Choriomon is indicated when the function of the gonads has to be activated; its therapeutic therapeutic
success depends on the functional capacity of the gonads. Cases of gonadotropins hypersecretion,
which is a sign of irreversible primary gonadal insufficiency, do not respond to Choriomon.
In women
Induction of ovulation after a treatment with HMG (human Menopausal Gonadotropin, Menotropin)
intended for the maturation of the follicle; or after a treatment with FSH
(Follicle Stimulating Hormone, Urofollitropin) in the following cases of functional sterility;
• Primary amenorrhoea
• Chronic secondary amenorrhoea
• Chronic anovulation.
Moreover, Choriomon is indicated in the treatment of sterility due to shortening of the luteal phase of the
cycle, since it induces a delay in the onset of the bleeding, it prolongs the mature phase of the corpus
luteum, and thus the most favourable conditions for nidation.
In patients suffering from chronic amenorrhoea or chronic anovulation a treatment with hMG (FSH)/HCG
is indicated only when a previous progesterone test has given a negative result or when reiterated
treatments with ovulation stimulators such as Clomiphene, Cyclofenyl remained unsuccessful.
In children and men
Cryptorchidism; hypogonadotropic hypogonadism, and delayed puberty. A treatment of cryptorchidism
with Choriomon is likely to prove successful only in the absence of primary congenital testicular lesions
and if the inguinal canal is open. In case of hypogonadotropic hypogonadism Choriomon is especially
indicated for hypogonadotropic eunuchoidism due to functional deficiency ofthe diencephalohypophysial
system, in which the testicular tissues remains at the prepuberal stage of development.
CHORIOMON 5’000 IU
Powder and solvent for solution for injection 1.3.1
Ed.2019-001 2
Combination with menopausal gonadotropin (hMG) also stimulates the tubal function of the testicles with
the possibility to improve fertility.

Do not use CHORIOMON if you:
 are allergic to the active substance or any of the other ingredients of this medicine (listed in section
6)
 have known or suspected pituitary disorder (tumour)
 have untreated diseases involving thyroid, pituitary or adrenal glands
 have ovarian, womb or breast cancer or any tumour that grows as a result of hormonal stimulation
(i.e. hormone-dependent cancer)
 have a condition that makes a normal pregnancy impossible, e.g. ovarian failure, absence of a
uterus, premature menopause, fallopian tube obstruction, fibroids in the womb or other
abnormalities of the reproductive organs
 have recently had unexplained vaginal bleeding.
Tell your doctor or pharmacist if you have any of the above because this medicine might not be the right
medicine for you.
Warnings and precautions
Before the treatment, your doctor should have checked that your reproductive organs are normal.
In women
• pregnancy;
• sterility without attainment of a normal follicle maturation (e.g.: of tubal or cervical origin);
• ovarian cysts not related with polycystic ovarian syndrome;
• uterine bleeding of unknown etiology;
• hyperprolactinemia;
• ovarian, endometrium or breast carcinoma.
In men
• infertility unrelated to hypogonadotropic hypo gonadism;
• androgenic tumors, such as prostate or breast carcinoma.
In both sexes
Known hypersensitivity to HCG or to other gonadotropins (hMG, FSH), hyperprolactinemia, pituitary
gland tumor, thyroid or adrenal endo-crinopathy which are not being treated.
A treatment with gonadotropic hormones should only be performed by a specialist physician, with
experience in the diagnosis and the treatment of fertility problems.
The treatment should be started only when other infertility causes have been discarded (mechanical,
immunological or androgenic).
In women
Choriomon must only be administered after the age of sexual maturity, since before puberty it could
induce undesirable stimulation of the ovaries.
On the other hand, after the menopause the ovaries are no longer sensitive to gonadotropins. Before
starting the treatment with HMG (FSH)/HCG the patient must undergo a gynaecological and
endocrinological examination.
The partner's fertility must be assessed and both the patient and her partner must be informed that the
treatment involves the risk of ovarian hyperstimulation, as well as the risk of a multiple pregnancy or
spontaneous abortion.
The treatment must take place in a hospital suitably equipped. Ovarian hyperstimulation occurs in 5-6%
of the patients treated with gonadotropic hormones, mostly 7 to 1 0 days after the administration of HCG.

