ELONVA 100 MCG Инъекционный раствор

Содержание инструкции

1. Elonva 100 micrograms injectable solution, 150 micrograms injectable solution
   1. What is Elonva and what is it used for
   2. What you need to know before using Elonva
   3. How to use Elonva
   4. Possible side effects
   5. How to store Elonva
   6. Contents of the pack and other information

Elonva 100 micrograms injectable solution, 150 micrograms injectable solution

corifollitropin alfa

Read this leaflet carefully before you use this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

• 1. What Elonva is and what it is used for
• 2. What you need to know before you use Elonva
• 3. How to use Elonva
• 4. Possible side effects
• 5. How to store Elonva
• 6. Contents of the pack and other information

1. What is Elonva and what is it used for

Elonva contains the active substance corifollitropin alfa and belongs to a group of medicines called
gonadotropins. Gonadotropins play an important role in human fertility and
reproduction. One of these gonadotropins is Follicle Stimulating Hormone ( Follicle Stimulating HormoneFSH), which in women is necessary for the growth
and development of follicles (small, round sacs in the ovaries that contain eggs) and in
adolescent males (from 14 years of age onwards) for the treatment of delayed puberty due to
hypogonadotropic hypogonadism (HH) in association with a medicine called human
chorionic gonadotropin (hCG).
In women
Elonva is used to promote the establishment of pregnancy in women undergoing
treatment for infertility, such as in vitro fertilization (IVF). IVF involves the removal of eggs from the ovary, their
fertilization in the laboratory and the transfer of embryos into the uterus after a few days.
Elonva generates the growth and development of numerous follicles at the same time, through a
controlled stimulation of the ovaries.
In adolescent males (from 14 years of age onwards)
Elonva is used to stimulate the development and function of the testicles and to induce the development of
male sexual characteristics in adolescent males with delayed puberty due to HH.

2. What you need to know before using Elonva

Do not use Elonva if:

• you are allergic (hypersensitive) to corifollitropin alfa or to any of the other ingredients of this medicine (listed in section 6)
• you have a tumor of the ovaries, breast, uterus or brain (pituitary gland or hypothalamus)
• you have recently had unexpected vaginal bleeding, other than your menstrual period, without any diagnosed cause
• your ovaries are not functioning due to a condition called primary ovarian insufficiency
• you have ovarian cysts or enlarged ovaries
• you have abnormalities of the reproductive organs that make a normal pregnancy impossible
• you have fibroid tumors in the uterus that make a normal pregnancy impossible
• you have risk factors for OHSS (OHSS is a serious medical problem that can occur when the ovaries are excessively stimulated. See below for further explanation): you have polycystic ovary syndrome (PCOS) or you have a history of ovarian hyperstimulation syndrome (Ovarian HyperstimulationSyndrome- OHSS) or you have previously had a cycle of controlled ovarian stimulation treatment that led to the growth of more than 30 follicles with a size of 11 mm or greater or you have a basal antral follicle count (the number of small follicles present in the ovaries at the beginning of the menstrual cycle) greater than 20.

Warnings and precautions
Talk to your doctor before using Elonva.
Ovarian hyperstimulation syndrome (OHSS)
Treatment with gonadotropin hormones like Elonva can cause ovarian hyperstimulation
syndrome (OHSS). This is a serious medical condition in which the ovaries are excessively
stimulated and the growth of the follicles becomes greater than normal. In rare cases, severe OHSS can
be life-threatening. Therefore, careful medical supervision is very important. To
monitor the effects of treatment, the doctor will perform ultrasound scans of the ovaries. The doctor may also
check hormone levels in the blood (see also section 4).
OHSS causes a sudden accumulation of fluid in the stomach and chest areas and can cause the
formation of blood clots. Call your doctor immediately if you have:

• severe abdominal swelling and pain in the stomach area (abdomen)
• feeling unwell (nausea)
• vomiting
• sudden weight gain due to fluid accumulation
• diarrhea
• decreased urine output
• difficulty breathing

You can only use Elonva once during the same treatment cycle, otherwise it may increase the
likelihood of developing OHSS.
Before starting to use this medicine, tell your doctor if you have ever had ovarian hyperstimulation
syndrome (OHSS).
Ovarian torsion
Ovarian torsion is the twisting of an ovary. Twisting of the ovary may cause
blood flow to the ovary to be cut off.
Before starting to use this medicine, tell your doctor if:

• you have ever had ovarian hyperstimulation syndrome (OHSS).
• you are currently pregnant or suspect you may be pregnant.
• you have ever had stomach (abdominal) surgery.
• you have ever had a twisted ovary.
• you have had or have cysts in one or both ovaries.

