英文药名: Suprefact(Buserelin Injection)
中文药名: 布舍瑞林注射剂
生产品牌药厂家: Sanofi Aventis

【通用名称】布舍瑞林
【英文名称】Buserelin
其他英文名：Suprefact
【别　　名】Hoe-766, Profact, Receptal, S-746766, Suprecor, Suprecur, Suprefact, Suprefakt
【化学名称】 1-9-Luteinizing hormone-releasing factor (swine), 6-[O-(1,1-dimethylethyl)-D-serine]-9-(N-ethyl-L-prolinamide)-
【开发单位】HMR
【首次上市】1984年，德国
【药理】　
本品为克nRH类似屋，使用初期可促使LH、FSH和性激素分泌增加，经1-2周后开始产生相反的作用，性激素分泌可降低到去势水平。开始时采用皮下注射，维持治疗可采用鼻腔喷入。
【适应症】　
临床主要用于前列腺癌、乳腺癌等。
【用法用量】　　
皮下注射：每次500微克，每日3次，连续7天
鼻腔喷入：每次100-200微克，每日3次
喷鼻液；l毫克(l毫升),喷1次100微克
注射液：每支l毫克(1毫升)
【禁用或慎用】
孕妇、哺乳期、对苯甲醇过敏者应停药。
【不良反应】
可有面部发热、恶心、呕吐、头痛、皮疹、无力、骨痛、性欲减低、排尿困难等。

规格：1mg/ml 2支 x 5.5ml 
1.Product Description
The name of your medicine is Suprecur 1mg/ml Injection (called Suprecur Injection throughout this leaflet). It contains a medicine called buserelin acetate. This belongs to a group of medicines called gonadotropin releasing hormone analogues. This is a synthetic version of a hormone that occurs naturally in the body. It works by lowering the production of sex hormones.
It can be used to treat infertility. It works by stopping the natural production of hormones that control ovulation. Synthetic hormones are then used to artificially stimulate ovulation. Your doctor should give you more information about how your treatment works.
2. Before you are given Suprecur Injection
Do not have this medicine and tell your doctor if:
You are allergic (hypersensitive) to buserelin or other similar medicines such as goserelin, or any of the other ingredients of Suprecur Injection (listed in Section 6 below) Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue

You have abnormal menstrual bleeding
You are pregnant or breast-feeding
You have a tumour that is not affected by changes in hormone levels
This medicine is for use in women only. However there is another form of this medicine that can be used in men. Men should not use either form of this medicine if they have had their testicles removed
Do not have this medicine if any of the above apply to you. If you are not sure, talk to your doctor or nurse before having Suprecur Injection.
Take special care with Suprecur Injection
Check with your doctor or nurse before you have this medicine if:
You have depression
You have high blood pressure. Your blood pressure must be checked regularly
You have diabetes. You should check your blood glucose levels regularly
You have metabolic bone disease or have additional risk factors for osteoporosis such as chronic alcohol abuse, smoking, a family history of osteoporosis or are on long term therapy with anticonvulsants or corticosteroids
You have polycystic ovarian disease If you are not sure if any of the above apply to you, talk to your doctor, nurse or pharmacist before having Suprecur Injection.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines you buy without a prescription, including herbal medicines. This is because Suprecur Injection can affect the way some other medicines work. Also some medicines can affect the way Suprecur Injection works.
In particular, tell your doctor or pharmacist if you are taking the following:
Medicines for diabetes
Pregnancy and breast-feeding

Do not have this medicine if:

You are pregnant, might become pregnant or think you may be pregnant. This is because Suprecur Injection may be harmful to the developing baby. Women must have a pregnancy test to make sure they are not pregnant before being given this medicine. Suprecur Injection will be stopped before you are given the hormones used to stimulate ovulation
You are breast-feeding or planning to breast-feed. This is because small amounts may pass into mothers’ milk
If you get pregnant during treatment, stop having this medicine and tell your doctor immediately.
Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or breast-feeding.

Driving and using machines

You may feel dizzy, drowsy or have blurred eyesight while having this medicine. If this
happens, do not drive or use any tools or machines.

Important information about some of the ingredients of Suprecur Injection Suprecur injection contains:

Benzyl alcohol. It must not be given to premature or newborn babies. Benzyl alcohol may cause toxic reactions and allergic reactions in infants and children up to 3 years old.
3. How Suprecur Injection is given

Suprecur is normally given by a doctor or nurse. This is because it needs to be given as an injection underneath the skin (subcutaneous injection).
Using this medicine
The doctor or nurse will usually give you the first injections
You may then be trained how to give the injections to yourself. Your doctor or nurse will show you how to do this. Do not try to inject yourself if you have not been trained how to do so.
If you are not sure what to do, talk to your doctor or nurse immediately.
How much Suprecur Injection is given
If you are not sure why you are being given Suprecur Injection or have any questions about how much Suprecur Injection is being given to you, speak to your doctor or nurse. Your doctor will start treatment on day 1 or day 21 of your menstrual cycle. Your daily dose will be:

200 to 500 micrograms given as a single daily injection or 500 micrograms twice a day
You will be given daily injections until blood tests show that levels of sex hormones are lowered. This usually takes one to three weeks
You will then be given other hormones as well as Suprecur Injection
Your doctor will tell you how long you are to continue having these medicines
If you are able to give Suprecur Injection to yourself, your doctor or nurse will show you how to do this. Do not try to inject yourself if you have not been trained how to do so. If you are not sure what to do, talk to your doctor or nurse immediately.
If you have more Suprecur Injection than you should
It is unlikely that your doctor or nurse will give you too much medicine. Your doctor and nurse will monitor your progress, and check the medicine you are given. Always ask if you are not sure why you are getting a dose of medicine.
If you give yourself more Suprecur Injection than you should, tell a doctor or go to a hospital casualty department straight away. Take the medicine pack with you. This is so the doctor knows what you have taken.
Having too much Suprecur Injection may make you feel weak, nervous, dizzy and sick. You may also have a headache, hot flushes, stomach pain, swelling of the legs and breast pain. You may also have pain, bleeding or hardening of the skin at the site of injection.
If you miss a dose of Suprecur Injection

