PUREGON 50 IU Powder

Зміст інструкції

1. Puregon 150 IU/0.18 mL injectable solution, 300 IU/0.36 mL injectable solution, 600 IU/0.72 mL injectable solution, 900 IU/1.08 mL injectable solution
   1. What is Puregon and what is it used for
   2. What you need to know before using Puregon
   3. How to use Puregon
   4. Possible side effects
   5. How to store Puregon
   6. Package contents and other information

Puregon 150 IU/0.18 mL injectable solution, 300 IU/0.36 mL injectable solution, 600 IU/0.72 mL injectable solution, 900 IU/1.08 mL injectable solution

beta follitropin
Read this leaflet carefully before you start using this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

• 1. What Puregon is and what it is used for
• 2. What you need to know before you use Puregon
• 3. How to use Puregon
• 4. Possible side effects
• 5. How to store Puregon
• 6. Contents of the pack and other information

1. What is Puregon and what is it used for

Puregon injectable solution contains beta follitropin, a hormone known as follicle-stimulating hormone (FSH).
FSH belongs to the group of gonadotropins, which play an important role in human fertility
and reproduction. In women, FSH is necessary for the growth and maturation of follicles
in the ovaries. Follicles are small, round vesicles that contain egg cells. In men,
FSH is necessary for the production of sperm.
Puregon is used in the treatment of infertility in any of the following conditions:

Women
In women who do not ovulate and who do not respond to treatment with clomifene citrate, Puregon may
be used to induce ovulation.
In women undergoing assisted reproductive technologies, including in vitrofertilization (IVF)
and other methods, Puregon can induce the development of multiple follicles.

Men
In men who have infertility due to low hormone levels, Puregon may be used
for sperm production.

2. What you need to know before using Puregon

Do not use Puregon
If:

• you are allergic to beta follitropin or any of the other ingredients of Puregon (listed in section 6)
• you have a tumor of the ovary, breast, uterus, testicle or brain (pituitary gland or hypothalamus)
• you have severe or irregular vaginal bleeding of unknown origin
• your ovaries are not functioning because you have a condition called primary ovarian insufficiency
• you have ovarian cysts or enlarged ovaries not caused by polycystic ovary syndrome (PCOS)
• you have malformations of the sex organs that make a normal pregnancy impossible
• you have uterine fibroid tumors that make a normal pregnancy impossible
• you are a man and are infertile due to a condition called primary testicular insufficiency.

Warnings and precautions
Talk to your doctor before using Puregon if:

• you have had an allergic reaction to certain antibiotics (neomycin and/or streptomycin)
• your pituitary gland is not under control or you have hypothalamic problems
• you have reduced thyroid gland activity (hypothyroidism)
• your adrenal glands are not functioning properly (adrenal insufficiency)
• you have high levels of prolactin in your blood (hyperprolactinemia)
• you have any other medical condition (for example, diabetes, heart disease or any other long-term illness).

If you are a woman:

Ovarian Hyperstimulation Syndrome (OHSS)
The doctor will regularly check the effects of the treatment to be able to choose the appropriate dose of
Puregon day by day. They may, at regular intervals, perform an ultrasound examination of the ovaries.
The doctor may also check hormone levels in the blood. This is very important because a dose that is
too high of FSH can cause rare but serious complications in which the ovaries become hyperstimulated
and the growth of the follicles becomes above normal. This serious medical condition is called ovarian
hyperstimulation syndrome (OHSS). In rare cases, severe OHSS can be life-threatening. OHSS causes
sudden accumulation of fluid in the stomach and chest areas and can cause the formation of blood clots.
Call your doctor immediately if you notice severe abdominal swelling, pain in the stomach area (abdomen),
feeling unwell (nausea), vomiting, sudden weight gain due to fluid retention, diarrhea, decreased urine
output, or breathing problems (see also section 4 on Possible side effects).
→ Regular monitoring of the response to treatment with FSH helps to prevent ovarian hyperstimulation.
Contact your doctor immediately if you experience stomach pain even if this occurs several days after the
last injection.

