FOSTIMON 75 UI/ML Порошок и раствор для инъекционного раствора

Содержание инструкции

1. FOSTIMON 75 IU /1 ml powder and solvent for injectable solution, 150 IU /1 ml powder and solvent for injectable solution
   1. What FOSTIMON is and what it is used for
   2. What you need to know before using FOSTIMON
   3. How to take FOSTIMON
   4. Possible side effects
   5. How to store FOSTIMON
   6. Content of the pack and other information
2. FOSTIMON 75 IU /1 ml powder and solvent for injectable solution, 150 IU /1 ml powder and solvent for injectable solution, 225 IU /1 ml powder and solvent for injectable solution, 300 IU /1 ml powder and solvent for injectable solution
   1. What FOSTIMON is and what it is used for
   2. What you need to know before using FOSTIMON
   3. How to take FOSTIMON
   4. Possible side effects
   5. How to store FOSTIMON
   6. Contents of the pack and other information

FOSTIMON 75 IU /1 ml powder and solvent for injectable solution, 150 IU /1 ml powder and solvent for injectable solution

Urofollitropin

Read this leaflet carefully before you start to take this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What FOSTIMON is and what it is used for
• 2. What you need to know before you take FOSTIMON
• 3. How to take FOSTIMON
• 4. Possible side effects
• 5. How to store FOSTIMON
• 6. Contents of the pack and other information

1. What FOSTIMON is and what it is used for

FOSTIMON is a powder to be dissolved with a liquid (solvent) before use; it is administered with a
subcutaneous injection (subcutaneous route) or into a muscle (intramuscular route).
The powder contains urofolitropin, a "follicle-stimulating hormone" (FSH) obtained from human urine, belonging to the family of "gonadotropins," natural hormones involved in reproduction and
fertility. The urofolitropin contained in FOSTIMON is highly purified.
FOSTIMON is used

• in WOMEN, to promote ovulation or to develop several follicles (and therefore several eggs) during fertility treatments;
• in infertile MEN, to stimulate sperm formation.

Treatment with FOSTIMON must be carried out under strict medical supervision.

2. What you need to know before using FOSTIMON

Before starting therapy with FOSTIMON, couple fertility should be adequately assessed; in
particular, the following conditions must have been analyzed to determine if any further
treatments are necessary:

• reduced thyroid function (hypothyroidism) or adrenal gland function;
• elevated levels of a hormone called prolactin in the blood (hyperprolactinemia);
• tumors of the pituitary gland (gland located in the brain) or hypothalamus (an area of the brain).

Do not use FOSTIMON

• if you are allergic to the active ingredient or any of the other ingredients of this medicine (listed in section 6);
• if you are a WOMAN:
• with enlarged ovaries or fluid-filled sacs in the ovary (ovarian cysts), not caused by hormonal disorders (polycystic ovary syndrome);
• with vaginal bleeding of unknown origin;
• with cancer of the ovary, uterus, or breast;
• with cancer of the hypothalamus or pituitary gland;
• with a condition that makes normal pregnancy impossible, e.g., ovarian insufficiency, some types of reproductive system malformations, and uterine fibroids;
• during pregnancy or breastfeeding;
• if you are a MAN with irreversible testicular damage (e.g., primary testicular insufficiency).

Warnings and precautions
Therapy with FOSTIMON must be carried out only under strict medical supervision, who will determine how much
medicine you should use and how often. During treatment, the doctor will assess the response, with
ultrasound monitoring and/or estrogen dosage (in women) and with semen analysis
(in men).
Even if no cases of allergic reactions to FOSTIMON have been reported, tell your doctor if you have had
episodes of allergy to similar medicines.

