PREGNYL 1500 IU POWDER FOR SOLUTION FOR INJECTION

Active substance: CHORIONIC GONADOTROPHIN

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Pregnyl® 1500 I.U.
powder for solution for injection
(Human Chorionic Gonadotrophin)
INFORMATION FOR THE
DOCTOR
1 NAME OF THE MEDICINAL
PRODUCT
Pregnyl 1500 I.U.
powder for solution for injection.
2 QUALITATIVE AND
QUANTITATIVE
COMPOSITION
Pregnyl consists of a freeze-dried
powder for injection. The active
ingredient [human chorionic
gonadotrophin (hCG)] which is
obtained from the urine of pregnant
women, has luteinizing hormone (LH)
activity.
An ampoule contains 1500 I.U. hCG.
For a full list of excipients, see
section 6.1.
3 PHARMACEUTICAL FORM
Powder for solution for injection. The
powder is a white, dry powder or
cake.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
In the female
Sterility due to the absence of
follicle-ripening or ovulation.
In combination with FSH or HMG,
promotion of controlled
superovulation in medically assisted
reproduction programmes.
In the male
Hypogonadotrophic hypogonadism.
Delayed puberty associated with
insufficient gonadotrophic pituitary
function.
Sterility in selected cases of deficient
spermatogenesis.
4.2 Posology and method of
administration
Dosage
In the female
Sterility due to the absence of follicleripening or ovulation.
5,000–10,000 IU hCG to induce
ovulation, following treatment with
an FSH (Follicle Stimulating
Hormone) or HMG (Human
Menopausal Gonadotrophins)
preparation.
In combination with FSH or HMG,
promotion of controlled
superovulation in medically assisted
reproduction programmes.
5,000–10,000 IU hCG 30–40 hours
after the last FSH or HMG injection.
Pregnyl should not be administered if
the following criteria have not been
met: at least 3 follicles greater than
17mm in diameter are present with
17ß estradiol levels of at least
3500 pmol/L (920 picogram/ml).
Oocyte collection is carried out
32–36 hours after the hCG injection.
As luteal phase support, two to three
injections of 1,000 to 3,000 IU hCG
each may be given within nine days
of ovulation or embryo transfer, for
example on day 3, 6 and 9 after
ovulation induction or embryo
transfer.
In the male
Hypogonadotrophic hypogonadism.
500–1,000 IU hCG 2-3 times
weekly.

Sterility in selected cases of deficient
spermatogenesis.
Usually, 3,000 IU hCG per week in
combination with an FSH or HMG
preparation.
This treatment should be continued
for at least three months before any
improvement in spermatogenesis can
be expected. During this treatment
testosterone replacement therapy
should be suspended. Once
achieved, the improvement may
sometimes be maintained by hCG
alone.
Method of Administration
After addition of the solvent to the
freeze-dried substance, the solution
should be given immediately by
intramuscular or subcutaneous
injection. Any unused solution should
be discarded. Subcutaneous injection
may be carried out by patient or
partner, provided that proper
instruction is given by the physician.
Self administration of Pregnyl should
only be performed by patients who
are well-motivated, adequately
trained and with access to expert
advice.
4.3 Contraindications
• Hypersensitivity to human
gonadotrophins or any of the
excipients of Pregnyl.
• Presence of uncontrolled nongonadal endocrinopathies (e.g.
thyroid, adrenal or pituitary
disorders).
• Breast, uterine, ovarian tumours.
• Vaginal bleeding of unknown
cause.
• Known or suspected androgendependent tumours such as
testicular tumours, carcinoma of
the prostate or mammary
carcinoma in males.
• Malformations of the sexual organs
incompatible with pregnancy.
• Fibroid tumours of the uterus
incompatible with pregnancy.
4.4 Special warnings and
precautions for use
In the female
• Since infertile women undergoing
assisted reproduction, and
particularly IVF, often have tubal
abnormalities the incidence of
ectopic pregnancies might be
increased. Early ultrasound
confirmation that a pregnancy is
intrauterine is therefore important.
• Prior to treating patients for
inadequate endogenous
stimulation of the gonads, an
examination should be performed
to exclude anatomical
abnormalities of the genital organs
or nongonadal endocrinopathies
(e.g. thyroid or adrenal disorders,
diabetes). Primary ovarian failure
should be excluded by the
determination of gonadotrophin
levels.
• In the pregnancies occurring after
induction of ovulation with
gonadotrophic preparations, there
is an increased risk of abortion and
multiplets. Multiple pregnancy,
especially high order, carries an

