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1. Fostimon Pfs 225 Iu Powder And Solvent For Solution For Injection
2. Fostimon Pfs 225 Iu Powder And Solvent For Solution For Injection

Read all of this leaflet carefully before you

start using this medicine because it contains

important information for you.

-    Keep this leaflet. You may need to read it again.

-    If you have any further questions, please ask your doctor or pharmacist.

-    This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

-- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

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

2.    What you need to know before you use Fostimon PFS

3.    How to take Fostimon PFS

4.    Possible side-effects

5.    How to store Fostimon PFS

6.    Content of the pack and other information

1. WHAT FOSTIMON PFS IS AND WHAT IT IS USED FOR

-- Fostimon PFS is used to promote ovulation in women who are not ovulating and who have not responded to other treatment (clomifene citrate).

-- It is used to bring about the development of several follicles (and therefore several eggs) in women receiving fertility treatment. Urofollitropin is a highly purified human follicle stimulating hormone, belonging to a group of medicines called gonadotropins.

This medicinal product must be used under the supervision of your doctor.

2. WHAT YOU NEED TO KNOW BEFORE YOU USE FOSTIMON PFS

You and your partner's fertility will be evaluated before your treatment is started.

DO NOT USE FOSTIMON PFS if you have

any of the following:

-    Enlarged ovaries or cysts not caused by a hormonal disorder (polycystic ovarian disease).

-    Bleeding of unknown cause.

-- Cancer of the ovaries, uterus or breast.

-    Abnormal swelling (tumour) of the pituitary gland or hypothalamus (brain).

-    Hypersensitivity (allergy) to Urofollitropin or any of the ingredients in Fostimon PFS.

This medicine should not be used if you have an early menopause, a malformation of the sexual organs or certain tumours of the womb that would make a normal pregnancy impossible.

TAKE SPECIAL CARE WITH FOSTIMON PFS

Although no allergic reactions to Fostimon PFS have yet been reported, you should tell your doctor if you have an allergic reaction to similar medicines.

This treatment increases your risk of developing a condition known as ovarian hyperstimulation syndrome (OHSS) (see Possible side effects). If ovarian hyperstimulation occurs then your treatment will be stopped and pregnancy will be avoided. The first signs of ovarian hyperstimulation are pain in the lower abdominal region as well as nausea (feeling sick), vomiting and weight gain. If these symptoms occur you should be examined by your doctor as soon as possible. In serious, but rare cases, the ovaries can become enlarged and fluid can build up in the abdomen or chest. The drug used to bring about the final release of mature eggs (containing human chorionic gonadotropin-hCG) can increase the likelihood of OHSS. It is therefore not advisable to use hCG in cases where OHSS is developing and you should not have sexual intercourse even if using a barrier methods of contraception for at least 4 days.

It should be noted that women with fertility problems have a higher rate of miscarriages than the normal population.

In patients having treatment to help ovulation, the occurrence of multiple pregnancies and births is increased compared to natural conception. However, this risk can be minimised by using the recommended dose.

There is a slightly increased risk of extra-uterine pregnancy (an ectopic pregnancy) in women with damaged fallopian tubes.

Multiple pregnancies and characteristics of the parents undergoing fertility treatments (e.g. maternal age, sperm characteristics) may be associated with an increased risk of birth defects.

Treatment with Fostimon PFS, just as pregnancy itself, may increase the chance of having thrombosis. Thrombosis is the formation of a blood clot in a blood vessel, most often in the veins of the legs or the lungs.

Please discuss this with your doctor, before starting treatment, especially:

-    if you already know you have an increased chance of having thrombosis

-    if you, or anyone in your immediate family, have ever had a thrombosis

-    if you are severely overweight.

This medicine is prepared from human urine. The risk of passing on an organism that could cause an infection or disease cannot be definitely excluded; however, this is limited by steps in the manufacturing process to remove viruses, especially HIV, Herpes virus and Papillomavirus.

No cases of viral contamination have been reported.

Other medicines and Fostimon PFS

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

Pregnancy and breast-feeding

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

3. HOW TO USE FOSTIMON PFS

Dosage and duration of the treatment:

Always take this medicine exactly as your doctor has told you. Check with your doctor if you are not sure.

