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EIGENORM PFS 75 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION

Active substance(s): MENOTROPHIN

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Eigenorm PFS 75IU-150IU
Powder and solvent for solution for injection

1.3.1

PACKAGE LEAFLET

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Eigenorm PFS 75IU-150IU
Powder and solvent for solution for injection

1.3.1

Eigenorm PFS 75 IU
powder and solvent for solution for injection
Eigenorm PFS 150 IU
powder and solvent for solution for injection
Menotrophin
▼ This medicine is subject to additional monitoring. This will allow quick identification of
new safety information. You can help by reporting any side effects you may get. See the end
of section 4 for how to report side effects.

Read all of this leaflet carefully before you start using this medicine because it contains
important information for you.






Keep this leaflet. You may need to read it again.
If you have any further questions, please ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm
them, even if their signs of illness are the same as yours.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible
side effects not listed in this leaflet. See section 4.
In this leaflet Eigenorm PFS 75 IU powder and solvent for solution for injection and
Eigenorm PFS 150 IU powder and solvent for solution for injection are called Eigenorm
PFS.

What is in this leaflet:
1.
2.
3.
4.
5.
6.

What Eigenorm PFS is and what it is used for
What you need to know before you use Eigenorm PFS
How to use Eigenorm PFS
Possible side-effects
How to store Eigenorm PFS
Contents of the pack and other information

1.

What Eigenorm PFS is and what it is used for



Eigenorm PFS is used to promote ovulation in women who are not ovulating and who
have not responded to other treatment (clomiphene citrate).
Eigenorm PFS is used to bring about the development of several follicles (and
therefore several eggs) in women receiving fertility treatment.

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Eigenorm PFS 75IU-150IU
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Eigenorm PFS is a highly purified human menopausal gonadotrophin, belonging to a group
of medicines called gonadotrophins.
Each freeze-dried vial contains 75 IU human follicle stimulating hormone activity (FSH) and
75 IU human luteinising hormone activity (LH).
Human Chorionic Gonadotrophin (hCG), a hormone naturally present in urine of pregnant
women, is added to contribute to the total LH activity.
Each freeze-dried vial contains 150 IU human follicle stimulating hormone activity (FSH)
and 150 IU human luteinising hormone activity (LH).
Human Chorionic Gonadotrophin (hCG), a hormone naturally present in urine of pregnant
women, is added to contribute to the total LH activity.
This medicinal product must be used under the supervision of your doctor.

2.

What you need to know before you use Eigenorm PFS

You and your partner’s fertility will be evaluated before your treatment is started.
Do not use Eigenorm PFS if you have any of the following:






Enlarged ovaries or cysts not caused by a hormonal disorder (polycystic
ovarian disease).
Bleeding of unknown cause.
Cancer of the ovaries, uterus or breast.
Abnormal swelling (tumour) of the pituitary gland or hypothalamus (brain).
Hypersensitivity (allergy) to Menotrophin or any of the ingredients in
Eigenorm PFS

This medicine should not be used if you have an early menopause, a malformation of the
sexual organs or certain tumours of the womb that would make a normal pregnancy
impossible.
Warnings and Precautions
Although no allergic reactions to Eigenorm PFS have yet been reported, you should tell your
doctor if you have an allergic reaction to similar medicines.
This treatment increases your risk of developing a condition known as ovarian
hyperstimulation syndrome (OHSS) (see Possible side effects). If ovarian hyperstimulation
occurs then your treatment will be stopped and pregnancy will be avoided. The first signs of
ovarian hyperstimulation are pain in the lower abdominal region as well as nausea (feeling
sick), vomiting and weight gain. If these symptoms occur you should be examined by your

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Eigenorm PFS 75IU-150IU
Powder and solvent for solution for injection

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doctor as soon as possible. In serious, but rare cases, the ovaries can become enlarged and
fluid can build up in the abdomen or chest.
The drug used to bring about the final release of mature eggs (containing human chorionic
gonadotrophin-hCG) can increase the likelihood of OHSS. It is therefore not advisable to use
hCG in cases where OHSS is developing and you should not have sexual intercourse even if
using a barrier method of contraception for at least 4 days.
It should be noted that women with fertility problems have a higher rate of miscarriages than
the normal population.
In patients having treatment to help ovulation, the occurrence of multiple pregnancies and
births is increased compared to natural conception. However, this risk can be minimised by
using the recommended dose.
There is a slightly increased risk of extra-uterine pregnancy (an ectopic pregnancy) in women
with damaged fallopian tubes.
Multiple pregnancies and characteristics of the parents undergoing fertility treatments (e.g.
maternal age, sperm characteristics) may be associated with an increased risk of birth defects.
Treatment with Eigenorm PFS, just as pregnancy itself, may increase the chance of having
thrombosis. Thrombosis is the formation of a blood clot in a blood vessel, most often in the
veins of the legs or the lungs.
Please discuss this with your doctor, before starting treatment, especially:

If you already know you have an increased chance of having thrombosis.