increased risk in adverse maternal
and perinatal outcomes. The
parents should be advised of the
potential risks of multiple births
before starting treatment.
• The incidence of congenital
malformations after Assisted
Reproductive Technologies (ART)
may be higher than after
spontaneous conceptions. This is
thought to be due to differences in
parental characteristics (e.g.
maternal age, sperm
characteristics) and an increased
incidence of multiple gestations.
• Women with generally recognised
risk factors for thrombosis, such as
a personal or family history, severe
obesity (Body Mass Index > 30 
kg/m2) or thrombophilia, may have
an increased risk of venous or
arterial thromboembolic events,
during or following treatment with
gonadotrophins. In these women
the benefits of IVF treatment need
to be weighed against the risks. It
should be noted, however, that
pregnancy itself also carries an
increased risk of thrombosis.
• There have been reports of ovarian
and other reproductive system
neoplasms, both benign and
malignant, in women who have
undergone multiple drug regimens
for infertility treatment. It is not yet
established whether or not
treatment with gonadotrophins
increases the baseline risk of these
tumours in infertile women.
Unwanted Hyperstimulation
During treatment of female patients,
determinations of oestrogen levels
and assessment of ovarian size and if
possible, ultrasonography should be
performed prior to treatment and at
regular intervals during treatment.
High dosages may cause oestrogen
levels to rise excessively rapidly, e.g.
more than doubling on 2 or 3
consecutive days, and possibly
reaching excessively high preovulatory values. The diagnosis of
unwanted ovarian hyperstimulation
may be confirmed by ultrasound
examination.
If unwanted hyperstimulation occurs
(i.e. not as part of a treatment
preparing for IVF/ET or GIFT or other
assisted reproduction techniques),
the administration of FSH or HMG
should be discontinued immediately.
HCG must not be given, because the
administration of an hLH - active
gonadotrophin at this stage may
induce, in addition to multiple
ovulations, the ovarian
hyperstimulation syndrome. This
warning is particularly important with
respect to patients with polycystic
ovarian disease.
Clinical symptoms of mild ovarian
hyperstimulation syndrome include
gastro-intestinal problems (pain,
nausea, diarrhoea, abdominal
discomfort and bloating), painful
breasts, and mild to moderate
enlargement of ovaries and ovarian
cysts. Transient liver function test
abnormalities suggestive of hepatic
dysfunction, which may be
accompanied by morphologic
changes on liver biopsy, have been
reported in association with ovarian
hyperstimulation syndrome.
The severe form of ovarian
hyperstimulation syndrome may be

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Pregnyl® 1500 I.U.
powder for solution for injection
(Human Chorionic Gonadotrophin)
INFORMATION FOR THE USER
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 doctor or pharmacist.
• 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 or
pharmacist.
In this leaflet:
1. What Pregnyl is and what it is
used for
2. Before you use Pregnyl
3. How to use Pregnyl
4. Possible side effects
5. How to store Pregnyl
6. Further information
1. What Pregnyl is and what it is
used for
Pregnyl belongs to a group of
medicines called gonadotrophins (sex
hormones). It controls the release of
eggs from the ovary in women, and
controls production of the male
hormone, testosterone in men.
Women
In female infertility it can be used to
cause women to ovulate (Ovulation
induction). Pregnyl is also used
along with other fertility drugs, to
help produce eggs in medically
assisted reproduction programmes.
(IVF treatment),
Men
In men it is used to help treat
delayed puberty, undescended
testes or oligospermia (low sperm
count).
Ask your doctor if you are unsure
why you have been given Pregnyl.
2. Before you use Pregnyl
Do not use Pregnyl if you:
• are allergic (hypersensitive) to
Human Chorionic Gonadotrophin
(HCG) or any of the other
ingredients in Pregnyl
• have a thyroid, adrenal or
pituitary illness which is not being
treated
• have cancer, (especially a
hormone-dependent cancer of the
breast, ovaries or womb)
• have recently had unexpected
vaginal bleeding
• if you have fibroids in the womb
or abnormalities of the sexual
organs which make a normal
pregnancy impossible
• are a man and have, or suspect
you have a hormone related
tumour, such as testicular,
prostate or breast cancer.
Take special care with Pregnyl
Medicines are not always suitable for
everyone.
Tell your doctor before you use
Pregnyl if you suffer from or have
suffered in the past from any of the
following conditions:
• Men with
o heart problems
o kidney problems
o high blood pressure
o epilepsy, or
o migraine
• abnormalities of the sexual
organs. Before treatment with
Pregnyl your doctor should have
checked that your sexual organs
are normal
• in women patients your doctor
should have checked how your
ovaries are working before
starting treatment with Pregnyl.
Extra supervision may be
necessary in some cases.
Pregnyl should be used carefully
when treating boys who have not