Women
Ovarian hyperstimulation syndrome (see section 4)
This medicine increases the risk of developing ovarian hyperstimulation syndrome. This condition
occurs when the follicles develop excessively and transform into large cysts that
can also rupture. The risk of ovarian hyperstimulation is less likely in patients who do not
ovulate or who carefully follow the recommended treatment. However, if a
medicine for final egg maturation (containing human chorionic gonadotropin, hCG) is used, this
risk increases.
If you are developing ovarian hyperstimulation, your doctor will advise you not to carry out the hCG
therapy and to avoid sexual intercourse, or use a barrier contraceptive, for at least 4 days.
Multiple pregnancies
During the use of FOSTIMON, there is a greater probability of having a multiple pregnancy, in most
cases twins, compared to natural conception. This risk can be reduced by using
FOSTIMON at the recommended doses.
Abortion
In patients with fertility problems, the risk of abortion is higher than in other women.

Children
This medicine should not be used for pediatric use.

Other medicines and FOSTIMON
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines,
including those without a prescription. This is particularly important if you are taking medicines
that:

• promote ovulation (such as hCG and clomiphene);
• reduce the levels of sex hormones and block ovulation (such as agonists or antagonists of the gonadotropin-releasing hormone). FOSTIMON should not be mixed with other medicines in the same syringe.

Pregnancy and breastfeeding
Do not use FOSTIMON during pregnancy or breastfeeding.

Driving and using machines
FOSTIMON does not impair the ability to drive vehicles and operate machinery.

FOSTIMON containslactose and sodium.
Lactose: if your doctor has diagnosed you with intolerance to certain sugars, you should consult him before
taking this medicine.
Sodium: this medicine contains less than 1 mmol (23 mg) of sodium per 1 ml of reconstituted solution, i.e.
essentially ‘sodium-free’.
For athletes: the use of this drug without therapeutic necessity constitutes doping and may
still result in positive anti-doping tests.

3. How to take FOSTIMON

Take this medicine exactly as your doctor has told you. If you have any doubts, ask your doctor or pharmacist.

WOMEN who do not ovulate and have irregular or absent menstrual cycles
Treatment must begin within the first 7 days of the menstrual cycle.
The usual starting dose of FOSTIMON is between 75 and 150 IU, to be taken by injection daily. This dose may be increased by 37.5-75 IU every 7 or 14 days until the desired response is obtained.
If the doctor does not observe the desired response after 4 weeks, treatment with FOSTIMON must be stopped. In the next cycle, the doctor will administer a higher dose of FOSTIMON.
When an adequate response is obtained, to complete follicle maturation, you will be prescribed another medicine (hCG up to 10,000 IU), to be taken 24-48 hours after the last FOSTIMON injection. The most suitable days for sexual intercourse are the day of the hCG injection and the following day.
If your body responds excessively, treatment will be stopped and you will not be administered hCG. In the next cycle, the doctor will administer a lower dose of FOSTIMON.

WOMEN who need ovarian stimulation for the development of several eggs to be collected

during fertility treatments (in vitro fertilization and other assisted reproductive techniques)
If you have menstruation, treatment begins on the 2nd or 3rd day of the cycle.
The initial dose is generally between 150 and 225 IU, to be taken by injection daily.
This dose may be increased up to a maximum daily dose of 450 IU, depending on the response.
Treatment continues until the eggs have reached an adequate degree of development, which the doctor will determine with blood tests and/or ultrasound.
Once the desired response is obtained, to complete follicle maturation, you will be prescribed another medicine (hCG up to 10,000 IU), to be taken 24-48 hours after the last FOSTIMON injection.
If you are using a gonadotropin-releasing hormone (GnRH) agonist medicine, you should start therapy with FOSTIMON about 2 weeks after starting treatment with this medicine. You should take both medicines until adequate follicle development is achieved.
The usual dose of FOSTIMON is 225 IU, to be taken by injection daily, for 7 days. This dose may be modified based on the ovarian response.

