Cetrotide 0.25 mg powder and solvent for solution forinjecti - United Kingdom[英国药品]

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Cetrotide 0.25 mg powder and solvent for solution forinjecti

2014-12-30 18:49:54 来源: 作者: 【大中小】浏览:487次评论:0条

For doctors

What is it and how is it used?

What Cetrotide is
Cetrotide contains a medicine called ‘cetrorelix acetate’. 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’).

What do you have to consider before using it?

Do not use Cetrotide

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.

Take special care with Cetrotide

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

Ovarian Hyper-Stimulation 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 Ovarian Hyper-Stimulation 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 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.

Using other medicines
Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Pregnancy and breast-feeding
Do not use Cetrotide if you are pregnant, think you may be pregnant, or if you are breast-feeding. Ask your doctor or pharmacist for advice before taking any medicines

Driving and using machines
Cetrotide is not expected to affect you being able to drive and use machines.

How is it used?

Always use Cetrotide 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.

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

What are possible side effects?

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

Allergic reactions

How should it be stored?

Keep out of the reach and sight of children.

Do not use Cetrotide after the expiry date which is stated on the vial after EXP. The expiry date refers to the last day of that month.
The Cetrotide powder in the vial and the sterile water (solvent) in the pre-filled syringe have the same expiry date. It is printed on the labels and on the carton.

Do not store above 25°C.

Keep the vial in the outer carton in order to protect from light.

The solution should be used immediately after preparation.

Do not use Cetrotide if the white pellet in the vial has changed in appearance. Do not use it if the prepared solution in the vial is not clear and colourless or if it has particles in it.

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

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For doctors

What is it?

Cetrotide is a powder and solvent that are made up in a solution for injection. Cetrotide contains the active substance cetrorelix.

What is it used for?

Cetrotide is given to women having ovarian stimulation (fertility treatment where the ovaries are stimulated to produce more eggs). It is used to prevent premature ovulation (early release of eggs from the ovary).
The medicine can only be obtained with a prescription.

How is it used?

Treatment with Cetrotide should be carried out by a doctor who has experience in this type of fertility treatment.
Cetrotide is given at doses of either 0.25 mg or 3 mg:

How does it work?

The active substance in Cetrotide, cetrorelix, blocks the effects of a natural hormone called luteinising hormone releasing hormone (LHRH). LHRH controls the production and release of another hormone called luteinising hormone (LH), which causes ovulation during the menstrual cycle. During fertility treatment, ovarian stimulation is normally 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 it 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 are medicines that also 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 benefits has it 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?

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 local 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 should not be used in people who may be hypersensitive (allergic) to cetrorelix or any of the other ingredients, to any hormones that are similar in structure to gonadotropin-releasing hormone, or to extrinsic peptide hormones (hormone-based medicines similar to Cetrotide). It must not be used in women who are pregnant or breast-feeding, in women who have been through the menopause, or in patients with moderate or severe kidney or liver disease. For the full list of restrictions, see the Package Leaflet.

Why has it been approved?

The Committee for Medicinal Products for Human Use (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 for the prevention of premature ovulation in patients undergoing a controlled ovarian stimulation, followed by oocyte pick-up and assisted reproduction techniques. The Committee recommended that Cetrotide be given marketing authorisation.

Further information

The European Commission granted a marketing authorisation valid throughout the European Union for Cetrotide on 13 April 1999. The marketing authorisation holder is Merck Serono Europe Limited. The marketing authorisation was renewed on 13 April 2004 and on 13 April 2009.

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Name

Cetrotide 0.25 mg powder and solvent for solution for
injection

Composition

Each vial contains 0.25 mg cetrorelix (as acetate).
After reconstitution with the solvent provided, each ml of the solution contains 0.25 mg cetrorelix.

For a full list of excipients, see section 6.1.