Blood clots (Thrombosis)
Treatment with gonadotropin hormones like Elonva may (as in pregnancy) increase the risk
of developing a blood clot (thrombosis). Thrombosis is the formation of a blood clot
in a blood vessel.
Blood clots can cause serious medical conditions, such as:

• blockage at the level of the lungs (pulmonary embolism)
• stroke
• heart attack
• problems with blood vessels (thrombophlebitis)
• a lack of blood flow (deep vein thrombosis) which can cause loss of an arm or leg.

Talk to your doctor before starting treatment, especially if:

• you know you already have a high chance of developing thrombosis
• you or anyone in your family has ever had a thrombosis
• you are severely overweight.

Multiple births or congenital defects
There is an increased possibility of having twins or even more than two babies, even when
only one embryo is transferred into the uterus. Multiple pregnancies carry a greater risk
for the mother and the babies. Multiple pregnancies and specific characteristics of couples with
fertility problems (e.g. woman's age, some sperm problems, genetic history of
both parents) may also be associated with an increased likelihood of birth defects.
Pregnancy complications
If treatment with Elonva leads to the establishment of a pregnancy, there is an increased possibility
that the pregnancy will develop outside the uterus (ectopic pregnancy). Therefore, the doctor must first perform
an ultrasound examination to rule out the possibility of an extrauterine pregnancy.
Ovarian tumors and other tumors of the reproductive system
There have been reports of ovarian tumors and other tumors of the reproductive system in women who
had undergone treatment for infertility. It is not known whether treatment with fertility medicines increases the risk of these tumors in non-infertile women.
Other medical conditions
Also, before starting to use this medicine, tell your doctor if:

• you have a kidney disease.
• you have an uncontrolled pituitary gland or hypothalamic problems.
• you have an underactive thyroid gland (hypothyroidism).
• your adrenal glands are not functioning properly (adrenal insufficiency).
• you have high levels of prolactin in the blood (hyperprolactinemia).
• you have any other medical condition (for example, diabetes, heart disease or any other long-term illness).
• a doctor has told you that pregnancy could be dangerous for you.

Other medicines and Elonva
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines, including those available without a prescription.
If you perform a pregnancy test during infertility treatment with Elonva, the test may
falsely indicate that you are pregnant. The doctor will inform you about the appropriate time to
perform a pregnancy test. If the pregnancy test is positive, contact your doctor.

Pregnancy and breastfeeding
You must not use Elonva if you are pregnant, if you suspect you are pregnant or if you are breastfeeding with
breast milk.
Ask your doctor or pharmacist for advice before using this medicine.

Driving and using machines
Elonva can cause dizziness. If you feel dizzy, do not drive or use machines.

Elonva contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per injection, that is to say essentially
“sodium-free”.

3. How to use Elonva

Use Elonva following the doctor's instructions exactly. If you have any doubts, consult your doctor or pharmacist.
In women
Elonva is used in women undergoing infertility treatment, such as in vitro fertilization (IVF). During this treatment, Elonva is used in combination with a medication (called a GnRH antagonist) to prevent the ovary from releasing an egg too early. Treatment with the GnRH antagonist usually begins 5 to 6 days after the Elonva injection.
The use of Elonva in combination with a GnRH agonist (another medication to prevent the ovary from releasing an egg too early) is not recommended.
In adolescent male patients (14 years of age and older)
Elonva, in combination with a medicine called hCG, is used to treat delayed puberty due to HH. Elonva should be administered once every two weeks, in the morning on the same day of the week.