MEN
The usual dose of FOSTIMON is 150 IU, to be taken by injection, 3 times a week, in association with hCG. You should use these two medicines for at least 4 months. If you have not responded adequately, the doctor may decide to continue treatment for another 18 months.
Method of administration
Take FOSTIMON by subcutaneous injection (subcutaneously) or into a muscle (intramuscularly).
Prepare the solution for injection immediately before use, dissolving the powder contained in the vial with the clear and colorless liquid (solvent) found in the ampoule inside the package.
You can dissolve up to 5 vials of powder with a single ampoule (1 ml of solvent) to avoid injections of large volumes.
You must use each vial only once and discard any remaining solution.
To administer FOSTIMON, read carefully and follow the instructions at the end of this leaflet.

If you take more FOSTIMON than you should
ovarian hyperstimulation syndrome may occur (see section 4). If this happens, contact your doctor immediately.

If you forget to take FOSTIMON
Do not take a double dose to make up for a missed dose. Inform your doctor as soon as you realize you have forgotten the dose.
If you have any doubts about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, FOSTIMON can cause side effects, although not everybody gets them.
The frequency of the possible side effects listed below is defined using the following
classification:

Serious side effects
Ovarian hyperstimulation syndrome (see section 2)
In women using FOSTIMON, excessive stimulation of the ovaries (ovarian
hyperstimulation syndrome) may occur, with possible formation of large cysts that may also rupture. The early
symptoms of this condition are: pain in the lower abdomen accompanied by nausea, vomiting and
weight gain (common side effects). In more severe cases, decreased
urine production, difficulty breathing and/or possible fluid accumulation in the stomach and chest may also appear (uncommon
side effects).
Rare complications of ovarian hyperstimulation syndrome include the formation of blood clots in the
blood vessels (thromboembolic events), which can cause chest pain, shortness of breath, stroke or
heart attack.

If you notice any of the above reactions, contact your doctor immediately who will assess whether to
discontinue treatment with FOSTIMON and/or with hCG.
Very rarely, coagulation problems (thromboembolic events) may also occur
independently of ovarian hyperstimulation syndrome.

Other side effects
Very common side effects
Local reactions at the injection site such as pain, redness, small skin spots, swelling.
Headache.

Common side effects
Fever, joint pain
Increased breast volume (gynecomastia), acne, weight gain (in men).

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly
through the national reporting system at “https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse”.
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store FOSTIMON

Keep this medicine out of the sight and reach of children.
Do not store at a temperature above 25°C.
Keep the medicine in its original packaging to protect it from light.
Do not use FOSTIMON after the expiry date which is reported on the label. The expiry date refers
to the last day of that month.
Take FOSTIMON immediately after preparation.
Do not use FOSTIMON if the solution does not appear clear.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Content of the pack and other information

What FOSTIMON contains
The active ingredient is: urofolitropin, follicle-stimulating hormone (FSH), urinary, human, highly
purified.
The excipients are:

• in the vial containing the powder: lactose
• in the solvent vial: water for injections, sodium chloride.

Each container of 75 and 150 IU contains: 75 and 150 IU of urofolitropin in powder.
Each vial contains 1 ml of solvent.

Description of the appearance of FOSTIMON and contents of the pack
FOSTIMON 75 and 150 IU/1 ml is available in packs containing: 1, 5, 10 vials of powder and 1, 5,
10 vials of solvent.

Marketing authorization holder and manufacturer
IBSA Farmaceutici Italia S.r.l., Via Martiri di Cefalonia, 2, 26900 Lodi
INSTRUCTIONS FOR USE OF FOSTIMON WITH SOLVENT IN VIAL
Wash your hands thoroughly. Make sure the accessories are well cleaned and placed on a clean surface.
Place the following tools on the surface:

• 2 cotton swabs soaked with alcohol (not included in the pack);
• 1 vial containing FOSTIMON powder;
• 1 vial with the solvent (clear and colorless liquid);
• 1 empty syringe (not included in the pack);
• a needle for preparing the injection (not included in the pack);
• a thin needle if you want to administer FOSTIMON under the skin (not included in the pack).
• 1.PreparationOpen the vial containing the solvent. On the neck of the vial, there is a small colored mark. Gently tap the top of the vial to remove any liquid residue present at the tip; press firmly on the apex of the vial to break it near the colored mark. Attach the needle to the syringe; draw the solvent contained in the vial. Place the syringe on the surface, being careful not to touch the needle and preventing the needle from coming into contact with any object.
• 2.Reconstitution of the solution
• Remove the plastic cap on the stopper of the vial containing the powder; clean the surface of the stopper with an alcohol swab;
• slowly inject the solvent into the vial, through the rubber stopper;