Women who are not ovulating and are having irregular periods or no periods at all:

If you are having periods, the treatment should start within 7 days of the start of your period (the first 7 days of the menstrual cycle).

You will be given 1 injection per day under your skin (subcutaneous).

The usual starting dose is 75 to 150 IU of FSH (Fostimon PFS) every day. This dose may be increased, if necessary, by 37.5 to 75 IU at 7 or preferably 14-day intervals, to get the right response.

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

If your doctor cannot see a response after 4 weeks of treatment, that treatment cycle will be stopped. For the following cycle, your doctor will prescribe a higher starting dose.

When you get a good response (satisfying follicle growth) you will be given a single injection of another medicine (hCG), which is used to bring about the final maturing of the follicle and release of eggs. This will be given 24 to 48 hours after the last Fostimon PFS injection. You should have sexual intercourse the day hCG is given and again on the following day.

If you have too great a response, treatment will be stopped and hCG will not be given (see Possible side effects). For the following cycle, your doctor will prescribe a lower starting dose.

Women undergoing ovarian stimulation for multiple follicular development prior to in vitro fertilisation or other assisted reproductive techniques:

Situation 1 - If you are having periods The treatment should start 2 or 3 days after the start of your periods (the first 2 or 3 days of the menstrual cycle).

You will be given 1 injection per day by the subcutaneous route.

The usual starting dose for superovulation is 150 to 225 IU of Fostimon PFS every day. Treatment is continued, with the dose adjusted according to your response, until you are achieving adequate follicular development. This is usually achieved on average by the 10^th day of treatment (range 5 to 20 days) and is measured by taking blood samples and/or ultrasound examinations.

The maximum dosage is in general of 450 IU/ day.

Once adequate follicular development is achieved you will be given a single injection of a medicine used to bring about final maturing of the follicle; this medicine contains up to 10,000 IU human chorionic gonadotropin (hCG). It will be given 24 to 48 hours after the last Fostimon PFS injection.

Oocytes will be punctured about 35 hours later.

Situation 2 - When a gonadotropin-releasing hormone (GnRH) agonist is used Fostimon PFS will be given approximately 2 weeks after the start of this treatment. Both treatments are continued until adequate follicular development is achieved. Fostimon PFS will be given as 1 injection per day by the subcutaneous route. For example, following two weeks of treatment with an agonist of GnRH, 150 to 225 IU of Fostimon PFS will be given for the first 7 days. The dose will then be adjusted according to the ovarian response.

How Fostimon PFS should be given:

Fostimon PFS is given by injection under your skin (by the subcutaneous route).

Each vial should be used only once and the injection should be used as soon as it is prepared.

After suitable advice and training your doctor may ask you to inject Fostimon PFS yourself.

For the first time, your doctor must:

-    let you practise giving yourself a subcutaneous injection,

-    have shown you the possible places where you can inject yourself,

-    have shown you how to prepare the solution for injection,

-    have explained how to prepare the right dose of injection.

Before injecting Fostimon PFS yourself, read the following instructions carefully.

How to prepare and inject Fostimon PFS, using 1 vial of powder:

The solution must be prepared just before injection. One vial is for single use only. The medicinal product must be reconstituted under aseptic conditions.

Fostimon PFS must only be reconstituted with the solvent provided in the package.

Prepare a clean surface and wash your hands before the solution is reconstituted. It is important that your hands and the items you use are as clean as possible.

Set out all the following items on the clean surface:

-    two cotton wool alcohol swabs (not provided),

-    one vial containing Fostimon PFS powder,

-    one pre-filled syringe with solvent,

-    one needle for preparing the injection,

-    a fine bore needle for subcutaneous injection.

Reconstitution of the solution for injection using 1 vial of powder

Prepare the solution for the injection:

1.

Remove the cap from the pre-filled syringe; attach the reconstitution needle (long needle) to the syringe.

Carefully place the syringe on the clean surface and avoid touching the needle.

2.

•    Remove the coloured plastic cap from the powder vial by gently pushing it upwards.

