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PREGNYL 1500 IU POWDER FOR SOLUTION FOR INJECTION

Active substance(s): CHORIONIC GONADOTROPHIN

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11022
150915-2
402
487796A02

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Cyan

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Technical Info

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11022/150915-2

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
Posology
In the female
Sterility due to the absence of
follicle-ripening 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.
Delayed puberty associated with
insufficient gonadotrophic pituitary
function.
1,500 IU hCG twice weekly for at least
6 months.
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 listed in section 6.1.
§ Presence of uncontrolled
non-gonadal 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 pre-ovulatory
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
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.

Package Leaflet: Information for user

Pregnyl® 1500 I.U.
powder for solution for injection
(Human Chorionic Gonadotrophin)
Read all of this leaflet carefully
before you start taking 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, pharmacist or nurse.
• 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 you get any side effects, talk to
your doctor, pharmacist or nurse. This
includes any possible side effects not
listed in the 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
take 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 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. What you need to know before
you take Pregnyl
Do not use Pregnyl if you:
• are allergic (hypersensitive) to
Human Chorionic Gonadotrophin
(HCG) or any of the other ingredients
of this medicine (listed in section 6).
• have a thyroid, adrenal or pituitary
illness which is not being treated
• have cancer, (especially a hormonedependent 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.
Warnings and precautions
Medicines are not always suitable for
everyone.
Talk to your doctor before using 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.
Children and adolescents
Pregnyl should be used carefully when
treating boys who have not reached
puberty. This is because it can cause
early sexual development and may result
in final adult height not being reached.

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Other Medicines and Pregnyl
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.
 Tell your doctor or pharmacist if you
are taking or have recently taken any
other medicines, including medicines
obtained without a prescription.
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.
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.
Being pregnant increases the chance of
having a blood clot.
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).

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).

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

3. How to use Pregnyl
Always take this medicine exactly as
described in this leaflet or as your doctor
or pharmacist or nurse has told you.
Check with your doctor, pharmacist or
nurse if you are not sure.
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.
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 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.

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

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 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).

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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 Fertility, 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
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
Not all symptoms described are
always associated to OHSS.

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.
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 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, this medicine can cause
side effects, although not everybody gets
them.

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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.

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.

Reproduction system and breast
disorders
HCG treatment may sporadically cause
gynaecomastia.

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

Skin and subcutaneous tissue
disorders
Acne may occur occasionally during
hCG therapy.
Reporting of suspect adverse reactions
Reporting suspect adverse reactions
after authorisation of the medicinal
product is important. It allows
continued monitoring of the benefit/risk
balance of the medicinal product.
Healthcare professionals are asked
to report any suspect adverse
reactions via the Yellow Card Scheme,
at www.mhra.gov.uk/yellowcard.
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 half-lives 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 and lower in obese
women than in non-obese women.

5.3 Preclinical safety data

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 in refrigerator (2°C 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 2015
11. LEGAL CATEGORY
Prescription Only Medicine
SPC.PRG.1500.14.UK.4427-IB-QRD
© Merck Sharp & Dohme Limited 2015.
All rights reserved.

under the skin

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
Reporting of side effects
If you get any side effects, talk to your
doctor, pharmacist or nurse. This includes
any possible side effects not listed in this
leaflet. You can also report side effects
directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard. By reporting
side effects you can help provide more
information on the safety of this medicine.

5. How to store Pregnyl
Keep out of the sight and reach of
children.
Pregnyl should be stored in a refrigerator
(2°C to 8°C).
Do not freeze.
Keep the ampoules in the outer carton in
order to protect from light.
Do not use Pregnyl after the expiry date
which is stated on the carton after EXP.
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 throw
away medicines you no longer use.
These measures will help to protect the
environment.
6. Contents of pack and other
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.
Market Authorisation Holder and
Manufacturer
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
July 2015
Other sources of information
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.
PIL.PRG. 1500.14.UK.4428 IB-QRD
© Merck Sharp & Dohme limited, 2015.
All rights reserved.

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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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