• to completely dissolve the powder, slowly rotate the vial (without removing the syringe). Do notshaketo avoid the formation of bubbles. If the solution is not clear or contains particles, itmust be discarded;
• after the powder has dissolved (this should happen immediately), turn the vial upside down and slowly draw the solution into the syringe.

If you have been prescribed more than one vial of FOSTIMON powder for a single injection, you can draw
the solution again (the first dilution of FOSTIMON) into the syringe and inject it into a second vial
of powder. You can repeat the operation up to a maximum of five vials of powder in total.

• 3.Administration

If you want to administer FOSTIMON with an injection into a muscle (intramuscular route), you do not need
to change the needle.
If you want to administer FOSTIMON under the skin (subcutaneous route), you must remove the needle used for
reconstitution and replace it with the thin needle suitable for subcutaneous administration. Your doctor will tell you
where to give the injection (e.g. abdomen, front of the thigh).
Safety check: before administration, remove any air bubbles by holding the syringe vertically, with the
needle facing upwards, and gently tapping until the air bubbles collect at the top, then
gently push the syringe plunger to expel the air, until liquid appears on the
tip of the needle.

Inject the solution immediately after preparation.
To minimize skin irritation, choose a different injection site each day.
Clean the injection site with an alcohol swab. Firmly hold between your fingers the part where you intend
to give the injection and insert the needle at an angle between 45° and 90° with an arrow-like movement.

FOSTIMON must not be administered directly into a vein. To exclude this possibility, pull the
plunger to check for the presence of blood. If this occurs, withdraw the syringe and repeat the operation in
another site.
Inject all the solution, subcutaneously or intramuscularly, by slowly pressing the plunger.
Immediately remove the needle and clean the injection area with an alcohol swab in a circular motion.
Once the injection is finished, immediately dispose of the used needles and empty vials safely, preferably in a sharps container.

FOSTIMON 75 IU /1 ml powder and solvent for injectable solution, 150 IU /1 ml powder and solvent for injectable solution, 225 IU /1 ml powder and solvent for injectable solution, 300 IU /1 ml powder and solvent for injectable solution

Urofollitropin

Read this leaflet carefully before you start to use this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What FOSTIMON is and what it is used for
• 2. What you need to know before you use FOSTIMON
• 3. How to use FOSTIMON
• 4. Possible side effects
• 5. How to store FOSTIMON
• 6. Contents of the pack and other information

1. What FOSTIMON is and what it is used for

FOSTIMON is a powder to be dissolved with a liquid (solvent) before use; it is administered with a
subcutaneous injection (subcutaneous route) or into a muscle (intramuscular route).
The powder contains urofolitropin, a “follicle-stimulating hormone” (FSH) obtained from human urine,
belonging to the family of “gonadotropins”, natural hormones involved in reproduction and fertility.
The urofolitropin contained in FOSTIMON is highly purified.
FOSTIMON is used

• in WOMEN, to promote ovulation or to develop several follicles (and therefore several eggs) during fertility treatments;
• in infertile MEN, to stimulate sperm formation. Treatment with FOSTIMON must be carried out under strict medical supervision.

2. What you need to know before using FOSTIMON

Before starting therapy with FOSTIMON, couple fertility should be adequately assessed; in
particular, the following conditions must have been analyzed to determine if any further
treatments are necessary:

• reduced thyroid function (hypothyroidism) or adrenal glands;
• elevated levels of a hormone called prolactin in the blood (hyperprolactinemia);
• tumors of the pituitary gland (gland located in the brain) or hypothalamus (an area of the brain).