Multiple pregnancy or congenital defects
After treatment with gonadotropin-based preparations, there is an increased possibility of having
multiple pregnancies, even when only one embryo is transferred into the uterus. Multiple pregnancies
lead to an increased risk of health for both the mother and the children in the early period of life. In
addition, multiple pregnancies and characteristics of patients undergoing fertility treatment (e.g., woman's
age, sperm characteristics, genetic background of both parents) may be associated with an increased risk
of congenital defects.

Pregnancy complications
The risk of an ectopic pregnancy (a pregnancy outside the uterus) is slightly increased.
Therefore, the doctor must perform an early ultrasound examination to rule out the possibility of an
ectopic pregnancy.
In women undergoing infertility treatment, the possibility of miscarriage may be slightly higher.

Blood clot (Thrombosis)
Treatment with Puregon, like pregnancy itself, can increase the risk of developing a blood clot
(thrombosis). Thrombosis is the formation of a blood clot in a blood vessel.
Blood clots can lead to serious medical conditions, such as:

• blockage at the level of the lungs (pulmonary embolism)
• stroke
• heart attack
• problems with the blood vessels (thrombophlebitis)
• lack of blood flow (deep vein thrombosis) which can cause loss of an arm or leg.

Before starting treatment, talk to your doctor, especially:

• if you are already aware of having an increased possibility of having a thrombosis
• if you have personally, or a close family member has, had a thrombosis
• if you are very overweight.

Ovarian torsion
Ovarian torsion has occurred after treatment with gonadotropins, including Puregon. Ovarian torsion is
the twisting of an ovary. Twisting of the ovary may cause an interruption of blood flow to the ovary.
Before starting to use this medicine, tell your doctor if:

• you have ever had ovarian hyperstimulation syndrome OHSS
• you are currently pregnant or suspect you are pregnant
• you have ever had surgery on your stomach (abdominal)
• you have ever had a twisting of an ovary
• you have had or currently have cysts in one or both ovaries.

Ovarian tumors and other tumors of the reproductive system
In women who have had treatment for infertility, there have been cases of ovarian tumors and other
tumors of the reproductive system. It is not known whether treatment with fertility medicines increases the
risk of these tumors in infertile women.

Other medical conditions
Also, before starting to use this medicine, tell your doctor if:

• you have been told by a doctor that a pregnancy could be dangerous for you.

If you are a man:

Men with too much FSH in the blood
Increased plasma FSH levels are a sign of testicular damage. Puregon is usually not effective in these
situations. To check the effects of treatment, the doctor may request sperm samples for analysis, four to six
months after starting therapy.

Children and adolescents
The use of Puregon is not indicated in children and adolescents.

Other medicines and Puregon
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
The concomitant use of Puregon and clomifene citrate may increase the effect of Puregon.
In case of administration of a GnRH agonist (a medicine used to prevent premature ovulation), a higher
dose of Puregon may be necessary.

Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine. You should not use Puregon if you
are pregnant or suspect you are pregnant.
Puregon may affect milk production. It is unlikely that Puregon will pass into breast milk. If you are
breastfeeding, tell your doctor before using Puregon.

Driving and using machines
It is unlikely that Puregon will affect your ability to drive or operate machinery.

Puregon contains benzyl alcohol
This medicine contains 10 mg of benzyl alcohol per mL.
Benzyl alcohol can cause allergic reactions.
Ask your doctor or pharmacist if you have a liver or kidney disease. This is because large amounts of benzyl
alcohol can accumulate in the body and cause adverse effects (such as metabolic acidosis).
Ask your doctor or pharmacist if you are pregnant or breastfeeding. This is because large amounts of benzyl
alcohol can accumulate in the body and cause adverse effects (such as metabolic acidosis).

Puregon contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per injection, i.e. essentially “sodium-free”.

3. How to use Puregon

Use this medicine following the instructions of your doctor exactly. If you have any doubts, consult your
doctor or pharmacist.

