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Technical Info



Pregnyl® 5000 I.U.
powder for solution for injection
(Human Chorionic Gonadotrophin)
Pregnyl ® 5000 I.U.powder for solution
for injection.
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)
An ampoule contains 5000 I.U. hCG.
For a full list of excipients, see
section 6.1.
Powder for solution for injection. The
powder is a white, dry powder or cake.
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
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
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
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.

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.
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

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.

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
§ Breast, uterine, ovarian tumours.
§ Vaginal bleeding of unknown
§ 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
§ 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
• 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
The incidence of congenital
malformations after Assisted
Reproductive Technologies
(ART) may be higher than after

Package Leaflet; Information for user

Pregnyl® 5000 I.U.
powder for solution for injection
(Human Chorionic Gonadotrophin)

BS 12_234
160 x 600

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.

4.3 Contraindications

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

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 signs of illness 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 this leaflet.
See section 4.
What is in this leaflet
1. What Pregnyl is and what it is used
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

Method of Administration

In the male
Hypogonadotrophic hypogonadism.
500–1,000 IU hCG 2-3 times weekly.

Sterility in selected cases of deficient
Usually, 3,000 IU hCG per week in
combination with an FSH or HMG

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.

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.
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).
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.

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
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
Being pregnant increases the chance of
having a blood clot.
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).

2. What you need to know before
you use 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
• 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.
Warnings and precautions
Medicines are not always suitable for
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.

3. How to use Pregnyl
Always take this medicine exactly as
described in this leaflet or as your
doctor or pharmacist 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:
Patients undergoing ovulation
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.
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
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.

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
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
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.

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).

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).






Technical Info


Pregnyl should not be used for body
weight reduction. HCG has no effect
on fat metabolism, fat distribution or
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

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.

Reproduction system and breast
HCG treatment may sporadically cause

5.3 Preclinical safety data

Skin and subcutaneous tissue
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,
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”).

Not applicable.

5.1 Pharmacodynamic properties

4.7 Effects on ability to drive and
use machines

Pharmacotherapeutic group:
gonadotrophins: ATC code G03G A01

As far as known Pregnyl has no
influence on the ability to drive and
use machines.

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).

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
Psychiatric disorders
Mood changes.
In the female
Reproductive system and breast
Unwanted ovarian hyperstimulation,
mild or severe ovarian
hyperstimulation syndrome
(OHSS, see section 4.4):
Mild OHSS:
Painful breasts
Mild to moderate enlargement of
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
Weight gain
In rare instances, thromboembolism
has been associated with FSH/hCG

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
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
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
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.

BS 12_234
160 x 600

was higher with the IM route than
with the SC route and lower in obese
women than in non-obese women.

4.6 Pregnancy and lactation

4.8 Undesirable effects


Not all symptoms described are
always associated to OHSS.
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

Because HCG is of human origin, no
antibody formation is to be expected.
5.2 Pharmacokinetic properties

HCG is approximately 80 per cent
metabolized, predominantly in the
On basis of the recommended dose
regimens and elimination half-life,
accumulation is not expected to occur.
There are no preclinical data of
relevance to the prescriber which are
additional to that already included in
other sections of the SPC.
6.1 List of excipients
Powder for injection contains:
Carmellose sodium
Mannitol (E421)
Disodium phosphate (anhydrous)
Sodium dihydrogen phosphate
6.2 Incompatibilities
In the absence of compatibility
studies, this medicinal product must
not be mixed with other medicinal
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
2ml ampoule containing freezedried powder with 1ml ampoule of
solvent (sodium chloride 9mg/ml).
Pregnyl is available in packs of 1, 3 or
10 ampoules of powder and solvent.
Not all pack sizes may be marketed.
In correspondence please quote batch
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.

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.

Any unused product or waste material
should be disposed of in accordance
with local requirements.

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

PL 00025/0556

Merck Sharp & Dohme Limited
Hertford Road Hoddesdon
24th February 1991/25th March 2003
July 2015
Prescription Only Medicine
SPC.PRG.5000. 14.UK.4429 –IB QRD
© Merck Sharp & Dohme Limited 2015.
All rights reserved.

under the skin

4. Possible side effects
Like all medicines, this medicine
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
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 (see details
below). By reporting side effects you
can help provide more information on
the safety of this medicine.
United Kingdom: Yellow Card Scheme
Malta: ADR Reporting at:
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
container 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
What Pregnyl contains
Each ampoule contains 5000 I.U. of
the active ingredient Human Chorionic
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 5000 I.U. is available in packs
of 1, 3 or 10 ampoules of powder and
solvent. Not all pack sizes may be
Marketing Authorisation Holder
and Manufacturer
Marketing Authorisation Holder
Merck Sharp & Dohme Limited,
Hertford Road, Hoddesdon,
Hertfordshire, EN11 9BU, UK
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
Product name: Pregnyl 5000 I.U.
Reference Number: PL 00025/0556
This is a service provided by the Royal
National Institute of Blind people.
PIL.PRG. 5000.14. UK.4430 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.