LeukoScan

Основна информация

  • Търговско наименование:
  • LeukoScan
  • Използвай за:
  • Хората
  • Вид на лекарството:
  • алопатични наркотици

Документи

Локализация

  • Предлага се в:
  • LeukoScan
    Европейски съюз
  • Език:
  • английски

Терапевтична информация

  • Терапевтична група:
  • Diagnostic agents
  • Терапевтична област:
  • Osteomyelitis, Radionuclide Imaging
  • Терапевтични показания:
  • This medicinal product is for diagnostic use only.LeukoScan is indicated for diagnostic imaging for determining the location and extent of infection/ inflammation in bone in patients with suspected osteomyelitis, including patients with diabetic foot ulcers.LeukoScan has not been employed to diagnose osteomyelitis in patients with sickle cell anaemia.
  • Каталог на резюме:
  • Revision: 7

Състояние

  • Източник:
  • EMA - European Medicines Agency
  • Статус Оторизация:
  • Withdrawn
  • Номер на разрешението:
  • EMEA/H/C/000111
  • Дата Оторизация:
  • 14-02-1997
  • EMEA код:
  • EMEA/H/C/000111
  • Последна актуализация:
  • 12-05-2020

Доклад обществена оценка

European Medicines Agency

7 Westferry Circus, Canary Wharf, London E14 4HB, UK

Tel. (44-20) 74 18 84 00 Fax (44-20) 74 18 84 16

E-mail: mail@emea.europa.eu http://www.emea.europa.eu

EMEA 2007 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged

EMEA/H/C/111

EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR)

LEUKOSCAN

EPAR summary for the public

This document is a summary of the European Public Assessment R

eport (EPAR). It explains how

the Committee for Medicinal products for Human Use (CHMP) assessed the studies performed, to

reach their recommendations on how to use the medicine.

If you need more information about your medical condition

or your treatment, read the Package

Leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more

information on the basis of the CHMP recommendations, read the Scientific Discussion (also part

of the EPAR).

What is LeukoScan?

LeukoScan is a vial containing a powder to be made into a solution for injection. The powder contains

the active substance sulesomab.

What is LeukoScan used for?

LeukoScan is not used on its own, but must be radiolabelled before use. Radiolabelling is a technique

where a substance is tagged (labelled) with a radioactive co

mpound. LeukoScan is radiolabelled by

mixing it with a solution of radioactive technetium (

Tc).

This radiolabelled medicine is for diagnostic use. LeukoScan is used to fin

d the site and extent of

infection or inflammation in patients with suspected osteomyelitis (bone infection), including patients

with diabetic foot ulcers.

The medicine can only be obtained with a prescription.

How is LeukoScan used?

Radiolabelled LeukoScan treatment should only be handled and gi

ven by someone who is authorised

to use radioactive medicines. The radiolabelled solution is given as an intravenous injection, and a

scintigraphy is carried out 1 to 8 hours later. Scintigraphy is a scanning method that uses a special

camera (gamma camera) that can detect radioactivity. Because LeukoScan has not been studied in

patients aged 21 years or younger, doctors should carefully weigh the benefits and the risks of its use

before administering it to a patient in this age group.

How does LeukoScan work?

The active substance in LeukoScan, sulesomab, is a

monoclonal antibody. A monoclonal antibody is

an antibody (a type of protein) that has been designed to recognise and bind to a specific structure

(called an antigen) that is found in certain cells in the body. Sulesomab has been designed to target an

antigen called NCA90, which is present on the surface of granulocytes (a type of white blood cell).

When LeukoScan is radiolabelled, the radioactive compound technetium-99 (

Tc) becomes attached

to sulesomab. When the radiolabelled medicine is injected into the patient, the monoclonal antibody

carries the radioactivity to the target antigen on the granulocytes. As large numbers of granulocytes

gather at the site of an infection, the radioactivity will accumulate where there is an infection, and it

can be detected using special scanning techniques, such as scintigraphy or SPECT (single photon

emission computed tomography).

Medicinal product no longer authorised

How has LeukoScan been studied?

LeukoScan has been studied in two main studies. The first investig

ated LeukoScan in the detection of

osteomyelitis in 102 patients with diabetic foot ulcers. The second study investigated LeukoScan in

130 patients with suspected long bone osteomyelitis. Among these 232 patients, 158 had also

undergone a scan using a standard scintigraphy technique (when the patient receives a specially

prepared injection of their own white blood cells radiolabelled with a suitable radioactive marker). The

main measure of effectiveness was the comparison of the diagnosis made using LeukoScan imaging

with the diagnosis from bone biopsy histopathology and microbial culture (when a bone sample is

taken and grown in a laboratory to see if it is carrying an infection).

