Fostimon

Package leaflet: Information for the patient

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

Urofollitropin
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, consult 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 using 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 in a liquid (solvent) before use; it is administered by
subcutaneous injection (under the skin) or intramuscular injection (into a muscle).
The powder contains urofollitropin, a "follicle-stimulating hormone" (FSH) derived from human urine, belonging to the family of "gonadotropins", natural hormones involved in reproduction and fertility. The urofollitropin contained in FOSTIMON is highly purified.
FOSTIMON is used

• in WOMEN, to stimulate ovulation or the development of multiple follicles (and therefore multiple oocytes) during fertility treatments;
• in infertile MEN, to stimulate sperm production.

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

2. What you should know before taking FOSTIMON

Before starting treatment with FOSTIMON, the fertility status of both partners should be adequately assessed; in particular, the following conditions should be evaluated to determine whether additional treatments may be required:

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

Do not take FOSTIMON

• if you are allergic to the active substance or to 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 failure, certain types of reproductive tract malformations, or uterine fibroids;
• during pregnancy or breastfeeding;
  • if you are a MAN with irreversible testicular damage (e.g. primary testicular failure).

Warnings and precautions
Treatment with FOSTIMON must be carried out only under strict medical supervision. Your doctor will determine the dosage and frequency of administration. During treatment, your doctor will assess your response through ultrasound monitoring and/or estrogen measurements (in women) and semen analysis (in men).
Although no cases of allergic reactions to FOSTIMON have been reported, inform your doctor if you have previously experienced allergic reactions to similar medicines.

Women
Ovarian hyperstimulation syndrome (see section 4)
This medicine increases the risk of developing ovarian hyperstimulation syndrome. This condition occurs when ovarian follicles develop excessively and turn into large cysts, which may even rupture. The risk of ovarian hyperstimulation is less likely in patients who do not ovulate or who strictly follow the recommended treatment. However, the risk increases if a medicine used to trigger final oocyte maturation (containing human chorionic gonadotropin, hCG) is administered.
If ovarian hyperstimulation is developing, your doctor will advise you not to use hCG and to avoid sexual intercourse or to use a barrier contraceptive method for at least 4 days.

Multiple pregnancies
When using FOSTIMON, there is an increased chance of multiple pregnancy, most commonly twins, compared to natural conception. This risk can be reduced by using FOSTIMON at the recommended doses.

Spontaneous abortion
In patients with fertility problems, the risk of spontaneous abortion is higher than in other women.

Children
This medicine must not be used for pediatric purposes.

Other medicines and FOSTIMON
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription. This is particularly important if you are taking medicines that:

• promote ovulation (e.g. hCG and clomiphene);
• reduce sex hormone levels and suppress ovulation (e.g. gonadotropin-releasing hormone agonists or antagonists).
  FOSTIMON must 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 or operate machinery.

FOSTIMON contains lactose and sodium.
Lactose: if your doctor has diagnosed you with an intolerance to certain sugars, consult him/her 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: using this medicine without therapeutic need constitutes doping and may lead to a positive anti-doping test.

3. How to take FOSTIMON

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.

WOMEN who do not ovulate and have irregular or absent menstrual cycles
Treatment should begin within the first 7 days of the menstrual cycle.
The usual initial dose of FOSTIMON is between 75 and 150 IU, administered as one daily injection. This dose may be increased every 7 or 14 days by 37.5–75 IU until the desired response is achieved.
If your doctor does not observe the desired response after 4 weeks, treatment with FOSTIMON should be stopped. In the following cycle, your doctor will administer a higher dose of FOSTIMON.
When an adequate response is obtained, another medicine (hCG up to 10,000 IU) will be prescribed to complete follicular maturation, 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 receive hCG. In the next cycle, your doctor will administer a lower dose of FOSTIMON.

WOMEN who require ovarian stimulation to develop multiple eggs to be retrieved during fertility treatments (in vitro fertilization and other assisted reproductive techniques)
If you have menstrual periods, treatment starts on day 2 or 3 of the cycle.
The initial dose is generally between 150 and 225 IU, administered as one daily injection.
This dose may be increased up to a maximum daily dose of 450 IU, depending on your response.
Treatment continues until the eggs have reached an adequate stage of development, as determined by your doctor through blood tests and/or ultrasound.
Once the desired response is achieved, another medicine (hCG up to 10,000 IU) will be prescribed to complete follicular maturation, to be administered 24–48 hours after the last FOSTIMON injection.
If you are using a gonadotropin-releasing hormone (GnRH) agonist, you should start FOSTIMON therapy approximately 2 weeks after beginning treatment with this medicine. You must continue taking both medicines until adequate follicular development is achieved.
The usual dose of FOSTIMON is 225 IU, administered as one daily injection for 7 days. This dose may be adjusted based on ovarian response.

