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PREGNYL 1500 IU POWDER FOR SOLUTION FOR INJECTION

Active substance(s): CHORIONIC GONADOTROPHIN / CHORIONIC GONADOTROPHIN

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Package leaflet: Information for the user
Pregnyl 1500 IU, powder and solvent for solution for injection
Pregnyl 5000 IU, powder and solvent for solution for injection
human chorionic gonadotropin (hCG)
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, 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 Pregnyl is and what it is used for
2.
What you need to know before you use Pregnyl
3.
How to use Pregnyl
4.
Possible side effects
5.
How to store Pregnyl
6.
Contents of the pack and other information

1.

What Pregnyl is and what it is used for

Pregnyl contains the hormone known as human chorionic gonadotropin (hCG), which belongs to a group
of medicines called gonadotropins. These are important for fertility and reproduction.
Pregnyl is obtained from the urine of pregnant women. HCG has the same effect on the body as
luteinising hormone (LH), which is produced in the pituitary gland of men and women. The pituitary is a
small hormone-producing gland located at the base of the brain. Together with another pituitary
hormone, follicle-stimulating hormone (FSH), LH regulates the function of the reproductive organs
(ovaries in women and testicles in men). These hormones are necessary for the normal growth and
ripening of egg and sperm cells.
In women

In women, FSH and LH cause the monthly ripening of an egg cell in one of the ovaries. LH is also
needed for ovulation: the release of the egg cell. If the body does not produce enough FSH and LH
on its own, this can lead to low fertility. Daily injections of FSH can lead to ripening of the egg
cell. Pregnyl ensures that ovulation takes place afterwards.

Pregnyl can also be given in assisted reproductive techniques, both before and after ovulation.
In men

In men, Pregnyl can be used on its own or together with an FSH-containing product, when there is
underdevelopment of the sex glands or when there are problems with the formation of sperm.
In boys

In boys, Pregnyl can be used for delayed puberty, on its own or together with an FSH-containing
product.

In some cases Pregnyl can also be given to boys in whom one or both testicles have not descended.

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2.

What you need to know before you use Pregnyl

Do not use Pregnyl

if you are allergic to any of the ingredients in this medicine. These are listed in section 6.

if you have a known or suspected sex hormone-dependent tumour in the ovaries, breast, uterus,
prostate, testicles or brain (pituitary or hypothalamus).

if your reproductive glands (ovaries or testicles) are not working, due to so-called ‘gonadal
failure’.

if you are a woman and you have malformations of the sex organs that make pregnancy
impossible.

if you are a woman and you have uterine fibroids (myomas), which make pregnancy impossible.

if you are a woman and you have heavy or irregular vaginal bleeding, other than menstrual
bleeding without a diagnosed cause

if you are a woman and you have ovarian cysts or enlarged ovaries, not related to Polycystic Ovary
Syndrome (PCOS, a condition in which the egg cells do not ripen and no ovulation takes place).
Warnings and precautions
Talk to your doctor or pharmacist before using this medicine.
For men and women:
Please inform your doctor if you:






have uncontrolled pituitary gland or hypothalamic problems.
have an underactive thyroid gland (hypothyroidism).
have adrenal glands that are not working properly (adrenocortical insufficiency).
have high prolactin levels in the blood (hyperprolactinemia).
have any other medical conditions (for example, diabetes, heart disease, or any other long-term
disease).

Allergic reactions
Allergic reactions, both generalized and local, including swelling of the face, lips, tongue, and/or throat
that may cause difficulty in breathing or swallowing (angioedema and anaphylaxis) have been reported.
If you have an allergic reaction, stop taking Pregnyl and seek immediate medical assistance. (See also
Section 4 Possible side effects).
Misuse for weight control
Pregnyl must not be used for weight loss. HCG has no effect on fat metabolism (burning fat), distribution
of fat or appetite.
Chance of having ovarian hyperstimulation syndrome (OHSS)
Treatment with gonadotropic hormones like Pregnyl may cause ovarian hyperstimulation syndrome
(OHSS). This is a serious medical condition where the ovaries are overly stimulated and the growing
follicles become larger than normal. In rare cases, severe OHSS may be life-threatening. Therefore, close
supervision by your doctor is very important. To check the effects of treatment, your doctor will do
ultrasound scans of your ovaries. Your doctor may also check blood hormone levels. (See also Section 4
Possible side effects).
OHSS causes fluid to build up suddenly in your stomach and chest areas and can cause blood clots to
form. Call your doctor right away if you have:






severe abdominal swelling and pain in the stomach area (abdomen)
feeling sick (nausea)
vomiting
sudden weight gain due to fluid build-up
diarrhea