What benefit has LeukoScan shown during the studies?

When the results of both studies were looked at together, LeukoScan was shown to be as effective in

diagnosing bone infections as the biopsy and culture technique. LeukoScan was more effective than

the standard technique of radiolabelled white blood cells, with a higher sensitivity (detection of 88%

of the infections with LeukoScan, compared to 73% with the radiolabelled white blood cells).

What is the risk associated with LeukoScan?

Rare side effects are eosinophilia (increase in eosinophils, a type of white blood cells) and facial rash.

For the full list of all side effects reporte

d with LeukoScan, see the Package Leaflet.

LeukoScan should not be used in people who may be hypersensitive (allergic) to sulesomab, mouse

proteins, or any of the other ingredients. It should not be used in pregnant women.

Why has LeukoScan been approved?

The Committee for Medicinal products for Human Use (CHMP) decided that LeukoScan

’s benefits

are greater than its risks for determining the location and extent of infection/inflammation in bone in

patients with suspected osteomyelitis, including patients with diabetic foot ulcers. They recommended

that LeukoScan be given marketing authorisation.

Other information about LeukoScan:

The European Commission granted a marketing authorisation vali

d throughout the European Union,

for LeukoScan to Immunomedics GmbH on 14 February 1997. The marketing authorisation was

renewed on 14 February 2002 and 14 February 2007.

The full EPAR for LeukoScan is available here

This summary was last updated in 02-2007.

EMEA 2007

Medicinal product no longer authorised

Листовка за пациента: състав, показания, Нежелани лекарствени реакции, дозиране, взаимодействия, бременност, кърмене

B. PACKAGE LEAFLET

Medicinal product no longer authorised

PACKAGE LEAFLET: INFORMATION FOR THE USER

LeukoScan (0.31 powder for solution for injection)

(sulesomab)

Read all of this leaflet carefully before you start using this medicine.

Keep this leaflet. You may need to read it again.

It does not contain all the information about your medicine that you may need to know, so please

refer to the Summary of Product Characteristics or ask your doctor or nurse if you have any

questions. This leaflet only applies to LeukoScan.

If you have any further questions, please ask your doctor.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,

please tell your doctor.

In this leaflet:

1.

What LeukoScan is used for

2.

Before you use LeukoScan

3.

How to use LeukoScan

4.

Possible side effects

5.

How to store LeukoScan

6.

Further information

1.

WHAT LEUKOSCAN IS AND WHAT IT IS USED FOR

An antibody is a natural substance made by the body which binds to foreign substances to help remove

them from your body. You produce many different kinds of antibodies.

LeukoScan (sulesomab) is a special kind of antibody which binds to the surface of certain kinds of blood

cells called leukocytes. It is produced in mice and purified so that it can be used in humans. When it is

combined to the radioactive technetium isotope and injected into your vein, it finds an abnormal

accumulation of white blood cells and attaches to them. One to eight hours later after the injection you

will be placed on a special table and pictures will be taken with standard nuclear cameras. This helps your

doctor make a diagnosis and evaluate the extent of your illness. The doctor does this by using a special

imaging camera that reveals areas of radioactivity to see where the infections are located. This medicine

is for diagnostic use only.

LeukoScan is used to determine the presence of infections in long bones. Shortly after mixing the

LeukoScan with the radioactive technetium isotope, the doctor will inject it into your vein. One to eight

hours later you will be placed on a special table and pictures will be taken with standard nuclear cameras

to see where the infections are located.

LeukoScan is an antibody fragment which is linked to a radioactive substance called technetium.

LeukoScan is used in patients with suspected infection of the bone called osteomyelitis. The antibody is

able to bind to the surface of white blood cells which infiltrate the area of infection. When the radioactive

antibody binds to the white blood cells, your doctor can determine where the infection is located by using

a special imaging camera that reveals areas of radioactivity. The doctor can also determine how much

disease there is. This will help the doctor determine whether there is infection in the bone and what kind

of treatment to use.

Medicinal product no longer authorised

2.

BEFORE YOU USE LEUKOSCAN

You should not use LeukoScan 0.31 mg, sulesomab,

powder for solution for injection

If you know that you are allergic (hypersensitive) to sulesomab or any protein which comes from a

mouse, tell your doctor. You must then not be given LeukoScan.

Take special care with LeukoScan

It is possible to have a serious allergic reaction to LeukoScan. Therefore, you doctor should keep

you under close observation for a short time after he has given you this medicine.

