Active ingredients: Urofollitropin
FOSTIMON 75 IU / 1 ml powder and solvent for solution for injection
FOSTIMON 150 IU / 1 ml powder and solvent for solution for injection
FOSTIMON 225 IU / 1 ml powder and solvent for solution for injection
FOSTIMON 300 IU / 1 ml powder and solvent for solution for injection
Why is Fostimon used? What is it for?
FOSTIMON is a powder to be dissolved with a liquid (solvent) before being used; it is administered with an injection under the skin (subcutaneously) or into a muscle (intramuscularly).
The powder contains urofollitropin, a "follicle stimulating hormone" (FSH) obtained 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 favor ovulation or for the development of different follicles (and therefore of different eggs) during fertility treatments;
- in infertile MEN, to stimulate the formation of sperm.
Treatment with FOSTIMON must be carried out under strict medical supervision.
Contraindications When Fostimon should not be used
Do not take FOSTIMON
- if you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6);
- if you are a WOMAN:
- with enlarged ovaries or pockets of fluid 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;
- with a pathology that makes normal pregnancy impossible, eg. ovarian failure, some types of reproductive system malformations and uterine fibroids;
- pregnant or breastfeeding;
- if you are a MAN with irreversible testicular damage (eg primary testicular insufficiency).
Precautions for use What you need to know before taking Fostimon
Before starting therapy with FOSTIMON, the couple's fertility must be adequately assessed; in particular, the following conditions must have been analyzed to determine if any other treatments are necessary:
- reduced function of the thyroid gland (hypothyroidism) or adrenal glands;
- high levels of a hormone called prolactin in the blood (hyperprolactinaemia);
- tumors of the pituitary (gland in the brain) or hypothalamus (an area of the brain).
This medicine is prepared with human urine. The risk of transmitting agents that can cause infections or diseases cannot be totally excluded; this risk is minimized by the purification processes that are applied during the processing phases. No cases of viral contamination have ever been reported with the use of FOSTIMON.
Treatment with FOSTIMON should only be carried out under strict supervision of the doctor, who will decide how much medicine to use and how often. During the treatment, the doctor will evaluate the response, with ultrasound monitoring and / or estrogen measurement (in the woman) and with the analysis of the seminal fluid (in the man).
Although there have been no reports of allergic reactions to FOSTIMON, tell your doctor if you have ever had an allergy to similar medicines.
Women
Ovarian hyperstimulation syndrome
This medicine increases the risk of developing ovarian hyperstimulation syndrome. This condition occurs when the follicles overdevelop 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 follow the recommended treatment closely. However, if a final egg maturation medicine (containing human chorionic gonadotropin, hCG) is used, 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 use a barrier contraceptive, for at least 4 days.
Multiple pregnancies
While using FOSTIMON, there is a greater chance 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 miscarriage is higher than in other women.
Children
This medicinal product should not be used for pediatric use.
Interactions Which drugs or foods can change the effect of Fostimon
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This is especially important if you are taking medications that:
- promote ovulation (such as hCG and clomiphene);
- they reduce the levels of sex hormones and stop ovulation (such as gonadotropin-releasing hormone agonists or antagonists).
FOSTIMON must not be mixed with other drugs in the same syringe.
Warnings It is important to know that:
Pregnancy and breastfeeding
Do not use FOSTIMON if you are pregnant or breastfeeding.
Driving and using machines
FOSTIMON does not affect the ability to drive and use machines.
FOSTIMON contains lactose
If your doctor has diagnosed you with an "intolerance to some sugars, you must consult him before taking this medicine. For those who practice sports: the use of this drug without therapeutic necessity constitutes doping and can in any case determine positive anti-doping tests."
Dose, Method and Time of Administration How to use Fostimon: Posology
Always take this medicine exactly as your doctor has told you. If in doubt, 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 starting dose of FOSTIMON is between 75 and 150 IU, to be taken as one injection per day. This dose can be increased every 7 or 14 days by 37.5-75 IU until the desired response is achieved.
If the physician does not observe the desired response after 4 weeks, treatment with FOSTIMON should be discontinued. In the next cycle, your doctor will give you 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 injection of FOSTIMON. The best days for sexual intercourse. are the day of the hCG injection and the day after.