MEN
The usual dose of FOSTIMON is 150 IU, administered as an injection three times a week, in combination with hCG. You will need to use both medicines for at least 4 months. If you do not respond adequately, your doctor may decide to continue treatment for up to an additional 18 months.

Method of administration
Administer FOSTIMON by subcutaneous (under the skin) or intramuscular (into a muscle) injection.
Prepare the solution for injection immediately before use by dissolving the powder in the vial with the clear, colourless liquid (solvent) provided in the ampoule within the package.
You may dissolve up to 5 vials of powder with one ampoule (1 ml of solvent) to avoid large-volume injections.
Each vial must be used only once, and any unused solution must be discarded.
For instructions on how 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 the missed dose. Inform your doctor as soon as you realize you have missed a dose.

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

4. Possible adverse reactions

Like all medicines, FOSTIMON may cause adverse reactions, although not everyone experiences them. The frequency of the possible adverse reactions listed below is defined using the following classification:

Serious adverse effects
Ovarian hyperstimulation syndrome (see section 2)
In women using FOSTIMON, excessive ovarian stimulation (ovarian hyperstimulation syndrome) may occur, possibly leading to the formation of large ovarian cysts that may rupture.
The first symptoms of this condition are: *lower abdominal pain* accompanied by nausea, vomiting, and weight gain (common adverse effects). In more severe cases, reduced urine output, breathing difficulties, and/or possible accumulation of fluid in the stomach and chest may also occur (uncommon adverse effects).
Rare complications of ovarian hyperstimulation syndrome include blood clot formation in blood vessels (thromboembolic events), which may cause chest pain, shortness of breath, stroke, or heart attack.
If you experience any of the above-mentioned reactions, contact your doctor immediately. The doctor will evaluate whether treatment with FOSTIMON and/or hCG should be discontinued.
Very rarely, blood clotting problems (thromboembolic events) may also occur independently of ovarian hyperstimulation syndrome.

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

Common adverse effects
Fever, joint pain.
Breast enlargement (gynecomastia), acne, weight gain (in men).

Reporting of adverse effects
If you experience any adverse effect, including those not listed in this leaflet, please inform your doctor or pharmacist. You may also report adverse effects directly through the national reporting system at “https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse”.
By reporting adverse 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 above 25°C.
Keep the medicine in the original packaging to protect it from light.
Do not use FOSTIMON after the expiry date 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 medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

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

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

Each 75 and 150 UI container contains: 75 and 150 UI of urofollitropin in powder form.
Each vial contains 1 ml of solvent.

Description of the appearance of FOSTIMON and package contents
FOSTIMON 75 and 150 UI/1 ml are available in packages 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, Italy

INSTRUCTIONS FOR USING FOSTIMON WITH SOLVENT IN VIALS

Wash your hands thoroughly. Ensure that all accessories are clean and placed on a clean surface.
Place the following items on the surface:

• 2 alcohol swabs (not included in the package);
• 1 vial containing FOSTIMON powder;
• 1 vial with solvent (clear, colourless liquid);
• 1 empty syringe (not included in the package);
• one needle for preparing the injection (not included in the package);
• a fine needle if you wish to administer FOSTIMON subcutaneously (not included in the package).

1. 1. Preparation
   Open the vial containing the solvent. On the neck of the vial there is a small coloured mark. Gently tap the top of the vial to dislodge any liquid droplets that may be present at the tip. Press firmly on the top of the vial to break it at the coloured mark. Attach the needle to the syringe and draw up the solvent from the vial. Place the syringe on the surface, taking care not to touch the needle and avoiding any contact between the needle and other objects.

2. 2. Reconstitution of the solution

• Remove the plastic cap from the stopper of the vial containing the powder; clean the stopper surface with an alcohol swab;
• slowly inject the solvent into the vial through the rubber stopper;

• to completely dissolve the powder, gently rotate the vial (without removing the syringe). Do not shake to avoid formation of bubbles. If the solution is not clear or contains particles, it must be discarded;
• once the powder has dissolved (this should occur 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 may draw the solution (the first FOSTIMON dilution) into the syringe and inject it into a second vial of powder. You may repeat this procedure up to a maximum of five vials of powder in total.

3. 3. Administration
   If you are administering FOSTIMON via intramuscular injection, it is not necessary to change the needle.
   If you are administering FOSTIMON subcutaneously, you must discard the needle used for reconstitution and replace it with a fine needle suitable for subcutaneous administration. Your doctor will advise you where to administer 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. Gently tap the syringe until the air bubbles rise to the top, then slightly push the plunger to expel the air until a small amount of liquid appears at the tip of the needle.

