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NANOCOLL 500 MICROGRAMS KIT FOR RADIOPHARMACEUTICAL PREPARATION

Active substance(s): HUMAN ALBUMIN COLLOIDAL PARTICLES

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P724GB

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
NANOCOLL 500 micrograms kit for radiopharmaceutical preparation.

2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Human albumin colloidal particles 500 micrograms/vial.
At least 95% of human albumin colloidal particles have a diameter ≤ 80 nm.
NANOCOLL 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)
NANOCOLL is reconstituted with Sodium Pertechnetate (99mTc) Injection (not included in this
kit) to prepare technetium-99m albumin nanocolloid injection.
Technetium-99m decays with the emission of gamma radiation with an energy of 140 keV
and a half life of 6 hours to technetium-99 which can be regarded as quasi stable.
Excipients with known effect:
The reconstituted injection contains 0.24 mg/ml sodium.
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Kit for radiopharmaceutical preparation.
Powder for solution for injection.

CODE READS
L-R

4

CLINICAL PARTICULARS

4.1 Therapeutic indications
This medicinal product is for diagnostic use only.
After reconstitution with Sodium Pertechnetate (99mTc) Injection the product is indicated in
adults, neonates and children aged 1 to 18 years for:
Intravenous administration:
- 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.
Local administration:
Lymphoscintigraphy to demonstrate integrity of the lymphatic system, to differentiate
between venous and lymphatic obstructions, and to identify the sentinel lymph node
draining a primary tumour in the following malignant diseases: melanoma, breast,
prostate, penile, head and neck and female pelvic (cervical and vulvar) cancer.

4.2. Posology and method of administration
Posology
Adults
Bone Marrow and Inflammation Imaging
Recommended activities in adults are as follows:

Recommended activities in adults are as follows:
Lymphoscintigraphy: The recommended activity by single or multiple injections ranges
from 5-400 MBq, depending on the anatomical area to be investigated and the time interval
between injection and imaging. Higher doses are required where the interval between
injection and imaging is longer. For detailed sentinel node identification recommendations,
see below.
• Melanoma: 5-120 MBq
• Breast Cancer: 5-370 MBq
• Prostate Cancer: 90-400 MBq
• Squamous cell carcinoma of the penis: 40-131 MBq
• Head and Neck Cancer: 15-120 MBq
• Female Pelvic Cancer:
cervical (stage Ia2/Ib1, IIa1): 110 MBq
endometrial (stage I and II high-risk endometrial cancer, ie, endometrioid cancer
with the following: more than 50 % myometrial invasion or poorly differentiated
(grade 3) or serous papillary, clear-cell or carcinosarcoma histological subtype):
40-185 MBq
vulvar (squamous cell vulvar carcinoma Ib/II less than 4 cm in size, without
presurgical nodal metastases): 20-150 MBq
Renal and hepatic impairment
Careful consideration of the activity to be administered is required since an increased
radiation exposure is possible in these patients.
Paediatric population
The use in children and adolescents has to be considered carefully, based upon clinical
needs and assessing the risk/benefit ratio in this patient group. The activity for children may
be calculated from the recommended range of adult activity and adjusted according to
body weight or surface area. However the Paediatric Task Group of the European
Association of Nuclear Medicine (EANM) recommends to calculate the administered activity
from the body weight according to the following table.
Fraction of adult dose:

22 kg = 0.50
24 kg = 0.53
26 kg = 0.56
28 kg = 0.58
30 kg = 0.62
32 kg = 0.65
34 kg = 0.68
36 kg = 0.71
38 kg = 0.73
40 kg = 0.76

