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نشرة الممارس الصحي نشرة معلومات المريض بالعربية نشرة معلومات المريض بالانجليزية صور الدواء بيانات الدواء
  SFDA PIL (Patient Information Leaflet (PIL) are under review by Saudi Food and Drug Authority)

Merional HG is used to promote ovulation in
women who are not ovulating and who have not
responded to other treatment (clomiphene citrate).
Merional HG is used to bring about the
development of several follicles (and therefore
several eggs) in women receiving fertility
treatment.
Merional HG is a highly purifi ed human menopausal
gonadotrophin, belonging to a group of medicines
called gonadotrophins.
Each freeze-dried vial contains 75 IU human follicle
stimulating hormone activity (FSH) and 75 IU human
luteinising hormone activity (LH).
Human Chorionic Gonadotrophin (hCG), a hormone
naturally present in urine of pregnant women, is
added to contribute to the total LH activity.
Each freeze-dried vial contains 150 IU human follicle
stimulating hormone activity (FSH) and 150 IU human
luteinising hormone activity (LH).
Human Chorionic Gonadotrophin (hCG), a hormone
naturally present in urine of pregnant women, is
added to contribute to the total LH activity.
This medicinal product must be used under the
supervision of your doctor.


You and your partner’s fertility will be evaluated
before your treatment is started.
Do not use Merional HG if you have any of the
following:
Enlarged ovaries or cysts not caused by a hormonal
disorder (polycystic ovarian disease).
Bleeding of unknown cause.
Cancer of the ovaries, uterus or breast.
Abnormal swelling (tumour) of the pituitary gland
or hypothalamus (brain).
Hypersensitivity (allergy) to Menotrophin or any of
the ingredients in Merional HG

This medicine should not be used if you have an early
menopause, a malformation of the sexual organs
or certain tumours of the womb that would make a
normal pregnancy impossible.
Warnings and Precautions
Although no allergic reactions to Merional HG have
yet been reported, you should tell your doctor if you
have an allergic reaction to similar medicines.
This treatment increases your risk of developing
a condition known as ovarian hyperstimulation
syndrome (OHSS) (see possible side effects). If
ovarian hyperstimulation occurs then your treatment
will be stopped and pregnancy will be avoided. The
fi rst signs of ovarian hyperstimulation are pain in the
lower abdominal region as well as nausea (feeling
sick), vomiting and weight gain. If these symptoms
occur you should be examined by your doctor as soon
as possible. In serious, but rare cases, the ovaries
can become enlarged and fl uid can build up in the
abdomen or chest.
The drug used to bring about the fi nal release
of mature eggs (containing human chorionic
gonadotrophin-hCG) can increase the likelihood of
OHSS. It is therefore not advisable to use hCG in
cases where OHSS is developing and you should not
have sexual intercourse even if using a barrier method
of contraception for at least 4 days.
It should be noted that women with fertility problems
have a higher rate of miscarriages than the normal
population.
In patients having treatment to help ovulation, the
occurrence of multiple pregnancies and births is
increased compared to natural conception. However,
this risk can be minimised by using the recommended
dose.
There is a slightly increased risk of extra-uterine
pregnancy (an ectopic pregnancy) in women with
damaged fallopian tubes.
Multiple pregnancies and characteristics of the
parents undergoing fertility treatments (e.g. maternal
age, sperm characteristics) may be associated with an
increased risk of birth defects.
Treatment with Merional HG, just as pregnancy
itself, may increase the chance of having thrombosis.
Thrombosis is the formation of a blood clot in a blood
vessel, most often in the veins of the legs or the lungs.
Please discuss this with your doctor, before starting
treatment, especially:
If you already know you have an increased chance
of having thrombosis.
If you, or anyone in your immediate family, have
ever had a thrombosis.
If you are severely overweight.

Paediatric population
The product is not intended for paediatric use.
Other medicines and Merional HG
Tell your doctor or pharmacist if you are taking
or have recently taken or might take any other
medicines.
Pregnancy, breast-feeding and fertility
Merional HG should not be used if you are pregnant
or breast-feeding.
Driving and using machines
Merional HG has no or negligible infl uence on the
ability to drive and use of machinery. However,
no studies on the effect on ability to drive and use
machines have been performed.