If your body responds excessively, the treatment will be stopped and you will not be given hCG. In the next cycle, your doctor will give you a lower dose of FOSTIMON.
WOMEN who need ovarian stimulation for the development of different eggs to be collected during fertility treatments (in vitro fertilization and other assisted reproduction techniques)
If you are menstruating, treatment starts on the 2nd or 3rd day of your cycle.
The starting dose is usually between 150 and 225 IU, to be taken as one injection per day. This dose may be increased up to a maximum daily dose of 450 IU, depending on the response.
The treatment continues until the eggs have reached an adequate degree of development, which the doctor will establish with a blood test and / or ultrasound.
Once the desired response has been 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 injection of FOSTIMON.
If you are using a gonadotropin releasing hormone (GnRH) agonist drug, you should start therapy with FOSTIMON approximately 2 weeks after starting treatment with this drug. You must take both medicines until the follicles develop properly.
The usual dose of FOSTIMON is 225 IU, to be taken as one injection per day for 7 days. This dose can be adjusted according to the response of the ovary.
MEN
The usual dose of FOSTIMON is 150 IU, to be taken as an injection, 3 times a week, in combination with hCG. You will need to use these two medicines for at least 4 months. If you have not responded adequately, your doctor may decide to continue the treatment. treatment for another 18 months.
Method of administration
Take FOSTIMON by injection under the skin (subcutaneously) or into a muscle (intramuscularly).
Prepare the solution to be injected immediately before use by dissolving the powder contained in the vial with the clear and colorless liquid (solvent) found in the pre-filled syringe inside the package. You can dissolve up to 5 vials of powder with a single pre-filled syringe (1 ml of solvent), to avoid large volume injections.
You should use each vial only once and discard any remaining solution.
To administer FOSTIMON, please read carefully and follow the instructions at the end of this package leaflet.
If you forget to take FOSTIMON
Do not take a double dose to make up for a forgotten dose. Tell your doctor as soon as you realize you have forgotten your dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Overdose What to do if you have taken too much Fostimon
If you take more FOSTIMON than you should, ovarian hyperstimulation syndrome may occur (see section 4). If this happens, contact your doctor immediately.
Side Effects What are the side effects of Fostimon
Like all medicines, FOSTIMON can cause side effects, although not everybody gets them. The frequency of possible side effects listed below is defined using the following classification:
- Very common: may affect more than 1 in 10 people
- Common: may affect up to more than 1 in 100 people and less than 1 in 10 people
- Uncommon: may affect up to more than 1 in 1000 people and less than 1 in 100 people
- Rare: may affect up to more than 1 in 10,000 people and less than 1 in 1,000 people
- Very rare: may affect less than 1 in 10,000 people
Serious side effects
Ovarian hyperstimulation syndrome
In women using FOSTIMON, over-stimulation of the ovaries (ovarian hyperstimulation syndrome) may occur, with possible formation of large cysts which may also rupture. The first symptoms of this pathology are: pain in the lower abdomen accompanied by nausea, vomiting and weight gain (common side effects). In severe cases, reduced urine production, difficulty in breathing and / or may also appear. possible accumulation of fluid in the stomach and chest (uncommon side effects).
Rare complications of ovarian hyperstimulation syndrome include clot formation in 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 decide whether to stop treatment with FOSTIMON and / or hCG.
Very rarely, coagulation problems (thromboembolic events) can 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 spots on the skin, swelling.
- Headache.
Common side effects
- Fever, joint pain
- Breast enlargement (gynecomastia), acne, weight gain (in men).
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system at “www.agenziafarmaco.gov.it/it/responsabili.” By reporting side effects you can help provide more information on the safety of this medicine.
Expiry and Retention
Keep this medicine out of the sight and reach of children.
Do not store above 25 ° C.
Keep the medicine in the original package 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.
Take FOSTIMON immediately after preparation.
Do not use FOSTIMON if the solution does not appear clear.
Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
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 solvent pre-filled syringe: water for injections, sodium chloride.
Each container of 75, 150, 225, 300 IU contains: 75, 150, 225, 300 IU of urofollitropin 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 are available in packs containing: 1, 5, 10 vials of powder and 1, 5, 10 pre-filled syringes with solvent with back-stop.