•    Disinfect the top of the rubber stopper by wiping it with an alcohol swab and allow to dry.

3.

•    Pick up the syringe, remove the needle shield and slowly inject the solvent into the powder vial through the middle of the top of the rubber stopper.

•    Press the plunger down firmly to squirt all the solution onto the powder.

A backstop device is fitted on the syringe flange to prevent inadvertent withdrawal of the stopper from the syringe barrel and to improve syringe handling when giving the injection.

DO NOT SHAKE, but gently roll the vial between the hands until the powder is completely dissolved, taking care to avoid creating foam.

4.

Once the powder is dissolved (which, in general, occurs immediately), slowly draw the solution into the syringe:

•    With the needle still inserted, turn the vial upside down.

•    Make sure the needle tip is underneath the level of the liquid.

•    Gently pull the plunger to draw all the Fostimon PFS solution up into the syringe.

•    Check that the reconstituted solution is clear and colourless.

Preparation of higher doses, using more than 1 vial of powder

If your doctor has recommended higher doses for you, this can be achieved by using more than one vial powder with one pre-filled syringe of solvent.

When reconstituting more than 1 vial of Fostimon PFS, at the end of step 4 above, draw the reconstituted contents of the first vial back into the syringe, and slowly inject into a second vial. Repeat steps 2 to 4 for the second and subsequent vials, and until the contents of the required number of vials equivalent to the prescribed dosage are dissolved (within the limit of the maximum total dosage of 450 IU, corresponding to a maximum of 6 vials of Fostimon PFS 75 IU, 3 vials of Fostimon PFS 150 IU, or 2 vials of Fostimon PFS 225 IU).

Your doctor may increase your dose by 37.5 IU which represents half a vial of Fostimon PFS 75 IU. For this you should reconstitute the contents of

the 75 IU vial according to steps 2 to 3 described above and draw half of this reconstituted solution (0.5 ml) back into the syringe according to step 4.

In that situation you will have two preparations to be injected: the first preparation reconstituted in 1 ml and the second containing 37.5 IU in 0.5 ml.

Both preparations will be injected with their own syringe according to the following steps.

The solution must be clear and colourless.

your medicine subcutaneously:

•    When the syringe contains the described dose, attach the protective cap of the needle. Remove the needle from the syringe and replace it with the fine bore needle for subcutaneous injection including its protective cap.

•    Push the fine bore needle onto the syringe barrel, then twist it slightly to ensure it is fully screwed on and to create a firm seal.

•    Remove the protective cap of the needle. Hold the syringe with the needle pointing upwards and gently tap the side of the syringe to force any air bubbles up to the top;

•    Push the plunger until a bead of liquid appears at the tip of the needle.

•    Do not use if it contains any particles or is cloudy.

The injection site:

•    Your doctor or nurse will have already advised you where on your body to inject your medicine. The usual places are the thigh or the lower abdominal wall below the navel.

•    Wipe the injection site with an alcohol swab. Inserting the needle:

Injecting the solution:

• Inject under the skin as you were shown. Do not inject directly into a vein. Push the plunger slowly and steadily, so the solution is correctly injected and the skin tissues are not damaged.

Take as much time as you need to inject the volume of solution prescribed. As described for the preparation of the solution, depending on the dosage prescribed by your doctor, you may not use the entire volume of the solution.

Removing the needle:

• Pull the syringe out quickly and apply pressure to the injection site with a swab containing disinfectant. A gentle massage of the site - while still maintaining pressure - helps disperse the Fostimon PFS solution and relieve any discomfort.

Dispose of all used items:

Any unused product or waste material should be disposed of in accordance with local requirements (once the injection is ended, all the needles and empty syringes should be disposed of in an appropriate container).

If you use more Fostimon PFS than you should:

The effects of an overdose of Fostimon PFS are unknown, nevertheless, one could expect ovarian hyperstimulation syndrome to occur (see Possible side effects). If you use more Fostimon PFS than you should, speak to your doctor or pharmacist.

If you forget to use Fostimon PFS:

Take it at the next normal time for an injection. Do not take a double dose to make up for a forgotten dose.

