Do not use Fertavid
- 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 184
- 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?.