Each syringe is supplied with 2 needles: 21 gauge with green cap (for reconstitution of the solution to be injected and intramuscular administration) and 27 gauge needle with gray cap (for subcutaneous administration).
INSTRUCTIONS FOR USING FOSTIMON PRE-FILLED SYRINGES
Wash your hands thoroughly. Make sure the accessories are clean and placed on a clean surface.
Place the following tools on the surface:
- 2 alcohol wipes (not present in the package);
- 1 vial containing FOSTIMON powder;
- 1 pre-filled syringe with solvent (clear and colorless liquid);
- 2 needles: 21 gauge (green cap) and 27 gauge (gray cap).
- Preparation
Remove the cap from the pre-filled syringe. Insert the 21 gauge needle (green cap) suitable for the reconstitution of the solution. Place the syringe on the surface taking care not to touch the needle and avoiding that the needle comes into contact with any object.
- Reconstitution of the solution
- Remove the plastic cover placed on the stopper of the vial containing the powder; clean the surface of the cap 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 not shake to 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 for a 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.
- Administration
If you want to give FOSTIMON by injection into a muscle (intramuscularly), it is not necessary to change the needle.
If you want to administer FOSTIMON under the skin (subcutaneously), you must discard the needle used for reconstitution and replace it with the 27 gauge needle (gray cap) suitable for subcutaneous administration. Your doctor will tell you where to inject (eg belly, front of thigh).
Safety check: before administration, remove any air bubbles by holding the syringe vertically, with the needle pointing upwards, and tap lightly until the air bubbles collect at the top, then push the syringe plunger slightly to eject the air, until the 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 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 motion.
FOSTIMON must not be administered directly into a vein. To rule out this possibility, pull the plunger to check for blood. If this happens, remove the syringe and repeat the operation at another site.
Inject all of 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 discard the used needles and empty glasses safely, preferably in the sharps bin.
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
FOSTIMON POWDER AND SOLVENT FOR INJECTABLE SOLUTION
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains:
urofollitropin, corresponding to human urinary follicle stimulating hormone (FSH), highly purified.
Each vial of 75, 150, 225, 300 contains 75 IU, 150 IU, 225 IU, 300 IU urofollitropin powder.
Excipient with known effect: lactose.
For the full list of excipients, see section 6.1.
03.0 PHARMACEUTICAL FORM
Powder and solvent for solution for injection.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Female infertility
Induction of ovulation, in association with chorionic gonadotropin, in patients with polycystic ovary syndrome; amenorrhea or anovulatory states due to follicular phase failure; other infertility states associated with an increased LH / FSH ratio.
FOSTIMON is indicated for the stimulation of multiple follicular development in women undergoing induction of ovulation in in vitro fertilization programs (IVF) and other assisted reproduction techniques (IVF-GIFT-ZIFT).
Male infertility
Induction of spermatogenesis in men with hypogonadotropic hypogonadism, in association with human chorionic gonadotropin (hCG).
04.2 Posology and method of administration
Dosage
The doses and duration of therapy must be customized by the doctor according to the needs of the individual patient.
The recommended dosage regimens are shown below with reference to each therapeutic indication.
Women with hypothalamic-pituitary dysfunction accompanied by oligomenorrhea or amenorrhea
The goal of the treatment is to stimulate the maturation of a single Graafian follicle that will undergo ovulation after administration of chorionic gonadotropin (hCG).
Treatment should start within the first 7 days of the menstrual cycle and can be done with daily injections. The posology must be adapted case by case, on the basis of the individual response which must be evaluated through the ultrasound study of the size of the follicle and / or by measuring the estrogen.
Initiate therapy with daily administrations of 75-150 IU of FOSTIMON which can be increased or decreased if necessary by 37.5 IU (up to 75 IU) at intervals of 7 or 14 days to obtain an adequate but not excessive response.
If the patient does not respond adequately after 4 weeks of treatment, the course of therapy should be interrupted.
Once optimal response is achieved, 24 to 48 hours after the last FOSTIMON injection, up to 10,000 IU hCG should be administered.
It is preferable for the patient to have sexual intercourse for procreative purposes on both the day of hCG administration and the day after.
If an excessive response is obtained, treatment should be discontinued and hCG administration abandoned (see section 4.4). In the next cycle, treatment should be resumed at a lower dose.