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decreased urine output
trouble breathing

Ovarian Torsion
Ovarian torsion is the twisting of an ovary. Twisting of the ovary could cause the blood flow to the ovary
to be cut off.
Before starting to use this medicine, it is important to inform your doctor if you:






have ever had ovarian hyperstimulation syndrome OHSS
are pregnant or think that you may be pregnant
have ever had stomach (abdominal) surgery
have ever had a twisting of an ovary
have past or current cysts in your ovary or ovaries

Chance of having multiple births or birth defects
In pregnancies occurring after treatment with gonadotropic preparations, there is an increased risk of
having twins or multiple pregnancies. Multiple pregnancies carry an increased health risk for both the
mother and her babies during pregnancy and around the time of birth. Furthermore, multiple pregnancies
and characteristics of the patients undergoing fertility treatment (e.g. age of the female, sperm
characteristics) may be associated with an increased risk of congenital anomalies.
Chance of having pregnancy complications
In women undergoing fertility treatment there is a slightly increased risk of a pregnancy outside of the
uterus (an ectopic pregnancy). Therefore, your doctor should perform an early ultrasound examination to
exclude the possibility of pregnancy outside the uterus.
Miscarriage
In women undergoing fertility treatment there may be a slightly higher risk of miscarriage.
Chance of having a blood clot (thrombosis)
Treatment with Pregnyl (like pregnancy itself) may increase the risk of the formation of a blood clot in a
blood vessel (thrombosis), most often in the veins of the legs or the lungs.
Blood clots can lead to serious medical conditions, such as:







blockage in your lungs (pulmonary embolus)
stroke
heart attack
blood vessel problems (thrombophlebitis)
reduced blood flow to the vital organs that may result in organ damage
reduced blood flow to your arm or leg that may result in a loss of your arm or leg

Please discuss this with your doctor, before starting treatment, especially if:




you already know you have an increased risk of blood clots
you, or anyone in your immediate family, have ever had a blood clot
you are severely overweight

For up to 10 days after administration of Pregnyl, a pregnancy test may give a false-positive result.
If you are a man:
Antibody formation
If the treatment with Pregnyl is not working, consult with your doctor who may perform additional tests.

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Treatment with Pregnyl (hCG) can cause the body to produce substances that act against hCG (antibodies
to hCG). In rare cases this could result in ineffective treatment.
Androgen production
Treatment with hCG leads to increased androgen (male sexual hormone) production. Therefore extra
supervision by the doctor is necessary


in the treatment of boys who have not reached puberty. This is because Pregnyl can
cause early sexual development and delay growth.

if you have or have ever had:
- heart or blood vessel disease
- kidney disease
- epilepsy
- migraine headaches
because worsening or recurrence may occasionally be induced as a result of increased production of
androgens (male sexual hormones).
Using other medicines
Interactions of Pregnyl with other medicines have not been investigated; interactions with commonly
used medicines can therefore not be excluded.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines,
including medicines obtained without a prescription.
For up to ten days after administration, Pregnyl may result in a false positive pregnancy test.
Pregnancy and breast-feeding
You must not use Pregnyl during pregnancy. Pregnyl may be used to support a (possible) pregnancy
during the period just after ovulation (luteal phase).
If you are breast-feeding, ask your doctor for advice before taking this medicine. Use of Pregnyl can be
considered while nursing a baby.
Driving and using machines
As far as is known, Pregnyl has no effect on the ability to drive or operate machines.
Pregnyl contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per injection, i.e. essentially ‘sodium-free’.

3.

How to use Pregnyl

Dosage
Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if
you are not sure. Your doctor will decide on the dose of Pregnyl to be given and will supervise your first
injection.
In female patients one injection is usually given to induce ovulation and up to 3 injections to support the
luteal phase that follows.
In male patients (men and boys) the injections are given 2 or 3 times a week. The treatment will last
from a few weeks to at least 3 months, depending on the problem being treated. The length of treatment
depends on the time needed for development of sperm and the period in which an improvement can be
expected.
How the injections are given
The powder for injection from the one vial must be dissolved with the liquid from the other vial (the
solvent). This solution must be used immediately after that. The Pregnyl solution can be injected slowly
into muscles (for instance, in the buttock [see Figure 1], the upper leg or the upper arm) or just under the

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skin (for instance, in the lower abdomen [see Figures 2 and 3]).
When injecting into a muscle, the injection must be given by the doctor or nurse.

