Fertavid 300 IU/0.36 ml solution for injection

Fertavid 300 IU/0.36 ml solution for injectioncontains 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, Fertavidcan 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 172
• 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 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?

Fertavid solution for injection in cartridges has been developed for use in the Puregon Pen. The separate instructions for using the pen must be followed carefully. Do not use the cartridge if the solution contains particles or if the solution is not clear.
Using the pen, injections just under the skin (in the lower stomach, for example) can 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 carefully to give Fertavid properly and with minimal discomfort. The very first injection of Fertavid should only be given in the presence of a doctor or nurse.

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 cartridge in the outer carton.

Once the rubber inlay of a cartridge is pierced by a needle, the product may be stored for a maximum of 28 days.
Please put the day of first use of the cartridge on the dosing record table as shown in the Instruction Manual of the Puregon Pen.
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.

Discard used needles immediately after injection.
Do not mix any other drug into the cartridges.
Empty cartridges must not be refilled.

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 cartridge contains the active substance follitropin beta, a hormone known as follicle-stimulating hormone (FSH) in a strength of 833 IU/ml aqueous solution.
• The other ingredients are sucrose, sodium citrate, L-methionine, polysorbate 20 and benzyl alcohol 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 cartridge. It is available in packs of 1 cartridge.

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

This leaflet was last approved in

In correspondence please quote the batch number.