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GONAL-F_FOLLITROPIN_果纳芬-F_重组人卵泡刺激说明书

GONAL-F RFF PEN 900IU(重组人卵泡刺激素注射笔)

  药店国别:

  产地国家:美国

  处 方 药:

  所属类别:900单位/瓶/套

  包装规格:900单位/瓶/套

  计价单位:

  生产厂家中文参考译名:默克雪兰诺

  生产厂家英文名:Merck Serono

  原产地英文商品名:GONAL-F 900IU/VIAL/KIT

  原产地英文药品名:FOLLITROPIN ALPHA,RECOMB

  中文参考商品译名:果纳芬 900单位/瓶/套

  中文参考药品译名:重组人卵泡刺激

  简介:

  部份中文Gonal- F处方资料(仅供参考)

  第三代排卵针R-FSH

  Gonal-˚F果纳芬注射剂

  Gonal- F(R- FSH)

  性质:

  Gonal-˚F是利用中国仓鼠卵巢细胞(中国仓鼠卵巢细胞; CHO细胞)经基因工程(基因重组)技术制造的滤泡刺激素(FSH)。

  在女性,滤泡刺激素(FSH)最主要的效用是促进成熟滤泡的产生,亦会引发动情激素的分泌及子宫内膜增生。

  在男性,滤泡刺激素(FSH)藉由作用在细精小管的托利氏细胞而促进精子的生成。

  重组FSH – GONAL-F

  适应症:

  妇女经克罗米芬治疗,仍无法排卵者(含多囊性卵巢症,多囊性卵巢疾病)。

  对于实施人工协助生殖技术(ART),如体外受精(IVF),配子输卵管植入(GIFT),合子输卵管植入(ZIFT)的病人,可刺激其多滤泡发育。

  Gonal-˚F有下列优点

  Gonal-˚F为全球第1个以基因工程技术制造的FSH,其所含的FSH纯度最高,达99.9%以上,临床怀孕率最高。

  Gonal-˚F完全无尿液来源的杂质蛋白,安全性最高,能降低过敏反应的发生。

  Gonal-˚F完全不含黄体刺激素(LH),可提高卵及胚胎的品质,增加受精率。

  Gonal- F每批產品間的品質完全一致,產品穩定度最高,可摒除因每批產品間的差異對臨床效果的干擾.

  Gonal- F可以皮下注射給藥,減低注射疼痛,提高病人順從性及耐受度.病患亦可自行注射,方便性高.

  Gonal-˚F1200 IU有下列优点:

  弹性:高剂量设计,可针对病人不同的需求来调整剂量,并且适合病人带回家自行注射。

  便利:注射液配置一次,可以多次使用,省時又方便,降低因使用多瓶藥劑所帶來的恐懼.

  舒适:较低的注射量,降低了注射时的疼痛。

  准确:每次注射時,以IU為注射單位之特製針筒,劑量準確,不論是對病人或是護士,皆更為方便,大大降低了劑量錯誤的發生頻率.

  FSH制剂比较

  分类尿液萃取基因工程

  产品Pergonal

  (HMG)Metrodin

  (FSH)Metrodin HP

  (FSH HP)Gonal-˚F

  (R-FSH)

  全球上市年份1960年1980年1995年1990年

  来源妇女的尿液CHO细胞

  品质管制部份管制(从尿液收集后开始)全程管制

  纯化技术抽取/沉淀多株抗体单株抗体基因工程

  FSH / Amp75 IU75,1,200IU

  LH / Amp75 IU <1 IU <0.1 ​​IU IU0

  FSH特异活性(IU /毫克)60 IU IU100> 9,000IU10,000IU

  FSH的纯度5%5%95%> 99.9%

  GONAL-f® PEN

  Recombinant human follicle stimulating hormone (follitropin 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 Gonal-f. It does not contain all the information that is known about Gonal-f. 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 is GONAL-f used for

  GONAL-f contains follitropin alfa, which is similar to follicle stimulating hormone (FSH) found naturally in humans.