Stimulation of superovulation for in vitro fertilization (IVF) programs and other assisted reproductive techniques
Administer 150 - 225 IU of FOSTIMON per day starting on the 2nd or 3rd day of the cycle.
The dose can then be adjusted based on individual response up to a maximum of 450 IU per day until adequate follicular development is achieved, as assessed by estrogen concentration monitoring and / or ultrasound examination.
To induce final follicular maturation, up to 10,000 IU of chorionic gonadotropin (hCG) should be administered in a single dose 24 to 48 hours after the last injection of FOSTIMON.
Commonly a down-regulation is caused with GnRH agonist drugs in order to suppress the endogenous LH peak and to control its tonic secretion.
The most common treatment scheme involves the use of FOSTIMON about 2 weeks after the start of therapy with the GnRH agonist: both treatments are continued until adequate follicular development is achieved.
An indicative scheme could be the following: 225 IU of FOSTIMON (s.c. or i.m.) for the first 7 days and, then, dose adjustment based on the ovarian response.
Men with hypo-gonadotropic hypogonadism
Pretreatment: hCG 2,000 IU i.m. or s.c. twice a week (possibly customizable to the subject), until normalization of serum testosterone levels.
Treatment: FOSTIMON 150 IU, a vial i.m or s.c. three times a week in combination with hCG 2,000 IU i.m. or s.c. twice a week (or at the dosage required to normalize the serum testosterone level), for 4 months, to be continued eventually up to 18 months, at the discretion of the prescribing specialist in case of lack of therapeutic response.
Method of administration
FOSTIMON can be used for intramuscular or subcutaneous injection.
The solution to be injected must be prepared immediately before use by dissolving the lyophilisate using the solvent attached to the package.
FOSTIMON should be administered immediately after reconstitution.
To avoid injections of large volumes, up to 5 vials of the product can be solubilized in 1 ml of solvent.
For instructions on reconstitution and dilution of the medicinal product before administration, see section 6.6.
04.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
In the woman
FOSTIMON is contraindicated in case of pregnancy and lactation, ovarian enlargement or cysts not referable to polycystic ovary syndrome; gynecological haemorrhages of unknown origin, carcinoma of the ovary, uterus and breast, tumors of the hypothalamus and pituitary.
FOSTIMON is contraindicated in women even when an effective response cannot be obtained due to: primary ovarian failure; malformations of the reproductive system incompatible with pregnancy, uterine fibroids incompatible with pregnancy.
In the "man
FOSTIMON is contraindicated in men when an effective response cannot be obtained, such as in primary testicular failure.
04.4 Special warnings and appropriate precautions for use
FOSTIMON can cause local reactions at the injection site.
Although no cases of viral contamination associated with the administration of gonadotropins extracted from human urine have been reported, the risk of transmission of known or unknown pathogens cannot be totally excluded.
Women
Before starting treatment with FOSTIMON the couple's infertility should be adequately assessed and any contraindications for pregnancy should be evaluated. In particular, patients should be examined for the presence of hypothyroidism, adrenocortical insufficiency, hyperprolactinaemia, hypothalamic tumors or pituitary and treated appropriately.
Although adherence to the recommended dosages of FOSTIMON minimizes the risk of ovarian hyperstimulation, the possibility of hyperstimulation and multiple ovulation must be considered and monitored during treatment.
This syndrome can become a serious clinical event characterized by large cysts that can easily rupture.
Significant hyperstimulation due to an excessive estrogen response can be avoided if hCG is not given to induce ovulation. It is advisable in these cases not to administer hCG and to advise the patient to refrain from having sexual intercourse for at least 4 days.
Patients who have undergone superovulation have an increased risk of hyperstimulation due to excessive estrogen response and multiple follicular development. Aspiration of all follicles prior to ovulation can reduce the incidence of hyperstimulation.
The risk of multiple pregnancies following the use of assisted reproductive techniques is related to the number of oocytes / embryos transferred. In other patients the incidence of multiple births and pregnancies is increased by FOSTIMON as by other products that stimulate ovulation. however, the majority of multiple conceptions are twins.
