Fertavid 50 IU/0.5 ml solution for injection

Fertavid solution for injection contains follitropin beta, a hormone known as follicle-stimulating hormone (FSH).
FSH belongs to the group of gonadotrophins, which play an important role in human fertility and reproduction. In women, FSH is needed for the growth and development of follicles in the ovaries. Follicles are small round sacs that contain the egg cells. In men, FSH is needed for the production of sperm.

Fertavid is used to treat infertility in any of the following situations:

Women

In women who do not ovulate and do not respond to treatment with clomifene citrate, Fertavid can be used to cause ovulation.
In women undergoing assisted reproduction techniques, including in vitro fertilisation (IVF) and other methods, Fertavid can bring about the development of multiple follicles.

Men

In men who are infertile due to lowered hormone levels, Fertavid can be used for the production of sperm.

Do not use Fertavid

If you:

• are allergic (hypersensitive) to follitropin beta or any of the other ingredients of Fertavid (see a list of all the ingredients in section 6: Further information)
• have a tumour of the ovary, breast, uterus, testis or brain (pituitary gland or hypothalamus)
• have heavy or irregular vaginal bleeding where the cause is unknown
• have ovaries that do not work because of a condition called primary ovarian failure
• have ovarian cysts or enlarged ovaries not caused by polycystic ovarian syndrome (PCOS)
• have malformations of the sexual organs which make a normal pregnancy impossible
• have fibroids in the womb which make a normal pregnancy impossible
• are a man and are infertile because of a condition called primary testicular failure.

Take special care with Fertavid

Please tell your doctor if you have had an allergic reaction to certain antibiotics (neomycin and/or streptomycin).

If you are a woman:

Your doctor will check the effects of the treatment regularly to be able to choose the correct dose of Fertavid from day to day. You may regularly have ultrasound scans of the ovaries, and blood or urine samples are regularly needed. This is very important since too high a dose of FSH may lead to rare but serious complications in which the ovaries become hyperstimulated. This condition is called ovarian hyperstimulation syndrome. You may notice this as severe abdominal swelling, pain in the stomach, feeling sick or diarrhoea (see also section 4 on Possible side effects).
Contact your doctor immediately if you are experiencing stomach pains, also if this occurs some days after the last injection has been given.

If treatment with Fertavid results in pregnancy, there is an increased chance of having twins or multiple births. Multiple pregnancies carry an increased health risk for both the mother and her babies around the time of birth. Furthermore, the multiple pregnancies and the specific characteristics of the patients undergoing fertility treatment (e.g. age of the female, sperm characteristics) may be associated with an increased chance of congenital abnormalities. The chance of a pregnancy outside the womb (an ectopic pregnancy) is slightly increased in women with damaged fallopian tubes. In women undergoing fertility treatment there may be a slightly higher chance of a miscarriage.

Treatment with Fertavid, 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.

If you are a man:

Increased FSH blood levels are a sign of damage to the testicles. Fertavid is usually not effective in such cases. To check the effects of treatment, your doctor may ask you for a semen sample to be analysed, four to six months after the start of treatment.

Using other medicines

If Fertavid is used in a combination with clomifene citrate, the effect of Fertavid may be increased. If a GnRH agonist (a medicine used to prevent early ovulation) has been given, higher doses of Fertavid may be needed.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine. You should not use Fertavid if you are already pregnant, or suspect you might be pregnant.

If you are breast-feeding, tell your doctor before using Fertavid.

Driving and using machines

No effects on the ability to drive and use machines have been observed.

Important information about some of the ingredients of Fertavid

This medicinal product contains less than 1 mmol sodium (23 mg) per injection, i.e. essentially ?sodium-free?.

Always use Fertavid exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Dosage in women

Your doctor will decide on your starting dose. This dose may be adjusted during your treatment period. Further details on the treatment schedule are given below.
There are large differences between women in the response of the ovaries to FSH, which makes it impossible to set a dosage schedule which is suitable for all patients. To find the right dosage, your doctor will check your follicle growth by means of ultrasound scanning, and measurement of the amount of estradiol (female sex hormone) in blood or urine.