Dosage and duration of the treatment:
Always use this medicine exactly as your doctor has
told you. Check with your doctor if you are not sure.
Women who are not ovulating and are having
irregular periods or no periods at all:
As a general rule, the fi rst injection of one Merional
HG 75 IU vial is given during the fi rst week of the cycle
after spontaneous or induced menses.
Subsequently, Merional HG is injected daily at
the dosage prescribed by the physician and the
treatment will continue until one or more ripe follicle
have developed in the ovary. Your physician will
adjust the Merional HG dosage depending on the
ovarian response, which is determined by clinical
examinations.
As soon as one follicle reaches the required
development stage, the Merional HG treatment will
be withheld, and ovulation will be triggered with
another hormone (chorionic gonadotropin, hCG).
Ovulation generally takes place after 32 to 48 hours.
In this phase of the treatment, fertilization is possible.
You will be advised to have sexual intercourse every
day starting from the day preceding the administration
of hCG. If pregnancy is not achieved in spite of
ovulation, the treatment can be repeated.
Women undergoing ovarian stimulation for multiple
follicular development prior to in vitro fertilisation
or other assisted reproductive techniques:
The aim of this method is to obtain concomitant
multiple follicular development. The treatment will
start on the 2nd or 3rd day of the cycle with injections
of 150-300 IU of Merional HG (1-2 vials of Merional
HG 150 IU). Your physician may decide to administer
higher dosages if required. The injected dosage of
Merional HG is higher than in the method used for
natural fertilization. The continuation of the treatment
is adjusted individually by the physician.
As soon as a suffi cient number of follicles has
developed, the treatment with Merional HG is
withheld and ovulation is triggered by injecting
another hormone (chorionic gonadotropin, hCG).
How Merional HG should be given:
Merional HG is given by injection under your skin
(by the subcutaneous route) or into your muscle
(intramuscular injection).
Each vial should be used only once and the injection
should be used as soon as it is prepared.

After suitable advice and training your doctor may
ask you to inject Merional HG yourself.
For the fi rst time, your doctor must:
let you practise giving yourself a subcutaneous
injection,
have shown you the possible places where you
can inject yourself,
have shown you how to prepare the solution for
injection,
have explained how to prepare the right dose of
injection.
Before injecting Merional HG yourself, read the
following instructions carefully.
How to prepare and inject Merional HG using 1
vial of powder:
the solution must be prepared just before injection.
One vial is for single use only.
The medicinal product must be reconstituted under
aseptic conditions.
Merional HG must only be reconstituted with the
solvent provided in the package.
Prepare a clean surface and wash your hands before
the solution is reconstituted. 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),
one vial containing Merional HG powder,
one solvent in ampoule,
one syringe (not provided),
one needle for preparing the injection (not
provided),
a fi ne bore needle for subcutaneous injection (not
provided).
Reconstitution of the solution for injection using 1
vial of powder
Prepare the solution for injection:
1.
The ampoule neck is specifi cally
designed to break more easily
below the coloured dot. Gently
fl ick the top of the ampoule to
dislodge any liquid remaining in
the tip. Hold the ampoule with
the coloured dot facing away from
you and snap off the top of the
ampoule as shown in the picture.
Using a cloth or ampoule-snapper
to hold the ampoule will help
protect your fi ngers.
Carefully place the opened
ampoule upright on the cleaned
surface.