The risk of hyperstimulation is particularly high in patients with polycystic ovaries (chronic
hyperandrogenic anovulation).
The therapeutic gap between a sufficient dosage and hyperstimulation is very limited. In order to reduce
the risk of hyperstimulation, the patient must undergo a clinical and endocrinological examination at least
every two days during the course of treatment and during 2 weeks after the end of treatment.
The treatment with HMG (or FSH) must be immediately discontinued in the following cases:
If the hormone concentration shows an excessive oestrogen reaction (plasmatic oestradiol+ 100% in 2-3
days and/or a rate> 4 pMol/ml ~ > 11 00 pg/ml), if clinical or ultrasonographic symptoms of an ovarian
hyperstimulation should occur (diameter of one or several follicles> 22 mm).
An injection of hCG is strictly contraindicated in such courses of treatment. Ovarian hyperstimulation is
featured by a substantial increase of the vascular permeation that provokes a rapid accumulation of
fluids in the peritoneal cavity, in the thorax and in the pericardium.
In most cases, it appears 5 to 1 0 days after the administration of HCG. There are three degrees of
severity: mild moderate and severe. In case of mild hyperstimulation (Grade I) accompanied by slight
ovaries swelling (size 5 to 7 em), as well as by excessive secretion of steroids and abdominal pain, a
therapy is not necessary, but the patient should be informed and kept under strict control.
In case of moderate hyperstimulation (Grade II) accompanied by ovarian cysts (size of the ovaries 8 to 10
em), as well as abdominal discomfort, nausea and vomiting, a clinical observation and a symptomatic
treatment are recommended. In case of high blood concentration, an intravenous plasma substitution is
also indicated. A severe hyperstimulation (Grade Ill, frequency< 2%), characterized by oversized ovarian
cysts (size of the ovaries > 12 em), as well as by ascites, hydrothorax, substantial abdominal relaxation,
abdominal pain, dyspnea, salt retention, blood concentration, increase of blood viscosity and platelets
aggregation, may endanger the patient's life and require a treatment in a hospital in order to steady the
vital functions and normalize the plasma volume, the renal perfusion and the e lectrolytes balance.
Cysts of the ovaries may form in patients suffering from amenorrhoea due to SteinLeventhal syndrome.
This may provoke abdominal pain of various intensity and require the interruption of the treatment.
Multiple pregnancies occur in roughly 20% of patients treated with gonadotropins. In most cases, the
multiple conception results in twins. The risk of multiple pregnancies during a medically assisted
procreation process is related to the number of oocytes or embryos replaced. The rate of spontaneous
abortion is higher than in normal pregnancies, but it is comparable to that observed in women with
fertility problems.
The risk of extra-uterine pregnancies is higher, especially in subjects with previous tubal pathologies.
In men
In patients suffering from Klinefelter syndrome, which is accompanied by an increased urinary excretion
of gonadotropins, the treatment with Choriomon is unsuccessful. During a treatment of hypogonadism
and hypogonadotropic eunuchoidism, especially in young subjects, a clinical and endocrinological
examination must be carried out, to avoid an excessive development of the gonads. The treatment must be
discontinued if symptoms of a premature puberty should appear. In order to avoid a possible
desensitization of Leydig's cells following a treatment with HCG, the testosterone level must be
controlled during the whole course of treatment and the posology must be adapted to that level.
Other medicines and CHORIOMON
No interactions with other drugs have been reported so far.

Pregnancy and breastfeeding
Pregnancy category C: no controlled studies in animals and in pregnant women are available. The
administration of HCG at the early stage of pregnancy due to luteal insufficiency as well as afterfollicle
ponction and embryo transfer, support the development of the endometrium in the periimplantation phase.
There are no indications for HCG beyond this usage. It is not known whether HCG penetrates into the
milk and which could be the effects on breast-fed babies. This drug has no indications concerning breastfeeding
women.
Driving and using machines
CHORIOMON does not alter your ability to drive vehicles or use machines.
CHORIOMON 5’000 IU
Powder and solvent for solution for injection 1.3.1
Ed.2019-001 4
CHORIOMON contains lactose
If you are allergic or suspected to be allergic to cow’s milk, you must not receive this medicine as it may
contain trace amounts of cow’s milk proteins