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Delayed puberty associated with
insufficient gonadotrophic pituitary
function.
1,500 IU hCG twice weekly for at
least 6 months.

reached puberty. This is because it
can cause early sexual development
and may result in final adult height
not being reached.
If you have risks factors for having a
blood clot (for example being
overweight, or if blood clots run in
your family), the chance of having a
blood clot may be increased during
IVF treatment.

how to do this. If you inject yourself
with Pregnyl, follow the instructions
on this leaflet carefully to give
Pregnyl properly and with minimal
discomfort.

Being pregnant increases the chance
of having a blood clot.
Fertility treatment
Close supervision of female patients
undergoing fertility treatment is
extremely important to avoid the
rare complication of
hyperstimulation of the ovaries.
This side effect may be felt as pain in
the stomach.
 If you are troubled with stomach
pains, contact your doctor
straight away.
No one is sure if IVF treatment
causes congenital malformations,
or some cancers of the sex organs.

Step 1 - Preparing Pregnyl
Pregnyl comes in two glass ampoules
whose contents must be mixed
together and used immediately.
First, break the top off the ampoule
with the sodium chloride solution (a).

Taking other medicines
Some medicines can affect the way
Pregnyl works, or Pregnyl may affect
how other medicines work. For the
ten days following your Pregnyl
injection a pregnancy test may give a
false positive result.
 your doctor or pharmacist
Tell
if you are taking or have recently
taken any other medicines,
including medicines obtained
without a prescription.
Pregnancy
If treatment with Pregnyl results in
pregnancy, there is an increased
chance having twins or multiple
births. Multiple pregnancies carry an
increased health risk for both the
mother and her babies around the
time of birth. There is also an
increased chance of a miscarriage, or
a pregnancy outside of the womb (an
ectopic pregnancy).

Draw up the liquid through the
larger needle into the syringe (b).

3. How to use Pregnyl
Your doctor will choose the most
suitable starting dose for you. The
usual starting doses for men and
women are as follows:
Women
Patients undergoing ovulation
induction:
5,000–10,000 I.U. Pregnyl following
treatment with other fertility drugs.
2 to 3 repeat injections of 1,000 to
3,000 I.U. each may be given within
the following 9 days.

Break open the second ampoule
containing the dry white powder (c)
and add the sodium chloride solution
from the syringe (d).

Patients undergoing IVF treatment:
5,000–10,000 I.U. Pregnyl
30–40 hours after the last injection
of other fertility drugs.
Men
In male patients injections are given
2 to 3 times a week for some weeks
or months, depending on the
problem. Because the development
of sperm cells takes about 74 days,
treatment should be continued for at
least three months before any
improvement can be expected.
How are the injections given?
The very first injection of Pregnyl
should only be given under medical
supervision.
Injections may be given slowly into a
muscle (for instance in the bottom,
upper leg or upper arm) or under
the skin (in the stomach wall, for
example).
When given into a muscle the
injection should be given by the
doctor or nurse. The best site for
injection of Pregnyl is the muscle of
your bottom. The area shown in blue
in the diagram contains a large
amount of muscle with few blood
vessels or major nerves.
When given under the skin the
injection may, in some cases, be
given by yourself or your partner.
Your doctor will tell you when and

Do not shake, but gently swirl until
the solution is clear.
The Pregnyl usually dissolves
immediately.
If the solution contains particles
or does not become clear, do not
use it.
Draw the Pregnyl solution up into the
empty syringe (e), and now replace
the needle with a smaller sterile
injection needle (f). Finally hold the
syringe with the needle pointing
upwards and gently tap the side to