Prostate cancer: dose 90-400 MBq, injected transrectally into the prostate with
ultrasound guidance, with total dose split into aliquots to be administered to each
lobe.
• Squamous cell carcinoma of the penis: dose 40-131 MBq, administered in aliquots
intradermally, into or around the tumour, under local anaesthesia.
• Head and Neck Cancer: dose 15-120 MBq, administered in two to four aliquots,
according to the size and location of the lesion, submucosally for lesions in sites with
abundant soft tissue (eg, soft palate or floor of the mouth), or to the depth of the
lesion for those located in muscle (eg, tongue).
• Female Pelvic Cancer: in cervical cancer the product is injected peritumorally/
periorificially into the four quadrants of the cervix. In endometrial cancer the
following approaches may be used: cervical (periorificially into the four quadrants of
the cervix), or myometrial/subserosal injection (guided by transvaginal
ultrasonography). In vulvar cancer three or four intradermal/intramucous
peritumoral injections may be given under local anaesthesia.
For instructions for preparation and control of the radiochemical purity of the
radiopharmaceutical, see section 12.
For patient preparation, see section 4.4.
Image acquisition
Dynamic or delayed image acquisition should be performed according to local practice.
4.3 Contraindications
Hypersensitivity to the active substance(s), to any of the excipients listed in section 6.1, or
to any of the components of the labelled radiopharmaceutical. In particular, the use of
99m
Tc-human albumin colloidal particles is contraindicated in persons with a history of
hypersensitivity to products containing human albumin.
During pregnancy, lymphoscintigraphy, including sentinel node detection, involving the
pelvis is strictly contraindicated due to the accumulation in lymph nodes.
4.4 Special warnings and precautions for use
Paediatric population
Paediatric population, see section 4.2.
Individual benefit / risk justification
For each patient, the radiation exposure must be justifiable by the likely benefit. The
activity administered should in every case be as low as reasonably achievable to obtain
the required diagnostic information.
Lymphoscintigraphy is not advised in patients with total lymphatic obstruction because
of the potential radiation hazard at injection sites.
The limitations of Nanocoll in sentinel lymph node identification include:
• Unusual drainage patterns may be detected, especially in patients who have had
previous surgery or radiotherapy.
• The nearest node may not be on direct path and a potential secondary node may be
involved with metastasis. All detected nodes should be assessed.
• Lower success rates are possible in secondary biopsies after surgery.
• In gynaecological cancer, Nanocoll is not recommended for patients with suspected
extrauterine involvement, in the presence of pathological pelvic or paraaortic lymph
nodes on radiological examination, and in cases of a previous history of surgery or
radiotherapy to nodal areas under study. Caution should be taken with midline vulvar
tumours, which may drain bilaterally.
• In oral squamous carcinoma failure to detect sentinel nodes may be related to
incorrect injection technique or close proximity of sentinel nodes to the injection site
(eg, floor of mouth tumours). In addition, metastatic deposits may block lymphatic
drainage causing nonvisualization of sentinel nodes. A repeat injection and imaging
procedure, or preferably neck dissection should be considered.
Renal impairment and hepatic impairment
Careful consideration of the benefit risk ratio in these patients is required since an
increased radiation exposure is possible.

Bone marrow scanning: 185-500 MBq.
Inflammation imaging: 370-500 MBq.
Lymphoscintigraphy and Sentinel Lymph Node Imaging

3 kg = 0.10
4 kg = 0.14
6 kg = 0.19
8 kg = 0.23
10 kg = 0.27
12 kg = 0.32
14 kg = 0.36
16 kg = 0.40
18 kg = 0.44
20 kg = 0.46



42 kg = 0.78
44 kg = 0.80
46 kg = 0.82
48 kg = 0.85
50 kg = 0.88
52-54 kg = 0.90
56-58 kg = 0.92
60-62 kg = 0.96
64-66 kg = 0.98
68 kg = 0.99

