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MENOTROPHIN LG 75 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION

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Menotrophin LG 75IU-150IU
Powder and solvent for solution for injection

1.3.1

PACKAGE LEAFLET

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Menotrophin LG 75IU-150IU
Powder and solvent for solution for injection

1.3.1

Menotrophin LG 75 IU
powder and solvent for solution for injection
Menotrophin LG 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 Menotrophin LG 75 IU powder and solvent for solution for injection and
Menotrophin LG 150 IU powder and solvent for solution for injection are called
Menotrophin LG.

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

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

1.

What Menotrophin LG is and what it is used for



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

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Menotrophin LG 75IU-150IU
Powder and solvent for solution for injection

1.3.1

Menotrophin LG 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 Menotrophin LG

You and your partner’s fertility will be evaluated before your treatment is started.
Do not use Menotrophin LG 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
Menotrophin LG

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 Menotrophin LG 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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Menotrophin LG 75IU-150IU
Powder and solvent for solution for injection

1.3.1

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 Menotrophin LG, 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 Menotrophin LG
Tell your doctor or pharmacist if you are taking or have recently taken or might take any
other medicines.
Pregnancy, breast-feeding and fertility
Menotrophin LG should not be used if you are pregnant or breast-feeding.
Driving and using machines

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Menotrophin LG 75IU-150IU
Powder and solvent for solution for injection

1.3.1

Menotrophin LG 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 Menotrophin LG

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 Menotrophin LG 75 IU vial is given during the
first week of the cycle after spontaneous or induced menses.
Subsequently, Menotrophin LG 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 Menotrophin LG dosage depending on the ovarian response,
which is determined by clinical examinations.
As soon as one follicle reaches the required development stage, the Menotrophin LG
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
Menotrophin LG (1-2 vials of Menotrophin LG 150 IU). Your physician may decide to
administer higher dosages if required. The injected dosage of Menotrophin LG 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 Menotrophin
LG is withheld and ovulation is triggered by injecting another hormone (chorionic
gonadotropin, hCG).
How Menotrophin LG should be given:

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Menotrophin LG 75IU-150IU
Powder and solvent for solution for injection

1.3.1

Menotrophin LG 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 Menotrophin LG
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 Menotrophin LG yourself, read the following instructions carefully.
How to prepare and inject 1 vial of Menotrophin LG:
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
Menotrophin LG 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 Menotrophin LG 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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Menotrophin LG 75IU-150IU
Powder and solvent for solution for injection

1.3.1

150 IU dark green) from the Menotrophin LG 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
Menotrophin LG 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 Menotrophin LG 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 Menotrophin LG
solution up into the syringe.
• Check that the reconstituted solution is clear.
When reconstituting more than 1 vial of Menotrophin LG, 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:






The injection site:

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.



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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Menotrophin LG 75IU-150IU
Powder and solvent for solution for injection

1.3.1

 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 Menotrophin LG solution and relieve any discomfort.

Injecting your medicine intramuscularly:
For intramuscular injections your healthcare provider will prepare and then inject
Menotrophin LG 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 Menotrophin LG than you should:
The effects of an overdose of Menotrophin LG are unknown, nevertheless, one could expect
ovarian hyperstimulation syndrome to occur (see Possible side effects). If you use more
Menotrophin LG than you should, speak to your doctor or pharmacist.
If you forget to use Menotrophin LG:
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 Menotrophin LG:
Do not stop on your own initiative: Always consult your doctor if you are considering
stopping this medicine.

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Menotrophin LG 75IU-150IU
Powder and solvent for solution for injection

1.3.1

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4.

Possible side effects

Like all medicines, Menotrophin LG 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 Menotrophin LG 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 somach

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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Menotrophin LG 75IU-150IU
Powder and solvent for solution for injection

1.3.1

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 Menotrophin LG

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 Menotrophin LG 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 Menotrophin LG 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.

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Menotrophin LG 75IU-150IU
Powder and solvent for solution for injection

1.3.1

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), 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:
Menotrophin LG 75 IU

Menotrophin LG 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 Menotrophin LG looks like and contents of the pack
Powder: white to almost white lyophilized powder
Solvent: clear and colourless solution
Menotrophin LG 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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Menotrophin LG 75IU-150IU
Powder and solvent for solution for injection

1.3.1

Marketing Authorisation Holder:
Laboratoires Genévrier SA
280 rue de Goa – ZI Les Trois Moulins
Parc de Sophia – Antipolis
06600 Antibes
France

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

This leaflet was last revised December 2014.

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Expand Transcript

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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