ZINFORO INFUSION（CONCENTRATE）头孢洛林酯粉针剂
Zinforo(ceftaroline fosamil)输液剂-由阿斯利康创新的治疗成人复杂性皮肤和软组织感染以及社区获得性肺炎抗生素药物
药品名称
通用名：头孢洛林酯，又名头孢他洛林酯​
英文名：ceftaroline fosamil​
化学名：​(6R,7R)-7-{(2Z)-2-(ethoxyimino)-2-[5-(phosphonoamino)-1,2,4-thiadiazol-3-yl]acetamido}-3-{[4-(1­methylpyridin-1-ium-4-yl)-1,3-thiazol-2-yl]sulfanyl}-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate monoacetate monohydrate.​
分子式：C22H21N8O8PS4.C2H4O2.•H2O​
分子量：762.75​
剂型：无菌粉针剂
规格：400mg、600mg。​
适应症：
用于治疗成人社区获得性细菌性肺炎(CABP)和急性细菌性皮肤和皮肤结构感染(ABSSSI)，包括耐甲氧西林金黄色葡萄球菌(MRSA)。
​用法用量：
静脉滴注，大于的18岁的患者每次600mg，每12小时一次，于一小时内滴注完成。肾功能不全患者的使用剂量详见说明书。
Zinforo®
Ceftaroline fosamil
Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions people ask about Zinforo. It does not contain all the available information. It does not take the place of talking to your doctor, nurse or pharmacist.
All medicines have risks and benefits. Your doctor will have weighed the risks of you taking Zinforo against the benefits they expect it will have for you.
If you have any concerns about taking this medicine, ask your doctor, nurse or pharmacist.
Keep this leaflet with the medicine. You may need to read it again.
What Zinforo is used for
Zinforo is an antibiotic used to treat serious infections caused by bacteria (germs), such as:
•Infections of the skin and tissue below the skin
•Infection of the lungs (pneumonia)
Zinforo will not work against fungal or viral infections (such as colds or the flu).
Zinforo belongs to a group of antibiotics called cephalosporins. These antibiotics work by killing the bacteria that are causing your infection.
Zinforo is given by injection and is mostly given in hospital. Some patients may also be given Zinforo in "hospital in the home". It is available only with a doctor's prescription.
Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed it for another reason.
This medicine is not addictive.
This medicine is not expected to affect your ability to drive a car or operate machinery.
Before you are given Zinforo
When you must not be given it
Do not take Zinforo if you have an allergy to:
•Any medicine containing ceftaroline, the active ingredient in Zinforo
•L-arginine (inactive ingredient in Zinforo)
•other cephalosporin antibiotics
Some of the 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 take Zinforo if you have had a serious allergy to penicillins or beta-lactam antibiotics (eg carbapenems). You may be more likely to have an allergic reaction to ceftaroline if you have had an allergic reaction to these other antibiotics.
The hospital staff will check that the expiry date printed on the pack has not passed and that the packaging is not torn or showing signs of tampering.
If you are not sure whether you should be given this medicine, talk to your doctor, pharmacist or nurse.
Before you are given it
Tell your doctor or nurse if you have any type of allergic reaction to penicillin or beta-lactam antibiotics (eg carbapenems). You may be more likely to have an allergic reaction to Zinforo if you are allergic to these other antibiotics.
Tell your doctor or nurse if you have allergies to any other medicines, foods, preservatives or dyes.
Tell your doctor or nurse if you have or have had any of the following medical conditions:
•Kidney problems
•Fits (seizures/convulsions)
•Severe diarrhoea after taking any antibiotics
Tell your doctor if you are pregnant or plan to become pregnant or are breast-feeding. Your doctor can discuss with you the risks and benefits involved.
If you have not told your doctor about any of the above, tell him/her before you are given Zinforo.
Taking other medicines
Tell your doctor, nurse or pharmacist if you are taking any other medicines, including any that you get without a prescription from your pharmacy, supermarket or health food shop.
Your doctor, nurse and pharmacist have more information on medicines to be careful with or avoid while taking this medicine.
How Zinforo is given
Your Zinforo treatment is mostly given in hospital. Some patients may also be given Zinforo in "hospital in the home". It is given as a slow injection (infusion) directly into a vein, which usually takes 60 minutes.