Inject the solution immediately after preparation.
To minimize skin irritation, select a different injection site each day. Clean the injection site with an alcohol swab. Firmly hold the skin at the injection site and insert the needle at an angle between 45° and 90° with a quick, dart-like motion.

FOSTIMON must not be administered directly into a vein. To rule out this possibility, pull back on the plunger to check for blood. If blood appears, remove the syringe and repeat the procedure at another site.
Inject the entire solution subcutaneously or intramuscularly by slowly pushing the plunger.
Immediately remove the needle and clean the injection site with an alcohol swab using a circular motion.
After completing the injection, immediately dispose of used needles and empty glass vials safely, preferably in a sharps container.

Patient Information Leaflet

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
Please read this leaflet carefully before using this medicine because 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 give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, please consult 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 using 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 by
subcutaneous injection (subcutaneous route) or into a muscle (intramuscular route).
The powder contains urofollitropin, a "follicle-stimulating hormone" (FSH) derived from human urine,
belonging to the family of "gonadotropins", natural hormones involved in reproduction and fertility.
The urofollitropin contained in FOSTIMON is highly purified.
FOSTIMON is used

• in WOMEN, to stimulate ovulation or to promote the development of multiple follicles (and thus multiple oocytes) during fertility treatments;
• in infertile MEN, to stimulate sperm production.
  Treatment with FOSTIMON must be carried out under strict medical supervision.

2. What you need to know before taking FOSTIMON

Before starting treatment with FOSTIMON, the fertility status of both partners should be adequately assessed; in particular, the following conditions should be evaluated to determine whether additional treatments may be required:

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

Do not take FOSTIMON

• if you are allergic to the active substance or to 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 ovarian, uterine, or breast cancer;
• with cancer of the hypothalamus or pituitary gland;
• with a condition that makes normal pregnancy impossible, e.g. ovarian failure, certain types of reproductive tract malformations, or uterine fibroids;
• during pregnancy or breastfeeding;
• if you are a MAN with irreversible testicular damage (e.g. primary testicular failure). Warnings and precautions Treatment with FOSTIMON must be carried out only under strict medical supervision. Your doctor will determine the dose and frequency of administration. During treatment, your doctor will assess your response by ultrasound monitoring and/or measurement of estrogen levels (in women) and by analysis of seminal fluid (in men).

Although allergic reactions to FOSTIMON have not been reported, inform your doctor if you have ever experienced allergic reactions to similar medicines.

Women

Ovarian hyperstimulation syndrome (see section 4)
This medicine increases the risk of developing ovarian hyperstimulation syndrome. This condition occurs when follicles develop excessively and turn into large cysts, which may even rupture. The risk of ovarian hyperstimulation is less likely in patients who do not ovulate or who closely follow the recommended treatment. However, if a medicine used to trigger final egg maturation (containing human chorionic gonadotropin, hCG) is administered, this risk increases.
If you are developing ovarian hyperstimulation, your doctor will advise you not to use hCG therapy and to avoid sexual intercourse, or to use a barrier contraceptive method, for at least 4 days.

Multiple pregnancies
When using FOSTIMON, there is an increased chance of multiple pregnancy, most commonly twins, compared to natural conception. This risk can be reduced by using FOSTIMON at the recommended doses.

Spontaneous abortion (miscarriage)
In patients with fertility problems, the risk of miscarriage is higher than in other women.

Children
This medicine must not be used for pediatric purposes.

Other medicines and FOSTIMON
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription. This is particularly important if you are taking medicines that:

• promote ovulation (e.g. hCG and clomiphene);
• reduce sex hormone levels and suppress ovulation (e.g. gonadotropin-releasing hormone agonists or antagonists). FOSTIMON must 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 affect the ability to drive or operate machinery.

FOSTIMON contains lactose and sodium.

Lactose: if your doctor has diagnosed you with an intolerance to certain sugars, consult him/her 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 individuals engaged in sports: using this medicine without therapeutic need constitutes doping and may lead to a positive anti-doping test.

3. How to take FOSTIMON

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.

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

WOMEN requiring ovarian stimulation for the development of multiple oocytes to be retrieved during fertility treatments (in vitro fertilization and other assisted reproductive techniques)
If you have menstruation, treatment starts on day 2 or 3 of the cycle.
The initial dose is generally between 150 and 225 IU, administered as one daily injection. This dose may be increased up to a maximum daily dose of 450 IU, depending on the response.
Treatment continues until the oocytes have reached an adequate stage of development, as determined by your doctor through blood tests and/or ultrasound.
Once the desired response is achieved, another medicine (hCG up to 10,000 IU) will be prescribed to complete follicular maturation, to be administered 24–48 hours after the last FOSTIMON injection.
If you are using a gonadotropin-releasing hormone (GnRH) agonist, you should start FOSTIMON treatment approximately 2 weeks after beginning treatment with this medicine. You must continue both medicines until adequate follicular development is achieved.
The usual dose of FOSTIMON is 225 IU, administered as one daily injection for 7 days. This dose may be adjusted based on ovarian response.

