Cetrotide

Основна информация

  • Търговско наименование:
  • Cetrotide
  • Използвай за:
  • Хората
  • Вид на лекарството:
  • алопатични наркотици

Документи

Локализация

  • Предлага се в:
  • Cetrotide
    Европейски съюз
  • Език:
  • английски

Терапевтична информация

  • Терапевтична група:
  • PITUITARY AND HYPOTHALAMIC HORMONES AND ANALOGUES
  • Терапевтична област:
  • Ovulation, Ovulation Induction
  • Терапевтични показания:
  • Prevention of premature ovulation in patients undergoing a controlled ovarian stimulation, followed by oocyte-pick-up and assisted-reproductive techniques.In clinical trials, Cetrotide was used with human menopausal gonadotropin (HMG), however, limited experience with recombinant follicule-stimulating hormone (FSH) suggested similar efficacy.
  • Каталог на резюме:
  • Revision: 25

Състояние

  • Източник:
  • EMA - European Medicines Agency
  • Статус Оторизация:
  • Authorised
  • Номер на разрешението:
  • EMEA/H/C/000233
  • Дата Оторизация:
  • 11-04-1999
  • EMEA код:
  • EMEA/H/C/000233
  • Последна актуализация:
  • 23-07-2019

Доклад обществена оценка

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© European Medicines Agency, 2016. Reproduction is authorised provided the source is acknowledged.

EMA/337942/2016

EMEA/H/C/00233

EPAR summary for the public

Cetrotide

cetrorelix

This is a summary of the European public assessment report (EPAR) for Cetrotide. It explains how the

Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in

favour of granting a marketing authorisation and its recommendations on the conditions of use for

Cetrotide.

What is Cetrotide?

Cetrotide is a medicine that contains the active substance cetrorelix. It is available as a powder and

solvent used to make a solution for injection.

What is Cetrotide used for?

Cetrotide is used to prevent premature ovulation (early release of eggs from the ovary). It is given to

women having ovarian stimulation (fertility treatment where the ovaries are stimulated to produce

more eggs).

The medicine can only be obtained with a prescription.

How is Cetrotide used?

Treatment with Cetrotide should be carried out by a doctor who has experience in this type of fertility

treatment. Cetrotide is given by injection under the skin of the lower abdomen (belly). The

recommended dose is 0.25 mg given every 24 hours, either in the morning or in the evening.

Treatment starts on day 5 or 6 of ovarian stimulation, and is continued throughout the ovarian

stimulation period, until the evening before or the morning of the day when the induction of ovulation

(the release of eggs) is planned.

Cetrotide

EMA/337942/2016

Page 2/3

Because of the risk of severe allergic reactions, the first injection should be supervised by a doctor,

and the patient closely watched for 30 minutes. Further injections may be given by the patient herself,

as long as she is made aware of the signs of allergic reaction and what to do if they appear. The

medicine should be injected slowly at different places on the abdomen every day.

How does Cetrotide work?

The active substance in Cetrotide, cetrorelix, blocks the effects of luteinising-hormone-releasing

hormone (LHRH) in the body. LHRH controls the production and release of another hormone called

luteinising hormone (LH), which causes ovulation. During fertility treatment, ovarian stimulation is

used to make the ovaries produce more eggs. By blocking the effect of LHRH, Cetrotide stops the

production of LH, and therefore prevents premature ovulation, which can result in the release of eggs

that are immature and unsuitable for use in techniques such as in vitro fertilisation (IVF).

How has Cetrotide been studied?

The ability of Cetrotide to prevent premature ovulation has been studied in three main studies

involving 814 women. Cetrotide was compared with buserelin nasal spray and triptorelin depot

injection. These medicines act on the secretion of LH, but work by overstimulating the production of

LHRH so that the body stops making LH. The main measure of effectiveness was the prevention of

premature LH production.

What benefit has Cetrotide shown during the studies?

Cetrotide was as effective as the comparator treatments in preventing a surge in the production of LH.

Between 95 and 97% of the patients receiving Cetrotide had no LH surge, compared with 98% for

buserelin and 97% for triptorelin. Once the assisted-reproduction procedure was completed, 23% of

patients who received Cetrotide became pregnant, compared with 32% in the comparator groups.

What is the risk associated with Cetrotide?

The most common side effects with Cetrotide (seen in between 1 and 10 patients in 100) are mild to

moderate overstimulation of the ovaries (which can occur as a side effect of the ovarian stimulation

procedure itself) and reactions at the injection site, such as redness, swelling and itching. For the full

list of all side effects reported with Cetrotide, see the package leaflet.