The rate of miscarriages is higher than in the normal population but is similar to the rate found in women with other fertility problems. In patients not subjected to superovulation, the possible presence of smaller, secondary follicles, in association with more than one dominant follicle viewable by ultrasound, is considered to be related to a higher incidence of hyperstimulation.
Men
Elevated levels of endogenous FSH are indicative of primary testicular failure. Such patients are unresponsive to FOSTIMON / hCG therapy.
Semen analysis is recommended 4-6 months after starting treatment to assess response.
Important information about some of the excipients
This medicinal product contains lactose. Patients with rare hereditary problems of galactose intolerance eg galactosemia due to the Lapp lactase deficiency should not take this medicine.
Allergic-type reactions in which lactose intolerance has been suspected, although not proven, have been reported rarely. It is important to consider the possible effect of lactose when administered to sensitive patients.
04.5 Interactions with other medicinal products and other forms of interaction
No significant adverse interactions have been reported during therapy with FOSTIMON. The concomitant use of FOSTIMON and other ovulation stimulating drugs may lead to an enhancement of the follicular response, while the concomitant use of a GnRH agonist drug, causing pituitary desensitization, may require an increase in the dosage of FOSTIMON necessary to obtain an adequate response. ovarian.
No incompatibilities have been reported between FOSTIMON and other drugs.
FOSTIMON must not be mixed with other drugs in the same syringe.
04.6 Pregnancy and breastfeeding
FOSTIMON should not be administered if you are pregnant or breastfeeding.
04.7 Effects on ability to drive and use machines
The state of attention and alertness and the common psychophysical abilities are not changed by the administration of FOSTIMON.
04.8 Undesirable effects
Adverse reactions are classified below by MedDRA organ class system and frequency. The frequency categories used are: very common (≥1 / 10), common (≥1 / 100 and
WOMEN
MEN
Mild or moderate ovarian hyperstimulation syndrome (OHSS) is a common report and should be considered an inherent risk of the ovarian stimulation procedure.
The first symptoms of ovarian hyperstimulation are pains in the lower abdomen sometimes in combination with nausea and vomiting. In severe cases, ovarian hyperstimulation syndrome with clear enlargement of the ovaries may be accompanied by fluid accumulation in the abdomen or chest and weight gain, as well as more serious thromboembolic complications which may rarely occur. Thromboembolic events may occur regardless of the condition. hyperstimulation syndrome.
A careful medical examination is recommended in these cases. In addition, FOSTIMON treatment should be discontinued and hCG treatment abandoned.
The incidence of multiple pregnancies is increased by FOSTIMON as well as by other drugs used to stimulate ovulation. The majority of multiple conceptions were found to be twins: in fertilization in vitro it is related to the number of embryos transferred.
In rare cases, the therapy with menotropin / chorionic gonadotropin has been accompanied by phenomena of arterial thromboembolism which could also occur during treatment with FOSTIMON / hCG.
The frequency of miscarriages is comparable to that seen in patients with other fertility problems. In patients with previous tubal disorders there is a possibility of ectopic pregnancies occurring.
Reporting of suspected adverse reactions
Reporting of suspected adverse reactions occurring after authorization of the medicinal product is important as it allows continuous monitoring of the benefit / risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system. "address www.agenziafarmaco.gov.it/it/responsabili.
04.9 Overdose
No overdose effects of FOSTIMON have been described; however, ovarian hyperstimulation syndrome may occur as described in section 4.4.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: gonadotropins and other ovulation stimulants: urofollitropin.
ATC code: G03GA04 - gonadotropins.
Women: FOSTIMON contains urophyllotropin, a hormone with only follicle-stimulating activity (FSH), highly purified starting from human post-menopausal gonodotropin (hMG).
The main effect of parenteral administration of FSH is the development of mature Graafian follicles.
Men: FOSTIMON, administered in combination with hCG for at least 4 months, induces spermatogenesis in men with FSH deficiency.
05.2 Pharmacokinetic properties
Following a single IM administration of 150 IU of urofollitropin in healthy volunteers, the FSH peak is reached in 10 ± 4 hours. A 4 ± 2 IU / l increase in FSH is obtained from baseline values. 72 hours after administration of 150 IU urofollitropin, serum FSH levels are still significantly higher than baseline.
The elimination half-life is approximately 30-40 hours.
