75 IU and 150 IU powder and solvent for injection, solution
Urofollitropin

1. What Fostimon Set is and what it is used for

  • Fostimon is used to induce ovulation in women who are not ovulating and who have not responded to any other drug treatment (clomiphene citrate).
  • Fostimon is used to develop more follicles (egg vesicles), and thus more eggs, in women undergoing assisted reproduction.

The active substance in Fostimon Set is a very pure human follicle-stimulating hormone ( FSH ) that belongs to a group of medicines called gonadotropins.

This medicine should only be used under the supervision of a doctor.

Urofollitropin contained in Fostimon Set may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.

2. What you need to know before using Fostimon Set

Do not use Fostimon Set

Before starting treatment, your and your partner’s fertility should be evaluated.

Do not use Fostimon Set if you have any of the following conditions:

  • enlargement of the ovaries or ovarian cysts not caused by a hormonal disorder ( polycystic ovary syndrome ),
  • bleeding, where the cause is not known,
  • malignant tumor of the ovaries, uterus, or breasts,
  • abnormal swelling ( tumor ) in pituitary gland or hypothalamus (brain),
  • if you are allergic (hypersensitive) to urofollitropin or any of the other ingredients of this medicine (listed in section 6).

This medicine should not be used in early menopause, genital malformation, or in certain tumors of the uterus that would make a normal pregnancy impossible.

Take special care with Fostimon Set:

Tell your doctor if you have had allergic reactions to similar medicines. To date, no allergic reactions have been reported with Fostimon Set.

This treatment increases your risk of developing a condition called ovarian hyperstimulation syndrome (OHSS), (see section Possible side effects ). If hyperstimulation of the ovaries occurs, treatment should be discontinued and pregnancy avoided. The first signs of ovarian hyperstimulation are pain in the lower abdomen as well as nausea, vomiting, and weight gain. If these symptoms occur, contact your doctor as soon as possible. In severe, but rare, cases of ovarian hyperstimulation syndrome, the ovaries may become enlarged and fluid may accumulate in the abdomen or thoracic cavity.

The drug used to achieve the final release of mature eggs (containing human chorionic gonadotropin – hCG ) may increase the risk of OHSS. It is therefore not advisable to be treated with hCG when OHSS has started to develop and you should not have intercourse for at least 4 days, even if you use a barrier prevention method.

It should be noted that miscarriages are more common in women with fertility problems than in the rest of the population.

In patients undergoing ovulation stimulation, the incidence of multiple births or multiple births increases compared with natural conception but can be minimized by using the recommended dose.

Women with damaged fallopian tubes have a slightly increased risk of ectopic pregnancy.

Multiple births and characteristics of the parents undergoing fertility treatment (eg mother’s age, sperm quality) can be associated with an increased risk of congenital malformations.

Treatment with Fostimon Set can, just like the pregnancy itself, increase the risk of getting thrombosis. Thrombosis is the formation of a blood clot in a blood vessel, usually in the veins of the legs or lungs.

Discuss this with your doctor before starting treatment, especially:

  • if you know you have an increased risk of getting a blood clot
  • if you, or anyone else in your immediate family, has had a thrombosis
  • if you are severely overweight.

This medicine is made from human urine. The risk of transmission of infectious substances, which can cause infection or disease, can not be completely ruled out. This risk is limited by the use of manufacturing methods that include removal of viruses, in particular HIV, herpes virus, and papillomavirus.

No cases of virus infection have been reported.

Other medicines and Fostimon Set

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Pregnancy and breastfeeding

Fostimon Set should not be used if you are pregnant or breast-feeding.

Driving and using machines

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

3. How to use Fostimon Set

Dosage and duration of treatment:

Always use this medicine exactly as your doctor has told you. Consult a doctor if you are unsure.

Women who do not ovulate and have irregular periods or do not menstruate:

If you are menstruating, treatment should be started within the first 7 days after menstruation begins (the first 7 days of the menstrual cycle).

You get an injection every day, under the skin ( subcutaneously ).

The usual starting dose is 75-150 IU FSH (Fostimon Set) every day. If necessary, this dose can be increased by 37.5-75 IU at 7 or preferably at 14-day intervals to achieve the appropriate treatment response.

The maximum daily dose is usually not higher than 225 IU.

If your doctor does not see any effect after 4 weeks of treatment, the treatment cycle will be interrupted. In the next cycle, your doctor will prescribe a treatment with a higher starting dose than in the previous cycle.

To induce final follicular maturation and ovulation when sufficient effect is achieved (sufficient growth of the ovaries), an injection of another drug (containing hormone et hCG ) is given. This is done 24-48 hours after the last Fostimon Set injection. You are recommended to have sexual intercourse on the day of hCG – injection a given and even the next day.

If the effect becomes too strong, treatment should be discontinued and hCG will not be given (see Possible side effects ). In the next cycle, your doctor will prescribe a dose that is lower than the one in the previous cycle.

Women undergoing ovarian stimulation for multiple follicle development before in vitro fertilization or other assisted reproduction techniques:

Option 1. If you are menstruating:

Treatment should be started 2 or 3 days after the start of menstruation (days 2 to 3 of the menstrual cycle).