Choriomon must always be injected intramuscularly or subcutaneously. The aqueous
solution of gonadotropins has a limited shelf-life.
Consequently, the solution of Choriomon in the solvent should be prepared directly before the injection.
Unused solutions must be discarded.
How CHORIOMON should be given:
In women
Primary amenorrhoea, chronic secondary amenorrhoea, and chronic anovulation:
If the genital organs are markedly underdeveloped, it is necessary to start with a preliminary
treatment, lasting several months, with an oestrogen-progestogen combination in order to stimulate the
growth and vascularization of the uterus, the Fallopian tubes and the vagina. The administration of
gonadotropins is carried out in two phases;
1st phase:
Daily intramuscular or subcutaneous injection of menopausal gonadotropin (HMG) at a dose of 75 I.U.
during 7-12 days, until the increase of oestrogens, the ultrasonography and the changes in the cervical
factor indicate the presence of a ripe follicle (plasmatic oestradiol1.1 -2.9 pMol/ml ~ 300-800 pg/ml;
diameter of the main follicle 18-22 mm; cervical score according to lnsler > 8 point out of 12).
2nd phase:
In order to induce ovulation, a single dose of 5,000 to 10,000 I.U. of Choriomon i.m. or s.c. must be
administered, 24 to 48 hours after the last hMG (or FSH) administration.
Ovulation generally occurs after 32 to 48 hours.
The patient will be recommended to have sexual intercourse& every day from the day
before the administration of Choriomon and until the ovulation takes place.
If pregnancy does not occur, the treatment may be repeated, following the same method. For more details,
it is recommended to refer to the "Information for physicians" of an HMG or FSH preparation.
Sterility due to the shortening of the luteal phase of the cycle: 5000 I.U. of Choriomon i.m. or s.c. on the
21st, 23rd and 25th day of the cycle.
In children and men
Cryptorchidism:
The treatment should be given before the age of two years, as after this age the physiologically abnormal
position of the testicle can lead to irreversible lesions, which become more serious with time. On the other
hand, it is unadvisable to start a hormonal therapy in newborn babies before the age of three months,
because the spontaneous descent of the testicles is still possible.
The recommended duration of the treatment is of 5 weeks (10 injections) as follows;
-6 to 12 months: 250 or 300 I.U. i.m. or s.c. twice weekly.
- 1 to 6 years: 500* I.U. i.m. or s.c. twice weekly
-Over 6 years: 1000 I.U. i.m. or s.c. twice weekly
* 1/2 vial of 1000 I.U.
If the treatment proves unsuccessful or only partly successful it may be repeated after 2-3 months (also
after 6 months). If complete success is not obtained after the second course of treatment, surgical
correction will be necessary