Remove the protective cap of the needle.
Attach the reconstitution needle (large
needle) to the syringe.
With the syringe in one hand, pick up
the opened solvent ampoule, insert the
needle and draw up all the solvent into
the syringe.
Attach the protective cap of the needle.
Carefully set the syringe down on the
surface.
2.
Remove the coloured plastic cap (75 IU
light green, 150 IU dark green) 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 needle
shield and slowly inject the solvent into
the powder vial through the middle of
the top of the rubber stopper.
Press the plunger down fi rmly to squirt all
the solution onto the powder.
DO NOT SHAKE, but 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:
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 reconstitut

Preparation of higher doses, using more than 1 vial
of powder
If your doctor has recommended higher doses for
you, this can be achieved by using more than one vial
powder with one ampoule of solvent.
When reconstituting more than 1 vial of Merional HG
, at the end of step 4 above, draw the reconstituted
contents of the fi rst vial back into the syringe and
slowly inject into a second vial. Repeat steps 2 to
4 for the second and subsequent vials, and until the
contents of the required number of vials equivalent to
the prescribed dosage are dissolved (within the limit of
the maximum total dosage of 450 IU, corresponding
to a maximum of 6 vials of Merional HG 75 IU or 3
vials of Merional HG 150 IU).
Your doctor may increase your dose by 37.5 IU which
represents half a vial of Merional HG 75 IU.
For this you should reconstitute the contents of the 75
IU vial according to steps 2 to 3 described above and
draw half of this reconstituted solution (0.5 ml) back
into the syringe according to step 4.
In that situation you will have two preparations to be
injected: the fi rst preparation reconstituted in 1 ml
and the second containing 37.5 IU in 0.5 ml.
Both preparations will be injected with their own
syringe according to the following steps.
The solution must be clear and colourless.

Injecting your medicine subcutaneously:
When the syringe contains the
described dose, attach the protective
cap of the needle. Remove the needle
from the syringe and replace it with
the fi ne bore needle for subcutaneous
injection including its protective cap.
Push the fi ne bore needle fi rmly onto
the syringe barrel, then twist it slightly
to ensure it is fully screwed on and to
create a fi rm 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 to the top;
Push the plunger until a bead of liquid
appears at the tip of the needle.
Do not use 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 your medicine. The
usual places are the thigh or the lower abdominal
wall below the navel.
Wipe the injection site with an alcohol swab.

The injection site:
Your doctor or nurse will have already advised you
where on your body to inject your medicine. The
usual places are the thigh or the lower abdominal
wall below the navel.
Wipe the injection site with an alcohol swab.
Inserting the needle:
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 you were shown. 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. As described for the preparation
of the solution, 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 Merional HG solution
and relieve any discomfort.

Injecting your medicine intramuscularly:
For intramuscular injections your healthcare provider
will prepare and then inject Merional HG into the
side of your thigh or buttock.
Dispose of all used items:
Once you have fi nished 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 Merional HG than you should:
The effects of an overdose of Merional HG are
unknown, nevertheless, one could expect ovarian
hyperstimulation syndrome to occur (see Possible
side effects). If you use more Merional HG than you
should, speak to your doctor or pharmacist.
If you forget to use Merional HG :
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 Merional HG :
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.


Like all medicines, Merional HG can cause side
effects, although not everybody gets them.
The following side effect is important and will require
immediate action if you experience it. You should
stop taking Merional HG and see your doctor
immediately if the following occurs:
Common, affects 1 to 10 users in 100:
Ovarian Hyperstimulation Syndrome (symptoms
include ovarian cyst formation or enlargement
of existing cysts, lower stomach pain, feeling
thirsty and sick, and sometimes being sick,
passing reduced quantities of concentrated urine
and weight gain) (see Section 2 for additional
information).
The following side-effects have also been reported:
Very Common (likely to affect up to 1 in 10 users):
Headache
Swollen or bloated stomach
Common (likely to affect between 1 in 100 and 1 in
10 users):
Abdominal pain or discomfort
Pelvic pain
Back pain
Sensation of heaviness
Breast discomfort
Dizziness
Hot fl ushes
Thirst
Feeling sick
Tiredness
Feeling generally unwell
Injection site reaction such as pain and infl ammation
(frequency higher with IM than SC).
Rare, (likely to affect between 1 in 10,000 and 1 in
1000 users):
Ovarian torsion (twisting of the ovary which causes
extreme pain in the lower abdomen)
Very rare, (likely to affect between 1 in 100,000 and 1
in 10,000 users):
Thromboembolism (formation of a clot in a blood