Dosage in women
The doctor will decide the initial dose. This dose may be adjusted during the treatment period. Further details on the treatment schedule are provided below. There are significant differences between women in the response of the ovaries to FSH; it is therefore
impossible to define a dosage schedule that suits all patients. To establish the appropriate dosage,
the doctor will monitor the growth of the follicle by ultrasound and measure the amount of estradiol (female sex hormone) in the blood.

• Women who do not ovulateThe doctor establishes a starting dose. This dose is maintained for at least 7 days. If there is no ovarian response, the daily dose is gradually increased until the size of the follicle and/or plasma levels of estradiol indicate an appropriate response. The daily dosage is then maintained until the presence of a follicle of appropriate size is found. Generally, 7-14 days of treatment are sufficient. Treatment with Puregon is then stopped and ovulation will be induced by administering human chorionic gonadotropin (hCG).
• Assisted reproductive technology programs, e.g. IVFThe doctor establishes a starting dose. This dose is maintained for at least the first four days. Subsequently, the dose may be adjusted based on the ovarian response. When an appropriate number of follicles of adequate size are present, the final maturation phase is induced by administering hCG. Egg (ova) retrieval is performed 34-35 hours later.

Dosage in men
Puregon is normally prescribed at a dose of 450 IU per week, mostly divided into 3 doses of
150 IU, in combination with the administration of another hormone (hCG), for at least 3-4 months. The
treatment period is equal to the time of sperm development and the time in which improvement is expected. If sperm production has not started after this period, therapy may be
prolonged for at least 18 months.

How the injection should be given
Puregon injectable solution in cartridges has been developed to be used with Puregon Pen.
Follow the instructions for use of the pen device, provided separately, carefully. Do not use
the cartridge if the solution contains particles or does not appear clear.
Using the pen device, injections can be given just under the skin (e.g. in the lower part of the abdomen) by yourself or your partner. The doctor will tell you when and
how to give the injection. If you inject Puregon yourself, follow the instructions carefully
to administer Puregon appropriately and with minimal discomfort.
The first injection of Puregon must be given exclusively in the presence of the doctor or
nurse.
A small amount of the medicine may remain in the cartridge after completion of the
treatment with Puregon even if all doses have been administered correctly. Do not try to
use the remaining medicine. After administering the last dose, the cartridge must be
disposed of properly.

If you use more Puregon than you should
Tell your doctor immediately.
An overdose of Puregon can cause ovarian hyperstimulation syndrome (OHSS). This can
manifest as stomach pain. Tell your doctor immediately if you have stomach pain.
See also section 4 on Possible side effects.

If you forget to use Puregon
If you have forgotten a dose, do not take a double dose to make up for the missed dose.
→ Contact your doctor.
If you have any doubts about the use of this medicine, ask your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell your doctor immediately if you notice:
Signs of a severe allergic reaction (anaphylactic reaction) such as swelling of the face, lips, throat or tongue making it difficult to swallow or breathe, wheezing, feeling
of losing consciousness.

Serious side effects in women
A complication of treatment with FSH is ovarian hyperstimulation. Excessive ovarian stimulation can lead to the development of a medical condition called ovarian hyperstimulation syndrome (OHSS), which can be a serious medical problem. The risk can be
reduced by careful monitoring of follicular development during treatment. The doctor
will perform ultrasounds of the ovaries to carefully monitor the number of follicles that mature. The doctor may also check hormone levels in the blood. Early symptoms are stomach pain, feeling unwell or diarrhea. In more severe cases, symptoms may include
enlargement of the ovaries, fluid accumulation in the abdomen and/or chest (which can cause
sudden weight gain due to fluid retention) and the formation of blood clots
in circulation. See Warnings and precautions in section 2.
→ Consult your doctor immediately if you have stomach pain or any of the other symptoms of
ovarian hyperstimulation, even if this occurs a few days after the last injection.