Delayed puberty: if puberty has not started by the age of 15 years, the process of maturation of the
gonads may be stimulated by a course of treatment with Choriomon, which induces the onset of puberty
and the development of the physical characteristics of maturity.
Dosage: 1000 I.U. i.m. or s.c. twice weekly for 8-12 weeks. The treatment may be repeated, if necessary,
after 3 months.
Hypogonadotropic hypogonadism:
Usually, the treatment starts with a dosage of 500 to 1000 I.U. of Choriomon i.m. or s.c. every 2 days for
4-6 weeks, in order to bring Leydig's cells to full ripeness. Subsequently, 500 I.U. of Choriomon i.m. or
s.c. are administered in concomitance with 75 I.U. of
FSH, twice or three t imes weekly for 3 months or more. In order to monitor the response to the treatment,
a spermiogram is carried out at least once a month. In certain cases, once the spermatogenesis is induced,
it is possible to continue the treatment with Choriomon alone, at a dosage of 5000 I.U. weekly. if sterility
is acknowleged in case of secondary hypogonadism, it is advisable to resort to alternative therapies
with the administration of an androgen, in order to establish and maintain a virile habitus.
After suitable advice and training your doctor may ask you to inject CHORIOMON yourself.
For the first time, your doctor must:
 have explained how to prepare the right dose of injection
 have shown you how to prepare the solution for injection
 have shown you the possible places where you can inject yourself
 let you practise giving yourself a subcutaneous injection.
Before injecting CHORIOMON yourself, read the following instructions carefully.
How to prepare CHORIOMON using 1 vial of powder
The solution must be prepared just before injection. Each vial is for single use only.
CHORIOMON must only be made up with the solvent provided in the pack.
Use a clean surface and wash your hands before the solution is made up. It is important that your hands
and the items you use are as clean as possible.
Set out all the following items on the clean surface:
- two cotton wool alcohol swabs (not provided in the pack)
- one vial containing CHORIOMON powder
- one solvent in a glass container called an ampoule
- one syringe (not provided in the pack)
- one long needle for the reconstitution and for the intramuscular injection (not provided in the pack)
- one fine bore needle for the subcutaneous injection (not provided in the pack).
A B
1. Gently flick the top of the ampoule to dislodge any liquid remaining
in the tip.
 Hold the ampoule with the coloured dot facing away from you
(A) and snap off the top of the ampoule as shown in the picture
(B). Using a cloth or ampoule-snapper to hold the ampoule will
help protect your fingers.
 Carefully place the opened ampoule upright on the cleaned
surface.
 Remove the protective cap of the reconstitution needle (long needle) and attach to the syringe.
 With the syringe in one hand, pick up the opened solvent
ampoule, insert the needle into the ampoule and draw up all the
solvent into the syringe.
 Attach the protective cap of the needle and carefully set the
syringe down on the surface.
2. Remove the coloured plastic from the powder vial by gently
pushing it upwards. Disinfect the top of the rubber stopper by wiping it
with an alcohol swab and allow to dry.
3. Pick up the syringe, remove the long needle shield and push the
needle through the middle of the top of the rubber stopper.
 Press the plunger down firmly to squirt all the solution into the
vial containing the powder.
 DO NOT SHAKE, gently roll the vial between the hands until
the powder is completely dissolved, taking care to avoid creating
foam.
4. Once the powder is dissolved (which, in general, occurs
immediately), slowly draw the solution into the syringe as described
below:
 With the needle still inserted, turn the vial upside down.
 Make sure the needle tip is underneath the level of the liquid.
 Gently pull the plunger to draw all the solution up into the
syringe.

Check that the reconstituted solution is clear and colourless.
Preparation of higher doses, using more than 1 vial of powder
If your doctor has recommended the 10’000 IU higher dose for you, this can be achieved by using two
vials of powder with one ampoule of solvent.
When making up 2 vials of CHORIOMON, at the end of step 4 above, draw the made-up contents of the
first vial back into the syringe and slowly inject into the second vial of powder. Repeat steps 2 to 4 for
the second vial.
The solution must be clear and colourless.
Injecting your medicine subcutaneously
 When the syringe contains the correct dose for you, attach the protective cap of
the needle. Remove the needle from the syringe and replace it with the fine bore
needle for subcutaneous injection with its protective cap attached.
 Push the fine bore needle firmly onto the syringe barrel, then twist it slightly to
ensure it is fully screwed on, to create a firm seal.
 Remove the protective cap of the needle. Hold the syringe with the needle
pointing upwards and gently tap the side of the syringe to force any air bubbles up

 Push the plunger until a bead of liquid appears at the tip of the needle.
 DO NOT USE the solution if it contains any particles or is cloudy.
The injection site:
 Your doctor or nurse will have already advised you, where on your body to inject
the medicine. The usual places are the thigh or the lower abdominal wall (stomach
area), below the navel.
 Wipe the injection site with an alcohol swab.

