КЕТРОТИД 0.25 МГ Порошок и раствор для инъекционного раствора

Содержание инструкции

1. Cetrotide 0,25 mg powder and solvent for injectable solution
   1. What is Cetrotide and what is it used for
   2. What you need to know before using Cetrotide
   3. How to use Cetrotide
   4. Possible side effects
   5. How to store Cetrotide
   6. Package Contents and Other Information
   7. This medicine must be brought to room temperature before injection.
   8. Wash your hands
   9. Place everything you need on a clean surface:
   10. Remove the closure cap from the vial
   11. Adding the water from the prefilled syringe to the powder in the vial
   12. Mixing the powder with water in the vial
   13. Refilling the syringe with the medicine present in the vial
   14. Removing air bubbles
   15. Cleaning the injection site
   16. Skin puncture
   17. Injection of the medicine
   18. If blood appears:
   19. Disposal

Cetrotide 0,25 mg powder and solvent for injectable solution

Cetrorelix

Read this leaflet carefully before you start to 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 Cetrotide is and what it is used for
• 2. What you need to know before you use Cetrotide
• 3. How to use Cetrotide
• 4. Possible side effects
• 5. How to store Cetrotide
• 6. Contents of the pack and other information How to mix and inject Cetrotide

1. What is Cetrotide and what is it used for

What is Cetrotide
Cetrotide contains an active substance called “cetrorelix”. This medicine blocks the release of an
egg from the ovary (ovulation) during the menstrual cycle. Cetrotide belongs to a family of
medicines called “gonadotropin-releasing hormone antagonists”.

What is Cetrotide used for
Cetrotide is one of the medicines used during “assisted reproductive technologies” to promote a
pregnancy. It blocks the immediate release of the eggs, because if the eggs are released too
early (premature ovulation), the doctor cannot collect them.

How Cetrotide works
Cetrotide blocks a natural hormone in the body, called LHRH (luteinizing hormone-releasing hormone).

• LHRH controls another hormone, called LH (“luteinizing hormone”).
• LH stimulates ovulation during the menstrual cycle.

This means that Cetrotide blocks the chain of events that leads to the release of the egg from the
ovary. When the eggs are ready to be collected, you will be given another
medicine that induces the release of the eggs (ovulation induction).

2. What you need to know before using 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 hormone).
• if you are pregnant or breastfeeding.
• if you have severe kidney disease.

Do not use Cetrotide if you fall into any of the above cases. If you have any doubts, ask your doctor before using
this medicine.

Warnings and precautions
Allergies
If you suffer from an active allergy or if you have suffered from allergies in the past, tell your doctor before
taking Cetrotide.
Ovarian Hyperstimulation Syndrome (Ovarian Hyperstimulation Syndrome, OHSS)
Cetrotide is used together with other medicines that stimulate the ovaries to produce a larger number of
eggs ready to be released. During or after taking these medicines, OHSS may occur. This happens when the follicles develop too much, becoming large cysts.
For possible effects to monitor and to know what to do if they occur, see
section 4 “Possible side effects”.
Use of Cetrotide for more than one cycle
Experience with the use of Cetrotide for more than one cycle is limited. If you need to
take Cetrotide for more than one cycle, your doctor will carefully assess the benefits and risks.
Liver disease
Tell your doctor before using Cetrotide if you have liver disease. Cetrotide has not been studied
in patients with hepatic disease.
Kidney disease
Tell your doctor before using Cetrotide if you have kidney disease. Cetrotide has not been studied in
patients with renal disease.

Children and adolescents
The use of Cetrotide is not indicated in children and adolescents.

Other medicines and Cetrotide
Tell your doctor if you are taking, have recently taken or might take any other medicine.

Pregnancy and breastfeeding
Do not use Cetrotide if you are pregnant, if you suspect you are pregnant or if you are breastfeeding.

Driving and operating machinery
It is not expected that the use of Cetrotide will interfere with the ability to drive vehicles and operate
machinery.

3. How to use Cetrotide

Use this medicine following the instructions of your doctor exactly. If you have any doubts, consult your
doctor.

Use of this medicine
This medicine is indicated only for abdominal injection just below the surface of the skin
(subcutaneous). To avoid skin irritation, choose a different area of the abdomen each day.