If you, or anyone in your immediate family, have ever had a thrombosis.

If you are severely overweight.
Paediatric population
The product is not intended for paediatric use.
Other medicines and Eigenorm PFS
Tell your doctor or pharmacist if you are taking or have recently taken or might take any
other medicines.
Pregnancy, breast-feeding and fertility
Eigenorm PFS should not be used if you are pregnant or breast-feeding.
Driving and using machines

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Eigenorm PFS 75IU-150IU
Powder and solvent for solution for injection

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Eigenorm PFS has no or negligible influence on the ability to drive and use of machinery.
However, no studies on the effect on ability to drive and use machines have been performed.

3.

How to use Eigenorm PFS

Dosage and duration of the treatment:
Always use this medicine exactly as your doctor has told you. Check with your doctor if you
are not sure.
Women who are not ovulating and are having irregular periods or no periods at all:
As a general rule, the first injection of one Eigenorm PFS 75 IU vial is given during the first
week of the cycle after spontaneous or induced menses.
Subsequently, Eigenorm PFS is injected daily at the dosage prescribed by the physician and
the treatment will continue until one or more ripe follicle have developed in the ovary. Your
physician will adjust the Eigenorm PFS dosage depending on the ovarian response, which is
determined by clinical examinations.
As soon as one follicle reaches the required development stage, the Eigenorm PFS treatment
will be withheld and ovulation will be triggered with another hormone (chorionic
gonadotropin, hCG).
Ovulation generally takes place after 32 to 48 hours.
In this phase of the treatment, fertilization is possible. You will be advised to have sexual
intercourse every day starting from the day preceding the administration of hCG. If
pregnancy is not achieved in spite of ovulation, the treatment can be repeated.
Women undergoing ovarian stimulation for multiple follicular development prior to in
vitro fertilisation or other assisted reproductive techniques:
The aim of this method is to obtain concomitant multiple follicular development. The
treatment will start on the 2nd or 3rd day of the cycle with injections of 150-300 IU of
Eigenorm PFS (1-2 vials of Eigenorm PFS 150 IU). Your physician may decide to administer
higher dosages if required. The injected dosage of Eigenorm PFS is higher than in the
method used for natural fertilization. The continuation of the treatment is adjusted
individually by the physician.
As soon as a sufficient number of follicles has developed, the treatment with Eigenorm PFS
is withheld and ovulation is triggered by injecting another hormone (chorionic gonadotropin,
hCG).
How Eigenorm PFS should be given:

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Eigenorm PFS is given by injection under your skin (by the subcutaneous route) or into your
muscle (intramuscular injection).
Each vial should be used only once and the injection should be used as soon as it is prepared.
After suitable advice and training your doctor may ask you to inject Eigenorm PFS
yourself.
For the first time, your doctor must:
-

let you practise giving yourself a subcutaneous injection,
have shown you the possible places where you can inject yourself,
have shown you how to prepare the solution for injection,
have explained how to prepare the right dose of injection.

Before injecting Eigenorm PFS yourself, read the following instructions carefully.
How to prepare and inject 1 vial of Eigenorm PFS:
The injection must be prepared just before you are ready to use it, using the prefilled syringe
of solvent (a solution of 0.9% sodium chloride in water for injections) included in each
Eigenorm PFS pack.
Prepare a clean surface and wash your hands. It is important that your hands and the items
you use are as clean as possible.
On the surface lay out the following items:
-

two alcohol swabs (not provided),
one vial containing Eigenorm PFS powder,
one prefilled syringe with solvent,
one needle for preparing the injection,
a fine bore needle for subcutaneous injection.