Dose
Women
In the treatment of women of reproductive age, the dose of Elonva is based on weight and age.

• A single dose of 100 micrograms is recommended in women with a weight of 60 kilograms or less and an age of 36 years or less.
• A single dose of 150 micrograms is recommended in women:
• weighing more than 60 kilograms, regardless of age.
• weighing 50 kilograms or more and over 36 years of age.

Women over 36 years of age weighing less than 50 kilograms have not been studied.
During the first seven days after the injection with Elonva, you should not use recombinant follicle-stimulating hormone ((rec)FSH). Seven days after the injection with Elonva, the doctor may decide to

continue the stimulation cycle with another gonadotropin hormone, such as (rec)FSH.
This can continue for a few days until a sufficient number of follicles of the right size are present, which can be checked by ultrasound examination. Treatment with (rec)FSH is then stopped and the eggs are matured by administering hCG (human chorionic gonadotropin). The eggs are retrieved from the ovary 34-36 hours later.
In adolescent male patients (14 years of age and older)
The dose of Elonva is based on body weight:
For adolescent male patients weighing 60 kg or less

• 100 micrograms of Elonva once every two weeks for 12 weeks, followed by administration of Elonva (once every 2 weeks) with hCG. If body weight increases to more than 60 kg during treatment, the doctor may increase the dose of Elonva to 150 micrograms.

For adolescent male patients weighing more than 60 kg

• 150 micrograms of Elonva once every two weeks for 12 weeks, followed by administration of Elonva (once every 2 weeks) with hCG.

Combined therapy with hCG twice a week (500-5,000 IU) may be necessary for 52 weeks or longer in order to achieve adult gonadal development.

How Elonva is administered
Treatment with Elonva must be supervised by a doctor experienced in the treatment of fertility problems. Elonva must be injected under the skin (subcutaneously) into a skin fold (which you pinch between your thumb and index finger), preferably just below the navel.
The injection can be administered by a healthcare professional (e.g., a nurse), your partner, or yourself, if you carefully follow the doctor's instructions .Always use Elonva following the doctor's instructions exactly. If you have any doubts, consult your doctor or pharmacist. At the end of this leaflet, there are step-by-step "instructions for use".
Do not inject Elonva into a muscle.
Elonva is supplied in pre-filled syringes that have an automatic safety system to help prevent needle-stick injuries after use.

If you use more Elonva or (rec)FSH than you should
If you think you have used more Elonva or (rec)FSH than you should have, contact your doctor immediately.

If you forget to use Elonva
If you forget to inject Elonva on the day you were supposed to, contact your doctor immediately. Do not inject Elonva without talking to your doctor.
If you have any doubts about using this medicine, ask your doctor.

4. Possible side effects

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

Serious side effects
A possible complication of treatment with gonadotropins such as Elonva is
ovarian hyperstimulation syndrome. The possibility of this complication can be
reduced with careful monitoring of the number of follicles that mature. The doctor will perform ultrasounds
of the ovaries to carefully monitor the number of follicles that mature. The doctor may also
check hormone levels in the blood. The first symptoms of ovarian hyperstimulation may be
noticed as stomach (abdominal) pain, feeling unwell or diarrhea. Ovarian hyperstimulation
can develop into a medical condition called ovarian hyperstimulation syndrome
(OHSS), which can be a serious medical problem. In the most severe cases, it has involved enlargement
of the ovaries, fluid accumulation in the abdomen and/or chest (which can cause weight gain due to
fluid retention) or blood clots in the blood vessels.
Contact your doctor immediately if you experience stomach (abdominal) pain or any other
symptoms of ovarian hyperstimulation, even if it occurs a few days after the injection.
The possibility of experiencing side effects is described according to the following categories:

Common (may affect up to 1 in 10 women)

• Ovarian hyperstimulation syndrome (OHSS)
• Pelvic pain
• Feeling unwell (nausea)
• Headache
• Pelvic discomfort
• Increased breast sensitivity
• Fatigue (tiredness)

Uncommon (may affect up to 1 in 100 women)

• Ovarian torsion
• Increased liver enzymes
• Miscarriage
• Pain after egg retrieval
• Procedure pain
• Premature release of an egg (premature ovulation)
• Abdominal distension
• Vomiting
• Diarrhea
• Constipation
• Back pain
• Breast pain
• Burning or pain at the injection site
• Irritability
• Mood swings
• Dizziness
• Hot flushes

Not known (frequency cannot be estimated from available data)

• Allergic reactions (hypersensitivity reactions, both local and generalized, including rash).