Figure 1
When given under the skin (see Figures 2 and 3), injections may, in some cases, be given by yourself or
your partner. Your doctor will tell you when and how to do this. If you are injecting yourself with
Pregnyl, follow accurate the instructions in the section ‘Instructions for use’, so that you administer
Pregnyl properly and with minimal discomfort from the injection.

Figure 2

Figure 3

Instructions for use
Step 1 – Getting ready

Remove the vials of powder and solvent from the refrigerator.

For the injection, you will need a clean dry surface, alcohol, cotton balls, and a puncture-proof
container (sharps bin) to throw away the used syringe and needles.

Wash your hands and dry them.
Step 2 – Preparing the injection syringe

Flip off the protective top of the vial of dry powder and of the vial of solvent. Do not remove the
rubber stopper.

Wipe the tops of the rubber stoppers with an alcohol wipe.

Use a syringe and needle that has been recommended by your healthcare provider.

Attach a needle to the syringe.

Carefully remove the needle cover (cap) from the needle (See Figure 4).

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Figure 4



The dry powder in the glass vial must be dissolved in the solvent from the other glass vial.
Pierce the needle through the rubber stopper of the solvent vial (see Figure 5).

Figure 5


Draw all the solvent up into the syringe (see Figure 6).

Figure 6


Inject all the solvent into the vial with the dry powder (see Figure 7).

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Figure 7







Remove the syringe and needle from the vial.
DO NOT SHAKE OR TURN THE VIAL UPSIDE DOWN, but swirl gently until the solution is
clear. Pregnyl usually dissolves immediately.
The prepared solution should not be used if it contains particles or is cloudy.
The solution should be used immediately after reconstitution.
Make sure that everything is carried out so that during reconstitution sterile conditions are
maintained (e.g., never put the syringe down without first putting the protective cap on the needle).
Draw all op the Pregnyl solution up into the same empty syringe (see Figure 8).

Figure 8


Replace the longer needle used for drawing up the solution with a shorter sterile injection needle
(see Figure 9).

Figure 9


Hold the syringe with the needle pointing upwards and gently tap the side to allow any air bubbles
to rise to the top (see Figure 10).

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Figure 10


Then, push the plunger until all the air is out of the syringe and only Pregnyl solution is present in
the syringe and the needle (see Figure 11).

Figure 11
Step 3 – The injection site
The best injection site for subcutaneous injection is in the abdomen around the navel (see Figure 2),
where there is a lot of loose skin and layers of fatty tissue. Other injection sites are also possible. Choose
a slightly different place for each injection. Your doctor or nurse will tell you where to inject.
Step 4 - Preparing the injection site
Tap a few times on the injection site to stimulate tiny nerve endings. This reduces the pain when the
needle goes into the subcutaneous tissue. Wash your hands and clean the injection site with alcohol to
remove any surface bacteria. Clean an area of about five centimetres (two inches) around the injection
site and let the alcohol dry for at least one minute before you go on to the next step.
Step 5 - Inserting the needle
Grasp a fold of skin between thumb and forefinger. With the other hand, stick the needle into the fold of
skin at a 45-degree angle, as shown in Figure 3.
Step 6 - Checking the correct needle position
Pull the plunger of the syringe back gently, to check that the needle is in the correct position. If blood is
drawn into the syringe, it means a vein has been punctured. If this happens, remove the needle from the
skin and apply pressure on the injection site with cotton-wool containing alcohol; bleeding should stop
after about two minutes. Do not use the solution contaminated with blood. Start again from step 1 using
a new syringe, new needles, and new vials of Pregnyl and solvent.
Step 7 - Injecting the solution
Depress the plunger slowly and steadily. This way the solution will be injected properly without injuring
subcutaneous tissue.