If you are a woman:

Common side effects (may affect up to 1 in 10 people)

• Headache
• Injection site reactions (such as burning, pain, redness, swelling and itching)
• Ovarian hyperstimulation syndrome (OHSS)
• Pelvic pain
• Stomach pain and/or bloating Uncommon side effects (may affect up to 1 in 100 people)
• Breast disorders (including tenderness)
• Diarrhea, constipation or stomach discomfort
• Uterine enlargement
• Feeling unwell
• Hypersensitivity reactions (such as skin rash, redness, hives and itching)
• Ovarian cysts or enlargement of the ovaries
• Ovarian torsion (twisting of the ovaries)
• Vaginal bleeding

Rare side effects (may affect up to 1 in 1,000 people)

• Blood clots (this can occur even without unintentional ovarian overstimulation, see Warnings and precautions in section 2).

Side effects with unknown frequency (frequency cannot be estimated from available data):

• Allergic reactions:
• swelling of the face, lips, throat or tongue making it difficult to swallow or breathe, wheezing
• pale skin, weak and rapid pulse or feeling of losing consciousness

Ectopic pregnancy (a pregnancy outside the uterus), miscarriage and multiple pregnancies have also been reported. These side effects are not considered to be related to the use of Puregon, but to the
assisted reproductive technology (ART) or subsequent pregnancy.

If you are a man:

Common side effects (may affect up to 1 in 10 people)

• Acne
• Injection site reactions (such as hardening and pain)
• Headache
• Skin rash
• Enlargement of the breast gland
• Testicular cyst

Side effects with unknown frequency (frequency cannot be estimated from available data):

• Allergic reactions:
• swelling of the face, lips, throat or tongue making it difficult to swallow or breathe, wheezing
• pale skin, weak and rapid pulse or feeling of losing consciousness

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system listed in Annex V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Puregon

Keep this medicine out of the sight and reach of children.

Storage at the pharmacy
Store at 2°C – 8°C (in a refrigerator). Do not freeze.

Storage at the patient's home
You have two options:

• 1. Store at 2°C – 8°C (in a refrigerator). Do not freeze.
• 2. Store at a temperature equal to or below 25°C (room temperature) for a single period not exceeding 3 months. Note when you start storing the product outside the refrigerator. Keep the cartridge in the outer packaging.

Once pierced with a needle, the rubber disc of a cartridge, the product may be stored
for a maximum of 28 days.
Please note the day you start using the cartridge on the registration card, as
described in the Puregon Pen device instruction manual.
Do not use Puregon after the expiry date that is stated on the label and the carton after “EXP”. The
expiry date refers to the last day of that month.
Dispose of used needles immediately after injection.
Do not mix any other medicine into the cartridges.
Empty cartridges must not be refilled.
Do not dispose of any medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Puregon contains

• Each cartridge contains the active substance beta follitropin, a hormone known as follicle-stimulating hormone (FSH) in a dosage of 833 IU/mL aqueous solution.
• The other components are sucrose, sodium citrate, L-methionine, polysorbate 20 and benzyl alcohol in water for injectable preparations. The pH may have been adjusted with sodium hydroxide and/or hydrochloric acid.

Description of the appearance of Puregon and contents of the pack
Puregon injectable solution (injectable preparation) is a clear, colorless liquid. It is
supplied in a glass cartridge. It is available in packs of 1 cartridge.

Marketing Authorisation Holder and Manufacturer
N.V. Organon
Kloosterstraat 6
5349 AB Oss
The Netherlands
For further information on this medicine, contact the local representative of the Marketing
Authorisation Holder:

België/Belgique/Belgien
Organon Belgium
Tél/Tel: 0080066550123 (+32 2 2418100)
[email protected]

Lietuva
Organon Pharma B.V. Lithuania representative office
Tel.: +370 52041693
[email protected]

България
Органон (И.А.) Б.В. - клон България
Тел.: +359 2 806 3030
[email protected]

Luxembourg/Luxemburg
Organon Belgium
Tél/Tel: 0080066550123 (+32 2 2418100)
[email protected]

