Ovitrelle250 micrograms powder and solvent for solution forinjection

Ovitrelle is a medicinal product containing choriogonadotropin alfa, which is very similar to chorionic gonadotrophin found naturally in humans, but it is made in laboratories by special recombinant DNA techniques. It belongs to the family of hormones called gonadotrophins, which are involved in the normal control of reproduction.

Ovitrelle is used in women undergoing assisted reproductive techniques such as in vitro fertilisation (IVF). Other medicines are given first to bring about the growth and development of several follicles, to produce eggs. Ovitrelle is then used to ripen (mature) these follicles.

Ovitrelle is also used in women who do not produce eggs (a condition called anovulation) or who produce too few eggs (oligo-ovulation). It is given to bring about the release of eggs (ovulation), after other medicines have been used to develop the follicles.

You and your partner's fertility should be evaluated before the treatment is started.

Do not take Ovitrelle:

• If you are pregnant or breast-feeding
• If you have ovarian enlargement or one or more large ovarian cysts
• if you have unexplained vaginal bleeding
• if you have been diagnosed as having ovarian, uterine or breast cancer
• if you had a tumour of the hypothalamus or pituitary gland
• If you suffer from severe inflammation of the veins or blood clotting in the veins (active thrombo-embolic disorders)
• if you are allergic (hypersensitive) to choriogonadotropin, or any of the ingredients of Ovitrelle.
• if you have any condition which would make a normal pregnancy impossible (e.g. absent uterus, ovaries which have not developed properly, fibroids) or you have been through menopause
• if you had an extrauterine pregnancy within the last 3 months

Take special care with Ovitrelle:

Treatment with Ovitrelle may increase your risk of developing a condition called ovarian hyperstimulation syndrome (OHSS) (see also ?Possible side effects?). This is when the ovaries over-react to the treatment and develop too many follicles. The most common symptom is abdominal pain.

If you have significant abdominal pain or discomfort, do not take the injection, and speak to your doctor or nurse as soon as possible. You should not have intercourse for at least 4 days, or otherwise you should use a barrier method for contraception.

Compared with natural conception, the frequency of multiple pregnancies and births is increased in patients receiving this treatment. The majority of these are twins. In assisted conception techniques, the number of babies is related to the number of embryos replaced.

Your risk of OHSS or multiple pregnancy is reduced if the usual dose of Ovitrelle is used, and you are monitored closely throughout your treatment cycle (e.g. blood tests for estradiol levels and ultrasound).

Using other medicines:

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

Pregnancy and breast-feeding

You should not take Ovitrelle if you are pregnant or breast-feeding.

Always take Ovitrelle exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.The usual dose of Ovitrelle is 1 vial (250 micrograms) given as a single injection. Your doctor will have explained exactly when to give the injection.

Ovitrelle is intended for subcutaneous use, that means given by injection under the skin. Each vial is for single use only.

Sometimes the injection will be given to you by a doctor or nurse, or you or your partner may be trained to give the injection at home.

If you administer Ovitrelle to yourself, please carefully read the following instructions:

1. Wash your hands. It is important that your hands and the items you use be as clean as possible.

2. Assemble everything you need. Please note that alcohol, swabs, syringes and needles are not contained in the package. Find a clean area and lay out everything:

• two alcohol swabs,
• one solvent vial,
• one vial containing the medicinal product
• one syringe,
• one big needle for reconstitution,
• a fine-bore needle for subcutaneous injection.

3. Drawing up the solvent:Remove the protective cap from the solvent vial. Attach the needle for reconstitution (the bigger needle) to the syringe and draw up some air into the syringe by pulling the plunger to approximately the 1 ml mark. Then, insert the needle into the vial, push the plunger to expel the air, turn the vial upside down and gently draw up all the solvent. Set the syringe down carefully on the work-surface taking care not to touch the needle.

4. Preparing the injection solution : Remove the protective cap from the Ovitrelle powder vial, pick up your syringe and slowly inject the solvent into the vial of Ovitrelle. Swirl gently. Do not shake. The powder should dissolve into a clear solution immediately.

Turn the vial upside down, gently draw the solution back into the syringe.