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Step 8 - Removing the syringe
With a quick movement, pull the needle out of the skin and apply pressure on the injection site with
cotton-wool containing alcohol. Gently massaging the skin – while you are still applying pressure – helps
disperse the Pregnyl solution more easily and reduces the pain. Any remaining solution should be
discarded. Do not mix Pregnyl with any other medicines.
Step 9 – Disposing the needles
In order to prevent injury, do not put the syringe back into the protective sheath.
Carefully dispose of all the needles you used. You can either dispose of needles in a sharps bin or take
them to your pharmacy to be destroyed. Do not share your needles or syringes with others.
If you use more Pregnyl than you should
If you used too much Pregnyl, contact your doctor or pharmacist immediately.
The toxicity of Pregnyl is very low, but a dose of Pregnyl that is too high can cause ovarian
hyperstimulation syndrome (see also section 2, ‘Warnings and precautions’ and section 4 on ‘Possible
side effects’).
If you forget to use Pregnyl
Never take a double dose to make up for a forgotten dose.
Tell your doctor that you missed a dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Most of these
reactions are of a mild nature and go away on their own.
Common side effects occur in less than 1 in 10 patients.
Uncommon side effects occur in less than 1 in 100 patients.
Rare side effects occur in less than 1 in 1000 patients.
Pregnyl can cause bruising, pain, redness, swelling and itching at the site of injection. Allergic reactions
are rare, and mostly involve pain or rash at the injection site.
In rare cases generalized hypersensitivity can occur, such as a rash on several areas of the body, or fever
(see section 2 Warnings and precautions).
If you are a woman
A possible complication of treatment with gonadotropic hormones like Pregnyl is unwanted
overstimulation of the ovaries. The chance of having this complication can be reduced by carefully
monitoring the number of maturing follicles (small round sacs in your ovaries that contain the eggs).
Your doctor will do ultrasound scans of your ovaries to carefully monitor the number of maturing
follicles. Your doctor may also check blood hormone levels. The first symptoms of ovarian
overstimulation may be noticed as pain in the stomach (abdomen), feeling sick or diarrhea. Ovarian
overstimulation may develop into a medical condition called ovarian hyperstimulation syndrome
(OHSS), which can be a serious medical problem. In more severe cases this may lead to enlargement of
the ovaries, collection of fluid in the abdomen and/or chest (which may cause sudden weight gain due to
fluid build-up) or clots in the blood vessels (See also Section 2 Warnings and precautions).
Contact your doctor without delay if you have pain in the stomach (abdomen) or any of the other
symptoms of ovarian hyperstimulation, even if they occur some days after the administration of Pregnyl
has been given.
Rarely, blood clots may occur without unwanted overstimulation of the ovaries (see also section 2.
Before you use Pregnyl).
If you are a man

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In men, fluid and salt may be retained in the tissues, marked usually by swelling of the ankles or feet and,
in rare cases, enlargement of the breasts. This may be caused by increased androgen production due to
treatment with hCG. If any of these symptoms appear, tell your doctor immediately.
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 directly via Netherlands Pharmacovigilance Centre
Lareb, website www.lareb.nl. By reporting side effects you can help provide more information on the
safety of this medicine.

5.

How to store Pregnyl

Keep this medicine out of the sight and reach of children.
Store in the original package in order to protect from light.
Store in the dark at 2 – 8 °C (in a refrigerator).
The solution should be used immediately after reconstitution.
Do not use this medicine after the expiry date which is stated on the package after ‘EXP’. There you will
see a month and a year. The expiry date is the last date of that month.
Do not use Pregnyl if you notice that the reconstituted solution contains particles or if the solution is not
clear.
Medicines should not be flushed down the drain or the toilet, and do not dispose of them with household
waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will ensure
that they are disposed of responsibly and do not end up in the environment.

6.

Contents of the pack and other information

What Pregnyl contains

The active ingredient is human chorionic gonadotropin (hCG), in doses of
1500 IU or 5000 IU per vial.

The other ingredients of this medicine are mannitol, disodium hydrogen
phosphate, sodium dihydrogen phosphate and sodium carboxymethylcellulose. The solvent contains
sodium chloride (9 mg) and water for injection (1.0 ml).
What Pregnyl looks like and contents of the pack
One glassvial contains a white dry powder or cake. This powder or cake is reconstituted with the solvent
from the other glass vial. The solvent is a clear, colourless watery solution.
Pregnyl 1500

One pack contains 3 vials of 2 ml with powder for injection, equivalent to
1500 IU hCG, and 3 vials that contain 1 ml of solvent.
Pregnyl 5000

One pack contains 1 or 3 vials of 2 ml with powder for injection, equivalent to
5000 IU hCG, and 1 or 3 vials that each contain 1 ml of solvent.
Not all pack sizes listed may be available on the market.
Marketing Authorisation Holder and Manufacturer
N.V. Organon, Kloosterstraat 6, 5349 AB Oss, The Netherlands

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For information or correspondence, please contact:
Merck Sharp & Dohme BV, Waarderweg 39, 2031 BN Haarlem
Tel. 0800 9999000, medicalinfo.nl@merck.com
Registered under number:
RVG 00103 (Pregnyl 1500 IU)
RVG 00104 (Pregnyl 5000 IU)
This leaflet was last approved in 2017.

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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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