• Women who are not ovulating A starting dose is set by your doctor. This dose is continued for at least seven days. If there is no ovarian response, the daily dose will then be gradually increased until follicle growth and/or plasma estradiol levels indicate a proper response. The daily dose is then maintained until a follicle of proper size is present. Usually, 7 to 14 days of treatment are sufficient. Fertavid treatment is then stopped and ovulation will be induced by giving human chorionic gonadotrophin (hCG).
• Medically assisted reproduction programs, for instance IVF A starting dose is set by your doctor. This dose is continued for at least the first four days. After this, your dose may be adjusted, based upon your ovarian response. When a sufficient number of follicles of proper size are present, the final phase of maturation of the follicles is induced by giving hCG. Retrieval of the egg(s) is performed 34-35 hours later.

Dosage in men

Fertavid is usually prescribed at a dose of 450 IU per week, mostly in 3 dosages of 150 IU, in combination with another hormone (hCG), for at least 3 to 4 months. The treatment period equals the development time of sperm and the time in which improvement can be expected. If your sperm production has not started after this period, your treatment may carry on for at least 18 months.

How are the injections given?

The very first injection of Fertavid should only be given in the presence of a doctor or nurse. Injections may be given slowly into a muscle (for instance in the buttock, upper leg or upper arm) or under the skin (in the lower stomach, for example).
When given into a muscle the injection should be given by the doctor or nurse.
When given under the skin the injection may, in some cases, be given by yourself or your partner. Your doctor will tell you when and how to do this. If you inject yourself with Fertavid, follow the instructions for use in the next section, to give Fertavid properly and with minimal discomfort.

Instructions for use

Step 1 - Preparing the syringe

You should use sterile disposable syringes and needles for the administration of Fertavid. The volume of the syringe should be small enough so that the prescribed dose can be given with reasonable accuracy.
Fertavid solution for injection comes in a glass vial. Do not use the solution if it contains particles or is not clear. First, you should remove the flip-off cap of the vial. Place a needle on a syringe and pierce the needle through the rubber stopper of the vial (a). Draw the solution up into the syringe (b), and replace the needle with an injection needle (c). Finally hold the syringe with the needle pointing upwards and gently tap the side to force any air bubbles up to the top; then squeeze the plunger until all the air has been expelled, and only Fertavid solution is left in the syringe (d). If necessary, the plunger may be squeezed further, to adjust the volume to be administered.

Step 2 - The injection site

The best site for an injection under the skin is in the lower stomach around the navel (e) where there is a lot of loose skin and layers of fatty tissue. You should vary the injection site a little with each injection.
It is possible to inject in other areas. Your doctor or nurse will tell you where to inject.

Step 3 - Preparing the area

A few taps at the injection site will stimulate tiny nerve endings and help reduce discomfort when the needle goes in. Wash your hands and swab the injection site with disinfectant (for example chlorohexidine 0.5%) to remove any surface bacteria. Clean about two inches around the point where the needle will go in and let the disinfectant dry for at least one minute before you proceed.

Step 4 - Inserting the needle

Pinch the skin a little. With the other hand, insert the needle at an angle of 90 degrees into the skin?s surface, as shown in the picture (f).

Step 5 - Checking the correct needle position

If the needle position is correct the plunger should be quite difficult to draw back. Any blood sucked back into the syringe means that the needle tip has penetrated a vein or artery. If this happens pull out the syringe, cover the injection site with a swab containing disinfectant and apply pressure; the site will stop bleeding in a minute or two. Do not use this solution. Start again with Step 1 using a new syringe, new needles and a new vial of Fertavid .

Step 6 - Injecting the solution

Depress the plunger slowly and steadily, so the solution is correctly injected and the skin tissues are not damaged.