Cetrotide must not be used in people who are hypersensitive (allergic) to cetrorelix or any of the other

ingredients, to any hormones that are chemically similar to gonadotropin-releasing hormone, or to

extrinsic peptide hormones (hormone medicines similar to Cetrotide). It must not be used in women

who are pregnant or breastfeeding, or in patients with severe kidney disease. For the full list of

restrictions, see the package leaflet.

Why has Cetrotide been approved?

The CHMP concluded that Cetrotide is a safe and effective alternative to existing treatments for the

prevention of premature ovulation. The CHMP decided that Cetrotide’s benefits are greater than its

risks and recommended that it be given marketing authorisation.

Cetrotide

EMA/337942/2016

Page 3/3

What measures are being taken to ensure the safe and effective use of

Cetrotide?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe

and effective use of Cetrotide have been included in the summary of product characteristics and the

package leaflet.

Other information about Cetrotide

The European Commission granted a marketing authorisation valid throughout the European Union for

Cetrotide on 13 April 1999.

The full EPAR for Cetrotide is available on the Agency’s website:

ema.europa.eu/Find medicine/Human

medicines/European public assessment reports. For more information about treatment with Cetrotide,

read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

This summary was last updated in 06-2016.

Листовка за пациента: състав, показания, Нежелани лекарствени реакции, дозиране, взаимодействия, бременност, кърмене

B. PACKAGE LEAFLET

Package leaflet: Information for the user

Cetrotide 0.25 mg powder and solvent for solution for injection

Cetrorelix

Read all of this leaflet carefully before you start using this medicine because it contains

important information for you.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,

even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side

effects not listed in this leaflet. See section 4.

What is in this leaflet

What Cetrotide is and what it is used for

What you need to know before you use Cetrotide

How to use Cetrotide

Possible side effects

How to store Cetrotide

Contents of the pack and other information

How to mix and inject Cetrotide

1.

What Cetrotide is and what it is used for

What Cetrotide is

Cetrotide contains a medicine called ‘cetrorelix’. This medicine stops your body from releasing an egg

from your ovary (ovulation) during your menstrual cycle. Cetrotide belongs to a group of medicines

called ‘anti-gonadotropin-releasing hormones’.

What Cetrotide is used for

Cetrotide is one of the medicines used during ‘assisted reproductive techniques’ to help you get

pregnant. It stops eggs being released straight away. This is because if the eggs are released too early

(premature ovulation) it may not be possible for your doctor to collect them.

How Cetrotide works

Cetrotide blocks a natural hormone in your body called LHRH (‘luteinising hormone releasing

hormone’).

LHRH controls another hormone, called LH (‘luteinising hormone’).

LH stimulates ovulation during your menstrual cycle.

This means that Cetrotide stops the chain of events that leads to an egg being released from your

ovary. When your eggs are ready to be collected, another medicine will be given to you that will

release them (ovulation induction).

2.

What you need to know before you use Cetrotide

Do not use Cetrotide

if you are allergic to cetrorelix or any of the other ingredients of this medicine (listed in

section 6).

if you are allergic to medicines similar to Cetrotide (any other peptide hormones).

if you are pregnant or breast-feeding.

if you have severe kidney disease.

Do not use Cetrotide if any of the above applies to you. If you are not sure, talk to your doctor before

using this medicine.

Warnings and precautions

Allergies

Tell your doctor before using Cetrotide if you have an active allergy or have had allergies in the past.

Ovarian Hyperstimulation Syndrome (OHSS)

Cetrotide is used together with other medicines that stimulate your ovaries to develop more eggs ready

to be released. During or after you receive these medicines, you may develop OHSS. This is when

your follicles develop too much and become large cysts.

For possible signs to look out for and what to do if this happens see section 4 ‘

Possible side effects

’.

Using Cetrotide during more than one cycle

Experience of using Cetrotide during more than one cycle is small. Your doctor will carefully look at

the benefits and risks for you, if you need to have Cetrotide during more than one cycle.

Liver disease

Tell your doctor before using Cetrotide if you have a liver disease. Cetrotide has not been investigated

in patients with hepatic disease.

Kidney disease

Tell your doctor before using Cetrotide if you have a kidney disease. Cetrotide has not been

investigated in patients with kidney disease.

Children and adolescents

Cetrotide is not indicated for the use in children and adolescents.

Other medicines and Cetrotide

Tell your doctor if you are using, have recently used or might use any other medicines.

Pregnancy and breast-feeding

Do not use Cetrotide if you are pregnant, think you may be pregnant, or if you are breast-feeding.

Driving and using machines

Cetrotide is not expected to affect your ability to drive and use machines.

3.

How to use Cetrotide

Always use this medicine exactly as your doctor has told you. Check with your doctor if you are not

sure.