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INFORMATION FOR THE
DOCTOR
life-threatening and is characterised
by large ovarian cysts (prone to
rupture), acute abdominal pain,
ascites, weight gain, very often
hydrothrax and occasionally
thrombo-embolic phenomena.
Pregnyl should not be used for body
weight reduction. HCG has no effect
on fat metabolism, fat distribution or
appetite.
In the male
Treatment with hCG leads to
increased androgen production.
Therefore:
• Patients with latent or overt
cardiac failure, renal dysfunction,
hypertension, epilepsy or migraine
(or a history of these conditions)
should be kept under close
medical supervision, since
aggravation or recurrence may
occasionally be induced as a result
of increased androgen production.
• HCG should be used cautiously in
prepubertal boys to avoid
premature epiphyseal closure or
precocious sexual development.
Skeletal maturation should be
monitored regularly.
4.5 Interaction with other
medicinal products and other
forms of interaction
No interaction studies have been
performed; interactions with
commonly used medicinal products
can therefore not be excluded.
Following administration, Pregnyl
may interfere for up to ten days with
the immunological determination of
serum/urinary hCG, leading to a false
positive pregnancy test.
4.6 Pregnancy and lactation
Not applicable.
4.7 Effects on ability to drive and
use machines
As far as known Pregnyl has no
influence on the ability to drive and
use machines.
4.8 Undesirable effects
Frequency is unknown for all
undesirable effects described below
(cannot be determined with available
data).
Immune system disorders
In rare cases generalized rash or
fever may occur.
General disorders and
administrative site conditions
Local site reactions such as bruising,
pain, redness, swelling and itching.
Oedema. Occasionally allergic
reactions have been reported, mostly
manifesting as pain and/or rash at
the injection site.
Tiredness.
Nervous system disorders
Headache.
Psychiatric disorders
Mood changes.
In the female
Reproductive system and breast
disorders
Unwanted ovarian hyperstimulation,
mild or severe ovarian
hyperstimulation syndrome (OHSS,
see section 4.4):
Mild OHSS:
Painful breasts
Mild to moderate enlargement of
ovaries
Ovarian cysts
Abdominal pain
Abdominal discomfort
Gastrointestinal symptoms such as
nausea, diarrhoea and bloating

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Severe OHSS:
Large ovarian cysts (prone to rupture),
Acute abdominal pain
Ascites
Weight gain
Hydrothorax
In rare instances, thromboembolism
has been associated with FSH/hCG
therapy

and lower in obese women than in
non-obese women.
HCG is approximately 80 per cent
metabolized, predominantly in the
kidneys.
On basis of the recommended dose
regimens and elimination half-life,
accumulation is not expected to
occur.

Not all symptoms described are
always associated to OHSS.

5.3 Preclinical safety data
There are no preclinical data of
relevance to the prescriber which are
additional to that already included in
other sections of the SPC.

In the male
Metabolism and nutrition
disorders
Water and sodium retention is
occasionally seen after
administration of high dosages; this
is regarded as a result of excessive
androgen production.
Reproduction system and breast
disorders
HCG treatment may sporadically
cause gynaecomastia.
Skin and subcutaneous tissue
disorders
Acne may occur occasionally during
hCG therapy.
4.9 Overdose
The toxicity of human chorionic
gonadotrophic hormone is very low.
However, too high a dose may lead
to hyperstimulation of the ovaries.
(See “Unwanted Hyperstimulation”).
5 PHARMACOLOGICAL
PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group:
gonadotrophins: ATC code G03G
A01
Pregnyl is a preparation of human
chorionic gonadotrophin obtained
from the urine of pregnant women. It
stimulates the steroidogenesis in the
gonads by virtue of a biological effect
similar to that of LH (Luteinizing
hormone, which is the same as
interstitial cell stimulating hormone).
In the male it promotes the
production of testosterone and in the
female the production of estrogens
and particularly of progesterone
after ovulation. In certain cases, this
preparation is used in combination
with human menopausal
gonadotrophin (HMG).
Because HCG is of human origin, no
antibody formation is to be expected.
5.2 Pharmacokinetic properties
In a study performed in healthy male
subjects, maximal hCG plasma levels
were reached after a single IM or SC
injection of hCG at approximately six
and sixteen hours respectively; in
addition, maximum concentrations
and areas under the concentration
curves were higher after the IM than
after the SC injection. However,
these differences did not translate
into significant differences in terms of
testicular steroidogenic response.
In a study performed in female
subjects under oral contraceptives,
IM and SC administration of hCG
were found to be bioequivalent
regarding the extent of absorption
and the apparent elimination halflives of approximately 33 hours;
maximal hCG plasma levels were
reached after approximately 20
hours regardless of the route of
administration. Although high
intersubject variability was observed,
the difference related to gender after
IM injection may be caused by
gluteal fat thickness in women which
exceeds that in men. In another
study performed in female patients
in the early follicular phase of their
menstrual cycle, the bioavailability of
a single dose of hCG was higher with
the IM route than with the SC route

