LYMPHOSEEK kit for the preparation of technetium [99m Tc] tilmanocept injection vial

País: Austràlia

Idioma: anglès

Font: Department of Health (Therapeutic Goods Administration)

ingredients actius:

tilmanocept, Quantity: 50 microgram

Disponible des:

HL Pharma Pty Ltd

formulario farmacéutico:

Injection, powder for

Composición:

Excipient Ingredients: sodium ascorbate; sodium hydroxide; trehalose dihydrate; hydrochloric acid; stannous chloride dihydrate; glycine

Vía de administración:

Intradermal, Subcutaneous, Intratumour

Unidades en paquete:

5, 1

tipo de receta:

exempt from scheduling - Appendix A; prescription medicine

indicaciones terapéuticas:

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.

Resumen del producto:

Visual Identification: White to off-white powder; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 18 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Estat d'Autorització:

Registered

Data d'autorització:

2018-12-21

Informació per a l'usuari

1
LYMPHOSEEK
®
(LIM·FOE·SEEK)
_technetium (_
_99m_
_Tc) tilmanocept_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET
This leaflet answers some
common questions about
Lymphoseek. It does not
contain all the available
information. It does not take
the place of talking to your
doctor or nuclear medicine
specialist.
All medicines, including
diagnostic agents, have
risks and benefits. Your
doctor, in consultation with
the nuclear medicine
specialist, has weighed the
risks of you using
Lymphoseek against the
benefits they expect the
procedure will have for
you.
IF YOU HAVE ANY CONCERNS
ABOUT USING THIS MEDICINE,
ASK YOUR DOCTOR AND/OR
NUCLEAR MEDICINE
SPECIALIST.
KEEP THIS LEAFLET.
You may
need to read it again.
WHAT
LYMPHOSEEK IS
USED FOR
Lymphoseek belongs to a
group of medicines called
radiopharmaceuticals.
Lymphoseek is used for
imaging and detection of
breast cancer, melanoma or
head and neck cancers. It is
not a treatment for your
illness.
Lymphoseek contains the
active ingredient,
tilmanocept.
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’.
Lymph nodes are small
round organs that are part of
the body’s lymphatic
system, and are part of the
immune system.
The lymph nodes nearest the
tumour are called ‘sentinel’
lymph nodes. These lymph
nodes are where cancer cells
are most likely to have
spread. There may be one or
more sentinel lymph nodes.
Lymphoseek will be
injected in or around your
tumour, and will then travel
to the sentinel lymph nodes.
A device that detects
radioactivity will be used to
locate the sentinel lymph
node(s). They can then be
removed to see if there are
any cancer cells present.
The use of Ly

Fitxa tècnica

1
LYMPHOSEEK PI
July 2019
AUSTRALIAN PRODUCT INFORMATION – LYMPHOSEEK
®
(TILMANOCEPT) INJECTION
1
NAME OF THE MEDICINE
Tilmanocept
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each clear glass vial of Lymphoseek contains tilmanocept 50 microgram.
An overfill is included in each vial to ensure that 50 microgram of
tilmanocept can be delivered.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Lymphoseek
is
defined
as
a
kit
for
radiopharmaceutical
preparation,
specifically
for
the
preparation of Technetium [99mTc] tilmanocept injection.
Lymphoseek is a sterile, non-pyrogenic, white to off-white lyophilized
powder (under nitrogen).
Vial shield labels are included with the kit. The radionuclide is not
part of the kit.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC 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
D
OSE AND METHOD OF ADMINISTRATION
Lymphoseek should only be administered by trained healthcare
professionals with technical
expertise in performing and interpreting sentinel lymph node mapping
procedures.
Dosage
The recommended dose is 50 microgram 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 microgram
should not be adjusted for body weight differences. The total
injection amount should not exceed
50 microgram tilmanocept, with a total maximum radioactivity of 74 MBq
(2.0 mCi) 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
labelled product. Ad