Ectopic pregnancy (a pregnancy outside the uterus) and multiple pregnancies have been reported.
These side effects have not been considered to be related to the use of Elonva, but to Assisted Reproductive
Technologies (ART) or the subsequent pregnancy.
In rare cases, as with other gonadotropins, blood clots (thrombosis) that have formed
inside a blood vessel, have detached and travelled within the
circulation to then block another blood vessel (thromboembolism) have been associated
with therapy with Elonva.

If you are a male adolescent

Side effects reported in male adolescents:
Common (may affect up to 1 in 10 male subjects)

• Vomiting
• Pain at the injection site
• Hot flushes

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. You can also report side effects directly through the national reporting system listed in Annex V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Elonva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label and the packaging after
“Exp.” (expiry date). The expiry date refers to the last day of that month.

Storage by the pharmacist
Store in a refrigerator (2°C-8°C). Do not freeze.

Storage by the patient
There are two options:

• 1. Store in a refrigerator (2°C-8°C). Do not freeze.
• 2. Store at a temperature equal to or below 25°C for a period of no more than one month. Note the day you start storing the medicine outside the refrigerator and use it within one month from that date.

Keep the syringe in the box to protect the medicine from light.

Do not use Elonva

• if it has been stored outside the refrigerator for more than one month.
• if it has been stored outside the refrigerator at a temperature higher than 25ºC.
• if you notice that the solution is not clear.
• if you notice that the syringe or needle is damaged.

Do not dispose of an empty or unused syringe down the drain or with household waste. Ask your
pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Elonva contains

• The active substance is chorionic gonadotropin alfa. Each pre-filled syringe of Elonva 100 micrograms solution for injection contains 100 micrograms in 0.5 millilitres (mL) of solution for injection. Each pre-filled syringe of Elonva 150 micrograms solution for injection contains 150 micrograms in 0.5 millilitres (mL) of solution for injection.
• The other ingredients are: sodium citrate, sucrose, polysorbate 20, methionine and water for injections. The pH may have been adjusted with sodium hydroxide and/or hydrochloric acid.

Description of Elonva and contents of the pack
Elonva is a clear and colourless aqueous solution for injection (injectable preparation) in a pre-filled syringe
with an automatic safety system, which prevents accidental needle stick injury after use.
The syringe is packaged together with a sterile needle for injection. Each syringe contains 0.5 mL of
solution.
Each single pack contains one pre-filled syringe.
Elonva is available in two strengths: 100 micrograms and 150 micrograms solution for injection.

Marketing Authorisation Holder and Manufacturer
N.V. Organon
Kloosterstraat 6
5349 AB Oss
The Netherlands
For further information on this medicine, contact the local representative of the Marketing Authorisation
Holder:

België/Belgique/Belgien
Organon Belgium
Tél/Tel: 0080066550123 (+32 2 2418100)
[email protected]

Lietuva
Organon Pharma B.V. Lithuania atstovybė
Tel.: +370 52041693
[email protected]

България
Органон (И.А.) Б.В. - клон България
Тел.: +359 2 806 3030
[email protected]

Luxembourg/Luxemburg
Organon Belgium
Tél/Tel: 0080066550123 (+32 2 2418100)
[email protected]

Česká republika
Organon Czech Republic s.r.o.
Tel: +420 233 010 300
[email protected]

Magyarország
Organon Hungary Kft.
Tel.: +36 1 766 1963
[email protected]

Danmark
Organon Denmark ApS
Tlf: +45 4484 6800
[email protected]

Malta
Organon Pharma B.V., Cyprus branch
Tel: +356 2277 8116
[email protected]

Deutschland
Organon Healthcare GmbH
Tel.: 0800 3384 726 (+49 (0) 89 2040022 10)
[email protected]

