MENOPUR 150 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION

Active substance: MENOTROPHIN

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M1.3.2 Mock-ups

The following mock-ups are enclosed:




Patient Information Leaflet - Annotated version
Patient Information Leaflet - Final clean version

The dimensions of the carton mock-ups have not yet been finalised and therefore
the drawings provided are not to scale.

11 mm

MENOPUR 150IU
®

8 mm

Powder and solvent for solution for injection

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

8 mm

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.
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.

What Menopur is
Menopur contains a medicine called Highly Purified Menotrophin.
This is a mixture of hormones extracted from the urine of women
who have passed the menopause, the mixture is then highly purified.
• The dose of these hormones is given in International Units (IU).
• Each bottle (vial) contains the equivalent of 150 IU of FSH
(follicle stimulating hormone) and 150 IU of LH (luteinising
hormone).

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.

Menopur helps reproductive organs to work normally in both
women and men. A fertility specialist should supervise your
treatment.

3. How to use Menopur

What Menopur is used for
In women, Menopur is used for:
• Infertility caused by eggs not being produced properly in the
ovaries (anovulatory infertility).
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.
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.

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 under the skin or into
a muscle.
• 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 provided,
it should be used straight away.

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.
If your clinic has asked you to inject Menopur yourself, you
should follow the instruction provided by them.
The first injection of Menopur should be given under the
supervision of a doctor.
DILUTING MENOPUR:
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 with the powder. Menopur should only be
diluted immediately before use.
continued

No text in this field

No text in this field

HIGHLY PURIFIED MENOTROPHIN

11 mm

What to do:

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

8 mm

4. Possible side effects

No text in this field

1. Firmly attach the long, thick needle (drawing up/reconsitution
needle) to the syringe.
2. Break the liquid ampoule with the dot pointing towards
yourself.
3. Insert the needle in the liquid ampoule.

Like all medicines, Menopur can cause side effects, although
not everybody gets them.
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).
• Pain or inflammation where the injection was given.

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

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.

4. Draw up all the liquid from the ampoule into the syringe.
5. Insert the needle through the rubber top of the powder vial and
slowly inject all of the liquid. Aim at the side of the vial, to
avoid creating bubbles.
6. The powder should quickly dissolve (within 2 minutes) to
form a clear solution.

8 mm

7. To help the powder dissolve, swirl the solution. Do not shake
as this will cause air bubble to form.
If the solution is not clear or if it contains particles it SHOULD
NOT be used.
8. Draw up the solution back into the syringe.
If you have been prescribed more than one vial of Menopur
powder per injection, you can draw up the solution (the first
Menopur solution) back into the syringe and inject it into a second
vial of powder. You can do this with up to three vials of powder in
total - but only do as your doctor has told you.

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.
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

10. Turn the syringe with the needle upwards and flick it gently so
if any air bubbles, they are collected at the tip. Depress the
plunger carefully until the first drop of fluid comes out.

6. Further information

11. Your doctor or nurse will tell you where to inject (e.g. front of
thigh, abdomen etc.).
12. Disinfect the injection site.

What Menopur contains
• Menopur is a sterile freeze dried powder for
injection. The active substance is Highly Purified
Menotrophin. Each vial contains 150 IU of the active
substance, corresponding to 150IU of FSH activitiy and
150IU of LH activity.
• The other ingredients for powder are Lactose monohydrate,
Polysorbate 20, Sodium hydroxide and Hydrochloride acid.
• The solvent contains Sodium chloride, Hydrochloric acid and
Water for injection.
What Menopur looks like and contents of the pack
Menopur is suppled in cartons of five or ten clear glass vials
which contain a light powder. The carton also contains an
equal number of clear glass ampoules conaining a colourless
solvent.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manfacturer

13. 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 to inject the solution, and then remove the needle.
14. 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.
15. Do not put used items into normal domestic waster; these
should be disposed of appropriately.

Marketing Authorisation Holder:
Ferring Pharmaceuticals Ltd., The Courtyard,
Waterside Drive, Langley, Berkshire, SL3 6EZ.
PL 03194/0109

Manufacturer:
Ferring GmbH, Wittland 11, D-24109 Kiel, Germany
This leaflet was last revised in July 2009.
Menopur is a registered Trademark.

No text in this field

9. Once you have your prescribed dose drawn up into the syringe,
change the needle to the short, thin needle (the injection needle).