• The first administration must be performed under the supervision of your doctor. The doctor or nurse will show you how to prepare and inject the medicine.
• You will be able to perform subsequent administrations, after the doctor has informed you of the symptoms that may indicate allergies and the possible serious or life-threatening consequences that require immediate treatment (see section 4 “ Possibleside effects”).
• Read carefully and follow the instructions described in the paragraph at the end of this
• On day 1 of the treatment cycle, you will start using another medicine. You will start using Cetrotide a few days later. (See the section “ How much medicine to use”.)

How much medicine to use
Inject the contents of one vial (0.25 mg of Cetrotide) once a day. It is recommended to use the
medicine at the same time each day, with a 24-hour interval between doses.
You can choose to perform the injection every morning orevery evening.

• If you choose morning administration, start the injections on day 5 or 6 of the treatment cycle. Based on the ovarian response, the doctor may decide to start on a different day. The doctor will tell you the exact date and time. You will continue to use this medicine until the morning of the egg collection (ovulation induction).

OR

• If you have chosen evening administration: start the injections on day 5 of the treatment cycle. Based on the ovarian response, the doctor may decide to start on a different day. The doctor will tell you the exact date and time. You will continue to use this medicine until the evening before the egg collection (ovulation induction).

If you use more Cetrotidethan you should
No serious effects are expected if you accidentally inject a higher dose of this medicine
than intended. The effect of the medicine will last longer. Therefore, specific measures are generally not necessary.

If you forget to use Cetrotide

• If you forget a dose, inject it as soon as you remember and contact your doctor.
• Do not inject a double dose to make up for a missed 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

• Warmth, redness of the skin, itching (often in the groin or armpits), raised, red, itchy areas (hives), runny nose, rapid or irregular pulse, swelling of the tongue and throat, sneezing, wheezing or severe difficulty breathing or dizziness. You may have a severe or life-threatening allergic reaction to the medicine. This reaction is uncommon (may affect up to 1 in 100 women). If you notice any of these side effects, stop using Cetrotide and tell your doctor immediately.

Ovarian hyperstimulation syndrome (OHSS)
This can occur due to the other medicines you are using to stimulate your ovaries.

• The symptoms of OHSS can be lower abdominal pain with a feeling of unwellness (nausea) or actual unwellness (vomiting). This may mean that your ovaries have reacted excessively to the treatment and that large ovarian cysts have developed. This event is common (may affect up to 1 in 10 women).
• OHSS can become severe with markedly enlarged ovaries, decreased urine production, weight gain, difficulty breathing, or fluid in the abdomen or chest. This event is uncommon (may affect up to 1 in 100 women).

If you notice any of these side effects, tell your doctor immediately.

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

• Mild and short-lived skin irritation may appear at the injection site, such as redness, itching or swelling.

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

• Feeling unwell (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 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 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 and do not keep near the freezer
compartment or ice packs.
Store in the original packaging to protect the medicine from light.
The closed product can be stored in the original packaging at room temperature (not
above 30°C) for a maximum of three months.
The solution must 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
solution prepared in the vial if it is not clear and colourless or if it contains particles.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What Cetrotide contains

• The active substance is cetrorelix. Each vial contains 0.25 mg of cetrorelix (as acetate).
• The other ingredients are:
• In the powder: mannitol.
• In the solvent: water for injections.

Description of the appearance of Cetrotide and package contents
Cetrotide is a powder and a solvent for injectable solution. The white powder is contained in a
glass vial fitted with a rubber stopper. The solvent is a clear and colourless solution contained
in a prefilled syringe.
The powder vial contains 0.25 mg of cetrorelix and the prefilled syringe contains 1 ml of
solvent.
It is available in packs of 1 vial and 1 prefilled syringe or of 7 vials and 7 prefilled syringes
(not all pack sizes may be marketed).
In addition, for each vial, the pack contains:

• a yellow-labelled injection needle for introducing the sterile water into the vial and withdrawing the prepared medicine from the vial
• a grey-labelled injection needle for injecting the medicine into the abdomen

Marketing Authorisation Holder
Merck Europe B.V., Gustav Mahlerplein 102, 1082 MA Amsterdam, Netherlands

Manufacturer
Merck Healthcare KGaA, Frankfurter Straße 250, D-64293 Darmstadt, Germany
More 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 describes how to mix the powder with the sterile water (solvent) and inject the medicine.
• Before you start using this medicine, read these instructions completely and carefully.
• This medicine is for your use only, no one else should use it.
• The needle, vial and syringe are for single use only.

