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MENOPUR 1200 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION

Active substance(s): MENOTROPHIN

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11 mm

®

Powder and solvent for solution for injection

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HIGHLY PURIFIED MENOTROPHIN

Patient Information

Read all of this leaflet carefully before you start using
this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, nurse or
pharmacist.
• This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if their symptoms are the same
as yours.
• If any of the side effects become serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor, nurse or
pharmacist.

In this leaflet:
1. What Menopur is and what it is used for
2. Before you use Menopur
3. How to use Menopur
4. Possible side effects
5. How to store Menopur
6. Further information

1. What Menopur is and what it is used for

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What Menopur is
Menopur contains a medicine called menotrophin. This is a mixture
of hormones obtained from the urine of women who have passed the
menopause.
• The dose of these hormones is given in International Units (IU).
• Each bottle (vial) contains the equivalent of 1200 IU of FSH
(follicle stimulating hormone) and 1200 IU of LH (luteinising
hormone).
Menopur helps reproductive organs to work normally in both
women and men. A fertility specialist should supervise your
treatment.
What Menopur is used for
In women, Menopur is used for:
• Infertility caused by eggs not being produced properly in the
ovaries (anovulatory infertility and polycystic ovarian disease).
It works by helping follicles (which contain eggs) to
mature in the ovaries.
• IVF (in vitro fertilisation) and other types of ‘assisted conception’.
It works by helping multiple follicles and eggs to develop. The
eggs are then harvested and fertilised outside the body.
In men, Menopur is used for:
• Low sperm count (oligospermia).

2. Before you use Menopur

Do not use Menopur if:
• You are allergic (hypersensitive) to menotrophin or any of the
other ingredients of Menopur (listed in Section 6).
• You have a tumour in your pituitary gland (a gland located on
the base of the brain which produces certain hormones,
including growth hormones).
• You have a tumour in a part of your brain called the
hypothalamus (part of the brain which controls the conditions
within your body including body temperature and blood
pressure).
• You have high levels of a hormone called prolactin
(hyperprolactinaemia).
Also, if you are a woman do not use Menopur if:
• You have tumours of your womb (uterus), ovaries or breasts.
• You have cysts on your ovaries or enlarged ovaries that are not due
to polycystic ovary syndrome (a condition that prevents eggs from
being released from the ovaries).
• You have bleeding from your vagina for an unknown reason.
• You have primary ovarian failure (a condition in which the ovaries
do not function properly).
• You have blocked fallopian tubes, unless you are having IVF
or ICSI (intracytoplasmic sperm injection).
• You are having an early (premature) menopause.
• You have certain physical problems in your reproductive
organs (womb, fallopian tubes, ovaries or cervix).
• Your womb has been removed (hysterectomy).
• You have fibroid tumours (tumours in your womb that are not
cancer).
• You are pregnant or breast-feeding.

Take special care
Check with your doctor or nurse before using this medicine if:
• You have had infertility treatment in the past.
• You or someone in your family has had blood clots. This is
because treatment with Menopur may increase the risk of
having a clot. Pregnancy also increases the risk of having
clots.
If any of the above applies to you (or if you are not sure), talk to
your doctor, nurse or pharmacist before using Menopur.

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Pregnancy and breast-feeding
If you are already pregnant or breast-feeding, you must not use
Menopur.
Tests before you start treatment
Before you start treatment with Menopur, your doctor will
normally do tests to check the following:
Men and women:
• Your thyroid and adrenal glands are working properly.
• You do not have tumours of the pituitary gland or
hypothalamus.
Women only:
• Your ovaries are working properly.
• You do not have higher than normal blood levels of a hormone
called prolactin.
Important information about some of the ingredients of
Menopur
Menopur contains lactose (which is a type of sugar). If you have
been told by your doctor that you cannot tolerate or digest some
sugars (have an intolerance to some sugars), talk to your doctor
before using this medicine.

