Product Details

What you need to know before you use Pergoveris
You and your partner’s fertility should be evaluated before the treatment is started by a doctor
experienced in treating fertility problems.
Do not use Pergoveris
• if you are allergic to follicle stimulating hormone (FSH), luteinising hormone (LH) or any of the
other ingredients of this medicine (listed in section 6)
• if you have a brain tumour (in your hypothalamus or pituitary gland)
• if you have large ovaries or sacs of fluid within your ovaries (ovarian cysts) of unknown origin
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• if you have unexplained vaginal bleeding
• if you have cancer in your ovaries, womb or breasts
• if you have a condition that would make a normal pregnancy impossible, such as an early
menopause, malformed sex organs or benign tumours of the womb.
Do not use this medicine if any of the above apply to you. If you are not sure, talk to your doctor,
pharmacist or nurse before using this medicine.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Pergoveris.
Porphyria
Talk to your doctor before you start your treatment.If you or any member of your family have
porphyria (an inability to breakdown porphyrins that may be passed on from parents to children).
Tell your doctor straight away if:
• your skin becomes fragile and easily blistered, especially skin that has been frequently exposed
to sunlight
• you have stomach, arm or leg pain.
In case of above events your doctor may recommend that you stop treatment.
Ovarian hyperstimulation syndrome (OHSS)
This medicine stimulates your ovaries. This increases your risk of developing ovarian
hyperstimulation syndrome (OHSS). This is when your follicles develop too much and become large
cysts. If you get lower abdominal pain, gain any weight rapidly, feel sick or are vomiting or if you
have difficulty in breathing, talk to your doctor straight away. They might ask you to stop using this
medicine (see in section 4. under “Most serious side effects”).
In case you are not ovulating and if the recommended dose and schedule of administration are adhered
to, the occurrence of severe OHSS is less likely. Pergoveris treatment seldom causes severe OHSS.
This becomes more likely if the medicine that is used for final follicular maturation (containing human
chorionic gonadotrophin, hCG) is administered (see in section 3. under “How much to use” for
details). If you are developing OHSS your doctor may not give you any hCG in this treatment cycle
and you may be told not to have sex or that you should use a barrier contraceptive method for at least
four days.
Your doctor will ensure, careful monitoring of the ovarian response, based on ultrasound and blood
tests (oestradiol measurements) before and during the course of treatment.
Multiple pregnancy
When using Pergoveris, you have a higher risk of being pregnant with more than one child at the same
time (“multiple pregnancy”, mostly twins), than if you conceived naturally. Multiple pregnancy may
lead to medical complications for you and your babies. You can reduce the risk of multiple pregnancy
by using the right dose of Pergoveris at the right times.
To minimise the risk of multiple pregnancy, ultrasound scans as well as blood tests are recommended.
Miscarriage
When undergoing stimulation of your ovaries to produce eggs, you are more likely to have a
miscarriage than the average woman.
Ectopic pregnancy
Women who have ever had blocked or damaged fallopian tubes (tubal disease) are at risk of pregnancy
where the embryo is implanted outside the womb (ectopic pregnancy). This is whether the pregnancy
is obtained by spontaneous conception or with fertility treatments.
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Blood clotting problems (thromboembolic events)
Talk to your doctor before using Pergoveris if you or a member of your family have ever had blood
clots in the leg or in the lung, or a heart attack or stroke. You may be at a higher risk of serious blood
clots or existing clots might become worse with Pergoveris treatment.
Tumours of sex organs
There have been reports of tumours in the ovaries and other sex organs, both benign and malignant, in
women who have undergone multiple regimens for infertility treatment.
Allergic reactions
There have been isolated reports of non-serious allergic reactions to Pergoveris. If you have ever had
this type of reaction to a similar medicine, talk to your doctor before using Pergoveris.
Children and adolescents
Pergoveris is not for use in children and adolescents below 18 years old.
Other medicines and Pergoveris
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
Do not use Pergoveris with other medicines in the same injection. You can use Pergoveris with a
licensed follitropin alfa preparation as separate injections, if prescribed by your doctor.
Pregnancy and breast-feeding
Do not use Pergoveris if you are pregnant or breast-feeding.
Driving and using machines
It is not expected that this medicine will affect your ability to drive or use machines.
Pergoveris contains sodium
Pergoveris contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially “sodium-free”.

How to store Pergoveris
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label and the carton after EXP.
The expiry date refers to the last day of that month.
Store in a refrigerator (2°C-8°C). Do not freeze.
Store in the original package in order to protect from light.
Once opened, the pre-filled pen may be stored for a maximum of 28 days outside of the refrigerator (at 25°C).
Do not use Pergoveris if you notice any visible signs of deterioration, if the liquid contains particles or
is not clear.
After the injection, dispose of the used needle safely.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.