Tygacil 50 mg powder for solution for infusionPatient’s Leaf - United Kingdom[英国药品]

TOP

Tygacil 50 mg powder for solution for infusionPatient’s Leaf

2013-10-27 18:56:15 来源: 作者: 【大中小】浏览:520次评论:0条

For doctors

What is it and how is it used?

Tygacil is an antibiotic of the glycylcycline group that works by stopping the growth of bacteria that cause infections.

Your doctor prescribed Tygacil because you have one of the following types of serious infections:

Tygacil is not indicated for the treatment of diabetic foot infections.

Tygacil should be used only in situations where it is known or suspected that other alternative antibiotics are not suitable.

What do you have to consider before using it?

Do not use Tygacil

Take special care with Tygacil

Using other medicines
Always tell your doctor if you are taking or have recently taken any other medicines, including medicines you buy without a prescription.

Tygacil may prolong certain tests that measure how well your blood is clotting. It is important that you tell your doctor if you are taking medicines to avoid an excess of blood clotting. If this were the case, your doctor will monitor you closely.

Tygacil may interfere with the contraceptive pill (birth control pill). Talk to your doctor about the need for an additional method of contraception while receiving Tygacil.

Pregnancy and breast-feeding
Tygacil may cause foetal harm. If you are pregnant, or are planning to become pregnant, talk to your doctor before receiving Tygacil.

It is not known if Tygacil passes into breast milk in humans. Ask your doctor for advice before breast-feeding your baby.

Driving and using machines
Tygacil may cause side effects such as dizziness. This may impair your ability to drive or operate machinery.

How is it used?

Tygacil will be given to you by a doctor or a nurse.

The recommended dose is 100 mg given initially, followed by 50 mg every 12 hours. This dose is given intravenously (directly into your blood stream) over a period of 30 to 60 minutes.

A course of treatment usually lasts for 5 to 14 days. Your doctor will decide how long you should be treated.

If you receive more Tygacil than you should

If you are concerned that you may have been given too much Tygacil, talk to your doctor or nurse immediately.

If you miss a dose of Tygacil
If you are concerned that you may have missed a dose, talk to your doctor or nurse immediately.

What are possible side effects?

Like all medicines, Tygacil may have side effects, although not everybody gets them.

The frequency of possible side effects listed below is defined using the following convention: very common (affects more than 1 user in 10)
common (affects 1 to 10 users in 100)
uncommon (affects 1 to 10 users in 1,000)
rare (affects 1 to 10 users in 10,000)
very rare (affects less than 1 user in 10,000)
not known (frequency cannot be estimated from the available data)

Very common side effects are:

Common side effects are:

Uncommon side effects are:

Not known side effects are:

Pseudomembranous colitis may occur with most antibiotics including Tygacil. This consists of severe, persistent or bloody diarrhoea associated with abdominal pain or fever, which can be a sign of serious bowel inflammation, which may occur during or after your treatment.

If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

How should it be stored?

Keep out of the reach and sight of children.

Store below 25°C.Do not use Tygacil after the expiry date which is stated on the vial.

Storage after preparation
Once the powder has been made into a solution and diluted ready for use, it should be given to you almost immediately.

↑ back to table of contents ↑

For doctors

What is it?

Tygacil is a powder that is made up into a solution for infusion (drip into a vein). It contains the active substance tigecycline.

What is it used for?

Tygacil is used to treat adults with complicated infections of the skin and soft tissue (the tissue below the skin), but not foot infections in people with diabetes). It is also used to treat complicated infections in the abdomen. ‘Complicated’ means that the infection is difficult to treat. Tygacil should be used only when other antibiotics are not suitable. Before using Tygacil, doctors should consider official guidance on the appropriate use of antibiotics.

The medicine can only be obtained with a prescription.

How is it used?

The recommended dose of Tygacil is a starting dose of 100 mg, followed by 50 mg every 12 hours for five to 14 days. Each infusion should last between 30 and 60 minutes. The length of treatment depends on where the infection is, how severe it is, and the patient’s response to treatment. Doses are lower in patients with severe liver problems.

How does it work?

The active substance in Tygacil, tigecycline, belongs to a group of antibiotics called ‘glycylcyclines’. It works by blocking the bacteria’s ribosomes, the parts of the cell where new proteins are made. By blocking the production of new proteins, the bacteria cannot multiply and they eventually die. The list of bacteria against which Tygacil is active can be found in the summary of product characteristics (also part of the EPAR).

How has it been studied?

Tygacil has been compared with other antibiotics in four main studies. In two of these studies, Tygacil was compared with the combination of vancomycin and aztreonam in 1,129 patients with complicated skin and soft tissue infections (not including infected diabetic foot ulcers). In the other two studies, Tygacil was compared with imipenem/cilastatin (a combination of two medicines used together as an antibiotic) in 1,568 patients with complicated infections in the abdomen. An additional study compared Tygacil with the antibiotic ertapenem in 813 diabetic patients with moderate to severe foot infections.

In all of the studies, the main measure of effectiveness was the number of patients whose infection was cured.

What benefits has it shown during the studies?

In the four main studies, Tygacil was as effective as the comparator antibiotics. In the studies of skin and soft tissue infections, around 86% of the patients receiving Tygacil were cured, compared with around 89% of those receiving vancomycin and aztreonam. In the studies of abdominal infection, around 86% of the patients receiving either Tygacil or imipenem/cilastatin were cured.

In the study looking at diabetic foot infections, Tygacil was less effective than ertapenem: 78% of the patients receiving Tygacil were cured, compared with 83% of those receiving ertapenem.

What is the risk associated?

The most common side effects with Tygacil are mild to moderate nausea (feeling sick) and vomiting, seen in 20% and 14% of patients, respectively. For the full list of all side effects reported with Tygacil, see the package leaflet.

Tygacil should not be used in people who may be hypersensitive (allergic) to tigecycline or any of the other ingredients. Patients allergic to tetracycline antibiotics may also be allergic to Tygacil.

Why has it been approved?

The CHMP decided that Tygacil’s benefits are greater than its risks and recommended that it be given marketing authorisation.

How has it been studied?

The company that makes Tygacil will communicate with healthcare professionals to ensure that they are aware of when Tygacil may be used, of its risks, and of the need to monitor patient’s response to treatment. Tygacil

Further information

The European Commission granted a marketing authorisation valid throughout the European Union for Tygacil to Wyeth Europa Limited on 24 April 2006. After five years, the marketing authorisation was renewed for a further five years. europa.eu/Find medicine/Human medicines/European Public Assessment Reports. For more information about treatment with Tygacil, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

This summary was last updated in 03-2011. Tygacil

↑ back to table of contents ↑