one or more mature follicles have developed in the ovary.
The doctor will modify the dose of MERIOFERT based on the ovary's response,
verified through clinical examinations.
As soon as a follicle reaches the required stage of development, treatment with
MERIOFERT will be suspended and ovulation will be initiated by means of another hormone
(chorionic gonadotropin, hCG).
Ovulation usually occurs after 32-48 hours.
Fertilization may occur during this phase of treatment. You will be advised to have
sexual intercourse every day starting from the day before the administration
of hCG. If pregnancy does not occur despite ovulation, the treatment can be repeated.

Women undergoing ovarian stimulation for the development of multiple follicles before
in vitro fertilization or other assisted reproductive techniques:
The purpose of this method is to obtain the simultaneous development of multiple follicles. Treatment
will begin on the 2nd or 3rd day of the cycle with injections of 150-300 IU of MERIOFERT. If
necessary, the doctor may decide to administer higher doses. The dose of MERIOFERT
injected is higher than the method used for natural fertilization. The treatment
continues with individual modifications decided by the doctor.
As soon as a sufficient number of follicles have developed, treatment with
MERIOFERT will be suspended and ovulation will be initiated by injecting another hormone
(chorionic gonadotropin, hCG).

How MERIOFERT should be administered:
MERIOFERT is administered by injection under the skin (subcutaneous route).
Each vial must be reconstituted only once and each single injection must be
performed as soon as the necessary dose is withdrawn.

After adequately informing and training you, your doctor may ask you to inject
MERIOFERT yourself.
Before your first injection, your doctor must:

• allow you to practice by giving yourself a subcutaneous injection,
• have shown you the possible areas where you can give yourself injections,
• have shown you how to prepare the injectable solution,
• have explained how to prepare the exact dose for the injection.

Before injecting MERIOFERT yourself, read the following instructions carefully.
Since this vial contains medicine for several days of treatment, you must
make sure to withdraw only the amount of medicine prescribed by your doctor. Your doctor has prescribed a dose of MERIOFERT in (units) IU. To obtain the correct dose, 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 in accordance with local regulations and in a suitable container.

How to prepare and inject 1 vial of MERIOFERT:
The injectable solution containing 900 IU of menotropine should be prepared as soon as
you are ready to take your first dose, adding the solvent for reconstitution in the prefilled syringe (included in each package) to the vial containing the powder.
Prepare a clean surface and wash your hands with soap and warm water. It is important that your
hands and the objects you use are as clean as possible.
Arrange the following materials:

• the vial containing the MERIOFERT powder
• the prefilled syringe containing the solvent for reconstitution
• the needle for preparing the reconstitution
• a single-dose syringe graduated in FSH/LH units with a needle already inserted, for subcutaneous administration
• an alcohol-soaked swab
• cotton and disinfectant solution (not supplied with the package)

WARNING:

• Before reconstitution and each administration, disinfect the upper rubber stopper of the vial containing the reconstituted solution with cottonand disinfectant (e.g. alcohol solution) and let it dry.
• Do not remove the back-stop (white collar) from the prefilled syringe, asit prevents accidental retraction of the plunger and improves grip on the syringeduring injection.

Reconstitution of the injectable solution
Preparation of the prefilled syringe:

• 1.
• Remove the cap from the prefilled syringe containing the solvent; insert the reconstitution needle into the syringe with the protective cap still in place.
• Carefully place the syringe on the clean surface.

Preparation of the vial:

• 2.
• Remove the colored plastic capsule from the vial by gently pushing it upwards with your thumb.
• Rub the upper rubber stopper with cotton and disinfectant and let it dry.
• 3.
• Take the syringe, remove the protective cap from the needle and push the needle through the rubber stopper in the center of the upper end of the vial.
• Press the plunger firmly downwards to inject all the solution onto the powder.
• During the addition of the solvent, a slight overpressure is created in the vial. Therefore, release the plunger and let it rise back up on its own for about 10 seconds. This will remove the overpressure from the vial. DO NOT SHAKE the reconstituted solution, but gently rotate it until the solution is clear. In general, MERIOFERT dissolves immediately. Check that the reconstituted solution is clear.