Firmly pinch the skin together. With the other hand, insert the needle with a
dart-like motion at an angle of 45° or 90°.
Injecting the solution:
 Inject under the skin as shown by your doctor.
 Do not inject directly into a vein.
 Push the plunger slowly and steadily, so the solution is correctly injected and the skin tissues are
not damaged.
Take as much time as you need to inject the volume of solution prescribed. Depending on the dosage
prescribed by your doctor, you may not use the entire volume of the solution.
Removing the needle:
 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
CHORIOMON solution and relieve any discomfort.
Injecting your medicine intramuscularly:
For intramuscular injections your doctor or nurse will prepare and then inject CHORIOMON into the side
of your thigh or buttock.
Dispose of all used items:
Once you have finished your injection, all the needles and empty syringes should be disposed of in an
appropriate container. Any unused solution or waste material should be disposed of in accordance with
local requirements.
If you use more CHORIOMON than you should:
The effects of an overdose of CHORIOMON are unknown, nevertheless, one could expect ovarian
hyperstimulation syndrome to occur (see ‘Possible side effects’). If you use more CHORIOMON than
you should, speak to your doctor or pharmacist.
If you forget to use CHORIOMON:
Take it at the next normal time for an injection. Do not take double dose to make up for a forgotten dose.
If you stop using CHORIOMON:
Do not stop on your own initiative: Always consult your doctor if you are considering stopping this
medicine.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

In rare cases the following side effects occurred: headache, irritability, tiredness, restlessness,
depression and pain on the injection site. Allergic reactions to chorionic gonadotropin have been
observed.
Occasionally, reiterated treatments with HCG may cause the formation of antibodies and can also be
the cause of therapeutic failure.
In men, the androgenic effect of high doses of Choriomon can cause oedemas. In such cases, but
especially in patients suffering from latent cardiac insufficiency, hypertension and migraine (as
reported in t he anamnesis), asthma or epilepsy, Choriomon should be administered cautiously and
only at low doses.
All severe complications occurring during a treatment with gonadotropins are generally due to ovarian
hyperstimulation (in women) and are androgenic (in men). Arterial thromboembolism and peripheral
and cerebral vascular occlusions (e.g. embolia, lung infarctus, cerebral ictus) have been associated
with HMG/HCG treatment only in rare cases, also not related to ovarian hyperstimulation.
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 the national
reporting system

 Saudi Arabia:
The National Pharmacovigilance and Drug Safety Centre (NPC)
o SFDA Call Center: 19999
o E-mail: npc.drug@sfda.gov.sa
o Website: www.sfda.gov.sa/npc


 Other GCC States:
Please contact the relevant competent authority.

Keep this medicine out of the sight and reach of children.
Do not store above 25°C. Store this medicine in the original carton in order to protect from light.
Use immediately after making up the solution.
CHORIOMON 5’000 IU
Powder and solvent for solution for injection 1.3.1
Ed.2019-001 9
Do not use this medicine after the expiry date which is stated on the outer carton, the vial and the ampoule
of solvent. The expiry date refers to the last day of the month.
Do not use CHORIOMON if you notice the solution does not look clear. After being made up the solution
must be clear and colourless.
Do not throw away any medicines via wastewater. Ask your pharmacist how to throw away medicines
you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What CHORIOMON contains
Choriomon 5000:
1 vial of lyophilized substance 5000 I.U. and
1 ampoule of solvent.
Choriomon 5000:
3 vials of lyophilized s ubstance 5000 I.U. and 1 3 ampoules of solvent.
Choriomon 5000:
10 vials of lyophilized s ubstance 5000 I.U. and
1 0 ampoules of solvent.
NOT ALL PACKS MAY BE MARKETED
What CHORIOMON looks like and contents of the pack
CHORIOMON is presented as a powder and a solvent
Powder: white to almost white lyophilized powder
Solvent: clear and colourless solution.
1 pack contains the following:
 One vial containing a white to almost white powder
 One ampoule (1 ml) containing a clear and colourless solution.
The product is packaged in secondary packaging along with instructions for use.
Marketing Authorisation Holder:
IBSA Institut Biochimique S.A., 6903 Lugano (Switzerland)
Manufacturer(s):
IBSA Institut Biochimique S.A., Via Cantonale – Zona Serta - 6814 Lamone (Switzerland)
This leaflet was last revised in: December 2020.
This is a Medicament
Medicament is a product which affects your health and its consumption contrary to
Instructions is dangerous for you.
 Follow strictly the doctor’s prescription, the method of use and the instructions of the
Pharmacist who sold the medicament.
The doctor and the pharmacist are the experts in medicines, their benefits and risks.
Do not by yourself interrupt the period of treatment prescribed for you.
Do not repeat the same prescription without consulting your doctor.
Keep all medicaments out of reach of children

CHORIOMON 5’000 IU
Powder and solvent for solution for injection