Lymphoseek

Maa: Euroopan unioni

Kieli: englanti

Lähde: EMA (European Medicines Agency)

Aktiivinen ainesosa:

tilmanocept

Saatavilla:

Navidea Biopharmaceuticals Europe Ltd.

ATC-koodi:

V09IA09

INN (Kansainvälinen yleisnimi):

tilmanocept

Terapeuttinen ryhmä:

Tumour detection, Diagnostic radiopharmaceuticals

Terapeuttinen alue:

Radionuclide Imaging

Käyttöaiheet:

This medicinal product is for diagnostic use only.Radiolabelled Lymphoseek is indicated for imaging and intraoperative detection of sentinel lymph nodes draining a primary tumour in adult patients with breast cancer, melanoma, or localised squamous cell carcinoma of the oral cavity.External imaging and intraoperative evaluation may be performed using a gamma detection device.

Tuoteyhteenveto:

Revision: 7

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2014-11-19

Pakkausseloste

24
B. PACKAGE LEAFLET
25
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LYMPHOSEEK 50 MICROGRAMS KIT FOR RADIOPHARMACEUTICAL PREPARATION
tilmanocept
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE
BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your nuclear medicine doctor
who will supervise the procedure.
•
If you get any side effects, talk to your nuclear medicine doctor.
This includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What Lymphoseek is and what it is used for
2. What you need to know before Lymphoseek is used
3. How to use Lymphoseek
4. Possible side effects
5. How to store Lymphoseek
6. Contents of the pack and other information
1.
WHAT LYMPHOSEEK IS AND WHAT IT IS USED FOR
This medicine is for diagnostic use in adults only. This means that it
is used in breast cancer, melanoma or
oral cavity cancers to help find out about your illness. It is not a
treatment for your illness.
Before it is used, the powder in the vial which contains tilmanocept
is mixed with a radioactive medicine
called sodium pertechnetate (containing
99m
Tc) to make a substance called technetium (
99m
Tc) tilmanocept.
Since technetium (
99m
Tc) tilmanocept contains a small amount of radioactivity it can make
parts of the body
areas visible to doctors during tests to help them see if the cancer
has spread to places called ‘lymph nodes’
that are found near tumours. The lymph nodes nearest the tumour are
called ‘sentinel’ lymph nodes. These
lymph nodes are where cancer cells are most likely to have spread.
When Lymphoseek has found the
sentinel lymph nodes, they can be removed and checked to see if there
are any cancer cells present.
Lymphoseek finds the lymph nodes and can be detected using a special
camera or detector.
The use of Lymphoseek does involve exposure to small amounts of
radioactivity. Your doctor and the
nuclear medicine doctor have conside

Valmisteyhteenveto

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Lymphoseek 50 micrograms kit for radiopharmaceutical preparation
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 50 micrograms of tilmanocept.
The radionuclide is not part of the kit.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Kit for radiopharmaceutical preparation.
The vial contains a sterile, non-pyrogenic, white to off-white
lyophilized powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
This medicinal product is for diagnostic use only.
Radiolabelled Lymphoseek is indicated for imaging and intraoperative
detection of sentinel lymph nodes
draining a primary tumour in adult patients with breast cancer,
melanoma, or localised squamous cell
carcinoma of the oral cavity.
External imaging and intraoperative evaluation may be performed using
a gamma detection device.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_ _
This medicinal product is restricted to hospital use only.
The medicinal product should only be administered by trained
healthcare professionals with technical
expertise in performing and interpreting sentinel lymph node mapping
procedures.
Posology
The recommended dose is 50 micrograms tilmanocept radiolabelled with
technetium Tc 99m at 18.5 MBq
for same day surgery or 74 MBq for next day surgery. The dose of 50
micrograms should not be adjusted for
body weight differences. The total injection amount should not exceed
50 micrograms tilmanocept, with a
total maximum radioactivity of 74 MBq per dose.
The recommended minimum time for imaging is 15 minutes post injection.
Intraoperative lymphatic
mapping may begin as early as 15 minutes post injection.
Patients scheduled for surgery on the day of injection will receive
18.5 MBq technetium Tc 99m
radiolabelled product. Administration should occur within 15 hours of
the scheduled time of the surgery and
intraoperative detection.
3
Patients scheduled for surgery on the day after injection will receive
74 MBq technetium Tc 99m
radiol