Do not take FOSTIMON

• if you are allergic to the active ingredient or any of the other ingredients of this medicine (listed in section 6);
• if you are a WOMAN:
• with enlarged ovaries or fluid-filled sacs in the ovary (ovarian cysts), not caused by hormonal disorders (polycystic ovary syndrome);
• with vaginal bleeding of unknown origin;
• with cancer of the ovary or uterus or breast;
• with cancer of the hypothalamus or pituitary gland;
• with a condition that makes normal pregnancy impossible, e.g. ovarian insufficiency, some types of reproductive system malformations and uterine fibroids;
• during pregnancy or breastfeeding;
• if you are a MAN with irreversible testicular damage (e.g. primary testicular insufficiency). Warnings and precautionsTherapy with FOSTIMON must be carried out only under strict medical supervision, who will determine how much medicine you need to use and how often. During treatment, the doctor will assess the response, with ultrasound monitoring and/or estrogen dosage (in women) and with semen analysis (in men).

Even if no cases of allergic reactions to FOSTIMON have been reported, tell your doctor if you have had episodes
of allergy to similar medicines.

Women
Ovarian hyperstimulation syndrome (see section 4)
This medicine increases the risk of developing ovarian hyperstimulation syndrome. This condition occurs when the follicles develop excessively and turn into large cysts that
can also rupture. The risk of ovarian hyperstimulation is less likely in patients who do not ovulate or who carefully follow the recommended treatment. However, if a medicine is used
for the final maturation of the eggs (containing human chorionic gonadotropin, hCG), this risk
increases.
If you are developing ovarian hyperstimulation, your doctor will advise you not to carry out the hCG therapy and
to avoid sexual intercourse, or use a barrier contraceptive, for at least 4 days.
Multiple pregnancies
During the use of FOSTIMON, there is a greater probability of having a multiple pregnancy, in most
cases twins, compared to natural conception. This risk can be reduced by using
FOSTIMON at the recommended doses.
Abortion
In patients with fertility problems, the risk of abortion is higher than in other women.

Children
This medicine should not be used for pediatric use.

Other medicines and FOSTIMON
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines,
including those without a prescription. This is particularly important if you are taking drugs that:

• promote ovulation (such as hCG and clomifene);
• reduce the levels of sex hormones and block ovulation (such as agonists or antagonists of gonadotropin-releasing hormone). FOSTIMON should not be mixed with other medicines in the same syringe.

Pregnancy and breastfeeding
Do not use FOSTIMON during pregnancy or breastfeeding.

Driving and using machines
FOSTIMON does not impair the ability to drive vehicles and operate machinery.

FOSTIMON containslactose and sodium.
Lactose: if your doctor has diagnosed you with intolerance to certain sugars, you should consult him before taking
this medicine.
Sodium: this medicine contains less than 1 mmol (23 mg) of sodium per 1 ml of reconstituted solution, i.e.
essentially ‘sodium-free’.
For those who play sports: the use of this drug without therapeutic necessity constitutes doping and can
still result in positive doping tests.

3. How to take FOSTIMON

Take this medicine always exactly as your doctor has instructed you. If you have any doubts, ask your doctor or pharmacist.

WOMEN who do not ovulate and have irregular or absent menstrual cycles
Treatment must begin within the first 7 days of the menstrual cycle.
The usual starting dose of FOSTIMON is between 75 and 150 IU, to be administered by an injection daily. This dose may be increased every 7 or 14 days by 37.5-75 IU until the desired response is obtained.
If the doctor does not observe the desired response after 4 weeks, treatment with FOSTIMON must be stopped. In the next cycle, the doctor will administer a higher dose of FOSTIMON.
When an adequate response is obtained, to complete the maturation of the follicles, you will be prescribed another medicine (hCG up to 10,000 IU), to be taken 24-48 hours after the last FOSTIMON injection. The most suitable days for sexual intercourse are the day of the hCG injection and the following day.
If your body responds excessively, treatment will be stopped and you will not be administered hCG.
In the next cycle, the doctor will administer a lower dose of FOSTIMON.