You will receive one injection under the skin ( subcutaneous injection ) per day.

The usual dosage for overstimulation of the ovaries is 150-225 IU Fostimon Set every day. The treatment is continued with a dose that is adapted to you until appropriate follicle development has been achieved. This is usually achieved on the tenth day of treatment (may vary between 5-20 days) and checked by blood tests and/or ultrasound examination.

The maximum daily dose is usually 450 IU.

When satisfactory follicular maturation has been achieved, an injection of another drug is given to induce final follicular maturation. This medicine contains up to 10,000 IU human chorionic gonadotropin ( hCG ). It is given 24-48 hours after the last Fostimon Set injection.

Egg cells will be collected about 35 hours later.

Alternative 2. In the use of the gonadotropin-releasing hormone agonist ( GnRH – agonist ) given Fostipur Set approximately 2 weeks after treatment with GnRH – agonist a begun. Both treatments continue until appropriate follicular development is achieved. Fostimon Set treatment is given as one subcutaneous injection per day.

Example: After 2 weeks of treatment with GnRH agonist, 150-225 IU Fostimon Set can be given for the following 7 days. Then dose one is adjusted according to the response from the ovaries.

How to give Fostimon Set:

Fostimon Set is given as a slow subcutaneous (under the skin) injection. Each bottle is for single use only and the solution should be given immediately after reconstitution.

After appropriate training, your doctor may ask you to inject Fostimon Set yourself.

For the first time, the doctor should:

  • let you practice how to proceed to give a subcutaneous injection
  • show you suitable injection sites on the body
  • show how to prepare the injection solution, a
  • Be sure to show you how to make the right dose of the injection solution, a

Carefully read the following instructions before injecting Fostimon Set yourself:

Preparation and injection of 1 bottle of Fostimon Set, using 1 powder bottle

Injection should be prepared immediately before injection. The bottle is for single use only. The drug must be prepared under sterile conditions.

Fostimon Set may only be prepared with the supplied diluent.

Prepare a clean work surface and wash your hands before preparing the solution. The hands and tools you use must be as clean as possible.

Place the following equipment on the clean work surface:

  • 2 cotton swabs moistened with alcohol (not included in the package)
  • 1 vial of Fostimon Set powder
  • 1 pre-filled syringe with diluent
  • 1 injection needle for preparation of solution for injection one
  • 1 thin injection needle for subcutaneous injection

Preparation of solution for injection with 1 powder vial

Prepare the injection solution:


1.Remove the lid from the prefilled syringe with the solvent and on the needle for preparation of solution (a long needle). Carefully place the syringe on the clean work surface to avoid touching the needle.


2.Remove the colored plastic cap from the powder bottle by gently pushing it upwards. Disinfect the top of the rubber stopper by wiping it with an alcohol swab and letting it dry.

3.Pick up the syringe, remove the needle cover and slowly spray the diluent into the powder bottle through the center of the top of the rubber stopper. Press the plunger firmly down to spray all the diluent on the powder. On the outer edge of the syringe is an aid that prevents the plunger plug from being accidentally pulled out of the syringe barrel and facilitates the handling of the syringe when injected. DO NOT SHAKE, but gently roll the vial between your hands until the powder is completely dissolved. Avoid foaming.

4.When the powder has dissolved (which usually happens immediately), slowly draw up the solution into the syringe: While the needle is still in place, turn the bottle upside down. Check that the needle tip is below the fluid level. Gently pull the plunger to soak up any Fostimon Set solution in the syringe. Check that the solution is clear and colorless.

Preparation of higher dose er, using more than 1 powder bottle

If your doctor has recommended a higher dose for you, this can be accomplished by using more than 1 powder bottle for a pre-filled syringe of diluent.

When preparing more than one Vostimon Set vial, at the end of step 4, the contents of the first vial are withdrawn into the syringe and slowly injected into a second vial. Repeat steps 2 to 4 for the second and subsequent vials until the contents of the number of vials corresponding to the prescribed dose one are dissolved (within the limit of the maximum total dose one of 450 IU, corresponding to a maximum of 6 vials for Fostimon Set 75 IU, 3 vials for Fostimon Set 150 IU, or 2 bottles for Fostimon Set 225 IU).

Your doctor may increase your dose by 37.5 IU. This dosage can be achieved with 0.5 ml of Fostimon Set 75 IU solution.

To do this, dissolve the contents of a 75 IU vial according to steps 2 to 3 as described above and withdraw half of this reconstituted solution (0.5 ml) back into the syringe according to step 4.

In this situation you will have two solutions to inject: the first dissolved in 1 ml and the second containing 37.5 IU in 0.5 ml.

Both solutions should be injected with their own syringes according to the following steps.

The solution must be clear and colorless.

Inject the drug subcutaneously (under the skin):


When the syringe contains the prescribed dose one, put on the needle cover. Remove the needle from the syringe and replace it with the thin subcutaneous injection needle with its needle guard. Press the thin needle firmly onto the syringe plunger, then turn it slightly to ensure that it is secure and to provide a tight seal. Remove the needle cover. Hold the syringe with the needle pointing upwards and tap the side of the syringe gently to force any air bubbles to the syringe tip.