Your doctor or nurse will have instructions on when to give you this medicine. It is unlikely that you will not be given the medicine as it has been prescribed. However, if you do think you have missed a dose, tell your doctor or nurse.
If you are injecting this medicine yourself and you forget a dose, take it as soon as you remember it. However, if it is nearly time for the next dose, skip the missed dose. Do not take a double dose to make up for a forgotten dose.

If you stop having Suprecur Injection.

Keep using Suprecur Injection until your doctor tells you to stop. If you stop, your infertility treatment may be affected.

Blood Tests

Using Suprecur Injection may affect the results of some blood tests. In particular, Suprecur Injection can change the level of liver enzymes and fats in the blood (lipids) shown up in blood tests. If you are going to have a blood test, it is important to tell your doctor you are having Suprecur Injection.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

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

Stop having Suprecur Injection and tell a doctor or go to hospital straight away if;

You have an allergic reaction. The signs may include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue. You may also have pain or a skin rash in the area you were
injected with Suprecur
You have diarrhoea, pain, swelling or a feeling of tension in your stomach, feel sick or are sick, have gained weight, are having difficulty breathing or are short of breath or are passing less urine. These could be signs of a serious side effect called ‘Ovarian Hyperstimulation Syndrome’. This is more likely if you are taking other hormones as well as Suprecur Injection (buserelin) as part of a treatment for infertility
Tell your doctor straight away if you notice any of the following serious side effects:

You bruise more easily than usual. This could be because of a blood problem called ‘thrombocytopenia’
You get a lot of infections. Signs include fever, sore throat or mouth ulcers. These could be signs of a blood problem called leucopenia
You have severe headaches and eyesight problems. This is very rare but if it happens it could be due to tumours on the pituitary gland. This gland is found at the base of the brain
Your blood pressure becomes higher. This is very rare but if it happens you may get symptoms such as crushing chest pain, confusion, problems with your eyesight, tiredness and an uneven heartbeat

Tell your doctor or pharmacist if any of the following side effects get serious or lasts longer than a few days:

Menopausal-like symptoms and withdrawal bleeding
Some weeks after starting treatment you may get signs such as hot flushes, increased sweating, dry vagina, painful sexual intercourse or loss of sex drive (libido). These may be severe in some cases. Breakthrough bleeding or spotting may also occur
Pain, discomfort or swelling in the lower part of the stomach, changes to your periods, constipation, diarrhoea or needing the toilet more often. These symptoms could be a sign of ovarian cysts.
Bone or muscle discomfort such as shoulder pain or stiffness. Bones may become less dense during long-term treatment, due to a lowering in the amount of bone mineral. This effect is reversible when treatment is stopped. If Suprecur Injection is used for a long period of time, it may increase the risk of you getting a condition called ‘osteoporosis’. This is when your bones are more likely to break
Lowered tolerance to glucose which may lead to worsening of existing diabetes
Changes in body weight, changes in appetite and increased thirst
Mood changes such as feeling depressed or worsening of depression and feeling anxious
Feeling nervous, dizzy, tired or drowsy
Headache (which may be like a migraine) and disturbed sleep
Problems with memory and concentration
Unusual skin sensations such as numbness, tingling, pricking, burning or creeping on the skin. This can feel like ‘pins and needles’ (usually in the arms and legs) and is called paraesthesia
Dry eyes (possibly leading to eye irritation in people who wear contact lenses), blurred eyesight, feeling of pressure behind the eyes
Hearing problems such as ringing in the ears (tinnitus)
Very fast, uneven or forceful heartbeat (palpitations)
Facial swelling (puffiness) due to water retention which may also cause swollen arms or legs
Feeling or being sick, stomach ache, pain in the lower abdomen, diarrhoea or constipation
Dry skin or acne

Hair grows more than normal (including body and facial hair)
Hair loss (including body or facial hair)
Splitting of nails
Vaginal discharge, changes in breast size, breast tenderness or milk production
Changes in the level of liver enzymes, fats (lipids) and a substance called ‘bilirubin’ in the blood shown up in blood tests · Worsening of your condition if you have uterine fibroids
Talk to your doctor or pharmacist if any of the side effects gets serious or lasts longer than a few days, or if you notice any side effects not listed.

5. How to store Suprecur Injection
This medicine should be kept in a safe place where children cannot see or reach it.
Do not use Suprecur Injection after the expiry date which is stated on the carton and label. The expiry date refers to the last day of that month.
Store between 2 °C and 25 °C. Do not freeze. Suprecur Injection must be protected from light.
Discoloured or cloudy solution should not be used.
Each vial contains enough solution for ten doses. After finishing a course of treatment the vial should be disposed of and a new vial started for the next treatment.
Medicines should not be disposed of via wastewater or household waste. If you are using this medicine at home you will be given a container (a sharps bin) to use for disposal. Return the sharps bin or any used or unused syringes to your doctor or nurse or pharmacist for disposal. These measures will help to
protect the environment.

6. Further Information

What Suprecur Injection contains

Each 1ml of solution contains 1 milligram of the active substance, buserelin as buserelin acetate
The other ingredients are, sodium chloride, sodium dihydrogen phosphate, sodium hydroxide, benzyl alcohol and water for injections