WOMEN who require ovarian stimulation for the development of several eggs to be collected during

fertility treatments (in vitro fertilization and other assisted reproductive techniques)
If you have your period, treatment begins on the 2nd or 3rd day of the cycle.
The starting dose is generally between 150 and 225 IU, to be administered by an injection daily. This dose may be increased up to a maximum daily dose of 450 IU, depending on the response.
Treatment continues until the eggs have reached an adequate degree of development, which the doctor will determine with blood tests and/or ultrasound.
Once the desired response is obtained, to complete the maturation of the follicles, you will be prescribed another medicine (hCG up to 10,000 IU), to be taken 24-48 hours after the last FOSTIMON injection.
If you are using a gonadotropin-releasing hormone (GnRH) agonist medication, you should start therapy with FOSTIMON approximately 2 weeks after starting treatment with this medication. You should take both medicines until adequate follicle development is achieved.
The usual dose of FOSTIMON is 225 IU, to be administered by an injection daily, for 7 days. This dose may be modified based on the ovarian response.

MEN
The usual dose of FOSTIMON is 150 IU, to be administered by an injection, 3 times a week, in association with hCG. You should use these two medicines for at least 4 months. If you have not responded adequately, your doctor may decide to continue treatment for another 18 months.
Method of administration
Take FOSTIMON by subcutaneous injection (subcutaneously) or into a muscle (intramuscularly).
Prepare the solution for injection immediately before use, dissolving the powder contained in the vial with the clear, colorless liquid (solvent) found in the prefilled syringe inside the package.
You can dissolve up to 5 vials of powder with a single prefilled syringe (1 ml of solvent) to avoid injections of large volumes.
You must use each vial only once and discard any remaining solution.
To administer FOSTIMON, read and follow the instructions at the end of this leaflet carefully.

If you take more FOSTIMON than you should
ovarian hyperstimulation syndrome may occur (see section 4). If this happens, contact your doctor immediately.

If you forget to take FOSTIMON
Do not take a double dose to make up for a missed dose. Inform your doctor as soon as you realize you have forgotten the dose.
If you have any doubts about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, FOSTIMON can cause side effects, although not everybody gets them.
The frequency of the possible side effects listed below is defined using the following
classification:

Serious side effects
Ovarian hyperstimulation syndrome (see section 2)
In women using FOSTIMON, excessive stimulation of the ovaries (ovarian hyperstimulation syndrome) may occur, with possible formation of large cysts that may also rupture. The first symptoms
of this condition are: pain in the lower abdomen accompanied by nausea, vomiting and weight gain (common side effects). In more severe cases, a decrease in urine production, difficulty breathing and/or possible fluid accumulation in the stomach and chest may also occur (uncommon side effects).
Rare complications of ovarian hyperstimulation syndrome include the formation of blood clots in the blood vessels (thromboembolic events), which can cause chest pain, shortness of breath, stroke or heart attack.

If you notice any of the above reactions, contact your doctor immediately who will assess whether to
discontinue treatment with FOSTIMON and/or with hCG.
Very rarely, coagulation problems (thromboembolic events) may also occur
independently of ovarian hyperstimulation syndrome.

Other side effects
Very common side effects
Local reactions at the injection site such as pain, redness, small skin spots, swelling.
Headache.

Common side effects
Fever, joint pain
Increased breast volume (gynecomastia), acne, weight gain (in men).

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system at “ https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse ”. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store FOSTIMON

Keep this medicine out of the sight and reach of children.
Do not store at a temperature above 25°C.
Keep the medicine in its original packaging to protect it from light.
Do not use FOSTIMON after the expiry date which is stated on the label. The expiry date refers
to the last day of that month.
Use FOSTIMON immediately after preparation.
Do not use FOSTIMON if the solution does not appear clear.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to eliminate
medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What FOSTIMON contains
The active ingredient is: urofollitropin, follicle-stimulating hormone (FSH), urinary, human, highly purified.
The excipients are:

• in the vial containing the powder: lactose
• in the pre-filled syringe of solvent: water for injections, sodium chloride.

