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BRAVELLE 75 IU POWDER FOR SOLUTION FOR INJECTION

Active substance(s): UROFOLLITROPIN

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BRAVELLE
2009051375_Bravelle

16.07.2009

11:02 Uhr

Seite 1

PACKAGE LEAFLET: INFORMATION FOR THE USER

BRAVELLE
75IU powder and solvent for solution for injection
(urofollitropin)
Read all of this leaflet carefully before you start taking
this medicine.
● Keep this leaflet. You may need to read it again.
● If you have any further questions, ask your nurse or doctor.
● 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 gets serious, or if you notice any
side effects not listed in this leaflet, please tell your doctor.
In
1.
2.
3.
4.
5.
6.

this leaflet:
What BRAVELLE is and what it is used for
Before you take BRAVELLE
How to take BRAVELLE
Possible side effects
How to store BRAVELLE
Further information

1. WHAT BRAVELLE IS AND WHAT IT IS USED
FOR

Keeping to your recommended dose and careful monitoring
of your treatment will reduce your chances of getting these
symptoms.
If you stop using this medicine you might still experience
these symptoms. Please contact your doctor immediately if
any of these symptoms occur.
While you are being treated with this medicine, your doctor
will normally arrange for you to have ultrasound scans and
sometimes blood tests to monitor your response to
treatment.
Being treated with hormones like this medicine can increase
the risk of:
● Ectopic pregnancy (pregnancy outside of the womb) if you
have a history of fallopian tube disease
● Miscarriage
● Multiple pregnancy (twins, triplets, etc.)
● Congenital malformations (physical defects present in
baby at birth).

This medicine is provided as a powder which must be mixed
with liquid (solvent) before it is used. It is given as an injection
under the skin.

Some women who have been given infertility treatment have
developed tumours in the ovaries and other reproductive
organs. It is not yet known if treatment with hormones like
this medicine causes these problems.

This medicine contains a hormone called follicle stimulating
hormone (FSH). FSH is a natural hormone produced in both
males and females. It helps the reproductive organs to work
normally. The FSH in this medicine is obtained from the urine
of postmenopausal women. It is highly purified, and is then
known as urofollitropin.

Blood clots in the veins or arteries are more likely to occur in
women who are pregnant. Infertility treatment can increase
the chances of this happening, especially if you are
overweight or if you or someone in your family (blood
relative) has had blood clots. Tell your doctor if you think this
applies to you.

This medicine is used to treat female infertility in the following
two situations:

Taking other medicines
Please tell your doctor if you are taking or have recently
taken any other medicines, including medicines obtained
without a prescription.

i. Women who cannot become pregnant because their
ovaries do not produce eggs (including polycystic ovarian
disease). BRAVELLE is used in women who have already
been given a medicine called clomiphene citrate to treat their
infertility, but this medicine has not helped.
ii. Women in assisted reproduction programmes (including in
vitro fertilisation/embryo transfer [IVF/ET], gamete intra-fallopian
transfer [GIFT] and intracytoplasmic sperm injection [ICSI]).
This medicine helps the ovaries develop many egg sacs
(follicles) where an egg might develop (multiple follicular
development).

2. BEFORE YOU TAKE BRAVELLE
Before starting treatment with this medicine, you and your
partner should be assessed by a doctor for causes of your
fertility problems. In particular you should be checked for the
following conditions so that any other appropriate treatment
can be given:
● Underactive thyroid or adrenal glands
● High
levels of a hormone called prolactin
(hyperprolactinemia)
● Tumours of the pituitary gland (a gland located on the base
of the brain)
● Tumours of the hypothalamus (an area located under the
part of the brain called the thalamus)
If you know you have any of the conditions listed above,
please tell your doctor before starting treatment with this
medicine.
Do not use BRAVELLE
•  If you are allergic (hypersensitive) to urofollitropin or any of the
other ingredients of this medicine (see section 6 – Further
information)
•  If you have tumours of the uterus (womb), ovaries, breasts,
pituitary gland or hypothalamus
•  If you have cycts on your ovaries or enlarged ovaries (unless
caused by polycystic ovarian disease)
•  If you have malformations of the sexual organs which make a
normal pregnancy impossible
•  If you suffer from bleeding from the vagina where the
cause is not known
•  If you have fibroids of the uterus (womb) which make a normal
pregnancy impossible
•  If you are pregnant or breastfeeding
•  if you have experienced an early menopause.
Take special care with BRAVELLE
If you get:
● Pain in the abdomen
● Swelling in the abdomen
● Nausea
● Vomiting
● Diarrhoea
● Weight gain
● Difficulty breathing
● Decreased urination.