05.3 Preclinical safety data
Animal toxicology and tolerability studies did not reveal any noteworthy effects.
In acute toxicity tests performed on mice and rats, doses of urofollitropin above 1500 IU / kg were used, in subacute toxicity studies performed on rats and monkeys, doses up to 100 IU / kg / day were used for 13 weeks .In mutagenicity studies, urofollitropin did not exhibit mutagenic activity.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
The lyophilized powder of the vial contains: lactose.
Each 1 ml vial / pre-filled syringe contains: saline.
06.2 Incompatibility
There are no chemical incompatibilities with FOSTIMON, but it is recommended not to mix the medicine with other drugs in the same syringe.
06.3 Period of validity
24 months.
06.4 Special precautions for storage
Do not store above 25 ° C.
Store in the original package to protect the medicine from light.
06.5 Nature of the immediate packaging and contents of the package
FOSTIMON is available in the following packages:
FOSTIMON 75 IU / 1 ml powder and solvent for solution for injection:
§ pack of 1 vial of 75 IU powder + 1 vial of solvent;
§ pack of 1 vial of 75 IU powder + 1 pre-filled syringe of solvent with n. 2 associated needles;
§ pack of 5 vials of 75 IU powder + 5 ampoules of solvent;
§ pack of 5 vials of 75 IU powder + 5 pre-filled syringes of solvent each with n. 2 associated needles;
§ pack of 10 vials of 75 IU powder + 10 ampoules of solvent;
§ pack of 10 vials of 75 IU powder + 10 pre-filled syringes of solvent each with n. 2 associated needles.
FOSTIMON 150 IU / 1 ml powder and solvent for solution for injection:
§ pack of 1 vial of 150 IU powder + 1 vial of solvent;
§ pack of 1 vial of 150 IU powder + 1 pre-filled syringe of solvent with n. 2 associated needles;
§ pack of 5 vials of 150 IU powder + 5 ampoules of solvent;
§ pack of 5 vials of 150 IU powder + 5 pre-filled syringes of solvent each with n. 2 associated needles;
§ pack of 10 vials of 150 IU powder + 10 ampoules of solvent;
§ pack of 10 vials of 150 IU powder + 10 pre-filled syringes of solvent each with n. 2 associated needles.
FOSTIMON 225 IU / 1 ml powder and solvent for solution for injection:
§ pack of 1 vial of 225 IU powder + 1 pre-filled syringe of solvent with n. 2 associated needles;
§ pack of 5 vials of 225 IU powder + 5 pre-filled syringes of solvent each with n. 2 associated needles;
§ pack of 10 vials of 225 IU powder + 10 pre-filled syringes of solvent each with n. 2 associated needles.
FOSTIMON 300 IU / 1 ml powder and solvent for solution for injection:
§ pack of 1 vial of 300 IU powder + 1 pre-filled syringe of solvent with n. 2 associated needles;
§ pack of 5 vials of 300 IU powder + 5 pre-filled syringes of solvent each with n. 2 associated needles;
§ pack of 10 vials of 300 IU powder + 10 pre-filled syringes of solvent each with n. 2 associated needles.
Containers:
Vial in class I glass with cap in elastomer material protected by an aluminum ring nut with "flip-off" plastic cover.
Vial in class I glass.
Pre-filled syringe in class I glass with tip equipped with cap in elastomer material, piston seal in elastomer material and equipped with back-stop device.
The following needles are provided with each pre-filled syringe:
§ 21 gauge needle (0.8 mm x 40 mm) with green cap for reconstitution of the solution to be injected and intramuscular administration;
§ 27 gauge needle (0.4 mm x 12 mm) with gray cap for subcutaneous administration.
Not all pack sizes may be marketed.
06.6 Instructions for use and handling
To avoid possible loss of FSH following adhesion to the syringe wall, FOSTIMON should be administered immediately after reconstitution. However, the degree of dispersion that may occur has no significant effect on the dose required for clinical efficacy.
Instructions for reconstitution of the solution
1. Preparation
Each vial is intended for single use only and is for single use only. The medicine must be reconstituted under sterile conditions by working on a clean surface and after washing the hands thoroughly.
Solvent in vial: with a syringe, withdraw the solvent contained in the vial.