6 PHARMACEUTICAL
PARTICULARS
6.1 List of excipients
Powder for injection contains:
Carmellose sodium, Mannitol (E421),
Disodium phosphate (anhydrous),
Sodium dihydrogen phosphate
(anhydrous)
6.2 Incompatibilities
In the absence of compatibility
studies, this medicinal product must
not be mixed with other medicinal
products.
6.3 Shelf life
36 months.
6.4 Special precautions for
storage
Store at 2 to 8°C. Do not freeze.
Keep the ampoules in the outer
carton to protect from light.
6.5 Nature and contents of
container
2ml ampoule containing freeze-dried
powder with 1ml ampoule of solvent
(sodium chloride 9mg/ml).
Pregnyl is available in packs of 1, 3,
5 or 10 ampoules of powder and
solvent. Not all pack sizes may be
marketed.
In correspondence please quote
batch number.
6.6 Special precautions for
disposal and other handling
Pregnyl should be reconstituted with
the solvent provided. Do not use if
the solution contains particles or if
the solution is not clear. Since an
opened ampoule cannot be resealed
in such a way to further guarantee
the sterility of the contents, the
solution should be used immediately
after reconstitution. Discard any
remaining solution after single use.
Any unused product or waste
material should be disposed of in
accordance with local requirements.
7 MARKETING
AUTHORISATION HOLDER
Merck Sharp & Dohme Limited,
Hertford Road, Hoddesdon,
Hertfordshire, EN11 9BU, UK
8 MARKETING
AUTHORISATION
NUMBER(S)
PL 00025/0555
9 DATE OF FIRST
AUTHORISATION/ RENEWAL
OF THE AUTHORISATION
24th February 1991/25th March 2003
10 DATE OF REVISION OF THE
TEXT
July 2013
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INFORMATION FOR THE USER

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force any air bubbles up to the top;
then squeeze the plunger until all the
air has been expelled, and only Pregnyl
solution is left in the syringe (g).
Step 2 - The injection site
The best site for injection is in the
stomach around the middle of the
tummy (h) where there is a lot of
loose skin and layers of fatty tissue.
Pinch up a large area of skin between
the finger and thumb. You should
change the injection site a little each
time you inject. It is possible to inject
in other areas. Your doctor or nurse
will advise you where to inject.

under the skin

Step 3 - Preparing the area
A few taps at the injection site will
stimulate tiny nerve endings and help
reduce discomfort when the needle
goes in. Hands should be washed and
the injection site swabbed with
disinfectant (for example
chlorohexidine 0.5%) to remove any
surface bacteria. Clean about two
inches around the point where the
needle will go in and let the
disinfectant dry for at least one
minute before proceeding.
Step 4 - Inserting the needle
The needle should be inserted at the
base of the pinched-up skin at an
angle of 45° to the skin surface (i).
Step 5 - Checking the correct
needle position
If the needle position is correct the
plunger should be quite difficult to
draw back. Any blood sucked back
into the syringe means that the
needle tip has entered a vein or
artery. If this happens pull out the
syringe, cover the injection site with a
swab containing disinfectant and
apply pressure; the site will stop
bleeding in a minute or two. Do not
use this solution but flush it away.
Start again with Step 1 using a new
needle and new ampoules of Pregnyl
and sodium chloride solution.
Step 6 - Injecting the solution
Depress the syringe plunger slowly
and steadily, so the solution is
correctly injected and the muscle or
skin tissues are not damaged.
Step 7 - Removing the syringe
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 Pregnyl solution and relieve any
discomfort. Any remaining solution
should be discarded. Do not mix
Pregnyl solution with any other
medicines.
Step 8 - Disposing of needles
Replace the needle guard on the
syringe to prevent injury.
Carefully dispose of any needles that
you use. You can dispose of needles
in a ‘sharps bin’, or take them to your
local pharmacy for disposal. Do not
share your needles or syringes.
Always take Pregnyl exactly as
your doctor has told you. Check
with your doctor or pharmacist if you
are still not sure.
If you take more Pregnyl than you
should
As your doctor will be keeping a close
eye on you it is unlikely you will be
given too much, however too high a
dose of Pregnyl may cause
hyperstimulation of the ovaries. This
may be noticed as pain in the
abdomen. See section on Possible
side effects below. If you are troubled
by stomach pains, tell your doctor
immediately.
If you accidentally use too much
Pregnyl contact your doctor at once
or go to the nearest hospital casualty
department. Always take the labelled
medicine package with you, whether
there is any Pregnyl left or not.
If you forget to take Pregnyl
If you forget to take a dose do not
take a double dose to make up for
a missed dose.