Then gently push the plunger upwards until a drop of liquid appears on the syringe tip. Do not inject the solution if it contains particles or is cloudy.

The injection site
 


Your doctor or nurse has already shown you where to inject the medicine. Common places are the thigh or lower abdomen below the navel. Wipe the injection site with an alcohol-soaked cotton swab.

Insert the needle:



Pinch the skin together. Insert the needle with the other hand with a quick movement at an angle of 45 ° to 90 °.

Inject the solution:

  • Inject under the skin as shown. Do not inject directly into a vein. Press the plunger down slowly and at a steady pace, so that the solution is injected correctly and the skin is not damaged.
  • Take the time you need to inject the volume prescribed by your doctor. As described in the reconstitution instructions for the solution, depending on the dose prescribed by your doctor, you may not use the full amount of solution.

Remove the needle:

  • Quickly pull out the needle and press an alcohol-soaked cotton swab against the injection site. Massage the injection site gently while still maintaining pressure. It helps to distribute the solution and reduces discomfort.

Discard all used material:

Any remaining solution or waste should be disposed of by local requirements. Once you have finished injecting one, throw all the needles and empty syringes into a suitable container.

If you use too much of Fostimon Set 

The effect of an overdose of Fostimon Set is not known, but ovarian hyperstimulation can be expected (see section 4 “Possible side effects”). If you are taking more Fostimon Seiten than you should, talk to your doctor or pharmacist.

If you have injected too much medicine or if e.g. if a child has inadvertently ingested the medicine, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.

If you forget to use Fostimon Set

Take dose one at the next predetermined injection. Do not take a double dose to make up for a forgotten dose.

If you stop taking Fostimon

Do not quit on your own initiative. Always consult your doctor if you are considering stopping this medicine.

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

4. Possible side effects

Like all medicines, Fostimon Set can cause side effects, although not everybody gets them.

The following side effect is serious and requires immediate treatment if you experience it. You should stop taking Fostimon Set and contact your doctor immediately if the following occur:

Common, affects 1 to 10 users in 100:

• Ovarian hyperstimulation syndrome (see section 2 for more information)

The following side effects have also been reported:

Common, affects 1 to 10 users in 100:

• headache

• weather voltage

• constipation

• injection site pain.

Uncommon affects 1 to 10 users in 1,000:

• overactive thyroid gland

• Mood swings

• fatigue

• dizziness

• shortness of breath

• nosebleeds

• nausea, indigestion, abdominal pain

• rash, itching

• hot flashes

• Cystitis

• breast enlargement, chest pain

• difficult to stop bleeding

Redness, pain, and bruising at the injection site may occur (frequency not known).

See section 2 for more information on the risk of blood clots, ectopic pregnancies, multiple pregnancies, and miscarriages.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5. How to store Fostimon Set

Keep this medicine out of the sight and reach of children.

Do not store above 25 ° C. Store the pre-filled syringe with solvent in the outer carton. Sensitive to light.

Do not use this medicine after the expiry date which is stated on the carton. The expiration date is the last day of the specified month.

A prepared solution should be used immediately.

Only use Fostimon Set if the liquid is ready. After reconstitution, the solution must be clear and colorless.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

The active substance is

Urofollitropin

75 IU in one vial: 1 ml reconstituted solution contains either 75 IU, 150 IU, 225 IU, 300 IU, 375 IU, or 450 IU urofollitropin when 1, 2, 3, 4, 5, or 6 powder vials have been used for dilution in 1 ml of diluent.

150 IU in one vial: 1 ml of reconstituted solution contains either 150 IU, 300 IU, or 450 IU urofollitropin when 1, 2, or 3 powder vials, respectively, have been used for dilution in 1 ml of diluent.

The specific in vivo activity is equivalent to or above 5000 IU FSH per mg protein.

  • Other ingredients are Powder: Lactose monohydrate. Diluent: Sodium chloride and water for injections.

What the medicine looks like and the contents of the pack

Fostimon Set contains powder and solvent for solution for injection. One set contains powder in a vial (75 IU or 150 IU) of diluent in a pre-filled syringe (1 ml), a needle for reconstitution, and a needle for subcutaneous injection. The package contains 1, 5, or 10 sets.

Marketing Authorisation Holder:

IBSA Farmaceutici Italia Srl

Via Martiri di Cefalonia 2, 26900 Lodi

Italy

Manufacturer and release:

IBSA FARMACEUTICI ITALIA SrL

Via Martiri di Cefalonia

26900 LODI (LO)

Italy

This medicinal product is authorized under European Economic Cooperation under the names:

Austria: Fostimon PFS

Belgium: Fostimon Kit

Cyprus: Fostimon PFS

Denmark: Fostimon Set

Finland: Fostimon Set

France: Fostimonkit

Luxembourg: Fostimon Kit

Ireland: Fostimon PFS

Netherlands: Fostimon Set

Norway: Fostimon Set

Spain: Fostipur Kit

United Kingdom: Fostimon PFS

Muhammad Nadeem

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