  GONAL-f belongs to a class of hormones called gonadotrophins. FSH is necessary for the growth and development of egg cells (follicles) in women, and sperm production in men.

  In women

  GONAL-f can be used to bring about the development of follicles in women who are not ovulating and who have not responded to treatment with clomiphene citrate.

  GONAL-f is also used to stimulate the development of several follicles in women undergoing assisted reproductive technologies (ART) such as in vitro fertilisation (IVF).

  In men

  GONAL-f is used in combination with human chorionic gonadotrophin (hCG) to stimulate the production of sperm.

  Ask your doctor if you have any questions about why GONAL-f has been prescribed for you.

  Your doctor may have prescribed it for another reason.

  GONAL-f is available only on a doctor’s prescription.

  GONAL-f is not habit-forming.

  Before you are given GONAL-f

  When you must not use GONAL-f

  Do not use GONAL-f if you have a history of allergy to any of the ingredients listed at the end of this leaflet.

  Symptoms of an allergic reaction 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 use GONAL-f if you have tumours of the hypothalamus or pituitary gland.

  For women

  Do not use GONAL-f if:

  you are pregnant

  you are breastfeeding

  your ovaries are enlarged

  you have an unexplained ovarian cyst

  you have unexplained vaginal or uterine bleeding

  you have cancer of the ovaries, uterus or breasts

  your ovaries have failed

  you have fibroids in your uterus which would make pregnancy impossible

  For men

  Do not use GONAL-f if:

  you have increased levels of gonadotrophins indicating failure of the testes

  your infertility is due to disorders other than hypogonadotrophic hypogonadism (low levels of gonadotrophins)

  If you are not certain whether these conditions apply to you, or you are worried about anything on this list, tell your doctor.

  Do not give this medicine to a child or elderly person.

  Do not use this medicine after the expiry date (month/year) on the packaging has passed, or if the packaging is torn or shows signs of tampering.

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

  If you are not sure whether you should start using GONAL-f, talk to your doctor.

  Before you start to use GONAL-f

  Your doctor will assess you and your partner’s fertility. 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 including GONAL-f.

  Tell your doctor if you have any allergies to any foods, dyes, preservatives or any other medicines.

  Tell your doctor if you have or have had any of the following medical conditions:

  disorders of the thyroid gland

  disorders of the adrenal glands

  high prolactin levels in the blood

  porphyria or a family history of porphyria

  For women

  Your doctor will assess if you have any medical conditions which interfere with your ability to become pregnant.

  Treatment with GONAL-f 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 become larger.

  The most common symptom is lower abdominal pain. During stimulation your doctor will monitor your treatment by the use of ultrasound and/or blood tests to help determine if you are likely to develop OHSS. If necessary your doctor will delay or cancel your GONAL-f injection. You may also be advised to refrain from sexual intercourse until the end of the cycle if this occurs.

  Compared to natural conception, the frequency of multiple pregnancies and births is higher in patients receiving treatments that stimulate follicle growth for ovulation induction. The majority of these are twins. Your doctor will monitor your response to treatment to minimise the chance of multiple pregnancies, because of the greater risks they carry for mothers and babies.

  Compared to natural conception, the frequency of pregnancy loss is higher in patients undergoing treatments to stimulate follicle growth for ovulation induction.

  There may be a slightly increased risk of birth defects in women using assisted reproductive technologies. This may be due to increased maternal age, genetic factors, multiple pregnancies or the procedures. An effect of medicines used to induce ovulation has not been excluded.

  Tell your doctor if you or a family member have or have had signs of blood clots (e.g. pain, warmth, redness, numbness or tingling in the arm or leg).

  Treatment with GONAL-f and hCG may increase the risk of blood clots forming in your blood vessels.