vessel that breaks loose and is carried by the blood
stream to block another vessel).
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 leafl et.
You can also report side effects directly via [the
national reporting system – to be completed
nationally]. By reporting side effects you can help
provide more information on the safety of this
medicine.
To report any side effects:
• Saudi Arabia:
The National Pharmacovigilance and Drug Safety
Centre (NPC)
o Fax: +966-11-205-7662
o Call NPC at +966-11-2038222, Exts: 2317-
2356-2353-2354-2334-2340.
o Toll free phone: 8002490000
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. Keep the vial and the
ampoule of solvent in the outer carton in order to
protect from light.
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.
Use immediately after reconstitution.
Do not use Merional HG if you notice the solution
does not look clear. After reconstitution 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.


The active substance is menotrophin.
Each freeze-dried vial contains 75 IU human follicle
stimulating hormone activity (FSH) and 75 IU human
luteinising hormone activity (LH).
Human Chorionic Gonadotrophin (hCG), an hormone
naturally present in urine of pregnant women, is
added to contribute to the total LH activity.
Each freeze-dried vial contains 150 IU human follicle
stimulating hormone activity (FSH) and 150 IU human
luteinising hormone activity (LH).
Human Chorionic Gonadotrophin (hCG), an hormone
naturally present in urine of pregnant women, is
added to contribute to the total LH activity.
If multiple vials of powder are used, the amount of
menotrophin contained in 1 ml of reconstituted
solution will be as follows:

Merional HG 75 IU
powder and solvent for solution for injection
Number of
vials used
Total amount of menotrophin in 1
ml of solution
1 75 IU
2 150 IU
3 225 IU
4 300 IU
5 375 IU
6 450 IU
Merional HG 150 IU
powder and solvent for solution for injection
Number of
vials used
Total amount of menotrophin in
1 ml of solution
1 150 IU
2 300 IU
3 450 IU
The other excipients are
For the powder: lactose monohydrate.
For the solvent: sodium chloride and water for
injections.


Powder: white to almost white lyophilized powder Solvent: clear and colourless solution. Merional HG is presented as a powder and solvent for solution for injection. 1 set contains the following: One vial containing a white to almost white powder One ampoule (1 ml) containing a clear and colourless solution It comes in pack sizes of 1, 5 or 10 sets. Not all pack sizes may be marketed.

IBSA Institut Biochimique S.A.
Via al Ponte 13
6903 Lugano (Switzerland)


This leafl et was last revised in December 2016
  نشرة الدواء تحت مراجعة الهيئة العامة للغذاء والدواء (اقرأ هذه النشرة بعناية قبل البدء في استخدام هذا المنتج لأنه يحتوي على معلومات مهمة لك)

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 Read this leaflet carefully before you start using this product as it contains important information for you

Merional HG 75 IU Merional HG 150 IU

ch freeze-dried vial contains 75 IU human follicle stimulating hormone activity (FSH) and 75 IU human luteinising hormone activity (LH). Human Chorionic Gonadotrophin (hCG), a hormone naturally present in urine of pregnant women, is added to contribute to the total LH activity. Each freeze-dried vial contains 150 IU human follicle stimulating hormone activity (FSH) and 150 IU human luteinising hormone activity (LH). Human Chorionic Gonadotrophin (hCG), a hormone naturally present in urine of pregnant women, is added to contribute to the total LH activity. For the full list of excipients, see section 6.1.

Powder and solvent for solution for injection. Powder: white to almost white lyophilized powder Solvent: clear and colourless solution.

Ovulation induction: for the induction of ovulation in amenorrhoeic or anovulatory women
who have not responded to treatment with clomiphene citrate .
Controlled ovarian hyperstimulation (COH) within a medically assisted reproduction
technology (ART): induction of multiple follicular development in women undergoing
assisted reproduction techniques such as in vitro fertilization (IVF).
 