If you have ever received LeukoScan or another product made from a mouse antibody, your doctor

should take a sample of blood for testing to be sure that you have not developed an allergy to it.

If the prepared solution of LeukoScan appears discoloured or contains particles, it should not be

used.

Using other medicines

No interactions with other medicines have been described to date.

Please tell your doctor if you are taking or have recently taken any other medicines, including medicines

obtained without a prescription.

Using Leukoscan with food and drink

No studies effects of food/drink have been performed.

Pregnancy and breast-feeding

Pregnancy

You should not be given LeukoScan if you are pregnant.

Breast-feeding

If you are breast feeding, you should stop breast feeding your baby for at least 24 hours after you

have been given LeukoScan.

Use of radiopharmaceutical agents

Radiopharmaceutical agents should be used only by qualified personnel with appropriate

government authorisation for the use and manipulation of radionuclides.

This radiopharmaceutical may be received, used and administered only by authorised persons in

designated clinical settings. Its receipt, storage, use, transfer and disposal are subject to the

regulations and/or appropriate licenses of local competent official organisations.

Medicinal product no longer authorised

Radiopharmaceuticals should be prepared by the user in a manner which satisfies both radiation

safety and pharmaceutical quality requirements. Appropriate aseptic precautions should be taken,

complying with the requirements of Good Manufacturing Practices (GMP) for pharmaceuticals.

After use, the container should be disposed of as radioactive waste.

Driving and using machines

No studies on the effects on the ability to drive and use machines have been performed.

Important information about some ingredients of LeukoScan

If you have been told that you have an intolerance to some sugars, inform your doctor before you are

given this medicine.

3.

HOW TO USE LEUKOSCAN

Dosage

You will receive a single dose of 0.25 mg of LeukoScan. It will contain the radioactive technetium

isotope in an amount called 740-1110 MBq.

Method and/or route(s) of administration

Your doctor will prepare the LeukoScan and the radioactive isotope technetium in a volume of 1.5 ml.

0.25 mg of LeukoScan will be labelled with 740-1110 MBq of technetium. This material will then be

injected into your vein. This dose of radioactivity is safe and will be gone from the body in about 24

hours.

Frequency of administration

LeukoScan is prepared for a single injection. If your doctor decides to give it to you again after several

weeks or several months, your blood should be tested first to see if you have developed an allergy to

LeukoScan.

If you take more LeukoScan than you should

The maximum amount of LeukoScan that can be administered has not been determined. Patients have

been given four times the amount you will receive with no adverse reactions.

In the unlikely event of the administration of a radiation overdose with LeukoScan, the absorbed dose to

the patient may be reduced by increased oral or intravenous intake of fluids to promote excretion of the

radiolabel.

If you stop using LeukoScan

LeukoScan is prepared for a single injection.

If you have any further questions on the use of this product, ask your doctor.

Medicinal product no longer authorised

4.

POSSIBLE SIDE EFFECTS

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

Some side effects, although not common, have been reported. These include a small increase in the

number of certain white blood cells called eosinophils (but without any apparent symptoms) and rash.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell

your doctor.

5.

HOW TO STORE LEUKOSCAN

Keep out of the reach and sight of children.

Expiry date and storage conditions

Kit - 48 months. Store in a refrigerator (2

C). Do not freeze.

Reconstituted and radiolabelled material - 4 hours. Do not store above 25

C. Do not refrigerate or freeze.

After use, the container should be disposed of as radioactive waste.

6.

FURTHER INFORMATION

What LeukoScan contains

Kit for the preparation of

Tc-labelled LeukoScan.

The kit does not include the radioisotope.

The active substance is sulesomab

Each 3 ml vial contains 0.31 mg sulesomab (IMMU-MN3 murine Fab

-SH antigranulocyte monoclonal

antibody fragments).

The other ingredients are:

Stannous Chloride, Dihydrate

Sodium Chloride

Acetic Acid, Glacial (Trace)

Hydrochloric Acid (Trace)

Sodium Potassium Tartrate, Tetrahydrate

Sodium Acetate, Trihydrate

Sucrose

Nitrogen

What LeukoScan looks like and contents of the pack

Powder for solution for injection.

One vial prepared so as to contain 0.31 mg lyophilised LeukoScan monoclonal antibody fragment.

The Type I glass vial is closed with a grey butyl rubber stopper with a green flip-off seal.

Pack size: one vial per carton container.

Medicinal product no longer authorised

Marketing Authorisation Holder and Manufacturer

Immunomedics GmbH

Otto-Röhm-Straße 69

D-64293 Darmstadt

Germany

Medicinal product no longer authorised