Each container of 75, 150, 225, 300 IU contains: 75, 150, 225, 300 IU of urofollitropin in powder.
Each pre-filled syringe contains 1 ml of solvent.

Description of the appearance of FOSTIMON and contents of the pack
FOSTIMON 75, 150, 225, 300 IU/1 ml is available in packs containing: 1, 5, 10 vials of powder
and 1, 5, 10 pre-filled syringes of solvent equipped with a back-stop.
Each syringe is supplied with 2 needles: 21 gauge with green cap (for reconstitution of the solution for
injection and intramuscular administration) and 27 gauge needle with grey cap (for subcutaneous
administration).

Marketing authorisation holder and manufacturer
IBSA Farmaceutici Italia S.r.l., Via Martiri di Cefalonia, 2, 26900 Lodi
INSTRUCTIONS FOR USE OF FOSTIMON WITH SOLVENT IN PRE-FILLED SYRINGES
Wash your hands thoroughly. Make sure the accessories are well cleaned and placed on a clean surface.
Place the following tools on the surface:

• 2 cotton wool balls soaked with alcohol (not included in the pack);
• 1 vial containing FOSTIMON powder;
• 1 pre-filled syringe with the solvent (clear and colourless liquid);
• 2 needles: 21 gauge (green cap) and 27 gauge (grey cap).
• 1. PreparationRemove the cap from the pre-filled syringe. Insert the 21 gauge needle (green cap) suitable for reconstituting the solution. Place the syringe on the surface, being careful not to touch the needle and avoiding contact between the needle and any object.
• 2. Reconstitution of the solution
• Remove the plastic cover on the vial cap containing the powder; clean the surface of the cap with a cotton wool ball soaked in alcohol;
• slowly inject the solvent into the vial, through the rubber stopper;
• to completely dissolve the powder, slowly rotate the vial (without removing the syringe). Do not

shaketo avoid the formation of bubbles. If the solution is not clear or contains particles, it must be
discarded;

• after the powder has dissolved (this should happen immediately), turn the vial upside down and slowly draw the solution into the syringe.

If you have been prescribed more than one vial of FOSTIMON powder per single injection, you can draw
the solution (the first dilution of FOSTIMON) back into the syringe and inject it into a second vial of
powder. You can repeat the operation up to a maximum of five vials of powder in total.

• 3. AdministrationIf you want to administer FOSTIMON with an injection into a muscle (intramuscular route), you do not need to change the needle. If you want to administer FOSTIMON under the skin (subcutaneous route), you must remove the needle used for reconstitution and replace it with the 27 gauge needle (grey cap) suitable for subcutaneous administration. Your doctor will tell you where to give the injection (e.g. abdomen, front of the thigh).

Safety check: before administration, remove any air bubbles by holding the
syringe vertically, with the needle pointing upwards, and gently tapping until the air bubbles collect at the top, then
slightly push the syringe plunger to expel the air, until liquid appears on the
needle tip.
Inject the solution immediately after preparation.

To minimise skin irritation, choose a different injection site each day.
Clean the injection site with a cotton wool ball soaked in alcohol. Firmly hold the part where you intend
to give the injection between your fingers and insert the needle at an angle between 45° and 90° with an arrow-like movement.
FOSTIMON must not be administered directly into a vein. To exclude this possibility, pull
the plunger to check for the presence of blood. If this occurs, withdraw the syringe and repeat the operation at a
different site.
Inject all the solution, subcutaneously or intramuscularly, by slowly pressing the plunger.
Immediately remove the needle and clean the injection area with a cotton wool ball soaked in alcohol with a circular
movement.
Once the injection is finished, immediately dispose of the used needles and empty vials safely, preferably in a sharps container.