NanoScan 500micrograms, Kit for radiopharmaceutical preparation

מדינה: הממלכה המאוחדת

שפה: אנגלית

מקור: myHealthbox

מרכיב פעיל:

Human Serum Albumin nano sized colloid

זמין מ:

RADIOPHARMACY Laboratory Ltd

קוד ATC:

V09DB01

INN (שם בינלאומי):

Human Serum Albumin nano sized colloid

כמות:

500micrograms

טופס פרצבטיות:

Kit for radiopharmaceutical preparation

מסלול נתינה (של תרופות):

Subcutaneous administration

יחידות באריזה:

1 pack contains 6 vials. Sample package: 2 vials. Bundle pack of 2 packs of 6 vials. Bundle pack of 4 packs of 6 vials.

סוג מרשם:

POM - Prescription Only Medicine

תוצרת:

Medi-Radiopharma Ltd

קבוצה תרפויטית:

Technetium (99mTc), particles and colloids

סממני תרפויטית:

This medicinal product is for diagnostic use only. After radiolabelling with sodium (99mTc) pertechnetate solution for injection the solution obtained is indicated in: • Bone marrow scanning (The product is not suitable to study the haematopoietic activity of the bone marrow) • Inflammation scanning in areas other than the abdomen • Conventional lymphoscintigraphy to demonstrate integrity of the lymphatic system and differentiation of venous from lymphatic obstruction • Sentinel node detection in: • Melanoma malignum • Breast cancer

מצב אישור:

Authorised

תאריך אישור:

2015-03-03

עלון מידע

PACKAGE LEAFLET: INFORMATION FOR THE USER 

NanoScan 500 micrograms, Kit for radiopharmaceutical 
preparation 
Human Serum Albumin nano sized colloid 

READ ALL OF THIS LEAFLET CAREFULLY
BEFORE YOU WILL BE ADMINISTERED 
THIS MEDICINE. 
- 
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 any of the side effects gets serious, or if you notice any 
side effects not listed in this leaflet, 

please tell your Nuclear medicine doctor who has 
supervised the procedure. 

IN THIS LEAFLET: 
_1. _
_What NanoScan  is and what it is used for _
_2. _
_Before NanoScan _ is used_ _
_3. _
_How NanoScan _is used_ _
_4. _
_Possible side effects _
_5. _
_How NanoScan is stored _
_6. _
_Further information _

1. WHAT NANOSCAN IS AND WHAT IT IS USED FOR 
This medicine is a radiopharmaceutical product for diagnostic use 
only. 

Before treatment with NanoScan your doctor will explain to you 
the procedure you are about to undergo, and radioactive medicine 
you will be given. 

NanoScan  kit is a sterile preparation for studies
of bone marrow 
scintigraphy, lymphoscintigraphy and sentinel node 
lymphoscintigraphy in melanoma malignum and in breast cancer. 
NanoScan belongs to a group of medicines called 
radiopharmaceutical agents. After labelling with 
99m
Tc-
pertechnetate the Nuclear medicine doctor injects you into the
vein 
(intravenous) or into the
skin (subcutaneous) for visualisation and 
detection under a scintillation camera.  

The use of radiolabelled NanoScan does involve exposure to small 
amounts of radioactivity. Your doctor and the Nuclear medicine 
doctor have considered that the clinical benefit that you will
obtain 
from the procedure with the radiopharmaceutical overcomes the 
risk due to radiation. 
 

מאפייני מוצר

SUMMARY OF PRODUCT CHARACTERISTICS 

1 
NAME OF THE MEDICINAL PRODUCT 
NanoScan 500 micrograms, Kit for radiopharmaceutical preparation 

2 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

Active substance 
Human Serum Albumin nano sized colloid 500 micrograms. 

At least 95 % of human albumin colloidal particles have a diameter 
≤ 80 nm. 
NanoScan is prepared from human serum albumin derived from human
blood 
donations tested according to the EEC Regulations and found non
reactive for: 

- hepatitis B surface antigen (HBsAg) 
- antibodies to human immunodeficiency virus (anti-HIV 1/2) 
- antibodies to hepatitis C virus (anti-HCV) 

The radionuclide is not part of the kit. 

Excipient(s) 
Sodium: 0.045 mmol. 
For a full list of excipients, see section 6.1. 

3 PHARMACEUTICAL 
FORM 

Kit for radiopharmaceutical preparation. 

White powder. 
Powder for solution for injection. 
To be reconstituted with sodium pertechnetate (
99m
Tc) solution for injection. 

4 CLINICAL 
PARTICULARS 

4.1 THERAPEUTIC 
INDICATIONS 
This medicinal product is for diagnostic use only. 
After radiolabelling with sodium (99mTc)
pertechnetate solution for injection the 
solution obtained is indicated in: 
•

Bone marrow
scanning (The product is not suitable to study the haematopoietic 
activity of the bone marrow) 
•

Inflammation scanning in areas other than the abdomen 
•

Conventional lymphoscintigraphy to demonstrate integrity of the
lymphatic 
system and differentiation of venous from lymphatic obstruction 
•

Sentinel node detection in: 
•

Melanoma malignum 
•

Breast cancer 

4.2 
POSOLOGY AND METHOD OF ADMINISTRATION 
_ _
Posology 

Recommended activities in adults are as follows:  

-

Bone marrow scanning: 185-500 MBq as a single intravenous
injection. 

-

Inflammation scanning: 370-500 MBq as a single intravenous
injection. 

_Subcutaneous administrat