Contact your doctor.
If you stop taking Pregnyl
Do not stop taking Pregnyl unless
your doctor tells you to. Your doctor

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will advise you if you need to stop
using Pregnyl for any reason.
If you have any further questions on
how to take Pregnyl, ask your doctor
or pharmacist.
4. Possible side effects
Like all medicines, Pregnyl can cause
side effects, although not everybody
gets them.
Serious side effects: tell a doctor
straight away
If you have an allergic reaction to
Pregnyl see a doctor straight away
• Pregnyl may cause reactions at
the site of injection, such as
bruising, pain, redness, swelling
and rashes at the injection site.
• more widespread rash and fever
may occur.
Contact a doctor immediately if you
are a woman and experience:
Severe pain in the abdomen, feeling
sick (nausea), diarrhoea, painful
breasts, also if it occurs a few days
after you receive your last injection,
since it could be a sign of unwanted
overstimulation of the ovaries (OHSS).
If you are a woman:
If your ovaries have been excessively
stimulated by an FSH-containing
preparation and Pregnyl is given, it
may lead to unwanted
overstimulation of the ovaries. This
condition (also called OHSS) can
become very serious, but the risk can
be minimised by careful monitoring of
egg cell development during
treatment. The first symptoms of
ovarian overstimulation may be
noticed as pain in the stomach
(abdomen), feeling sick (nausea) or
diarrhoea. In more severe cases
symptoms may include enlargement
of the ovaries, accumulation of fluid in
the abdomen and/or chest, weight
gain and the occurrence of blood
clots in the circulation.
 Contact your doctor without
delay if you are experiencing
significant abdominal pain, also if
this occurs some days after the
last injection has been given. The
following side effects might be the
result of OHSS:
• pain in the stomach (abdomen),
• feeling sick (nausea)
• diarrhoea
• bloating
• ovarian cysts or enlargement of
the ovaries
• painful breasts
• palpable ovarian cysts
• accumulation of fluid in the
abdomen and/ or chest
• blood clots
• ovarian cysts prone to rupture
• weight gain
If you are a man:
• fluid may be retained in the tissues,
usually marked by swelling of
ankles or feet, and occasionally
enlargement of the breast may
occur. This can be caused by an
increased androgen production by
treatment with hCG.
 If any of these signs appear, tell
your doctor immediately.

Other possible side effects
• acne (in men)
• fluid retention
• headache
• tiredness
• mood changes
 If you notice any side effects not
mentioned in this leaflet, please
inform your doctor or pharmacist.
If any of the side effects gets
serious, or if you notice any side
effects not listed in this leaflet,
please tell your doctor or
pharmacist.
5. How to store Pregnyl
Keep out of the reach and sight of
children.
Pregnyl should be stored at
2 to 8°C.
Do not freeze.
Keep the ampoules in the outer
container to protect from light.
Do not use Pregnyl after the expiry
date which is stamped on the pack.
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 Pregnyl contains
Each ampoule contains 1500 I.U. of
the active ingredient Human Chorionic
Gonadotrophin.
The other ingredients are carmellose
sodium, mannitol (E421), disodium
phosphate (anhydrous), sodium
dihydrogen phosphate (anhydrous).
The solvent contains sodium chloride
(9 mg) and water for injections.
What Pregnyl looks like and
contents of the pack
Pregnyl comes as 2 ml ampoules of
dry white powder with 1 ml ampoule
of solvent (sodium chloride solution).
Pregnyl 1500 I.U. is available in packs
of 1, 3, 5 or 10 ampoules of powder
and solvent. Not all pack sizes may be
marketed.
Marketing Authorisation Holder
Merck Sharp & Dohme Limited,
Hertford Road, Hoddesdon,
Hertfordshire, EN11 9BU, UK
Manufacturer
N.V. Organon, Oss, The Netherlands.
This leaflet was last updated in
07/2013
In correspondence please quote
packing number.
To listen to or request a copy of this
leaflet in Braille, large print or audio
please call, free of charge:
0800 198 5000 (UK Only)
Please be ready to give the following
information:
Product name: Pregnyl 1500 I.U.
Reference Number:
PL 00025/0555
This is a service provided by the Royal
National Institute of Blind people.

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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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