Step 7 - Removing the syringe

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 Fertavid solution and relieve any discomfort.

Any remaining solution should be discarded.
Do not mix Fertavid with any other medicines.

If you use more Fertavid than you should

Tell your doctor.
Too high a dose of Fertavid may cause hyperstimulation of the ovaries. This may be noticed as pain in the stomach. If you are troubled by stomach pains, tell your doctor immediately. See also section 4 on Possible side effects.

If you forget to use Fertavid

If you forget a dose do not use a double dose to make up for a missed dose.
Contact your doctor.

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

If you are a woman:

A complication with FSH treatment is hyperstimulation of the ovaries. This condition can become very serious, but the chance of having it can be reduced by checking the effect of Fertavid during treatment. Your doctor will take care of that. Pain in the stomach, feeling sick or diarrhoea are the first symptoms. In more severe cases symptoms may include enlargement of the ovaries, accumulation of fluid in the abdomen and/or chest, blood clots in the circulation and weight gain.
Contact your doctor immediately if you are experiencing stomach pains, or any of the other symptoms of ovarian hyperstimulation, also if this occurs some days after the last injection.

Common side effects (likely to affect 1 to 10 users in 100):

• Headache
• Injection site reactions (such as bruising, pain, redness, swelling and itching)
• Ovarian hyperstimulation syndrome (OHSS)
• Pelvic pain
• Stomach pain and/or bloating

Uncommon side effects (likely to affect 1 to 10 users in 1000):

• Breast complaints (including tenderness)
• Diarrhoea, constipation or stomach discomfort
• Enlargement of the womb
• Feeling sick
• Hypersensitivity reactions (such as rash, redness, hives and itching)
• Ovarian cysts or enlargement of the ovaries
• Ovarian torsion (twisting of the ovaries)
• Vaginal bleeding

Rare side effects (likely to affect 1 to 10 users in 10,000)

• Blood clots (this may also occur in the absence of unwanted overstimulation of the ovaries, see Take special care with Fertavid in section 2)

If you are a man:

Common side effects (likely to affect 1 to 10 users in 100):

• Acne
• Injection site reactions (such as hardening and pain)
• Headache
• Rash
• Some breast development
• Testicular cyst

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.

Keep out of the reach and sight of children.

Storage by the pharmacist

Store at 2°C ? 8°C (in a refrigerator). Do not freeze.

Storage by the patient

You have two options:

1. Store at 2°C ? 8°C (in a refrigerator). Do not freeze.

2. Store at or below 25ºC (at room temperature) for a single period of not more than 3 months. Make a note of when you start storing the product out of the refrigerator.

Keep the vial(s) in the outer carton.
The contents of a vial should be used immediately after piercing the rubber stopper. Do not use Fertavid after the expiry date which is stated on the label and carton after 'EXP'. The expiry date refers to the last day of that month.

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.

What Fertavid contains

• Each vial contains the active substance follitropin beta, a hormone known as follicle-stimulating hormone (FSH), in a strength of 50 IU in 0.5 ml aqueous solution per vial.
• The other ingredients are sucrose, sodium citrate, L-methionine and polysorbate 20 in water for injections. The pH may have been adjusted with sodium hydroxide and/or hydrochloric acid.

What Fertavid looks like and contents of the pack

Fertavid solution for injection (injection) is a clear, colourless liquid. It is supplied in a glass vial. It is available in packs of 1, 5 or 10 vials.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
SP Europe, Rue de Stalle 73, B-1180 Bruxelles, Belgium.

Manufacturer

• N.V. Organon, Kloosterstraat 6, Postbus 20, 5340 BH Oss, The Netherlands
• Organon (Ireland) Ltd., P.O. Box 2857, Drynam Road, Swords, Co. Dublin, Ireland
• SP, Usine Saint Charles, 60590 Eragny sur Epte, France

This leaflet was last approved in

In correspondence please quote the batch number.