If you stop using Fostimon PFS:

Do not stop on your own initiative: Always consult your doctor if you are considering stopping this medicine. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

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

The following side effect is important and will require immediate action if you experience it. You should stop taking Fostimon PFS and see your doctor immediately if the following occurs:

Common, affects 1 to 10 users in 100:

-    Ovarian Hyperstimulation Syndrome (see Section 2 for additional information)

The following side-effects have also been reported:

Common, affects 1 to 10 users in 100:

-- Headache

-    - bloated abdomen -- constipation

-- pain at the injection site.

Uncommon, affects 1 to 10 users in 1,000:

-- Overactive thyroid gland -- Mood swings -- Tiredness

-    Dizziness

-- Breathlessness -- Nose bleeds

-- Nausea, indigestion, abdominal pain -- Skin rash, itch,

-- Hot flush -- Cystitis

-- Breast enlargement, breast pain -- Difficulty stopping bleeding

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

See section 2 for additional information on risk of blood clots, ectopic pregnancy, multiple pregnancy and miscarriage.

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

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 direct (see details below). IRELAND: HPRA Pharmacovigiliance Earlsfort Terrace, IRL - Dublin 2;

Tel: +353 1 6764971;

Fax: +353 1 6762517;

Website: www.hpra.ie e-mail: medsafety@hpra.ie UNITED KINGDOM: Yellow Card Scheme. Website: www.mhra.gov.uk/yellowcard

By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE FOSTIMON PFS

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

Do not store above 25° C. Keep the vial and the pre-filled syringe of solvent in the outer carton in order to protect from light.

Do not use this medicine after the expiry date which is stated on the outer carton, the vial, and the pre-filled syringe of solvent. The expiry date refers to the last day or the month.

Use immediately after reconstitution.

Do not use Fostimon PFS if you notice the solution does not look clear. After reconstitution the solution must be clear and colourless.

Do not throw away any medicines via wastewater. Ask your pharmacist how to safely dispose of medicines you no longer use. These measures will help protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Fostimon PFS contains The active substance is Urofollitropin

One vial contains 225 IU of urofollitropin (follicle-stimulating hormone FSH): 1 ml of reconstituted solution contains either 225 IU or 450 IU of urofollitropin when respectively 1 or 2 vials of product are reconstituted in 1 ml of solvent.

One vial contains 300 IU of urofollitropin (follicle-stimulating hormone FSH): 1 ml of reconstituted solution contains 300 IU of urofollitropin.

The specific in vivo activity is equal or superior to 5000 IU of FSH per mg of protein.

The other excipients are

For the powder: lactose monohydrate.

For the solvent: sodium chloride and water for injections

What Fostimon PFS looks like and contents of the pack

Fostimon PFS is presented as a powder and solvent for solution for injection. (1 set contains powder in a vial (225 IU or 300 IU), solvent in a prefilled syringe (1ml), one needle for reconstitution and one needle for subcutaneous injection) - pack size of 1, 5 or 10 sets.

The powder is a white to off-white caked mass and the solvent is clear and colourless.

Marketing Autorisation Holder:

IBSA Farmaceutici Italia Srl Via Martiri di Cefalonia, 2 26900 LODI - ITALY

Manufacturer

IBSA Farmaceutici Italia Srl Via Martiri di Cefalonia, 2 26900 LODI - ITALY

Batch release (UK and Ireland): PHARMASURE LIMITED

4-6 Colonial Business Park Colonial Way Watford WD24 4PR UNITED KINGDOM

This medicinal product is authorized in the Member States of the EEA under the following names: (The stength and pharmaceutical form are identical in all countries, only the trade name changes).

Austria: Fostimon PFS Belgium: Fostimon Kit Cyprus:Fostimon PFS Denmark: Fostimon Set Finland: Fostimon Set France: Fostimon Kit Luxembourg: Fostimon Kit Ireland: Fostimon PFS The Netherlands: Fostimon Set Norway: Fostimon Set Spain: Fostipur Kit Sweden: Fostimon Set United Kingdom: Fostimon PFS

This leaflet was revised in April 2016