In very young children (up to 1 year) a minimum dose of 20 MBq (bone marrow scanning) is
necessary in order to obtain images of sufficient quality.
In children it is possible to dilute the product, see section 12. This product is not intended for
regular or continuous administration.
Method of administration
This medicinal product must be radiolabelled before administration to the patient.
Intravenous administration:
- Bone marrow scanning: Images may be acquired 45-60 minutes after administration.
- Inflammation imaging: Dynamic imaging is performed immediately.
Static imaging comprises an early phase, 15 minutes post-injection and a washout phase,
30-60 minutes post-injection.
Local administration:
To demonstrate integrity of the lymphatic system and to differentiate between venous and
lymphatic obstructions, Nanocoll is generally given by single or multiple subcutaneous
(interstitial) injection (5-110 MBq per injection site), depending on the anatomical areas to
be investigated and upon the time interval between injection and imaging. The injected
volume should not exceed 0.2-0.3 ml. A maximum volume of 0.5 ml per injection is critical.
The injection is given subcutaneously, after checking by aspiration, that a blood vessel has
not been inadvertently punctured. When imaging the lower limbs, dynamic pictures are
taken immediately following injection and static imaging 30-60 minutes later. In parasternal
lymph scanning, repeated injections and additional images may be required.
For sentinel node identification specific recommendations are given below. Dual mapping
with blue dye may increase sensitivity and decrease false-negative rate.
• Melanoma: dose 5-120 MBq, divided into volumes of 0.1-0.2 ml, with between 1 and 8
intradermal injections administered, depending on the location of the lesion and the
timing of the injection (eg, 4-8 injections for head-neck and trunk lesions, or wide
excisions/large lesions, administered roughly equatorially, around the lesion, and 2
injections for smaller lesions on the extremities, given medial and lateral to the
tumour/scar).
• Breast cancer: dose 5-370 MBq. When using superficial (periareolar, subdermal,
intradermal, or subareolar) injections, large volumes of injectate may interfere with
normal lymphatic flow; therefore, volumes of 0.05–0.5 mL are recommended. With
peritumoral injections, larger volumes (e.g. 0.5–1.0 mL) may be used.

Patient preparation
The patient should be well hydrated before the start of the examination and urged to
void as often as possible during the first hours after the study in order to reduce
radiation.
Potential for hypersensitivity or anaphylactic reactions
The possibility of hypersensitivity including serious, life-threatening, fatal anaphylactic/
anaphylactoid reactions should always be considered. If hypersensitivity or anaphylactic
reactions occur, the administration of the medicinal product must be discontinued
immediately and intravenous treatment initiated, if necessary. To enable immediate
action in emergencies, the necessary medicinal products and equipment such as
endotracheal tube and ventilator must be immediately available.
Specific warnings
It is strongly recommended that the product name and batch number are stated every
time Tc-albumin nanocolloid is given to a patient, in order to maintain a connection
between the patient and the product’s batch number.
Standard measures to prevent infections resulting from the use of medicinal products
prepared from human blood or plasma include selection of donors, screening of
individual donations and plasma pools for specific markers of infection and the inclusion
of effective manufacturing steps for the inactivation /removal of viruses. Despite this,
when medicinal products prepared from human blood or plasma are administered, the
possibility of transmitting infective agents cannot be totally excluded. This also applies to
unknown or emerging viruses and other pathogens.
The measures taken are considered effective for enveloped viruses such as human
immunodeficiency virus (HIV), hepatitis B virus (HBV) and hepatitis C virus (HCV), and for
the non-enveloped hepatitis A and parvovirus B19 viruses.
There are no reports of virus transmission in connection with albumin, made in
accordance with specifications in Ph. Eur. and in accordance with routine processes.
Precautions with respect to environmental hazard are in Section 6.6.
Before reconstitution this medicinal product contains less than 1mmol sodium (23mg) per
vial, i.e. essentially ‘sodium-free’. The reconstituted injection contains 0.24 mg/ml sodium.
This needs to be taken into consideration for patients on a controlled sodium diet.