3. How to use Menopur
Always use Menopur exactly as your doctor or nurse has told you.
You should check with your doctor, nurse or pharmacist if you
are not sure.
Menopur is not recommended for children or elderly people.
Using Menopur
• You will have Menopur as an injection into a muscle or under
the skin.
• You will either be given Menopur by a doctor or nurse or you
will be taught how to give it to yourself.
• Menopur comes as a dry powder in small bottles (vials).
• Once the dry powder has been mixed with the solvent it can be
stored for up to 28 days at room temperature (not more than
25°C).
• This mixed solution can now be used for multiple injections.
The dose and length of your treatment
• The dose, and how long your treatment lasts, depends on why
you are using Menopur and how well it works.
• Your doctor or nurse will monitor how you respond to your
treatment.
• This will help them to work out what dose you need and how
long you need to use Menopur for.
In women:
Infertility (to help follicles to mature):
• If you are having periods, your treatment will start within the
first 7 days of your menstrual cycle.
• You may use Menopur daily for up to 3 weeks.
• Or, you may use Menopur every other day for 6 days (three
doses in total).
‘Assisted conception’ such as IVF:
• The usual dose is 75 to 300 IU each day.
• Your doctor will decide how long you need to use Menopur for.
In men:
For low sperm count:
• The usual dose is 75 or 150 IU two or three times a week.
• Treatment is normally continued for at least 3 or 4 months.
Instructions for use:
If your doctor has asked you to inject Menopur yourself,
you should follow the instructions provided on page 2.
The first injection of Menopur should be given under the
supervision of a doctor.
Menopur is provided as a powder and must be dissolved before it
is injected. The liquid (solvent) which you should use to dilute
Menopur is provided in a pre-filled syringe. As this vial contains
medication for several days of treatment, you need to make sure
you only draw up the amount of medication that was prescribed
by your doctor. Your doctor has prescribed you a dose of
Menopur in IU. You should use one of the 18 administration
syringes graduated in FSH/LH units provided.

Also, if you are a man do not use Menopur if:
• You have cancer of your testicles.
• You have prostate cancer.
Do not use Menopur if any of the above applies to you. If you
are not sure, talk to your doctor, nurse or pharmacist before you
start using Menopur.
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MENOPUR 1200IU

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What to do:

2

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1

If you forget to use Menopur
If you think you have missed a dose, tell your doctor, nurse or
pharmacist.

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d l e i f

4. Possible side effects

Like all medicines, Menopur can cause side effects, although
not everybody gets them.

Remove the syringe and the needle for reconstitution.

4. The powder should quickly dissolve (within 2 minutes) to form a
clear solution. To help the powder dissolve, swirl the solution. Do
not shake as this will cause air bubbles to form.
If the solution is not clear or if it contains particles it SHOULD NOT
be used.
5. Take the administration syringe with pre-fixed needle and insert the
needle into the vial. Turn the vial upside down and draw the
prescribed dose of Menopur into the administration syringe for
injection.

If treatment with Menopur results in pregnancy
The following are more likely to happen in women
who have had fertility treatment than in women who
have got pregnant (conceived) naturally:
• Being pregnant with more than one baby. This
carries an increased risk of problems for the
mother during the pregnancy and at or around the
time of birth.
• The fertilised egg implanting outside the womb
(ectopic pregnancy). This is more likely if you
have had tubal disease in the past (a condition
where the fallopian tubes are blocked or damaged).
• Miscarriage or abortion.
• A slightly higher risk of your baby being born with
physical defects.
Your doctor will be able to discuss this with you
before you start treatment.
If any of the side effects become serious, or if you
notice any side effects not listed in this leaflet, please
tell your doctor, nurse or pharmacist.