Before you start

1. This medicine must be brought to room temperature before injection.

Remove it from the refrigerator about 30 minutes before use.

2. Wash your hands

• It is important that your hands and all objects used are as clean as possible.

3. Place everything you need on a clean surface:

• a vial with the powder
• a pre-filled syringe with sterile water (solvent)
• a needle with a yellowmarking, for introducing the sterile water into the vial and withdrawing the prepared medicine
• a needle with a greymarking, for injecting the medicine into the abdomen
• two alcohol-soaked pads (not supplied in the package).

Mixing the powder with sterile water to prepare the medicine

1. Remove the closure cap from the vial

• Underneath there is a rubber stopper, keep it on the vial.
• Clean the rubber stopper and the metal ring with a wipe soaked in alcohol.

2. Adding the water from the prefilled syringe to the powder in the vial

• Remove the needle with yellowmarking from the packaging.
• Remove the cap from the prefilled syringe and screw on the yellow needle. Remove the cap from the needle.
• Push the yellow needle through the center of the rubber stopper of the vial.
• Inject the water into the vial by slowly pushing the syringe plunger. Do not use any other type of water.
• Leave the syringe in the rubber stopper.

3. Mixing the powder with water in the vial

• Holding the syringe and vial carefully, gently rotate them to mix the powder with the water. Once mixed, the solution should appear clear, without particles.
• Do not shake to avoid creating bubbles in the medicine.

4. Refilling the syringe with the medicine present in the vial

• Invert the vial. Then, gently pull back the plunger to transfer the medicine from the vial into the syringe. Be careful not to fully withdraw the plunger with the rubber stopper attached. If you inadvertently withdraw the plunger with the rubber stopper, remember to discard the dose as it is no longer sterile and prepare a new one (starting from point 1).
• If some of the medicine remains inside the vial, slowly retract the yellow needle until its tip is just inside the rubber stopper. If you look sideways through the slit, you can check the movement of the needle and the solution.
• Make sure you have withdrawn all the medicine from the vial.

• Replace the cap on the yellow needle. Unscrew the yellow needle from the syringe and place the syringe on the surface.

Preparation of the injection site and injection of the medicine

1. Removing air bubbles

• Remove the needle with a greymarking from the package. Screw the grey needle onto the syringe and remove the needle cap.
• Hold the syringe with the grey needle facing upwards and check for air bubbles.
• To remove the bubbles, gently tap the syringe until all the air bubbles gather at the top; at this point, gently push the plunger to expel them from the syringe.
• Do not touch the grey needle and do not allow the grey needle to come into contact with any surface.

2. Cleaning the injection site

• Choose the injection site on the abdomen, preferably around the navel. To reduce skin irritation, choose a different area of the abdomen each day.
• Clean the skin at the chosen injection site using the second alcohol wipe, following circular movements.

3. Skin puncture

• Hold the syringe in one hand as if it were a pencil.
• Gently pinch the skin around the area where you want to inject the medicine with the other hand and hold it firmly.
• Push the grey needle completely and slowly into the skin at an angle of 45-90 degrees and release the skin.

4. Injection of the medicine

• Gently pull back the syringe plunger. If blood appears, proceed as described in point 5.
• If no blood appears, slowly push the plunger to inject the medicine.
• When the syringe is empty, slowly withdraw the grey needle at the same angle.
• Once the injection is complete, apply gentle pressure with the second alcohol-soaked swab to the injection site.

5. If blood appears:

• slowly remove the grey needle at the same angle
• apply gentle pressure to the injection site with the second alcohol-soaked pad
• empty the medicine into a container and proceed as described in point 6
• wash your hands and start again with a new vial and a new pre-filled syringe.

6. Disposal

• The needle, vial and syringe are for single use only.
• Replace the cap on the needles, so that they can be safely disposed of.
• Ask your pharmacist how to safely dispose of used needles, vials and syringes.