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FOSTIMON PFS 225 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION

Active substance(s): UROFOLLITROPIN

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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.
What is in this leaflet:
1. What Fostimon PFS is and what it is used for
2. What you need to know before you use
Fostimon PFS
3. How to take Fostimon PFS
4. Possible side-effects
5. How to store Fostimon PFS
6. Content of the pack and other information
1. WHAT FOSTIMON PFS IS AND WHAT IT
IS USED FOR

Fostimon® PFS 225 IU
Fostimon® PFS 300 IU
powder and solvent for
solution for injection

FI/150 (UK/Irl) xxxxx Ed. I/10.15

Urofollitropin (FSH)

-- Fostimon PFS is used to promote ovulation
in women who are not ovulating and who
have not responded to other treatment
(clomifene citrate).
-- It is used to bring about the development of
several follicles (and therefore several eggs)
in women receiving fertility treatment.
Urofollitropin is a highly purified human follicle
stimulating hormone, belonging to a group of
medicines called gonadotropins.
This medicinal product must be used under
the supervision of your doctor.
2. WHAT YOU NEED TO KNOW BEFORE
YOU USE FOSTIMON PFS
You and your partner’s fertility will be evaluated before your treatment is started.
DO NOT USE FOSTIMON 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 Urofollitropin or
any of the ingredients in Fostimon 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.
TAKE SPECIAL CARE WITH FOSTIMON PFS
Although no allergic reactions to Fostimon 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 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
gonadotropin-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 methods 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 Fostimon 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.
This medicine is prepared from human urine.
The risk of passing on an organism that could
cause an infection or disease cannot be
definitely excluded; however, this is limited by
steps in the manufacturing process to remove
viruses, especially HIV, Herpes virus and
Papillomavirus.
No cases of viral contamination have been
reported.
Other medicines and Fostimon PFS
Tell your doctor or pharmacist if you are taking
or have recently taken or might take any other
medicines.
Pregnancy and breast-feeding
Fostimon PFS should not be used if you are
pregnant or breast-feeding.

3. HOW TO USE FOSTIMON PFS
Dosage and duration of the treatment:
Always take 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:
If you are having periods, the treatment should
start within 7 days of the start of your period
(the first 7 days of the menstrual cycle).
You will be given 1 injection per day under your
skin (subcutaneous).
The usual starting dose is 75 to 150 IU of FSH
(Fostimon PFS) every day. This dose may be
increased, if necessary, by 37.5 to 75 IU at 7
or preferably 14-day intervals, to get the right
response.
The maximum daily dose of FSH is usually not
higher than 225 IU.
If your doctor cannot see a response after 4
weeks of treatment, that treatment cycle will be
stopped. For the following cycle, your doctor
will prescribe a higher starting dose.
When you get a good response (satisfying
follicle growth) you will be given a single
injection of another medicine (hCG), which is
used to bring about the final maturing of the
follicle and release of eggs. This will be given 24
to 48 hours after the last Fostimon PFS injection.
You should have sexual intercourse the day hCG
is given and again on the following day.
If you have too great a response, treatment
will be stopped and hCG will not be given (see
Possible side effects). For the following cycle,
your doctor will prescribe a lower starting
dose.
Women undergoing ovarian stimulation
for multiple follicular development prior
to in vitro fertilisation or other assisted
reproductive techniques:
Situation 1 - If you are having periods
The treatment should start 2 or 3 days after the
start of your periods (the first 2 or 3 days of the
menstrual cycle).
You will be given 1 injection per day by the
subcutaneous route.
The usual starting dose for superovulation
is 150 to 225 IU of Fostimon PFS every day.
Treatment is continued, with the dose adjusted
according to your response, until you are
achieving adequate follicular development.
This is usually achieved on average by the 10th
day of treatment (range 5 to 20 days) and is
measured by taking blood samples and/or
ultrasound examinations.
The maximum dosage is in general of 450 IU/
day.
Once adequate follicular development is
achieved you will be given a single injection of
a medicine used to bring about final maturing
of the follicle; this medicine contains up to
10,000 IU human chorionic gonadotropin
(hCG). It will be given 24 to 48 hours after the
last Fostimon PFS injection.
Oocytes will be punctured about 35 hours later.