Posology
Treatment with MERIONAL HG should be initiated under the supervision of a physician
experienced in the treatment of infertility problems.
There are great inter- and intra-individual variations in the response of the ovaries to
exogenous gonadotrophins. This makes it impossible to set a uniform dosage scheme. The
dosage should, therefore, be adjusted individually depending on the ovarian response. This
requires ultrasonography and may also include monitoring of oestradiol levels.
Females with anovulation:
The objective of a treatment with MERIONAL HG is to develop a single mature de Graaf
follicle from which the ovum will be released after the administration of human chorionic
gonadotrophin (hCG).
MERIONAL HG can be administered by daily injection. In menstruating patients the
treatment should begin within the first 7 days of the menstrual cycle.
A commonly used regimen starts at 75 to 150 IU of FSH per day and is increased if
necessary by 37.5 IU (up to 75 IU), with intervals of 7 or 14 days preferably, in order to
achieve an adequate but not excessive response.
Maximum daily dosages of HMG MERIONAL HG should generally not exceed 225 IU.
The treatment should be adjusted to the individual patient's response, assessed by measuring
the follicle size by ultrasonography and/or oestrogen levels.
The daily dose is then maintained until pre-ovulatory conditions are reached. Usually, 7 to 14
days of treatment is sufficient to reach this state.
The administration of MERIONAL HG is then discontinued and ovulation can be induced by
administering human chorionic gonadotrophin (hCG).

If the number of responding follicles is too high or oestradiol levels increase too rapidly, i.e.
more than a daily doubling for oestradiol for two or three consecutive days, the daily dose
should be decreased. Since follicles of over 14 mm may lead to pregnancies, multiple preovulatory
follicles exceeding 14 mm carry the risk of multiple gestations. In that case hCG
should be withheld and pregnancy should be avoided in order to prevent multiple gestations.
The patient should use a barrier method of contraception or refrain from having coitus until
the next menstrual bleeding has started (see section 4.4). The treatment should recommence
in the next treatment cycle at a lower dose than in the previous cycle.
If a patient fails to adequately respond after 4 weeks of treatment, the cycle should be
abandoned and the patient should recommence at a higher initial dose than in the previous
cycle.
Once the ideal response is obtained, a single injection of 5 000 IU to 10 000 IU of hCG
should be administered 24 to 48 hours after the last MERIONAL HG injection.
The patient is recommended to have coitus on the day of hCG injection and the following
day.

Alternatively, intrauterine insemination may be performed.

Females undergoing ovary stimulation for induction of multiple follicular development
– as part of assisted reproductive technology:
Pituitary down-regulation in order to suppress the endogenous LH peak and to control basal
levels of LH is now commonly achieved by administration of a gonadotrophin releasing
hormone agonist (GnRH agonist) or gonadotrophin releasing hormone antagonist (GnRHAntagonist).
In a commonly used protocol the administration of MERIONAL HG begins approximately
two weeks after the start of the agonist treatment, both treatments are then continued until
adequate follicular development has been achieved. For example, following two weeks of
pituitary down-regulation with agonist, 150 to 225 IU of MERIONAL HG are administered
for the first five-seven days. The dose is then adjusted according to the patient's ovarian
response.
An alternative protocol for controlled ovarian hyperstimulation involves the administration of
150 to 225 IU of MERIONAL HG daily starting on the 2nd or 3rd day of the cycle. The
treatment is continued until sufficient follicular development has been achieved (assessed by
monitoring of serum oestrogen concentrations and/or ultrasound) with the dose adjusted
according to the patient's response (usually not higher than 450 IU daily). Adequate follicular
development is usually achieved on average around the tenth day of treatment (5 to 20 days).
When an optimal response is obtained a single injection of 5 000 IU to 10 000 IU of hCG
administered 24 to 48 hours after the last MERIONAL HG injection, to induce final
follicular maturation.
Oocyte retrieval is performed 34-35 hours later.

Paediatric population
The product is not intended for paediatric use
Method of administration
MERIONAL HG is intended for subcutaneous and intramuscular administration.
The powder should be reconstituted immediately prior to use with the solvent provided.
To prevent painful injections and minimize leakage from the injection site MERIONAL HG
should be slowly administered subcutaneously. The subcutaneous injection site should be
alternated to prevent lipo-atrophy. Any unused solution should be discarded.
Subcutaneous injections can be self-administered by the patient, provided the physician's
instructions and recommendations are strictly followed.