5. Injection:Change the needle for the fine-bore needle and remove any air bubbles: If you see air bubbles in the syringe, hold the syringe with the needle pointing upwards and gently flick the syringe until all the air collects at the top. Gently push the plunger until the air bubbles are gone.

Immediately inject the solution Your doctor or nurse will have already advised you where to inject e.g. tummy, front of thigh. Wipe the chosen area with an alcohol swab. Firmly pinch the skin together and insert the needle at a 45 to 90 angle using a dart-like motion. Inject under the skin, as you were taught. Do not inject directly into a vein. Inject the solution by pushing gently on the plunger. Take as much time as you need to inject all the solution. Immediately withdraw the needle and clean the skin with an alcohol swab using a circular motion.

6. Dispose of all used items: Once you have finished your injection, immediately discard all needles and empty glass containers in a sharps container. Any unused solution must be discarded.

If you take more Ovitrelle than you should:

If too much Ovitrelle is used, there is a possibility that ovarian hyperstimulation syndrome may occur, which is further described under ?Take special care with Ovitrelle? and ?Possible side effects'. You should consult your doctor if symptoms of this syndrome occur.

If you forget to take Ovitrelle:

You should contact your doctor.

Like all medicines, Ovitrelle can cause side effects, although not everybody gets them. The majority of side effects seen to date have been mild or moderate. The most frequent side effects reported have been tiredness, pain and local reactions at the site of injection.

Ovarian hyperstimulation syndrome has been observed in approximately 4% of the patients in clinical studies; most of these cases were mild or moderate in nature. Blood in the peritoneal cavity, respiratory difficulties are possible complications of ovarian hyperstimulation syndrome.

This syndrome is characterized by large ovarian cysts. First symptoms of ovarian hyperstimulation are pain in the lower abdominal region, possibly in combination with nausea, vomiting and weight gain. Should the above mentioned symptoms occur, a careful medical examination is indicated as soon as possible.

Common side effects reported include abdominal pain, nausea and vomiting, headache, injection site inflammation and reaction, dizziness. Diarrhoea, depression, irritability, restlessness and breast pain have also been reported in some cases and are considered uncommon.

Extrauterine pregnancy, ovarian torsion (a condition affecting the ovaries) and other complications may arise from the assisted conception techniques your doctor may use.

Isolated cases of mild allergic reactions to Ovitrelle (rash) have been reported.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Keep out of the reach and sight of children.

Do not use after the expiry date which is stated on the label after EXP. The expiry date refers to the last day of that month.

Do not store above 25°C. Store in the original package.

Once the medicine is reconstituted (made up with the solvent), it should be used immediately.

Do not use Ovitrelle if you notice any visible signs of deterioration.

The reconstituted solution should not be administered if it contains particles or is not clear. Ovitrelle is for single use only. Any unused solution should be discarded.

What Ovitrelle contains

The active substance is choriogonadotropin alfa, each vial contains 285 micrograms. After reconstitution 250 micrograms, which is the equivalent of 6500 IU, is delivered because some choriogonadotropin alfa will be left in the vial, in the syringe and in the needle.

The other ingredients are sucrose, phosphoric acid, and sodium hydroxide.

The solvent is water for injections.

What Ovitrelle looks like and contents of the pack

Ovitrelle is provided as a powder and solvent for solution for injection. It is available in packs containing 1, 2, or 10 vials of powder containing the active substance which are accompanied by the corresponding number of solvent containers. Not all pack sizes may be marketed.

Each vial of powder contains 285 micrograms of choriogonadotropin alfa and each container of solvent contains 1 ml of water for injections. When one vial is reconstituted with 1 ml of solvent you will receive a dose of 250 micrograms.

Marketing Authorisation Holder

Merck Serono Europe Limited, 56 Marsh Wall, London E14 9TP,
United Kingdom

Manufacturer

Merck Serono S.p.A., Via delle Magnolie 15, I-70026 Modugno (Bari), Italy

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.

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Lietuva
Merck Serono Atstovyb-
C/o Ares Trading SA Baltic States
Zamenhofo 11-3,
LT-44287 Kaunas
Tel: +370 37320603

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