Reconstitution of the solution for injection
Preparing your injection:
1. • Remove the cap from the prefilled syringe; insert the
reconstitution needle (long needle) on the syringe.
• Carefully place the syringe on the clean surface.
• Avoid touching the needle.
Prepare the solution for the injection:
2.
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• Remove the coloured plastic cap (75 IU light green,
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Eigenorm PFS 75IU-150IU
Powder and solvent for solution for injection

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150 IU dark green) from the Eigenorm PFS vial by gently
pushing it upwards.
• Wipe the rubber top with an alcohol swab and allow to dry.
3.

• Pick up the syringe, remove the protective cap of the needle
and push the needle through the rubber middle of the
Eigenorm PFS vial top.
• Press the plunger down firmly to squirt all the solution onto the powder.
• DO NOT SHAKE, but gently swirl until the solution is clear.
Generally Eigenorm PFS dissolves immediately.

4. • With the needle still inserted, turn the vial upside down.
• Make sure the needle tip is underneath the level of the liquid.
• Gently pull the plunger to draw all the Eigenorm PFS
solution up into the syringe.
• Check that the reconstituted solution is clear.
When reconstituting more than 1 vial of Eigenorm PFS, draw back the reconstituted contents
of the first vial into the syringe and slowly inject into a second vial after repeating the steps
2-4.
Injecting your medicine subcutaneously:








When the syringe contains the described dose, attach the protective
cap of the needle. Remove the needle from the syringe and replace it
with the fine bore needle for subcutaneous injection including its
protective cap.
Push the fine bore needle firmly onto the syringe barrel, then twist it
slightly to ensure it is fully screwed on and to create a firm seal.
Remove the protective cap of the needle. Hold the syringe with the
needle pointing upwards and gently tap the side of the syringe to force
any air bubbles up to the top;
Push the plunger until a bead of liquid appears at the tip of the needle.
Do not use if it contains any particles or is cloudy.

The injection site:
Your doctor or nurse will have already advised you where on your
body to inject your medicine. The usual places are the thigh or the
lower abdominal wall below the navel.
• Wipe the injection site with an alcohol swab.



Inserting the needle:

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Eigenorm PFS 75IU-150IU
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• Firmly pinch the skin together. With the other hand, insert the needle
with a dart-like motion at an angle of 45° or 90°.
Injecting the solution:
• Inject under the skin as you were shown. Do not inject directly into a vein. Push the
plunger slowly and steadily, so the solution is correctly injected and the skin tissues
are not damaged.
Take as much time as you need to inject the volume of solution prescribed. Depending on
the dosage prescribed by your doctor, you may not use the entire volume of the solution.
Removing the needle:
• Pull the syringe out quickly and apply pressure to the injection site with a swab
containing disinfectant. A gentle massage of the site – while still maintaining pressure
– helps disperse the Eigenorm PFS solution and relieve any discomfort.

Injecting your medicine intramuscularly:
For intramuscular injections your healthcare provider will prepare and then inject Eigenorm
PFS into the side of your thigh or buttock.
Dispose of all used items:
Once you have finished your injection, put all needles and empty vials and syringes into the
sharps container. Any unused solution or waste material should be disposed of in accordance
with local requirements.
If you use more Eigenorm PFS than you should:
The effects of an overdose of Eigenorm PFS are unknown, nevertheless, one could expect
ovarian hyperstimulation syndrome to occur (see Possible side effects). If you use more
Eigenorm PFS than you should, speak to your doctor or pharmacist.
If you forget to use Eigenorm PFS:
Take it at the next normal time for an injection. Do not take double dose to make up for a
forgotten dose.
If you stop using Eigenorm PFS:
Do not stop on your own initiative: Always consult your doctor if you are considering
stopping this medicine.

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Eigenorm PFS 75IU-150IU
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If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4.

Possible side effects

Like all medicines, Eigenorm PFS can cause side effects, although not everybody gets them.
The following side effect is important and will require immediate action if you experience it.
You should stop taking Eigenorm PFS and see your doctor immediately if the following
occurs:
Common, affects 1 to 10 users in 100:


Ovarian Hyperstimulation Syndrome (symptoms include ovarian cyst formation or
enlargement of existing cysts, lower stomach pain, feeling thirsty and sick, and
sometimes being sick, passing reduced quantities of concentrated urine and weight
gain) (see Section 2 for additional information).

The following side-effects have also been reported:
Very Common (likely to affect up to 1 in 10 users):



Headache
Swollen or bloated stomach

Common (likely to affect between 1 in 100 and 1 in 10 users):













Abdominal pain or discomfort
Pelvic pain
Back pain
Sensation of heaviness
Breast discomfort
Dizziness
Hot flushes
Thirst
Feeling sick
Tiredness
Feeling generally unwell
Injection site reaction such as pain and inflammation (frequency higher with IM than
SC).