 Hypersensitivity to Menotrophin or to any of the excipients  Ovarian enlargement or cysts not related to polycystic ovarian syndrome  Gynaecological bleeding of unknown cause  Ovarian, uterine or breast carcinoma  Tumours of the hypothalamus or pituitary gland MERIONAL HG is contraindicated when an effective response cannot be achieved, for example:  Primary ovarian failure  Malformations of sexual organs incompatible with pregnancy  Fibroid tumours of the uterus incompatible with pregnancy

Anaphylactic reactions may occur, particularly in patients with known hypersensitivity to
gonadotropins. The first injection of MERIONAL HG should be always performed under
direct medical supervision and in settings with facilities for cardio-pulmonary resuscitation.
The first injection of MERIONAL HG should be performed under direct medical
supervision.
Self-injections of MERIONAL HG should be performed only by motivated, trained and well
informed patients. Prior to self-injections, the patient must be shown how to perform a
subcutaneous injection, showing her where the injection can be given and how to prepare the
solution to be injected.
Before starting the treatment, the couple's infertility should be assessed as appropriate and
putative contraindications for pregnancy evaluated. In particular, patients should be evaluated
for hypothyroidism, adrenocortical deficiency, hyperprolactinemia and pituitary or
hypothalamic tumours, for which appropriate specific treatments are given.
Ovarian hyperstimulation syndrome (OHSS)
Ultrasonographic assessment of follicular development, and determination of oestradiol
levels should be performed prior to treatment and monitored at regular intervals during
treatment. This is particularly important at the beginning of the stimulation (see below).
Apart from the development of a high number of follicles, oestradiol levels may rise very
rapidly, e.g. more than a daily doubling for two or three consecutive days, and possibly
reaching excessively high values. The diagnosis of ovarian hyperstimulation may be
confirmed by ultrasound examination. If this unwanted ovarian hyperstimulation occurs (i.e.
not as part of controlled ovarian hyperstimulation in medically assisted reproduction
programs), the administration of MERIONAL HG should be discontinued. In that case
pregnancy should be avoided and hCG must be withheld, because it may induce, in addition
to multiple ovulation, the ovarian hyperstimulation syndrome (OHSS). Clinical symptoms and
signs of mild ovarian hyperstimulation syndrome are abdominal pain, nausea, diarrhoea, and
mild to moderate enlargement of ovaries and ovarian cysts. In rare cases severe ovarian

hyperstimulation syndrome occurs, which may be life-threatening. This is characterised by
large ovarian cysts (prone to rupture), ascites, often hydrothorax and weight gain. In rare
instances, venous or arterial thromboembolism may occur in association with OHSS (see
section 4.8).
Multiple Pregnancies
In patients undergoing ART procedures the risk of multiple pregnancies is related mainly to
the number of replaced embryos. In patients undergoing a treatment for ovulation induction
the incidence of multiple pregnancies and births is increased as compared to natural
conception. The majority of multiple conceptions are twins. To minimise the risk of multiple
pregnancy, careful monitoring of ovarian response is recommended.
Pregnancy wastage
The incidence of spontaneous miscarriage is higher in patients treated with FSH than in the
general population, but it is comparable to the incidence found in women with other fertility
disorders.
Ectopic pregnancy
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.
Reproductive system neoplasms
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 if treatment with gonadotropins increases the baseline risk
of these tumours in infertile women.
Congenital malformation
The prevalence of congenital malformations after ART may be slightly higher than after
spontaneous conceptions. This is thought to be due to differences in parental characteristics
(e.g. maternal age, sperm characteristics) and multiple pregnancies.
Thromboembolic events
Women with generally recognised risk factors for thromboembolic events, such as 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 gonadotrophin administration need to
be weighed against the risks (see section 4.8).


