Patient leaflet - Ceziboe 0.25 mg solution for injection in Pre-filled syringe
1. What Ceziboe is and what it is used for
What Ceziboe is
Ceziboe contains a medicine called 'cetrorelix acetate'. This medicine stops your body from releasing an egg from your ovary (ovulation) during your menstrual cycle. Ceziboe belongs to a group of medicines called 'anti-gonadotropin-releasing hormones'.
What Ceziboe is used for
Ceziboe 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 Ceziboe works
Ceziboe 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 Ceziboe 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 Ceziboe
Do NOT use Ceziboe
- if you are allergic to cetrorelix (as acetate) or to any of the other ingredients of this medicine (listed in section 6)
- if you are allergic to medicines similar to Ceziboe (any other peptide hormones).
- if you are pregnant or breast-feeding
- if you have severe kidney disease.
Do not use Ceziboe 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 Ceziboe if you have an active allergy or have had allergies in the past.
Ovarian Hyperstimulation Syndrome (OHSS)
Ceziboe 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 Ovarian Hyperstimulation Syndrome (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 Ceziboe during more than one cycle
Experience of using Ceziboe during more than one cycle is small. Your doctor will carefully look at the benefits and risks for you, if you need to have Ceziboe during more than one cycle.
Liver disease
Tell your doctor before using Ceziboe if you have a liver disease. Ceziboe has not been investigated in patients with hepatic disease.
Kidney disease
Tell your doctor before using Ceziboe if you have a kidney disease. Ceziboe has not been investigated in patients with kidney disease.
Children and adolescents
Ceziboe is not indicated for the use in children and adolescents.
Other medicines and Ceziboe
Tell your doctor if you are taking, have recently taken or might take any other medicines.
Pregnancy and breast-feeding
Do not use Ceziboe if you are pregnant, think you may be pregnant, or if you are breast-feeding.
Driving and using machines
Ceziboe is not expected to affect your ability to drive and use machines.
3. How to use Ceziboe
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 inject Ceziboe'.
- You start by using another medicine on day 1 of your treatment cycle. You then start using Ceziboe a few days later. (See next section 'How much to use').
How much to use
Inject the contents of one syringe (0.25 mg Ceziboe) 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).
OR
- 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 Ceziboe 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 Ceziboe
- 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.
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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 Ceziboe 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 Ovarian Hyperstimulation Syndrome (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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Ceziboe
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 syringe after EXP. The expiry date refers to the last day of that month.
Store in a refrigerator (2°C – 8°C).
The unopened product may be stored in the original package at room temperature (not above 25°C) for up to three months.
Do not use it if the solution in the syringe is not clear and colourless or if it has particles in it.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Ceziboe contains
- The active substance is cetrorelix (as acetate). Each pre-filled syringe (1 ml) contains 0.25 mg cetrorelix (as acetate).
- The other ingredients are mannitol (E421), s-lactic acid and water for injection.
What Ceziboe looks like and contents of the pack
Ceziboe is a clear, colourless solution in a Type I clear glass barrel (1 ml) affixed with a 27 G ½ inch needle and stoppered with a bromobutyl elastomer plunger stopper. The pre-filled syringe has a white plunger rod and an automatic safety system.
It is available in a pack of 1 pre-filled syringe and in a multipack comprising 7 cartons, each containing 1 pre-filled syringe.
For each syringe, the pack contains:
- one pre-filled syringe assembled with a safety device containing the solution
- one alcohol swab for cleaning.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Sun Pharmaceutical Industries Europe B.V. Polarisavenue 87
2132JH Hoofddorp
The Netherlands
Manufacturer
Sun Pharmaceutical Industries Europe B.V. Polarisavenue 87
2132 JH Hoofddorp
The Netherlands
S.C. Terapia S.A.
124 Fabricii Street
400632, Cluj-Napoca
Cluj County
Romania
This medicinal product is authorised in the Member States of the EEA and United Kingdom (Northern Ireland) under the following names
Belgium Ceziboe Czech Republic Ceziboe Germany Ceziboe Greece Ceziboe France Ceziboe Hungary Ceziboe Ireland Ceziboe Italy Ceziboe The Netherlands Ceziboe Spain Ceziboe United Kingdom (Northern Ireland) Ceziboe
This leaflet was last revised in November 2022.
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