  Talk to your doctor about any concerns you may have before undergoing treatment or before you start using GONAL-f.

  For men

  Elevated FSH blood levels are indicative of testicular failure. Your doctor may ask you for a semen analysis to assess your response to treatment.

  Talk to your doctor about any concerns you may have before you start using GONAL-f

  Taking other medicines

  Tell your doctor if you are taking any other medicines, including:

  all prescription medicines

  any medicines, vitamins, herbal supplements or natural therapies you buy without prescription from your pharmacy, supermarket, naturopath or health food shop

  Some medicines may be affected by GONAL-f or may affect how well it works.

  Your doctor has more information on medicines to be careful with or avoid while using GONAL-f.

  How GONAL-f is given

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

  They may differ from the information contained in this leaflet.

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

  GONAL-f is given as a course of daily injections.

  You should have your injection at the same time each day.

  How much to inject

  Your doctor will decide the correct dose of GONAL-f for you. Your dose of GONAL-f may be adjusted depending on your individual response to treatment. Please consult your doctor if you are in any doubt.

  The following is a guide to the common dose.

  1. Women who are not ovulating

  The common dose usually starts at 75IU (5.46 microgram) daily. The dose may be adjusted as your treatment progresses. The maximal daily dose is usually not higher than 225 IU (16.5 microgram).

  2. Women undergoing assisted reproductive technologies

  The common dose usually starts at 150 IU (10.92 microgram) daily, commencing on day 2 or 3 of the cycle. The dose may be adjusted as your treatment progresses. The maximal daily dose is usually not higher than 450 IU (32.76 microgram).

  3. Men with hypogonadotrophic hypogonadism

  GONAL-f is commonly given with hCG. The common dose usually starts at 150 IU (10.92 microgram) three times a week.

  How to inject

  GONAL-f is given as a subcutaneous (under your skin) injection in the lower abdominal area or thigh.

  GONAL-f is intended to be injected by you or your partner.

  Alternatively your doctor or a nurse may give you these injections.

  If your doctor or nurse decides you can give the injections yourself, the doctor or nurse will teach you the injection technique.

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

  Read the Instructions for Use provided in the pack carefully before commencing injections.

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

  Where to inject

  GONAL-f is usually given in the lower abdominal area (except around the navel and waistline) or the front of your thigh. The injection site should be changed daily to lessen possible injection site reactions.

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

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

  How long to use GONAL-f for

  For women

  The length of treatment varies with each patient. It is possible to have more than one treatment cycle of GONAL-f.

  For men

  The combination treatment of GONAL-f and hCG could continue for at least 4 months and may continue for up to 18-24 months.

  If you forget to inject GONAL-f

  If you forget an injection or are not sure what to do, contact your doctor or nurse immediately for advice.

  Do not inject a double dose on any day.

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

  If you injected 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 or someone else has injected themselves with GONAL-f.

  While you are using GONAL-f

  Your doctor will carefully monitor your response to GONAL-f by using ultrasound, blood tests or semen analysis.

  Things you must do

  See your doctor regularly.

  Your doctor will monitor you closely throughout your treatment.

  If you are about to be started on any new medicine, tell your doctor and pharmacist that you are using GONAL-f.

  If you plan to have surgery, tell your doctor or dentist that you are using GONAL-f.

  Tell all doctors, dentists and pharmacists who are treating you that you are using GONAL-f.

  For Women

  Tell your doctor immediately if you become pregnant while using GONAL-f.

  Things you must not do

  If you are self-injecting do not:

  Stop using GONAL-f without telling your doctor.

  Change the dose unless your doctor tells you to.

  Changing your dose without advising your doctor can increase your risk of unwanted side effects or can prevent the drug from working properly.

  Give this medicine to anyone else, even if their symptoms seem similar to yours or if they have the same condition as you.

  Things to be careful of

  Be careful driving or operating machinery until you know how GONAL-f affects you.