Before the injection:

• 4.
• Check that the reconstituted solution is clear, colorless and free of particles. DO NOT USE if the solution contains particles, is cloudy or not colorless.
• 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 a needle already inserted, remove the protective cap from the needle and insert the needle vertically into the center of the top of the vial.
• Press the plunger all the way down.
• Turn the vial upside down. Make sure the needle is below the level of the medicine and draw the prescribed dose of MERIOFERT into the syringe for administration.
• Remove the needle from the vial. Hold the syringe with the needle pointing upwards and gently tap the side of the syringe to allow any air bubbles to rise.
• Slowly press the plunger until a drop of liquid appears on the tip of the needle.

WARNING: since this vial contains medicine for several days of
treatment, you must make sure to withdraw only the dose of medicine prescribed by your
doctor.
Administration of the injection
The injection site:

• Your doctor or nurse will have already explained which parts of your body

to inject the medicine. Common sites are the thigh or the surface
of the lower abdomen below the navel

• Rub the injection site with an alcohol-soaked swab. Firmly grasp the skin lifting it up. With the other hand, insert the needle with a dart-like movement at an angle of 45° or 90°.

Injection of the solution:

• Inject the solution under the skin as you have been shown. Do not inject it directly into a vein. Press the plunger with a slow and steady movement to inject the solution correctly without damaging the tissues.

Take as much time as necessary to inject the prescribed volume of solution.
Quickly withdraw the needle and compress the injection site with cotton and disinfectant.
Gently massage the site, always maintaining compression, this will help to
disperse the medicine and relieve any discomfort.
Further subsequent injections:
For subsequent injections with the reconstituted MERIOFERT solution, repeat the operations
from point 4 onwards.

If you use more MERIOFERT than you should
The effects of an overdose of MERIOFERT are unknown, however, ovarian hyperstimulation syndrome may occur (see Possible side effects). If
you use more MERIOFERT than you should, contact your doctor or nurse.

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

If you stop taking MERIOFERT:
Do not stop it on your own initiative. Always consult your doctor before stopping
treatment.
If you have any doubts 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 see your doctor immediately if you
experience the following:
Common: (may affect up to 1 in 10 people)

• Ovarian hyperstimulation syndrome (symptoms include the formation of an ovarian cyst or enlargement of pre-existing cysts, abdominal pain, feeling thirsty, nausea, sometimes vomiting, decreased 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
• Bloated stomach

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 feeling of unwellness
• Reaction at the injection site, such as pain and inflammation.

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

• 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 breaks off and is carried by the bloodstream to block another vessel).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist.
You can also report side effects directly through the Italian Medicines Agency
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 which is stated on the outer packaging, on the
vial and on the pre-filled syringe of solvent. If the expiry date is stated as
month/year, the expiry date refers to the last day of that month.
Before reconstitution: store at a temperature of 2-8°C.
After reconstitution, the solution can be stored for a maximum of 28 days at a
temperature not exceeding 25 °C.
Do not freeze before or after 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 in waste water or household waste. 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 ingredient is menotropin.
Each multi-dose vial contains lyophilized powder with 900 IU of follicle stimulating hormone (FSH) activity and 900 IU of luteinizing hormone (LH) activity.
Menopausal human 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.

Other components are
Powder: lactose monohydrate, polysorbate 20, disodium phosphate dihydrate, phosphoric acid and sodium hydroxide.
Solvent: metacresol and water for injections.

Description of the appearance of MERIOFERT and contents of the pack
Powder: cake or lyophilized powder of white color
Solvent: clear and colorless solution
MERIOFERT is supplied as powder and solvent for injection.
1 kit contains:

• 1 vial containing the powder of MERIOFERT
• 1 pre-filled syringe containing the solvent for reconstitution
• 1 needle for preparing the reconstitution
• 12 alcohol swabs for multiple injections
• 12 single-use syringes with needle already inserted for multiple injections

Marketing authorisation 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 authorised in the member states of the EEA and in the United Kingdom (Northern Ireland) with the following denominations: (dosage and pharmaceutical form are identical in all countries, only the trade name is different)
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