It must only be given by a doctor or nurse.
How much will you be given
Your doctor will decide what dose of Zinforo you will need depending on certain factors such as your type of infection and if you have kidney problems. The usual dose is 600 mg every 12 hours.
How long will you need to be given Zinforo
Zinforo needs to be given as a series of injections over a few days. Your doctor will decide how many days you will need to have Zinforo for.
Ask your doctor, nurse or pharmacist if you have any questions including how this medicine is prepared, how it will be given to you or how long you will need to be given it.
If you have missed a dose
If you are concerned that you may have missed a dose of Zinforo, tell your doctor or nurse straight away.
If you have been given too much (overdose)
As Zinforo is given under the close supervision of your doctor or nurse, it is unlikely that you will be given too much. If you are concerned that you have been given too much, tell your doctor, nurse or pharmacist immediately.
While you are using Zinforo
Things you must do
If the symptoms of your infection do not improve within a few days, or if they become worse, tell your doctor.
If you get severe diarrhoea tell your doctor, pharmacist or nurse immediately. Do this even if it occurs several weeks after Zinforo has been stopped. Diarrhoea may mean that you have a serious condition affecting your bowel. You may need urgent medical care. Do not take any diarrhoea medicine without first checking with your doctor.
If you are about to be started on any new medicine, remind your doctor, nurse and pharmacist that you are taking Zinforo.
Tell any other doctors (including surgeons and anaesthetists), dentists, nurses and pharmacists who treat you that you are taking this medicine.
If you find out you are pregnant while taking this medicine, tell your doctor immediately.
If you are about to have any blood tests, tell your doctor or nurse that you are taking this medicine.
Side effects
Tell your doctor, nurse or pharmacist as soon as possible if you do not feel well while you are taking Zinforo. This medicine helps most people with serious infections, but it may have unwanted side effects in a few people. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.
Do not be alarmed by the following lists of side effects. You may not experience any of them.
Ask your doctor, nurse or pharmacist to answer any questions you may have.
Tell your doctor, nurse or pharmacist if you notice any of the following and they worry you:
•Diarrhoea, stomach pain
•Headache
•Feeling sick (nausea) or being sick (vomiting)
•Itching, skin rash
•Feeling dizzy
•Fever
The above list includes the more common side effects of your medicine. They are usually mild and short-lived.
Other side effects (eg redness, pain and swelling) may occur where the injection was given.
If any of the following happen, tell your doctor or nurse immediately, or if not in hospital already go to Accident and Emergency at your nearest hospital:
•Sudden swelling of your lips, face, throat or tongue, a severe rash, swallowing or breathing problems. These may be signs of a severe allergic reaction (anaphylaxis) and may be life-threatening.
•Diarrhoea that becomes severe or does not go away, or stools that contains blood or mucus.
Do not take any diarrhoea medicine without checking with your doctor.
The above list includes very serious side effects. You may need urgent medical attention or hospitalisation.
Occasionally, Zinforo may be associated with changes in your blood that may require your doctor or nurse to do certain blood tests.
Tell your doctor, nurse or pharmacist if you notice anything that is making you feel unwell. Other side effects not listed above may also occur in some people.
After finishing Zinforo
Tell your doctor immediately if you notice watery or severe diarrhoea (which may also contain blood or mucus), particularly if it occurs several weeks after stopping treatment with Zinforo. You may have a serious condition affecting your bowel. Therefore, you may need urgent medical attention.
Do not take any diarrhoea medicine without first checking with your doctor.
Storage
The hospital and/or pharmacy staff will store Zinforo vials in a safe place at a temperature below 25°C and away from light. They will also prepare and store the infusion bags/bottles ready for your injection.
Product description
What it looks like
Zinforo vials contain a pale yellowish-white to light yellow powder. The hospital and/or pharmacy staff dissolves the powder in water for injection, then transfer to an infusion bag/bottle containing certain solutions (eg normal saline) ready for your injection.
Ask your doctor, nurse or pharmacist if you have any questions about how they prepare your injection.
Ingredients
Zinforo contains 600 mg of ceftaroline fosamil as the active ingredient.
It also contains L-arginine (an amino acid) as the inactive ingredient.
This medicine does not contain lactose, sucrose, gluten, tartrazine or any other azo dyes.