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OVIDREL_CHORIOGONADOTROPIN_绒毛膜促性腺激素预装注射器说明书

OVIDREL PFS 250MCG(绒毛膜促性腺激素预装注射器)

  药店国别:

  产地国家:美国

  处 方 药:

  所属类别:250微克/支

  包装规格:250微克/支

  计价单位:

  生产厂家中文参考译名:EMD SERONO INC

  生产厂家英文名:EMD SERONO INC

  原产地英文商品名:Ovidrel PFS 250MCG/Syringe

  原产地英文药品名:CHORIOGONADOTROPIN ALFA

  中文参考商品译名:OVIDREL预装注射器 250微克/支

  中文参考药品译名:绒毛膜促性腺激素阿尔法

  简介:

  部份中文Ovidrel®处方资料(仅供参考)

  功效主治:用于不孕症﹑黄体功能不足﹑功能性子宫出血﹑隐睾症﹑男性性腺功能减退症﹑先兆流产或习惯性流产等如在绝经促性素之后配合使用本品,则效果较好。主要用于促排卵,促黄体发育。在男性可促使睾丸间质细胞分泌睾酮,可用以检验睾丸间质细胞功能,与尿促性素联合长期应用,有生精作用。

  用法用量

  1.用于无排卵性不育症,于经期第10日起,每日肌注1次500-1000单位,连续5日。

  2.用于黄体功能不足,于经期第15-17日(基础体温上升3日后),每日肌注500-1000单位,连用5日。

  3.功能性子宫出血,每日肌注300-1500单位,连用3-5日。

  4.10岁以下隐睾症,每次肌注500-1000单位;10-14岁,每次肌注1500单位,每周2-3次,连用4-8周。

  5.用于男性性功能减退症,1次肌注4000单位,每周3次。

  6.先兆流产或习惯性流产,每日或隔日1次肌注3000-5000单位,共5-10次。任何疑问,请遵医嘱。

  Ovidrel® 250 microgram Solution for Injection

  Choriogonadotropin alfa (rch)

  Consumer Medicine Information

  NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia. This page contains answers to some common questions about Ovidrel. It does not contain all the information that is known about Ovidrel. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risk of you using this medicine against the benefits he/she expects it will have for you. If you have any concerns about using this medicine, ask your doctor or pharmacist. Bookmark or print this page, you may need to read it again.

  What Ovidrel is used for

  Ovidrel belongs to a family of hormones known as gonadotrophins, which are involved in the normal control of reproduction.

  The active substance of Ovidrel is choriogonadotropin alfa that is produced in mammalian cells modified by recombinant DNA technology.

  Ovidrel 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. Follicles are the structures in your ovaries that contain the egg. Ovidrel is then used to ripen (mature) these follicles.

  Ovidrel is also used in women who do not produce eggs (anovulation), or who produce too few eggs (oligo-ovulation). It is used to trigger the release of eggs (ovulation), after other medicines have been used to develop the follicles.

  Your doctor may prescribe Ovidrel for another reason. Ask your doctor if you have any questions about why Ovidrel has been prescribed for you.

  Ovidrel is not addictive.

  This medicine is available only with a doctor’s prescription.

  Before you use Ovidrel

  When you must not use it

  Do not use Ovidrel if:

  you have a history of allergy to choriogonadotropin alfa, or a similar medicine, or any other inactive ingredients (listed at the end of this leaflet).

  Symptoms of an allergic reaction to Ovidrel may include shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue or other parts of the body; rash, itching or hives on the skin.

  Do not take Ovidrel if you have, or have had, any of the following medical conditions:

  your ovaries are unable to be stimulated to produce eggs (primary ovarian failure or premature menopause).

  uncontrolled thyroid or adrenal gland disease.

  a tumour of the hypothalamus or pituitary gland.

  ovarian enlargement or one or more large ovarian cysts.

  cancer of your ovaries, uterus (womb) or breasts.

  fibroid tumours in your uterus which would make pregnancy impossible.

  if you have been through menopause.

  Ovidrel should not be used in the elderly or in children.

  Do not take Ovidrel after the expiry date printed on the pack.

  Do not take Ovidrel if the packaging is torn or shows signs of tampering.

  If your medicine has expired or is damaged, return it to your pharmacist for disposal.

  If you are not sure whether you should start using Ovidrel, contact your doctor.

  Before you start to use it

  Your doctor will assess you and your partner’s infertility. This may include tests for other medical conditions, which may interfere with your ability to become pregnant. If necessary, other medical conditions may be treated before starting infertility treatments and Ovidrel.

  Tell your doctor if you have or have had any other pre-existing medical conditions.