  Side Effects

  Tell your doctor as soon as possible if you do not feel well while using GONAL-f.

  All medicines can have side effects. Sometimes they are serious, most of the time they are not.

  Do not be alarmed by this list of possible side effects.

  You may not experience any of them.

  Ask your doctor or pharmacist to answer any questions you may have.

  If you get any side effects, do not stop using GONAL-f without first talking to your doctor.

  Tell your doctor immediately, or go to Accident and Emergency at your nearest hospital if you notice any of the following:

  signs of an allergic reaction, including swelling of the face, lips, tongue, or other parts of the body; shortness of breath, wheezing or difficulty breathing; severe skin rash, itching or hives.

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

  pain, redness, itching or swelling at the site of injection during your treatment with GONAL-f

  For women

  vaginal bleeding

  inflammation, swelling or pain in your legs

  signs of severe OHSS such as severe lower abdominal pain, severe pelvic pain, nausea, vomiting, diarrhoea followed by rapid weight gain, reduced amounts of urine and shortness of breath

  warning signs of stroke or heart attack

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

  Ectopic pregnancy (embryo implanted outside the womb) may occur, especially in women with prior tubal disease.

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

  headache, dizziness

  stomach pain, abdominal distension or abdominal discomfort

  nausea, vomiting

  diarrhoea

  For men

  acne

  some breast development

  weight gain

  These are common side effects.

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

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

  After Using GONAL-f

  Storage

  Prior to using, store GONAL-f PEN in the original package at 2°C to 8°C (Refrigerate. Do not freeze.). Protect from light.

  Should refrigeration be unavailable, the GONAL-f PEN can be stored below 25°C for up to 3 months and away from light.

  After first piercing the GONAL-f PEN with a needle, GONAL-f PEN may be stored below 25°C for a maximum of 21 days with the cap on, in order to protect the product from light.

  Do not use GONAL-f PEN if the solution contains particles or is not clear.

  Do not use the product after the expiry date printed on the label.

  Do not use GONAL-f if you notice any visible signs of deterioration or damage to the container.

  Do not use GONAL-f on anyone else.

  It is for your use only.

  Do not store it or any other medicine in the bathroom or near a sink.

  Do not leave it in the car.

  Keep this medicine where children cannot reach it.

  A locked cupboard at least one-and-a-half-metres above the ground is a good place to store medicines.

  Disposal

  If you are self-injecting, you should discard all sharps into a disposal unit.

  If you have any GONAL-f that has expired or is left over from your treatment refer this to your clinic.

  Product description

  What it looks like

  GONAL-f PEN is available in three strengths of 300 IU (21.84 microgram), 450 IU (32.76 microgram) and 900 IU (65.52 microgram).

  GONAL-f PEN is pre-filled with a clear, colourless solution of 0.5 mL (300 IU), 0.75 mL (450 IU) or 1.5 mL (900 IU).

  Each cartridge contains the following ingredients:

  Active ingredient

  Follitropin alfa

  300 IU (21.84 microgram), 450 IU (32.76 microgram) or 900 IU (65.52 microgram)

  Other ingredients

  Sucrose

  Sodium phosphate – dibasic dihydrate

  Sodium phosphate – monobasic

  Sodium hydroxide

  Phosphoric acid

  Poloxamer

  Methionine

  m-cresol

  Water for Injections

  GONAL-f 300 IU/0.5 mL (21.84 microgram/0.5 mL) PEN is supplied in packs of:

  1 cartridge pre-assembled in a disposable pen and 8 needles for administration.

  GONAL-f 450 IU/0.75 mL (32.76 microgram/0.75 mL) PEN is supplied in packs of:

  1 cartridge pre-assembled in a disposable pen and 12 needles for administration.

  GONAL-f 900 IU/1.5 mL (65.52 microgram/1.5 mL) PEN is supplied in packs of:

  1 cartridge pre-assembled in a disposable pen and 20 needles for administration.

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