Clomiphene citrate is another medicine used in the treatment
of infertility. If BRAVELLE is used at the same time as
clomiphene citrate the effect on the ovaries may be
increased.
BRAVELLE can be used at the same time as MENOPUR.
Please refer to section 3 ‘How to take BRAVELLE’.
Pregnancy and breast-feeding
This medicine should not be used during pregnancy or
breast-feeding.
Driving and using machines
This medicine is unlikely to affect your ability to drive and use
machines.
Important information about some of the ingredients of
BRAVELLE
BRAVELLE contains less than 1 mmol sodium (23 mg) per
dose, i.e. essentially “sodium-free”.

3. HOW TO TAKE BRAVELLE
Always take this medicine exactly as your doctor has told
you. You should check with your doctor if you are not sure.
i. Women who are not ovulating (not producing eggs):
Treatment should start within the first 7 days of the menstrual
cycle (day 1 is the first day of your period).
Treatment should be given every day for at least 7 days. The
starting dose is normally 75 IU daily (one vial of powder) but
this may be adjusted depending on your response (up to a
maximum of 225 IU – 3 vials of powders per day). A
particular dose should be given for at least 7 days before the
dose is changed. It is recommended that the dose should be
increased by 37.5 IU (half a vial of powder) each time (and
not more than 75 IU). The cycle of treatment should be
abandoned if there is no response after 4 weeks.
When a good response is obtained a single injection of
another hormone called human chorionic gonadotrophin
(hCG), at a dose of 5,000 to 10,000 IU, should be given 1 day
following the last BRAVELLE injection. It is recommended to
have sexual intercourse on the day of the hCG injection and
the day after. Alternatively, artificial insemination (injection of
sperm directly into the womb) may be performed.
Your doctor will closely monitor your progress for at least
2 weeks after you have received the hCG injection.
Your doctor will monitor the effect of BRAVELLE treatment.
Depending on your progress, your doctor may decide to
stop treatment with BRAVELLE and not give you the hCG
injection. In this case, you will be instructed to use a barrier
method of contraception (e.g. condom) or not have sexual
intercourse until your next period has started.

Tell your doctor straight away, even if the symptoms develop
some days after the last injection has been given. These can
be signs of high levels of activity in the ovaries which might
become severe.

ii. Women in assisted reproduction programs:
If you are also receiving treatment with a GnRH agonist (a
medicine which helps a hormone called Gonadotropin
Releasing Hormone (GnRH) to work), BRAVELLE should be
started approximately 2 weeks after the start of the GnRH
agonist therapy.

If these symptoms become severe, the infertility treatment
should be stopped and you should receive treatment in
hospital.

In patients not receiving a GnRH agonist, BRAVELLE
treatment should be started on day 2 or 3 of the menstrual
cycle (day 1 is the first day of your period).

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BRAVELLE
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Treatment should be given every day for at least 5 days. The
initial dose of this medicine is normally 150 - 225 IU
(2 or 3 vials of powder). This dose may be increased according
to your response to the treatment up to a maximum of 450 IU
(6 vials of powder) per day. The dose should not be increased
by more than 150 IU per adjustment. Normally treatment
should not continue for more than 12 days.
If enough egg sacs are present, you will be given a single
injection of a medicine called human chorionic gonadotrophin
(hCG) at a dose of up to 10,000 IU to induce ovulation
(release of an egg).
Your doctor will closely monitor your progress for at least
2 weeks after you have received the hCG injection.
Your doctor will monitor the effect of BRAVELLE treatment.
Depending on your progress, your doctor may decide to
stop treatment with BRAVELLE and not give you the hCG
injection. In this case, you will be instructed to use a barrier
method of contraception (e.g. condom) or not have sexual
intercourse until your next period has started.
INSTRUCTIONS FOR USE
If your clinic has asked you to inject this medicine
yourself, you should follow any instructions they provide.
The first injection of this medicine should be given under the
supervision of a doctor.
DILUTING BRAVELLE:
This medicine is provided as a powder, and must be diluted
before it is injected. The liquid which you should use to dilute
this medicine is provided with the powder. This medicine
should only be diluted immediately before use. To do this:
Firmly attach the
long, thick needle
(drawing up/
reconstitution
needle) to the
syringe.
Break the top off the ampoule with
the liquid.
Draw up all of the liquid from the
ampoule into the syringe.
Insert the needle through the
rubber top of the BRAVELLE
powder vial and slowly inject all of
the liquid. Aim at the side of the
vial, to avoid creating bubbles.
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.
Draw up the solution back into
the syringe.
If you have been prescribed more than one vial of BRAVELLE
powder per injection, you can draw up the solution (the first
BRAVELLE dilution) back into the syringe and inject it into a
second vial of powder. You can do this with up to six vials of
powder in total – but only do as your doctor has told you.
If you have been prescribed MENOPUR at the same time as
BRAVELLE, you may mix the two medicines by diluting
BRAVELLE and injecting the solution into the MENOPUR
powder. Allow this to dissolve, and draw up this combined
solution: you can then inject them together instead of
injecting each one separately.
INJECTING BRAVELLE:

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

Your doctor or nurse will tell you where to inject (e.g.
front of the thigh, abdomen etc.)
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.
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.
Do not put used items into normal
domestic waste; these should be
disposed of appropriately.
If you take more of this medicine that
thanyou
youshould
should
Please tell a nurse or doctor

If you forget to take this medicine
Do not
not take
take aadouble
doubledose
dosetotomake
make
a forgotten
dose.
upup
for for
a forgotten
dose.
Please tell a nurse
nurse or
or doctor.
doctor.

4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects,
although not everybody gets them.
Treatment with this medicine may cause high levels of
activity in the ovaries, especially in women with polycystic
ovaries. Symptoms include: pain in the abdomen, swelling
in the abdomen, nausea, vomiting, diarrhoea, weight
gain, difficulty breathing and decreased urination.
As complications to high levels of activity in the ovaries, blood
clots and twisting of an ovary might occur. If you experience
any of these symptoms contact your doctor immediately, even
if they develop some days after the last injection has been
given.
Allergic (hypersensitivity) reactions may occur when using this
medicine. Symptoms of these reactions might include: rash,
itching, swelling of the throat and difficulty breathing. If you
experience any of these symptoms, contact your doctor
immediately.
The following very common side effects affect more than
10 of every 100 patients treated:
Pain in the abdomen
Headache
The following common side effects affect between 1 and
10 of every 100 patients treated:
Urinary tract infection
Inflammation of the throat and nasal passage
Hot flushes
Nausea
Vomiting
Discomfort in the abdomen
Swelling in the abdomen
Diarrhoea
Constipation
Rash
Muscle spasms
Pelvic pain
Overstimulation of the ovaries (high levels of activity)
Breast tenderness
Vaginal bleeding
Vaginal discharge
Pain
Injection site pain and reactions (redness, bruising,
swelling and/or itching)
If you experience one or more of these side effects, or
any other problems, please tell a nurse or doctor.

5. HOW TO STORE BRAVELLE
Do not store above 25°C. Do not freeze.
Store in the original container in order to protect from light.
Keep out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated
on the carton. The expiry date refers to the last day of that
month.
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 BRAVELLE contains
The active substance is urofollitropin.
Each vial of powder contains 82.5 IU highly purified follicle
stimulating hotmone (FSH), urofollitropin. When reconstituted
with the solvent provided, each vial delivers 75 IU of FSH.
The other ingredients in the powder are:
Lactose monohydrate
Sodium phosphate dibasic heptahydrate
Polysorbate 20
Phosphoric acid
Water
The ingredients in the solvent are:
Sodium chloride
Water
Hydrochloric acid
What BRAVELLE looks like and contents of the pack
This medicine is a powder and solvent for solution for
injection.
The carton contains five or ten clear glass vials which
contain a light powder. The carton also contains an equal
number of clear glass ampoules containing a colourless
solvent.
Marketing Authorisation Holder of UK:
Ferring Pharmaceuticals Ltd, Drayton Hall, Church Road,
West Drayton UB7 7PS (UK).
PL 03194/0087 - Bravelle
PL 03194/0060 - Sodium Chloride Solution 0.9% w/v
Marketing Authorisation Holder of Ireland:
Ferring Ireland Ltd, United Drug House, Magna Drive, Magna
Business Park, Citywest Road, Dublin 24
PA 1009/19/1
Manufacturers
Ferring GmbH
Wittland 11, D-24109 Kiel, Germany
This leaflet was last revised in 09/2011
2009051375

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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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