  Treatment with Ovidrel may increase your risk of developing a condition called ovarian hyperstimulation syndrome (OHSS). This is when the ovaries over react to the hormonal treatment and develop too many follicles. The most common symptom is stomach pain. During stimulation your doctor will monitor your treatment by use of ultrasound and blood tests to measure oestrogen levels. This will help to indicate if you are likely to develop OHSS. If necessary, your doctor will delay or cancel your Ovidrel injection.

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

  There may be a slightly increased risk of birth defects in women using assisted reproductive technologies. This may be due to maternal age, genetic factors, multiple pregnancies or the assisted reproductive technologies. Talk to your doctor about any concerns you may have before undergoing treatment.

  Tell your doctor if you or your family have or have had increased risk of developing blood clots e.g. stroke, heart attacks.

  Taking other medicines

  Tell your doctor if you are taking any other medicines, including any that you buy without prescription from your pharmacy, supermarket or health food shop.

  Ovidrel may interfere with the results of a blood or urinary hCG (pregnancy) test for up to 10 days. This may lead to a false positive pregnancy test.

  How Ovidrel is given

  Follow all directions given to you by your doctor or pharmacist carefully.

  They may differ from the information contained in this leaflet.

  Treatment with Ovidrel should be started under the supervision of a specialist doctor experienced in fertility treatment.

  How much to inject

  The dose of Ovidrel is one pre-filled syringe (250 microgram in 0.5 mL) given as a single injection after stimulation of follicle growth by other medicines.

  Dosage may need to be varied on the instruction of your doctor and you should be confident in your ability to adjust the dose.

  Please consult your doctor or pharmacist if you are in any doubt.

  Your doctor will explain exactly when to give the injection.

  Each pre-filled syringe is for single use only.

  How to inject

  Ovidrel is given as an injection under the skin (subcutaneously), usually near your stomach.

  Ovidrel is intended to be injected by yourself or by your partner.

  Your doctor or nurse will instruct and assist you in learning the procedure and technique of self-injection.

  Do not attempt self-injection until you are sure of how to do it.

  Your partner may be trained to give the injection at home.

  Your doctor or nurse can also give the injection to you.

  Where to inject

  Ovidrel is usually given in the stomach area (except around navel and waistline) or the front of your thigh.

  Do not inject into any areas in which you feel lumps, firm knots, depressions, pain or discolouration.

  Talk to your doctor if you find anything unusual when injecting.

  If you forget to inject Ovidrel

  You should contact your doctor immediately.

  It is important that Ovidrel is injected on the correct day and at the correct time as instructed by your doctor. You must inform your doctor if your injection was not given when directed.

  Ask your doctor if you are not sure what to do or have trouble remembering to inject your medicine.

  If you inject too much

  Immediately contact your doctor or the Poisons Information Centre (In Australia telephone 131 126. In New Zealand telephone 0800 764 766) if you are concerned that you have given yourself too much Ovidrel.

  While you are using Ovidrel

  Things you must do

  Tell your doctor if you start taking any new medication while using Ovidrel.

  Things you must not do

  Do not give this medicine to anyone else, even if their symptoms seem similar to yours or if they have the same condition as you.

  Do not use Ovidrel to treat any other complaints unless your doctor says to.

  Do not stop Ovidrel or change the dose without checking with your doctor.

  Side effects

  Tell your doctor as soon as possible if you do not feel well while you are taking Ovidrel.

  Tell your doctor immediately if you experience any of the following:

  Early signs of ovarian hyperstimulation syndrome (OHSS) which include severe stomach pain, nausea, vomiting, diarrhoea, shortness of breath and low urine production.

  Tell your doctor if you notice any of the following and they worry you:

  Common side effects:

  injection site soreness/redness

  headache

  tiredness

  nausea/vomiting, abdominal pain

  rash

  Uncommon side effects:

  diarrhoea

  depression

  irritability

  restlessness

  breast pain

  severe OHSS

  warning signs of blood clots (such as pain, warmth, redness, numbness or tingling in arm or leg)

  mild allergic reaction

  warning signs of stroke or heart attack

  Other side effects not listed above may also occur in some patients.

  Tell your doctor if you notice anything else that is making you feel unwell.

  Do not be alarmed by this list of possible side effects. You may not experience any of them.

  After using Ovidrel

  Storage

  Keep this medicine where young children cannot reach it.

  Ovidrel must be stored at 2°C to 8°C (Refrigerate. Do not freeze) in its original container. Product is for single patient use in one patient only. Contains no antimicrobial preservative. Discard any residue. Ovidrel can also be stored for up to 30 days below 25°C in its original container and protected from light. Discard any residue.

  Disposal

  After injecting, you should discard the syringe even if you have not injected all its contents. Syringes should be discarded in an appropriate disposal unit.

用药温馨提示:当您服用此药物时,需定期接受医疗专业人士的检查,以便随时针对其药效、副作用等情况进行监测。本网站所包含的信息旨在为患者提供帮助,不能代替医学建议和治疗。
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