ELONVA 0.5 ml. 1 injection

WHAT ELONVA IS AND WHAT IT IS USED FOR?
Elonva is a medicine belonging to the group of gonadotropic hormones. They play an important role in fertility and reproduction in humans. One of these hormones is follicle stimulating hormone (FSH), which is needed in women for the growth and maturation of oocytes in the ovaries.
Elonva is used to help get pregnant in women treated for infertility, such as IVF. IVF involves taking ova from the ovaries, fertilizing them in laboratory conditions, and returning the embryos back to the uterus after a few days. Administration of Elonva leads to the development of several ova at the same time through controlled ovarian stimulation.

2. BEFORE YOU USE ELONVA
Do not use Elonva if:
- are allergic (hypersensitive) to corifollitropin alfa or any of the other ingredients of Elonva (for a full list of all ingredients, see section 6)
- have ovarian, breast, uterine or brain (pituitary or hypothalamic)
- you have recently had unexpected vaginal bleeding, non-menstrual, for no established cause
- your ovaries do not work because you have a condition called primary ovarian failure
- have ovarian cysts or enlarged ovaries
- you have had ovarian hyperstimulation syndrome (OHSS), see below for further information
- you have undergone a control cycle with controlled ovarian stimulation that has led to the development of more than 30 ova of 11 mm or larger
- the number of basal antral follicles (the number of small follicles found in your ovaries at the beginning of the menstrual cycle) is greater than 20
- you have malformations of the sexual organs inconsistent with normal pregnancy
- You have fibroid tumors of the uterus that are incompatible with normal pregnancy. Take special care with Elonva

Ovarian Hyperstimulation Syndrome (OHSS)
Treatment with gonadotrophic hormones such as Elonva may cause ovarian hyperstimulation syndrome (OHSS). This is a condition where oocytes in the ovaries increase more than normal. This can be seen as a severe swelling of the abdomen and pain, nausea or diarrhea. Therefore, it is very important for your doctor to closely monitor your condition. To monitor the effects of the treatment, ultrasound screening of ovaries and blood and urine testing will be performed regularly (see also section 4).
You can only use Elonva once during the same treatment cycle as otherwise the risk of developing OHSS may increase.
It is very important that you tell your doctor before you start using this medicine if:
- you have ever had ovarian hyperstimulation syndrome (OHSS)
- you have polycystic ovarian syndrome
- you have kidney disease.

Thrombosis
Treatment with gonadotrophic hormones such as Elonva (as well as pregnancy itself) may increase the risk of developing thrombosis. Thrombosis is the formation of a blood clot in the blood vessels, most often in the leg or leg veins. Please discuss this with your doctor before starting treatment especially if:
- You know you already have an increased risk of developing thrombosis
- You or your close relative have ever had a thrombosis
- You are significantly overweight.

Multiple pregnancy or congenital malformations in the fetus
If more than one embryo is returned to the uterus, there are a high probability of having twins and more than two babies born. Multiple pregnancies carry an increased risk to the health of the mother and her children. Multiple pregnancies and specific characteristics of couples treated for infertility (eg age) are associated with an increased risk of malformations in the fetus.

Complications in pregnancy
If the treatment with Elonva results in pregnancy in women with damage to the fallopian tube (the ovaries from the ovaries to the uterus), the risk of ectopic pregnancy (ectopic pregnancy) is increased. That is why your doctor will do an early ultrasound examination to rule out the possibility of an ectopic pregnancy.

Using other medicines
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 breastfeeding
You should not use Elonva if you are pregnant or think you may be pregnant or if you are breast-feeding.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Elonva may cause dizziness. If you experience dizziness, you should not drive or operate machinery.
Important information about some of the ingredients of Elonva
This product contains less than 1 mmol sodium (23 mg) per injection, ie. It practically does not contain sodium.