Česká republika
Organon Czech Republic s.r.o.
Tel: +420 233 010 300
[email protected]

Magyarország
Organon Hungary Kft.
Tel.: +36 1 766 1963
[email protected]

Danmark
Organon Denmark ApS
Tlf: +45 4484 6800
[email protected]

Malta
Organon Pharma B.V., Cyprus branch
Tel: +356 2277 8116
[email protected]

Deutschland
Organon Healthcare GmbH
Tel.: 0800 3384 726 (+49 (0) 89 2040022 10)
[email protected]

Nederland
N.V. Organon
Tel: 00800 66550123
(+32 2 2418100)
[email protected]

Eesti
Organon Pharma B.V. Estonian RO
Tel: +372 66 61 300
[email protected]

Norge
Organon Norway AS
Tlf: +47 24 14 56 60
[email protected]

Ελλάδα
BIANEΞ Α.Ε.
Τηλ: +30 210 80091 11
[email protected]

Österreich
Organon Healthcare GmbH
Tel: +49 (0) 89 2040022 10
[email protected]

España
Organon Salud, S.L.
Tel: +34 91 591 12 79
[email protected]

Polska
Organon Polska Sp. z o.o.
Tel.: +48 22 105 50 01
[email protected]

France
Organon France
Tél: +33 (0) 1 57 77 32 00

Portugal
Organon Portugal, Sociedade Unipessoal Lda.
Tel: +351 218705500
[email protected]

Hrvatska
Organon Pharma d.o.o.
Tel: +385 1 638 4530
[email protected]

România
Organon Biosciences S.R.L.
Tel: +40 21 527 29 90
[email protected]

Ireland
Organon Pharma (Ireland) Limited
Tel: +353 15828260
[email protected]

Slovenija
Organon Pharma B.V., Oss, podružnica Ljubljana
Tel: +386 1 300 10 80
[email protected]

Ísland
Vistor hf.
Sími: +354 535 7000

Slovenská republika
Organon Slovakia s. r. o.
Tel: +421 2 44 88 98 88
[email protected]

Italia
Organon Italia S.r.l.
Tel: +39 06 90259059
[email protected]

Suomi/Finland
Organon Finland Oy
Puh/Tel: +358 (0) 29 170 3520
[email protected]

Κύπρος
Organon Pharma B.V., Cyprus branch
Τηλ: +357 22866730
[email protected]

Sverige
Organon Sweden AB
Tel: +46 8 502 597 00
[email protected]

Latvija
Ārvalsts komersanta “Organon Pharma B.V.”
pārstāvniecība
Tel: +371 66968876
[email protected]

United Kingdom (Northern Ireland)
Organon Pharma (UK) Limited
Tel: +44 (0) 208 159 3593
[email protected]

Other sources of information
More detailed information on this medicine is available on the website of the European
Medicines Agency, https://www.ema.europa.eu .

ANNEX IV
SCIENTIFIC CONCLUSIONS AND JUSTIFICATION FOR THE VARIATION OF THE
MARKETING AUTHORISATION
Scientific conclusions
Taking into account the evaluation of the Pharmacovigilance and Risk Assessment Committee
(PRAC) of the Periodic Safety Update Report (PSUR) for follitropin beta, the PRAC’s scientific
conclusions are as follows:
In light of the available data on anaphylactic reactionfrom spontaneous reports, including
cases with a close temporal association, the PRAC considers that a causal relationship between
follitropin beta and anaphylactic reaction is at least a reasonable possibility. The PRAC concluded
that the product information for medicines containing follitropin beta should be amended
accordingly.
Having examined the PRAC recommendation, the Committee for Human Medicinal Products
(CHMP) agrees with the related overall conclusions and with the justification for the recommendation.

Justification for the variation of the marketing authorisation
Based on the scientific conclusions relating to follitropin beta, the CHMP considers that the benefit/risk
balance of the medicine(s) containing follitropin beta remains unchanged, save for the proposed
changes to the product information.
The CHMP recommends the variation of the marketing authorisation.