• Keep out of the reach and sight of children.
• Do not use Menopur after the expiry date which is stated on
the carton. The expiry date refers to the last day of that
month.
• Store below 25°C.
• Store in the original container to protect from light.
• 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.

INJECTING MENOPUR:

MENOPUR 150IU
®

Powder and solvent for solution for injection
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

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.
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.

What Menopur is
Menopur contains a medicine called Highly Purified Menotrophin.
This is a mixture of hormones extracted from the urine of women
who have passed the menopause, the mixture is then highly purified.
• The dose of these hormones is given in International Units (IU).
• Each bottle (vial) contains the equivalent of 150 IU of FSH
(follicle stimulating hormone) and 150 IU of LH (luteinising
hormone).

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.

Menopur helps reproductive organs to work normally in both
women and men. A fertility specialist should supervise your
treatment.

3. How to use Menopur

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.
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.

Using Menopur
• You will have Menopur as an injection under the skin or into
a muscle.
• 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 provided,
it should be used straight away.

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.
If your clinic has asked you to inject Menopur yourself, you
should follow the instruction provided by them.
The first injection of Menopur should be given under the
supervision of a doctor.
DILUTING MENOPUR:
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 with the powder. Menopur should only be
diluted immediately before use.
continued

No text in this field

What Menopur is used for
In women, Menopur is used for:
• Infertility caused by eggs not being produced properly in the
ovaries (anovulatory infertility).
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.

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.

What to do:

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

4. Possible side effects
1. Firmly attach the long, thick needle (drawing up/reconsitution
needle) to the syringe.
2. Break the liquid ampoule with the dot pointing towards
yourself.
3. Insert the needle in the liquid ampoule.

4. Draw up all the liquid from the ampoule into the syringe.
5. Insert the needle through the rubber top of the powder vial and
slowly inject all of the liquid. Aim at the side of the vial, to
avoid creating bubbles.
6. The powder should quickly dissolve (within 2 minutes) to
form a clear solution.

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

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.
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).
• Pain or inflammation where the injection was given.
Uncommon (affects less than 1 in 100 people):
• Blood clots in the veins, usually of the leg (deep vein
thrombosis).

If the solution is not clear or if it contains particles it SHOULD
NOT be used.
8. Draw up the solution back into the syringe.
If you have been prescribed more than one vial of Menopur
powder per injection, you can draw up the solution (the first
Menopur solution) back into the syringe and inject it into a second
vial of powder. You can do this with up to three vials of powder in
total - but only do as your doctor has told you.
INJECTING MENOPUR:

9. Once you have your prescribed dose drawn up into the syringe,
change the needle to the short, thin needle (the injection needle).
10. Turn the syringe with the needle upwards and flick it gently so
if any air bubbles, they are collected at the tip. Depress the
plunger carefully until the first drop of fluid comes out.
11. Your doctor or nurse will tell you where to inject (e.g. front of
thigh, abdomen etc.).
12. Disinfect the injection site.

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.

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 carton. The expiry date refers to the last day of that
month.
• Store below 25°C.
• Store in the original container to protect from light.
• 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 150 IU of the active
substance, corresponding to 150IU of FSH activitiy and
150IU of LH activity.
• The other ingredients for powder are Lactose monohydrate,
Polysorbate 20, Sodium hydroxide and Hydrochloric acid.
• The solvent contains Sodium chloride, Hydrochloric acid and
Water for injection.
What Menopur looks like and contents of the pack
Menopur is suppled in cartons of five or ten clear glass vials
which contain a white to off-white powder. The carton also
contains an equal number of clear glass ampoules containing a
colourless solvent.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manfacturer

13. 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 to inject the solution, and then remove the needle.
14. 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.
15. Do not put used items into normal domestic waster; these
should be disposed of appropriately.

Marketing Authorisation Holder:
Ferring Pharmaceuticals Ltd., The Courtyard,
Waterside Drive, Langley, Berkshire, SL3 6EZ.
PL 03194/0109

Manufacturer:
Ferring GmbH, Wittland 11, D-24109 Kiel, Germany
This leaflet was last revised in December 2010.
Menopur is a registered Trademark.

No text in this field

7. To help the powder dissolve, swirl the solution. Do not shake
as this will cause air bubble to form.

Expand view ⇕

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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