Situation 2 - When a gonadotropin-releasing
hormone (GnRH) agonist is used
Fostimon PFS will be given approximately 2
weeks after the start of this treatment. Both
treatments are continued until adequate
follicular development is achieved. Fostimon
PFS will be given as 1 injection per day by the
subcutaneous route. For example, following
two weeks of treatment with an agonist of
GnRH, 150 to 225 IU of Fostimon PFS will be
given for the first 7 days. The dose will then
be adjusted according to the ovarian response.
How Fostimon PFS should be given:
Fostimon PFS is given by injection under your
skin (by the subcutaneous route).
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 Fostimon 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 Fostimon PFS yourself, read
the following instructions carefully.
How to prepare and inject Fostimon PFS,
using 1 vial of powder:
The solution must be prepared just before
injection. One vial is for single use only. The
medicinal product must be reconstituted under
aseptic conditions.
Fostimon PFS must only be reconstituted with
the solvent provided in the package.
Prepare a clean surface and wash your hands
before the solution is reconstituted. It is
important that your hands and the items you
use are as clean as possible.
Set out all the following items on the clean
surface:
- two cotton wool alcohol swabs (not
provided),
- one vial containing Fostimon PFS powder,
- one pre-filled syringe with solvent,
- one needle for preparing the injection,
- a fine bore needle for subcutaneous
injection.
Reconstitution of the solution for injection
using 1 vial of powder
Prepare the solution for the injection:
1.
Remove the cap from the pre-filled
syringe; attach the reconstitution
needle (long needle) to the
syringe.

Carefully place the syringe on the
clean surface and avoid touching
the needle.
2.
• Remove the coloured plastic cap
from the powder vial by gently
pushing it upwards.
• Disinfect the top of the rubber
stopper by wiping it with an
alcohol swab and allow to dry.
3.
• Pick up the syringe, remove the
needle shield and slowly inject
the solvent into the powder vial
through the middle of the top of
the rubber stopper.
• Press the plunger down firmly to
squirt all the solution onto the
powder.
A backstop device is fitted on the syringe
flange to prevent inadvertent withdrawal of the
stopper from the syringe barrel and to improve
syringe handling when giving the injection.
DO NOT SHAKE, but gently roll the vial
between the hands until the powder is
completely dissolved, taking care to avoid
creating foam.
4.
Once the powder is dissolved
(which,
in
general,
occurs
immediately), slowly draw the
solution into the syringe:
• 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
Fostimon PFS solution up into the syringe.
• Check that the reconstituted solution is clear
and colourless.
Preparation of higher doses, using more than
1 vial of powder

the 75 IU vial according to steps 2 to 3
described above and draw half of this
reconstituted solution (0.5 ml) back into the
syringe according to step 4.
In that situation you will have two preparations
to be injected: the first preparation
reconstituted in 1 ml and the second
containing 37.5 IU in 0.5 ml.
Both preparations will be injected with their
own syringe according to the following steps.
The solution must be clear and colourless.
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 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:

If your doctor has recommended higher
doses for you, this can be achieved by using
more than one vial powder with one pre-filled
syringe of solvent.

• Firmly pinch the skin together.
With the other hand, insert the
needle with a dart-like motion at
an angle of 45° or 90°.

When reconstituting more than 1 vial of
Fostimon PFS, at the end of step 4 above,
draw the reconstituted contents of the first vial
back into the syringe, and slowly inject into a
second vial. Repeat steps 2 to 4 for the second
and subsequent vials, and until the contents
of the required number of vials equivalent to
the prescribed dosage are dissolved (within
the limit of the maximum total dosage of 450
IU, corresponding to a maximum of 6 vials of
Fostimon PFS 75 IU, 3 vials of Fostimon PFS
150 IU, or 2 vials of Fostimon PFS 225 IU).
Your doctor may increase your dose by 37.5 IU
which represents half a vial of Fostimon PFS 75 IU.
For this you should reconstitute the contents of

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. As described
for the preparation of the solution, 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 Fostimon PFS solution
and relieve any discomfort.
Dispose of all used items:
Any unused product or waste material should
be disposed of in accordance with local
requirements (once the injection is ended, all
the needles and empty syringes should be
disposed of in an appropriate container).