Solvent in pre-filled syringe: Remove the cap from the pre-filled syringe. Insert the 21 gauge needle (green cap) suitable for reconstitution of the solution.
2. Reconstitution of the solution
• Remove the flip-off lid from the vial of lyophilized powder;
• Inject the solvent into the vial through the elastomer seal;
• Slowly swirl the vial to dissolve the powder;
• Once the powder has completely dissolved (this usually happens immediately), draw up the solution with the syringe. The solution must be clear and transparent.
3. Administration
If necessary, discard the needle used for reconstitution and insert the appropriate needle for administration.
Disposal
Unused medicine and wastes derived from this medicine must be disposed of in accordance with local regulations.
07.0 MARKETING AUTHORIZATION HOLDER
IBSA Farmaceutici Italia S.r.l., Via Martiri di Cefalonia, 2, 26900 Lodi
08.0 MARKETING AUTHORIZATION NUMBER
FOSTIMON 75 IU / 1 ml powder and solvent for solution for injection:
§ Pack of 1 vial + 1 ampoule AIC: 032921013
§ Pack of 1 vial + 1 pre-filled syringe AIC: 032921076
§ Pack of 5 vials + 5 vials AIC: 032921037
§ Pack of 5 vials + 5 pre-filled syringes AIC: 032921088
§ Box of 10 vials + 10 vials AIC: 032921049
§ Box of 10 vials + 10 pre-filled syringes AIC: 032921090
FOSTIMON 150 IU / 1 ml powder and solvent for solution for injection:
§ Pack of 1 vial + 1 ampoule AIC: 032921025
§ Pack of 1 vial + 1 pre-filled syringe AIC: 032921102
§ Pack of 5 vials + 5 vials AIC: 032921052
§ Pack of 5 vials + 5 pre-filled syringes AIC: 032921114
§ Box of 10 vials + 10 vials AIC: 032921064
§ Box of 10 vials + 10 pre-filled syringes AIC: 032921126
FOSTIMON 225 IU / 1 ml powder and solvent for solution for injection:
§ Pack of 1 vial + 1 pre-filled syringe AIC: 032921138
§ Pack of 5 vials + 5 pre-filled syringes AIC: 032921140
§ Box of 10 vials + 10 pre-filled syringes AIC: 032921153
FOSTIMON 300 IU / 1 ml powder and solvent for solution for injection:
§ Pack of 1 vial + 1 pre-filled syringe AIC: 032921165
§ Pack of 5 vials + 5 pre-filled syringes AIC: 032921177
§ Box of 10 vials + 10 pre-filled syringes AIC: 032921189
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
FOSTIMON 75 IU / 1 ml powder and solvent for solution for injection:
§ Pack of 1 vial + 1 ampoule 12/2008
§ Pack size of 1 vial + 1 pre-filled syringe 01/2014
§ Pack of 5 vials + 5 vials 12/2008
§ Pack of 5 vials + 5 pre-filled syringes 01/2014
§ Box of 10 vials + 10 vials 12/2008
§ Box of 10 vials + 10 pre-filled syringes 01/2014
FOSTIMON 150 IU / 1 ml powder and solvent for solution for injection:
§ Pack of 1 vial + 1 ampoule 12/2008
§ Pack size of 1 vial + 1 pre-filled syringe 01/2014
§ Pack of 5 vials + 5 vials 12/2008
§ Pack of 5 vials + 5 pre-filled syringes 01/2014
§ Box of 10 vials + 10 vials 12/2008
§ Box of 10 vials + 10 pre-filled syringes 01/2014
FOSTIMON 225 IU / 1 ml powder and solvent for solution for injection:
§ Pack size of 1 vial + 1 pre-filled syringe 11/2014
§ Pack of 5 vials + 5 pre-filled syringes 11/2014
§ Box of 10 vials + 10 pre-filled syringes 11/2014
FOSTIMON 300 IU / 1 ml powder and solvent for solution for injection:
§ Pack size of 1 vial + 1 pre-filled syringe 11/2014
§ Pack of 5 vials + 5 pre-filled syringes 11/2014
§ Box of 10 vials + 10 pre-filled syringes 11/2014
10.0 DATE OF REVISION OF THE TEXT
12/2015