MEN
The usual dose of FOSTIMON is 150 IU, administered as an injection three times a week, in combination with hCG. You must use both medicines for at least 4 months. If you do not respond adequately, your doctor may decide to continue treatment for up to an additional 18 months.

Method of administration
Administer FOSTIMON by subcutaneous (under the skin) or intramuscular (into a muscle) injection.
Prepare the solution for injection immediately before use by dissolving the powder in the vial with the clear, colourless liquid (solvent) provided in the pre-filled syringe within the package.
You may dissolve up to 5 vials of powder with one pre-filled syringe (1 ml of solvent) to avoid injecting large volumes.
Each vial must be used only once, and any remaining solution must be discarded.
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 the missed dose. Inform your doctor as soon as you realize you have missed a dose.

If you have any doubts about how to use this medicine, consult 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 adverse effects
Ovarian hyperstimulation syndrome (see section 2)
In women using FOSTIMON, excessive stimulation of the ovaries (ovarian hyperstimulation syndrome) may occur, possibly leading to the formation of large cysts which may also rupture. Early symptoms of this condition include: pain in the lower abdomen, accompanied by nausea, vomiting, and weight gain (common adverse effects). In more severe cases, reduced urine output, difficulty breathing and/or possible accumulation of fluid in the stomach and chest may also occur (uncommon adverse effects).
Rare complications of ovarian hyperstimulation syndrome include formation of blood clots in blood vessels (thromboembolic events), which may 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 hCG.
Very rarely, blood clotting problems (thromboembolic events) may also occur independently of ovarian hyperstimulation syndrome.

Other adverse effects

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

Common adverse effects
Fever, joint pain
Breast enlargement (gynecomastia), acne, weight gain (in men).

Reporting of adverse effects
If you experience any adverse effect, including those not listed in this leaflet, please inform your doctor or pharmacist. You may also report adverse effects directly via the national reporting system at: “https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse”. By reporting adverse 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 above 25°C.
Keep the medicine in the original packaging to protect it from light.
Do not use FOSTIMON after the expiry date 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 via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What FOSTIMON contains
The active substance is: urofollitropin, urinary human follicle-stimulating hormone (FSH), 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 form.
Each pre-filled syringe contains 1 ml of solvent.
Description of the appearance of FOSTIMON and pack contents
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 back-stop.
Each syringe is supplied with 2 needles: 21 gauge with green cap (for reconstitution of the solution to be
injected and for 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 THE USE OF FOSTIMON WITH SOLVENT IN PRE-FILLED SYRINGES
Wash your hands thoroughly. Ensure that all accessories are clean and placed on a clean surface.
Place the following items on the surface:

• 2 alcohol swabs (not included in the pack);
• 1 vial containing FOSTIMON powder;
• 1 pre-filled syringe containing solvent (a clear, colourless liquid);
• 2 needles: 21 gauge (green cap) and 27 gauge (grey cap).

1. 1. Preparation Remove the cap from the pre-filled syringe. Attach the 21 gauge needle (green cap) suitable for reconstituting the solution. Place the syringe on the surface, taking care not to touch the needle and avoiding contact of the needle with any object.
2. 2. Reconstitution of the solution

• Remove the plastic cover from 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, gently rotate the vial (without removing the syringe). Do not shake to avoid formation of bubbles. If the solution is not clear or contains particles, it must be discarded;
• once the powder has dissolved (this should occur immediately), invert the vial 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 may draw the solution (the first dilution of FOSTIMON) back into the syringe and inject it into a second vial of powder. You may repeat this procedure up to a maximum of five vials of powder in total.

1. 3. Administration If you wish to administer FOSTIMON by intramuscular injection, it is not necessary to change the needle. If you wish to administer FOSTIMON subcutaneously, you must discard 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 administer 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, then gently tapping until the air bubbles rise to the top. Gently push the plunger to expel the air until liquid appears at 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 pinch the skin at the injection site and insert the needle at an angle between 45° and 90° with a quick, dart-like motion.

FOSTIMON must not be administered directly into a vein. To rule out this possibility, pull back on the plunger to check for blood. If blood appears, withdraw the syringe and repeat the procedure at another site.
Inject the entire solution subcutaneously or intramuscularly by slowly pushing the plunger.
Immediately remove the needle and clean the injection site with an alcohol swab using a circular motion.
After completing the injection, immediately dispose of used needles and empty glass vials safely, preferably in a sharps disposal container.