Using this medicine

This medicine is only for injection just under the skin of your belly (subcutaneous). To reduce skin

irritation, select a different part of your belly each day.

Your doctor must supervise your first injection. Your doctor or nurse will show you how to

prepare and inject the medicine.

You can carry out the following injections yourself as long as your doctor has made you aware

of the symptoms that may indicate allergy and of the possibly serious or life-threatening

consequences that would need immediate treatment (see section 4 ‘

Possible side effects’

Please carefully read and follow the instructions at the end of this leaflet called

‘How to mix and

inject Cetrotide’

You start by using another medicine on day 1 of your treatment cycle. You then start using

Cetrotide a few days later. (See next section

‘How much to use’

How much to use

Inject the contents of one vial (0.25 mg Cetrotide) once each day. It is best to use the medicine at the

same time each day, leaving 24 hours between each dose.

You can choose to inject every morning

or

every evening.

If you are injecting every morning: Start your injections on day 5 or 6 of the treatment cycle.

Based on your ovarian response, your doctor may decide to start on another day. Your doctor

will tell you the exact date and time. You will keep using this medicine up until and including

the morning that your eggs are collected (ovulation induction).

If you are injecting every evening: Start your injections on day 5 of the treatment cycle. Based

on your ovarian response, your doctor may decide to start on another day. Your doctor will tell

you the exact date and time. You will keep using this medicine up until and including the

evening before your eggs are collected (ovulation induction).

If you use more Cetrotide than you should

Bad effects are not expected if you accidentally inject more of this medicine than you should. The

effect of the medicine will last for longer. No specific measures are usually required.

If you forget to use Cetrotide

If you forget a dose, inject it as soon as you remember and talk to your doctor.

Do not inject a double dose to make up for a forgotten dose.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4.

Possible side effects

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

Allergic reactions

Warm, red skin, itching (often in your groin or armpits), red, itchy, raised areas (hives), runny

nose, fast or uneven pulse, swelling of your tongue and throat, sneezing, wheezing or serious

difficulty breathing, or dizziness. You may be having a possible serious, life-threatening allergic

reaction to the medicine. This is uncommon (may affect up to 1 in 100 women).

If you notice any of the side effects above, stop using Cetrotide and contact your doctor immediately.

Ovarian Hyperstimulation Syndrome (OHSS)

This may occur due to the other medicines that you are using to stimulate your ovaries.

Lower abdominal pain together with feeling sick (nausea) or being sick (vomiting) may be the

symptoms of OHSS. This may indicate that the ovaries over-reacted to the treatment and that

large ovarian cysts developed. This event is common (may affect up to 1 in 10 women).

The OHSS may become severe with clearly enlarged ovaries, decreased urine production,

weight gain, difficulty breathing or fluid in your stomach or chest. This event is uncommon

(may affect up to 1 in 100 women).

If you notice any of the side effects above, contact your doctor immediately.

Other side effects

Common (may affect up to 1 in 10 women):

Mild and short-lasting skin irritation may occur at the injection site like redness, itching or

swelling.

Uncommon (may affect up to 1 in 100 women):

Feeling sick (nausea)

Headache.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects

not listed in this leaflet.

You can also report side effects directly via the national reporting system

listed in Appendix V. By reporting side effects you can help provide more information on the safety of

this medicine.

5.

How to store Cetrotide

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 carton, vial and pre-filled syringe

after EXP. The expiry date refers to the last day of that month.

Store in a refrigerator (2°C – 8°C). Do not freeze or place next to the freezer compartment or a freezer

pack.

Store in the original package in order to protect from light.

The unopened product may be stored in the original package at room temperature (not above 30°C) for

up to three months.

The solution should be used immediately after preparation.

Do not use this medicine if you notice that the white powder in the vial has changed in appearance. Do

not use the prepared solution in the vial if it is not clear and colourless or if it has particles in it.

Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to throw

away medicines you no longer use. These measures will help to protect the environment.

6.

Contents of the pack and other information

What Cetrotide contains

The active substance is cetrorelix. Each vial contains 0.25 mg cetrorelix (as acetate).

The other ingredients are:

In the powder: mannitol.

In the solvent: water for injections.

What Cetrotide looks like and contents of the pack

Cetrotide is a powder and solvent for solution for injection. The white powder comes in a glass vial

with a rubber stopper. The solvent is a clear and colourless solution in a pre-filled syringe.

The powder vial contains 0.25 mg cetrorelix and the pre-filled syringe contains 1 ml solvent.

It is available in packs of 1 vial and 1 pre-filled syringe or 7 vials and 7 pre-filled syringes (not all

pack sizes may be marketed).