No drug/drug interaction studies have been conducted for MERIONAL HG in humans.
Although there is no clinical experience, it is expected that the concomitant use of
MERIONAL HG 75-150 IU and clomiphene citrate may enhance the follicular response.
When using GnRH agonist for pituitary desensitisation, a higher dose of MERIONAL HG
75-150 IU may be necessary to achieve adequate follicular response


Pregnancy
MERIONAL HG should not be used during pregnancy “Category X”.
No teratogenic risk has been reported following controlled ovarian stimulation in clinical use
with urinary gonadotrophins. To date, no other relevant epidemiological data are available.
Animal studies do not indicate teratogenic effect.
Lactation
MERIONAL HG should not be used during lactation.
During lactation the secretion of prolactin can entail a poor response to ovarian stimulation.


No studies on the effects on the ability to drive and use machines have been performed.
However, MERIONAL HG is unlikely to have influence on the patient’s performance to
drive and use machines.


The most relevant occurring adverse drug reaction in clinical trials with MERIONAL HG is
(dose-related) ovarian hyperstimulation (OHSS), generally mild with small ovarian
enlargement, abdominal discomfort or pain. Only one case of OHSS was serious.
The most frequent adverse reactions with MERIONAL HG were headache and abdominal
distension as well as nausea, fatigue, dizziness and pain at the injection site
The table below displays the main adverse drug reactions (>1%) in women treated with
MERIONAL HG in clinical trials according to body system and frequency. Within each
frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Within each system organ class, the ADRs are ranked under headings of frequency, most
frequent reactions first, using the following convention:
Very common ( 1/10); common (1/100 to 1/10); uncommon (1/1,000 to 1/100); rare
(1/10,000 to 1/1,000); very rare (1/10,000), not known (cannot be estimated form the
available data).

From published studies, the following adverse reactions have been seen in patients treated
with human menopausal gonadotrophins.
*Severe ovarian hyperstimulation (OHSS) with marked ovarian enlargement and cyst
formation, acute abdominal pain, ascites, pleural effusion, hypovolaemia, shock and
thromboembolic disorders. (See also section 4.4)
* Ovarian torsion, usually in association with severe cases of OHSS
* Rupture of ovarian cysts with intraperitoneal haemorrhage, fatal outcomes of cyst rupture
have been reported.
*Allergic reactions also with generalised symptoms have been reported after treatment with
gonadotrophin containing products. (See also section 4.4)
Local reactions at the site of injection such as pain, redness, bruising, swelling and/or
irritation are expected AE following administration of gonadotrophins.
The frequency of such events are expected to be higher with the intramuscular than with the
subcutaneous administration.

Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is
important. It allows continued monitoring of the benefit/risk balance of the medicinal
product.

To report any side effects:
 Saudi Arabia:
The National Pharmacovigilance and Drug Safety Centre (NPC)
 Fax: +966-11-205-7662
 Call NPC at +966-11-2038222, Exts: 2317-2356-2353-2354-2334-2340.
 Toll free phone: 8002490000
 E-mail: npc.drug@sfda.gov.sa
 Website: www.sfda.gov.sa/npc

 Other GCC States:
Please contact the relevant competent authority.


No data on acute toxicity of Menotrophin in humans is available, but the acute toxicity of
urinary gonadotrophin preparations in animal studies has been shown to be very low. Too
high a dosage of Menotrophin may lead to hyperstimulation of the ovaries (see section 4.4).


Pharmacotherapeutic group: Gonadotrophins.
ATC CODE: G03GA02
The active substance in MERIONAL HG is highly purified human menopausal
gonadotrophin.
The FSH activity in MERIONAL HG is obtained from urine of post-menopausal women; the
LH activity is obtained both from urine of post-menopausal women and urine of pregnant
women. The preparation is standardised to have a FSH/LH activity ratio of approximately 1.
In the ovaries, the FSH-component in HMG induces an increase in the number of growing
follicles and stimulates their development. FSH increases the production of oestradiol in the
granulosa cells by aromatising androgens that originate in the Theca cells under the influence
of the LH-component.