3. HOW DO YOU USE ELONVA?
Always use Elonva exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Elonva is used in women who are being treated for infertility such as IVF. During this treatment, Elonva is used in combination with another medicine to avoid premature ovulation (the so-called GnRH antagonist). Treatment with a GnRH antagonist usually begins 4 to 5 days after the injection of Elonva.
The use of Elonva in combination with a GnRH agonist (another medicine that prevents premature ovulation) is not recommended. It can lead to more stimulation of your ovaries.

Dose
- If your body weight is 60 kg or less, you will be given a single dose of 100 mg of Elonva on one of the first days of your monthly bleeding (menstruation), as instructed by your doctor.
- If your weight is over 60 kg, you will be given a single dose of Elonva from
150 micrograms on one of the first days of your monthly bleeding (menstruation), as instructed by your doctor.
During the first seven days after the administration of Elonva, (recombinant) follicle-stimulating hormone ((p) FSH) should not be used. Seven days after the injection of Elonva, at your doctor's discretion, treatment may continue with another gonadotropic hormone, such as (p) FSH. It may last for a few more days until sufficient numbers of follicles are available. This can be detected with an ultrasound scan. Treatment with (p) FSH is then stopped and ovarian maturation is induced by administration of hCG (human chorionic gonadotrophin). Taking the oocytes takes place 34-36 hours afterwards.

How is Elonva given?
Treatment with Elonva should be monitored by a doctor who is a specialist in the treatment of infertility. Elonva is injected subcutaneously into a skin fold, just below the navel. The injection can be made by a medical specialist (eg a nurse), your partner or you, after detailed instructions from a doctor. Always use Elonva exactly as your doctor has recommended. If you are not sure, talk to your doctor or pharmacist. At the end of this leaflet, the step-by-step instructions for use are presented, and when the following are followed closely, Elonva will be administered with minimal discomfort: Do not inject Elonva into a muscle.

If you use more than the required dose of Elonva or (p) FSH
If you are using a pre-filled syringe, it is not possible to inject more than you need.
The use of more Elonva or (p) FSH may occur if Elonva is administered more than once for the same treatment cycle or if (f) FSH is administered during the first seven days after the injection of Elonva (see also Elonva is administered. "In this case, the risk of ovarian hyperstimulation syndrome (OHSS) may increase.
If you think you have used more Elonva or (p) FSH than you should, contact your doctor immediately.
If you forget to use Elonva
If you forget to take Elonva on the day you should do so, contact your doctor immediately.
If you have any further questions on the use of this product, ask your doctor.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Elonva can cause side effects, although not everyone gets them.
The probability of occurrence of an adverse reaction is described in the following categories:
Common (affects 1 to 10 women in 100)
- Ovarian Hyperstimulation Syndrome (OHSS)
- Headache
- Nausea
- Fatigue (fatigue)
- Pain and discomfort in the pelvis
- Chest pain (including soreness)
Uncommon (affects 1 to 10 women in 1,000)
- Touched ovary
- Dizziness
- Vomiting
- Stomach pain (abdomen)
- Intestinal complaints (such as diarrhea, constipation and abdominal swelling).
One of the possible complications of gonadotrophic hormone treatment, such as Elonva, is undesired ovarian hyperstimulation. The risk of such a complication can be reduced by careful monitoring during treatment of the number of mature oocytes and hormone levels. Your doctor will take care of this. The first symptoms of ovarian hyperstimulation are pain in the stomach (abdomen), nausea or diarrhea. Ovarian hyperstimulation may pass into a disease state called Ovarian Hyperstimulation Syndrome (OHSS), which is a serious medical problem. In more severe cases, this can lead to enlargement of the ovaries, fluid accumulation in the abdomen and / or chest cavity (which may lead to weight gain) or blood clot formation.
Contact your doctor immediately if you experience stomach or abdominal pain or other symptoms of ovarian hyperstimulation, even if they occur several days after the injection is given.
There have also been reports of ectopic pregnancy, miscarriage and multiple pregnancy. These side effects are considered unrelated to the use of Elonva, but to the assisted reproductive procedure or subsequent pregnancy.
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 ELONVA?
Keep out of the reach and sight of children.

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