Nederland
N.V. Organon
Tel: 00800 66550123
(+32 2 2418100)
[email protected]

Eesti
Organon Pharma B.V. Estonian RO
Tel: +372 66 61 300
[email protected]

Norge
Organon Norway AS
Tlf: +47 24 14 56 60
[email protected]

Ελλάδα
BIANEΞ Α.Ε.
Τηλ: +30 210 80091 11
[email protected]

Österreich
Organon Austria GmbH
Tel: +43 (0) 1 263 28 65
[email protected]

España
Organon Salud, S.L.
Tel: +34 91 591 12 79
[email protected]

Polska
Organon Polska Sp. z o.o.
Tel.: +48 22 105 50 01
[email protected]

France
Organon France
Tél: +33 (0) 1 57 77 32 00

Portugal
Organon Portugal, Sociedade Unipessoal Lda.
Tel: +351 218705500
[email protected]

Hrvatska
Organon Pharma d.o.o.
Tel: +385 1 638 4530
[email protected]

România
Organon Biosciences S.R.L.
Tel: +40 21 527 29 90
[email protected]

Ireland
Organon Pharma (Ireland) Limited
Tel: +353 15828260
[email protected]

Slovenija
Organon Pharma B.V., Oss, podružnica
Ljubljana
Tel: +386 1 300 10 80
[email protected]

Ísland
Vistor hf.
Sími: +354 535 7000

Slovenská republika
Organon Slovakia s. r. o.
Tel: +421 2 44 88 98 88
[email protected]

Italia
Organon Italia S.r.l.
Tel: +39 06 3336407
[email protected]

Suomi/Finland
Organon Finland Oy
Puh/Tel: +358 (0) 29 170 3520
[email protected]

Κύπρος
Organon Pharma B.V., Cyprus branch
Τηλ : +357 22866730
[email protected]

Sverige
Organon Sweden AB
Tel: +46 8 502 597 00
[email protected]

Latvija
Ārvalsts komersanta “Organon Pharma B.V.”
pārstāvniecība
Tel: +371 66968876
[email protected]

United Kingdom (Northern Ireland)
Organon Pharma (Ireland) Limited
Tel: +353 15828260
[email protected]

Other sources of information
More detailed information on this medicine is available on the European Medicines Agency website, http://www.ema.europa.eu .

Instructions for use
Components of the Elonva syringe with needle

Preparation for injection

• 1.
• Wash your hands with soap and water and dry them before using Elonva.
• Clean the injection site (the area just below your belly button) with a disinfectant (for example, alcohol) to remove any bacteria from the surface.
• Clean approximately 5 cm around the point where the needle will be inserted and allow the disinfectant to dry for at least one minute before proceeding.

• 2.
• While waiting for the disinfectant to dry, break along the perforation of the label and pull off the needle cap.
• Leave the needle protective cap on the needle itself.
• Place the protective cap (containing the needle) on a clean, dry surface while you prepare the syringe.

• 3.
• Hold the syringe with the grey cap facing upwards.
• Gently tap the syringe with your finger to allow any air bubbles to rise to the top.

• 4.
• Hold the syringe facing upwards.
• Unscrew the syringe cap in an anticlockwise direction.

• 5.
• Hold the syringe facing upwards.
• Screw the needle protective cap (containing the needle) clockwise onto the syringe.

• 6.
• Hold the syringe facing upwards.
• Remove the needle protective cap by pulling it upwards and discard it.
• BE CAREFULwith the needle.

Injection

• 7.
• Now hold the syringe between your index finger and middle finger, holding it facing upwards.
• Place your thumb on the plunger.
• Carefully press the plunger upwards until you see a drop at the tip of the needle.

• 8.
• Pinch a fold of skin between your thumb and index finger.
• Insert the entire needle into the skin pinched between your fingers at a 90-degree angle.
• Gently press the plunger all the way down and hold it.
• COUNT TO FIVEto be sure that all the solution has been injected.

• 9.
• Release your thumb from the plunger.
• The needle will automatically retract into the syringe where it will be permanently locked.