The biological effectiveness of Menotrophin is mainly due to its FSH content. The
pharmacokinetics of Menotrophin following intramuscular or subcutaneous administration

shows great inter-individual variability. According to data collected from the studies
performed with Menotrophin, after a single injection of 300 IU, the maximum serum level of
FSH is reached approximately 19 hours after intramuscular injection and 22 hours after
subcutaneous injection. FSH peak concentrations reached 6.5 ±2.1 IU/L with an AUC0-t of
438.0 ± 124.0 IUxh/L after i.m. administration. After sc administration, Cmax reached 7.5
±2.8 IU/L with an AUC0-t of 485.0 ± 93.5 IUxh/L.
AUC and Cmax levels for LH resulted to be significantly lower in the s.c. group compared to
the i.m group. This result may be due to very low levels detected (close to or below the
detection limits) in both groups and to a great intra- and inter-individual variability.
After that, the serum level decreases by a half-life of approximately 45 hours following
intramuscular administration and 40 hours following subcutaneous administration.
Excretion of Menotrophin, following administration, is predominantly renal.
No pharmacokinetic studies were performed in patients with impaired hepatic or renal
function.


No non-clinical studies have been performed with MERIONAL HG


Powder: lactose monohydrate
Solvent: 0.9 per cent sodium chloride solution


In the absence of compatibility studies, this product must not be mixed with other medicinal
products.


2 years. After reconstitution, immediate use is recommended.

Do not store above 25°C. Keep the vial and the ampoule of solvent in the outer carton, in
order to protect from light.


1 set contains: Powder in a vial (type I glass), sealed with a rubber closure and held in place
with a flip-off cap (aluminium and coloured plastic: 75 IU light green, 150 IU dark green) +
1 ml of solvent in an ampoule (type I glass). Pack size of 1, 5 and 10 sets.
Not all pack sizes may be marketed.


The solution must be prepared just before injection.
Each vial is for single use only. The medicinal product must be reconstituted under aseptic
conditions.
Merional HG must only be reconstituted with the solvent provided in the package.
A clean preparation area should be prepared and hands should first be washed before the
solution is reconstituted.
Set out all the following items on the clean surface:
- two cotton-wool alcohol swabs (not provided)
- one vial containing Merional HG powder
- one solvent in ampoule
- one syringe (not provided)
- one needle for preparing the injection (not provided)
- a fine bore needle for subcutaneous injection (not provided)

Reconstitution of the solution for injection
Open the solvent ampoule containing the clear liquid.
A coloured mark is indicated on the tip of the solvent ampoule:
At this mark the ampoule neck is specifically designed to break more easily. Gently tap the
top of the ampoule to dislodge any liquid which may remain in the tip. Firmly press the
ampoule above the neck and break it while levering up at the coloured mark. Carefully place
the opened ampoule onto the preparation area.
Withdraw the solvent:
Attach the reconstitution needle (long needle) to the syringe. With the syringe in one hand,
hold the previously opened solvent ampoule, place the needle into it and withdraw all the
solvent.
Place the syringe very carefully on the preparation area and avoid touching the needle.

Prepare the solution for injection:
1. Remove the aluminium capsule cover from the vial containing Merional HG
powder and disinfect the rubber area of the cap with a cotton-wool swab
moistened with alcohol
2. Take the syringe and slowly inject the solvent into the powder vial through the
rubber cap.
3. 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.
When reconstituting more than 1 vial of Merional HG, draw back the reconstituted contents
of the first vial into the syringe and slowly inject into a second vial after repeating the step 1
to 4.
If multiple vials of powder are used, the amount of menotrophin contained in 1 ml of
reconstituted solution will be as follows:

Merional HG 75 IU powder and
solvent for solution for injection
Number
of vials
used
Total amount of
menotrophin in 1 ml of
solution
1 75 IU
2 150 IU
3 225 IU
4 300 IU
5 375 IU
6 450 IU

Merional HG 150 IU powder and
solvent for solution for injection
Number of
vials used
Total amount of
menotrophin in 1 ml of
solution
1 150 IU
2 300 IU
3 450 IU
The solution must be clear and colourless.
Dispose of all used items:
Any unused product or waste material should be disposed of in accordance with local
requirements (once the injection is ended, all the needles and empty syringes should be
disposed of in an appropriate container).

 


IBSA Institut Biochimique S.A. Via al Ponte 13 6903 Switzerland.

23.02.2016
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