Rare, (likely to affect between 1 in 10,000 and 1 in 1000 users):



Ovarian torsion (twisting of the ovary which causes extreme pain in the lower
abdomen)

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Eigenorm PFS 75IU-150IU
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Very rare, (likely to affect between 1 in 100,000 and 1 in 10,000 users):


Thromboembolism (formation of a clot in a blood vessel that breaks loose and is
carried by the blood stream to block another vessel).

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet.
You can also report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more
information on the safety of this medicine.

5.

How to store Eigenorm PFS

Keep this medicine out of the sight and reach of children.
Do not store above 25° C. Keep the vial and the prefilled syringe of solvent in the outer
carton in order to protect from light.
Do not use this medicine after the expiry date which is stated on the outer carton, the vial and
the prefilled syringe of solvent. The expiry date refers to the last day of the month.
Use immediately after reconstitution.
Do not use Eigenorm PFS if you notice the solution does not look clear. After reconstitution
the solution must be clear and colourless.
Do not throw away any medicines via wastewater. Ask your pharmacist how to throw away
medicines you no longer use. These measures will help protect the environment.
6.

Contents of the pack and other information

What Eigenorm PFS contains
The active substance is menotrophin.
Each freeze-dried vial contains 75 IU human follicle stimulating hormone activity (FSH) and
75 IU human luteinising hormone activity (LH).
Human Chorionic Gonadotrophin (hCG), an hormone naturally present in urine of pregnant
women, is added to contribute to the total LH activity.
Each freeze-dried vial contains 150 IU human follicle stimulating hormone activity (FSH)
and 150 IU human luteinising hormone activity (LH).
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Eigenorm PFS 75IU-150IU
Powder and solvent for solution for injection

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Human Chorionic Gonadotrophin (hCG), an hormone naturally present in urine of pregnant
women, is added to contribute to the total LH activity.
If multiple vials of powder are used, the amount of menotrophin contained in 1 ml of
reconstituted solution will be as follows:
Eigenorm PFS 75 IU

Eigenorm PFS 150 IU

powder and solvent for solution for
injection

powder and solvent for solution for
injection

Number of
vials used

Total amount of menotrophin
in 1 ml of solution

Number of
vials used

Total amount of menotrophin
in 1 ml of solution

1

75 IU

1

150 IU

2

150 IU

2

300 IU

3

225 IU

3

450 IU

4

300 IU

5

375 IU

6

450 IU

The other excipients are
For the powder: lactose monohydrate.
For the solvent: 0.9% sodium chloride solution.
What Eigenorm PFS looks like and contents of the pack
Powder: white to almost white lyophilized powder
Solvent: clear and colourless solution
Eigenorm PFS is presented as a powder and solvent for solution for injection.
1 set contains the following:
• One vial containing a white to almost white powder
• One prefilled syringe (1ml) containing a clear and colourless solution
• One needle for reconstitution and intramuscular injection (long needle)
• One needle for subcutaneous injection (short needle)
It comes in pack sizes of 1, 5 or 10 sets. Not all pack sizes may be marketed.

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Eigenorm PFS 75IU-150IU
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Marketing Authorisation Holder:
IBSA Farmaceutici Italia srl
Via Martiri di Cefalonia, 2
26900 Lodi - Italy

Manufacturer:
IBSA Farmaceutici Italia srl
Via Martiri di Cefalonia, 2
26900 Lodi - Italy

This medicinal product is authorized in the Member States of the EEA under the following
names: (The strength and pharmaceutical form are identical in all countries, only the trade
name changes)
Austria: Meriofert PFS
Belgium: Fertinorm Kit
Bulgaria: Meriofert PFS
Cyprus: Meriofert PFS
Czech Republic: Eigenorm Set
Denmark: Meriofert Set
France: Fertistartkit
Greece: Meriofert
Hungary: Meriofert Kit
Italy: Meriofert
Luxembourg: Fertinorm Kit
Poland: Mensinorm
Romania: Meriofert PFS
Slovakia: Meriofert
Spain: Meriofert Kit
The Netherlands: Meriofert spuit
United Kingdom: Eigenorm PFS

This leaflet was last revised November 2015.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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