Product Details

Product Information of Ovitrelle Injection Pre-filled Pen

What do you need to know before you use Ovitrelle

Do not use Ovitrelle · if you are allergic to choriogonadotropin alfa or any of the other ingredients of this medicine (listed in section 6). · if you have a tumour in your hypothalamus or pituitary gland (both are parts of the brain). · if you have large ovaries or sacs of fluid within the ovaries (ovarian cysts) of unknown origin. · if you have unexplained vaginal bleeding. · if you have cancer of your ovaries, womb or breast. · if you have severe inflammation of your veins or blood clotting in your veins (active thromboembolic disorders). · if you have any condition that usually makes a normal pregnancy impossible, such as menopause or early menopause (ovarian failure), or malformations of sexual organs. Do not use Ovitrelle if any of the above applies to you. If you are not sure, talk to your doctor before using this medicine. Warnings and precautions Before the treatment is started, your and your partner’s fertility should be evaluated by a doctor experienced in the treatment of fertility problems. Ovarian hyperstimulation syndrome (OHSS) This medicine may increase your risk of developing OHSS. This is when your follicles develop too much and become large cysts. If you get lower abdominal pain, gain any weight rapidly, feel sick or are vomiting, or have difficulty in breathing, do not give yourself the Ovitrelle injection and talk to your doctor straight away (see section 4). If you are developing OHSS, you may be told not to have sex or to use a barrier contraceptive method for at least four days. The risk of OHSS is reduced if the usual dose of Ovitrelle is used, and if you are monitored closely throughout your treatment cycle (e.g. blood tests for estradiol levels and ultrasound). Multiple pregnancy and/or birth defects When using Ovitrelle, you have a higher risk of being pregnant with more than one child at the same time (‘multiple pregnancy’, usually twins) than if you conceived naturally. Multiple pregnancy may lead to medical complications for you and your babies. When undergoing assisted reproductive technologies, the risk of having a multiple pregnancy is related to your age, the quality and the number of fertilised eggs or embryos placed inside you. Multiple pregnancies and specific characteristics of couples with fertility problems (e.g. age) may also be associated with an increased chance of birth defects. The risk of multiple pregnancy is reduced if you are monitored closely throughout your treatment cycle (e.g. blood tests for estradiol levels and ultrasound). Ectopic pregnancy Pregnancy outside of the womb (an ectopic pregnancy) may occur in women with damaged fallopian tubes (the tubes which carry the egg from the ovary to the womb). Therefore, your doctor should perform an early ultrasound examination to rule out the possibility of pregnancy outside the womb. Miscarriage When undergoing assisted reproductive technologies or stimulation of your ovaries to produce eggs, you are more likely to have a miscarriage than the average woman. Blood clotting problems (thromboembolic events) Talk to your doctor before using Ovitrelle if you or a member of your family have ever had blood clots in the leg or in the lung, or a heart attack or stroke. You may be at a higher risk of serious blood clots or existing clots might become worse with Ovitrelle treatment. Tumours of sexual organs There have been reports of tumours in the ovaries and other sex organs, both benign and malignant, in women who have undergone multiple regimens for infertility treatment. Pregnancy tests If you do a pregnancy test with serum or urine after use of Ovitrelle, and up to ten days later, it may happen that you get a false positive test result. If you are not sure, talk to your doctor. Children and adolescents Ovitrelle is not for use in children and adolescents. Other medicines and Ovitrelle Tell your doctor if you are taking, have recently taken or might take any other medicines. Pregnancy and breast-feeding Do not use Ovitrelle if you are pregnant or breast-feeding. If you are pregnant or breast-feeding, ask your doctor for advice before taking this medicine. Driving and using machines It is not expected that Ovitrelle will affect your ability to drive and use machines. Ovitrelle contains sodium This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially “sodiumfree”.