5. How to store Menopur

• Keep out of the reach and sight of children.
• Do not use Menopur after the expiry date which is stated on
the packaging.
• Before reconstitution, store in a refrigerator (2°C - 8°C)
in its original container to protect from light.
• After reconstitution, the solution may be stored for a
maximum of 28 days at not more than 25°C.
• Do not freeze before or after reconstitution.
• Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help to
protect the environment.

6. Further information

What Menopur contains
• Menopur is a sterile freeze dried powder for
injection. The active substance is Highly Purified
Menotrophin. Each vial contains 1200 IU of the active
substance.
• The other ingredients are Lactose monohydrate,
Polysorbate 20, Sodium phosphate dibasic
heptahydrate and Phosphoric acid (concentrated).
• The solvent contains Metacresol and Water for injection.
6. Gently flick the administration syringe so that any air bubbles will
be collected in the tip. Depress the plunger carefully until the first
drop of fluid comes out.
Your doctor or nurse will tell you where to inject (e.g. front of the
thigh, abdomen etc.).
Disinfect the injection site with the provided alcohol pads.
7. To inject, pinch the skin to produce a fold, and insert the needle in
one swift motion at 90 degrees to the body. Press down on the
plunger gently to inject the solution and then remove the needle.
After removing the syringe, apply pressure to the injection site to stop
any bleeding. Gently massaging the injection site will help to disperse
the solution under the skin.
8. For further injections with the reconstituted solution of Menopur,
repeat steps 5 to 7.

What Menopur looks like and contents of the pack
Menopur is supplied in boxes of 1 vial of Menopur powder, 2
pre-filled syringes with solvent for reconstitution, 1 needle for
reconstitution, 18 alcohol pads and 18 disposable syringes for
administration graduated in FSH/LH units with pre-fixed
needles.
Marketing Authorisation Holder and Manfacturer

Marketing Authorisation Holder:
Ferring Pharmaceuticals Ltd., Drayton Hall,
Church Road, West Drayton, UB7 7PS, UK.
PL 03194/0107

Manufacturer:
Ferring GmbH, Wittland 11, D-24109 Kiel, Germany
This leaflet was last revised in 03/2015.
Menopur is a registered Trademark.

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Remove the rubber syringe cap from the second pre-filled syringe
with solvent and firmly attach the syringe to the needle fixed in the
vial. Slowly inject all of the liquid to avoid creating bubbles.

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After a few seconds, gently remove the syringe from the needle with a
twist, leaving the needle in the vial.

Side effects that can happen in women:
If you notice any of the following signs, tell your
doctor straight away. It may mean that your ovaries
have been stimulated too much and you may need
urgent medical treatment. This side effect is
common (affects less than 1 in 10 people).
• Feeling sick.
• Being sick.
• Diarrhoea.
• Pain or swelling of the tummy.
• Weight gain.
• Difficulty breathing.
• Feeling more thirsty than usual.
• Producing less urine when you go to the toilet or
going to the toilet less often.
If you notice any of the above signs, tell your doctor
straight away.

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3. Insert the needle through the rubber top of the powder vial and slowly
inject all of the liquid to avoid creating bubbles.

Very rare (affects less than 1 in 10,000 people):
• Allergic reactions.
• If Menopur is used for a long time, your body may make
antibodies which can stop the treatment from working.

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Uncommon (affects less than 1 in 100 people):
• Blood clots in the veins, usually of the leg (deep vein
thrombosis).

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2. Firmly attach the thick needle ( Reconstitution needle ) to
the pre-filled syringe with solvent and remove the protective
cap.

Side effects that can happen in both women and men:
Common (affects less than 1 in 10 people):
• Headache.
• Feeling sick (nausea).
• Being sick (vomiting).
• Pain or swelling of the tummy (abdomen).
• Pelvic pain
• Pain or inflammation where the injection was given.

d l e i f

1. Remove the protective cap from the vial of powder and the
rubber syringe cap from the pre-filled syringe with solvent.

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If you use more Menopur than you should
If you think you have used too much Menopur, tell your
doctor, nurse or pharmacist.

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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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