For each vial, the pack also contains:

one needle with a

yellow

mark - for injecting the sterile water into the vial and drawing the

made up medicine out from the vial

one needle with a

grey

mark - for injecting the medicine into your belly

two alcohol swabs for cleaning

Marketing Authorisation Holder

Merck Europe B.V., Gustav Mahlerplein 102, 1082 MA Amsterdam, The Netherlands

Manufacturer

Merck KGaA, Frankfurter Straße 250, D-64293 Darmstadt, Germany

This leaflet was last revised in

MM/YYYY

Detailed information on this medicine is available on the European Medicines Agency website:

http://www.ema.europa.eu.

HOW TO MIX AND INJECT CETROTIDE

This section tells you how to mix the powder and the sterile water (solvent) together and then

how to inject your medicine.

Before starting to use this medicine, please read these instructions the whole way through first.

This medicine is only for you – do not let anyone else use it.

Use each needle, vial and syringe only once.

Before you start

1.

This medicine must be at room temperature prior to injection. Remove from the

refrigerator approximately 30 minutes before use.

2.

Wash your hands

It is important that your hands and the things you use are as clean as possible.

3.

Lay out everything you need on a clean surface:

one vial of powder

one pre-filled syringe with sterile water (solvent)

one needle with a

yellow

mark – for injecting the sterile water into the vial and drawing the

made-up medicine out from the vial

one needle with a

grey

mark – for injecting the medicine into your belly

two alcohol swabs.

Mixing the powder and water to make up your medicine

1.

Remove the cap from the vial

There will be a rubber stopper underneath – keep this in the vial.

Wipe the rubber stopper and metal ring with your first alcohol swab.

2.

Adding the water from the pre-filled syringe to the powder in the vial

Unwrap the needle with the

yellow

mark on it.

Remove the cap from the pre-filled syringe and screw the yellow needle onto it. Remove

the cap from the needle.

Push the yellow needle through the centre of the rubber stopper of the vial.

Slowly push in the plunger of the syringe to inject the water into the vial. Do not use any

other sort of water.

Leave the syringe in the rubber stopper.

3.

Mixing the powder and water in the vial

While carefully holding the syringe and vial, swirl gently to mix the powder and water

together. When it is mixed, it will look clear and have no particles in it.

Do not shake or you will create bubbles in your medicine.

4.

Re-filling the syringe with the medicine from the vial

Turn the vial upside down. Then, gently pull back the plunger, in order to draw the

medicine from the vial into the syringe. Take care not to pull out completely the plunger

with the attached plunger stopper. In case you pulled out the plunger with the plunger

stopper by mistake, make sure to discard the dose as sterility will be lost, and prepare a

new dose (and restart from step 1).

If any medicine is left in the vial, pull out the yellow needle until the end of the needle is

just inside the rubber stopper. If you look from the side through the gap in the rubber

stopper, you can control the movement of the needle and the liquid.

Make sure that you collect all of your medicine from the vial.

Put the cap back on the yellow needle. Unscrew the yellow needle from the syringe and lay

down the syringe.

Preparing the injection site and injecting your medicine

1.

Removing air bubbles

Unwrap the needle with the

grey

mark on it. Screw the grey needle onto the syringe and

remove the cap from the grey needle.

Hold the syringe with the grey needle pointing upwards and check for any air bubbles.

To remove air bubbles, gently flick the syringe until all the air collects at the top - then

slowly push the plunger in until the air bubbles are gone.

Do not touch the grey needle and do not let the needle touch any surface.

2.

Clean the injection site

Choose an injection site on your belly. It is best around the belly button (navel). To

reduce skin irritation, select a different part of your belly each day.

Clean the skin at your chosen injection site with your second alcohol swab - use a circular

motion.

3.

Piercing your skin

Hold the syringe in one hand – like you would hold a pencil.

Gently pinch up the skin around where you are going to inject and hold this firmly with

your other hand.

Slowly push the grey needle completely into your skin at an angle of about 45 to

90 degrees – then let go of your skin.

4.

Injecting your medicine

Gently pull back the plunger of the syringe. If blood appears, follow Step 5 below.

If no blood appears,

slowly

push the plunger in to inject your medicine.

When the syringe is empty, take out the grey needle slowly at the same angle.

Use your second alcohol swab to gently apply pressure where you have just injected.

5.

If blood appears:

take out the grey needle slowly at the same angle

use your second alcohol swab to gently apply pressure where you have just pierced your

skin

empty your medicine into a sink and follow Step 6 below

wash your hands and start again with a new vial and pre-filled syringe.

6.

Disposal

Use each needle, vial and syringe only once.

Put the cap back on the needles so that they are safe to be thrown away.

Ask your pharmacist how to safely dispose of used needles, vial and syringe.