-----

Hot flush
Cystitis
Breast enlargement, breast pain
Difficulty stopping bleeding

Redness, pain and bruising at the injection site
may occur (frequency not stated).
See section 2 for additional information on
risk of blood clots, ectopic pregnancy, multiple pregnancy and miscarriage.
If any of the side effects gets serious, or if you
notice any side effects not mentioned in this
leaflet, please tell your doctor or pharmacist.

If you forget to use Fostimon PFS:

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 direct (see details below).
IRELAND: HPRA Pharmacovigiliance
Earlsfort Terrace, IRL – Dublin 2;
Tel: +353 1 6764971;
Fax: +353 1 6762517;
Website: www.hpra.ie
e-mail: medsafety@hpra.ie
UNITED KINGDOM: Yellow Card Scheme.
Website: www.mhra.gov.uk/yellowcard

Take it at the next normal time for an injection.
Do not take a double dose to make up for a
forgotten dose.

By reporting side effects, you can help provide
more information on the safety of this
medicine.

If you use more Fostimon PFS than you
should:
The effects of an overdose of Fostimon PFS
are unknown, nevertheless, one could expect
ovarian hyperstimulation syndrome to occur
(see Possible side effects). If you use more
Fostimon PFS than you should, speak to your
doctor or pharmacist.

If you stop using Fostimon PFS:
Do not stop on your own initiative: Always
consult your doctor if you are considering
stopping this medicine. If you have any further
questions on the use of this medicine, ask
your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Fostimon 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 Fostimon PFS and
see your doctor immediately if the following
occurs:
Common, affects 1 to 10 users in 100:
-- Ovarian Hyperstimulation Syndrome (see
Section 2 for additional information)
The following side-effects have also been
reported:
Common, affects 1 to 10 users in 100:
-- Headache
-- bloated abdomen
-- constipation
-- pain at the injection site.
Uncommon, affects 1 to 10 users in 1,000:
-- Overactive thyroid gland
-- Mood swings
-- Tiredness
-- Dizziness
-- Breathlessness
-- Nose bleeds
-- Nausea, indigestion, abdominal pain
-- Skin rash, itch,

5. HOW TO STORE FOSTIMON PFS
Keep this medicine out of the sight and reach
of children.
Do not store above 25° C. Keep the vial and
the pre-filled 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 pre-filled syringe of solvent. The expiry
date refers to the last day or the month.
Use immediately after reconstitution.
Do not use Fostimon 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
safely dispose of medicines you no longer use.
These measures will help protect the
environment.
6. CONTENTS OF THE PACK AND OTHER
INFORMATION
What Fostimon PFS contains
The active substance is
Urofollitropin
One vial contains 225 IU of urofollitropin
(follicle-stimulating hormone FSH): 1 ml of
reconstituted solution contains either 225 IU
or 450 IU of urofollitropin when respectively 1
or 2 vials of product are reconstituted in 1 ml

of solvent.
One vial contains 300 IU of urofollitropin (follicle-stimulating hormone FSH): 1 ml of reconstituted solution contains 300 IU of
urofollitropin.
The specific in vivo activity is equal or superior
to 5000 IU of FSH per mg of protein.
The other excipients are
For the powder: lactose monohydrate.
For the solvent: sodium chloride and water for
injections
What Fostimon PFS looks like and contents
of the pack
Fostimon PFS is presented as a powder and
solvent for solution for injection. (1 set contains powder in a vial (225 IU or 300 IU),
solvent in a prefilled syringe (1ml), one needle
for reconstitution and one needle for
subcutaneous injection) - pack size of 1, 5 or
10 sets.
The powder is a white to off-white caked mass
and the solvent is clear and colourless.
Marketing Autorisation 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
Batch release (UK and Ireland):
PHARMASURE LIMITED
4-6 Colonial Business Park
Colonial Way
Watford WD24 4PR
UNITED KINGDOM
This medicinal product is authorized in the
Member States of the EEA under the
following names: (The stength and
pharmaceutical form are identical in all
countries, only the trade name changes).
Austria: Fostimon PFS
Belgium: Fostimon Kit
Cyprus:Fostimon PFS
Denmark: Fostimon Set
Finland: Fostimon Set
France: Fostimon Kit
Luxembourg: Fostimon Kit
Ireland: Fostimon PFS
The Netherlands: Fostimon Set
Norway: Fostimon Set
Spain: Fostipur Kit
Sweden: Fostimon Set
United Kingdom: Fostimon PFS
This leaflet was revised in April 2016

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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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