4.5 Interaction with other medicinal products and other forms of interaction
Iodinated contrast media used in lymphoangiography may interfere with lymphatic
scanning using Technetium-99m Albumin Nanocolloid.
4.6 Fertility, pregnancy and lactation
Women of childbearing potential
When an administration of radiopharmaceuticals to a woman of childbearing potential is
intended, it is important to determine whether or not she is pregnant. Any woman who
has missed a period should be assumed to be pregnant until proven otherwise. If in doubt
about her potential pregnancy (if the woman has missed a period, if the period is very
irregular, etc.), alternative techniques not using ionising radiation (if there are any) should
be offered to the patient.
Pregnancy
Radionuclide procedures carried out on pregnant women also involve radiation doses to
the foetus. Only essential investigations should therefore be carried out during
pregnancy, when the likely benefit far exceeds the risk incurred by mother and foetus.
Dose to the uterus arising for intravenous administration of 500 MBq of (99mTc) albumin
nanocolloid is 0.9 mGy. Dose to the uterus above 0.5 mGy will be regarded as a potential
risk to the foetus.
During pregnancy the subcutaneous administration of (99mTc) albumin nanocolloid for
lymphoscintigraphy, including sentinel node detection, is strictly contraindicated, due to
the possible accumulation in pelvic lymph nodes, see section 4.3.
Breastfeeding
Before administering radiopharmaceuticals to a mother who is breastfeeding
consideration should be given to the possibility of delaying the administration of
radionuclide until the mother has ceased breastfeeding and as to what is the most
appropriate choice of radiopharmaceutical, bearing in mind the secretion of activity in
breast milk. If the administration is considered necessary, breastfeeding should be
interrupted for 13 hours post injection and the expressed feeds discarded.

4.7 Effects on ability to drive and use machines
Effects on ability to drive and use machines have not been described.

4.8 Undesirable effects
The frequencies of undesirable effects are defined as follows:
Very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare
(≥1/10,000 to <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from
the available data)
Occasionally hypersensitivity reactions (including very rare life-threatening anaphylaxis)
may occur.

Immune system disorders
Not known: Hypersensitivity, anaphylaxis
Exposure to ionising radiation is linked with cancer induction and a potential for
development of hereditary defects. As the effective dose is 2,3 mSv when the maximal
recommended activity of 500 MBq is administered these adverse events are expected to
occur with a low probability.
For safety with respect to transmissible agents see section 4.4.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is
important. It allows continued monitoring of the benefit/risk balance of the medicinal
product. Healthcare professionals are asked to report any suspected adverse reactions
via United Kingdom Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard

4.9 Overdose
In the event of an overdose of radioactivity being administered when using 99mTc
albumin nanocolloid, no practical measure can be recommended to satisfactorily
diminish tissue exposure as the label is poorly eliminated in urine and faeces.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Diagnostic radiopharmaceuticals, hepatic and reticulo
endothelial system, technetium (99mTc) nanocolloid, ATC Code: V09DB01.
At the chemical concentrations and activities used for diagnostic procedures
technetium-99m albumin nanocolloid does not appear to exert any pharmacodynamic effects.
At least 95% of the colloidal particles which form Nanocoll have a diameter ≤80 nm, a
size range considered adequate for lymphoscintigraphy applications.
Sentinel Lymph Node Imaging
The sentinel node is defined as the first lymph node of the lymphatic basin to receive
drainage from a determined region. The latter virtually always corresponds to the first
tumoral implantation site, since dissemination typically occurs in an orderly and
sequential way. Nevertheless, sentinel node analysis can assist in defining the status of
the entire lymphatic basin.
Following reconstitution and labelling, Nanocoll is intended to be injected in close
proximity to the tumour and used in preoperative imaging and/or intraoperatively in
conjunction with a gamma detection probe to localise sentinel lymph nodes in the
lymphatic pathway draining the tumour. In published studies Nanocoll has demonstrated
an acceptable level of efficacy in sentinel lymph node identification.
5.2 Pharmacokinetic properties
Distribution
After intravenous injection, 99mTc-nanocolloid is rapidly cleared from plasma and taken
up by the reticuloendothelial system. About 15– 20% is accumulated in the bone marrow
by macrophages, the rest being distributed to the liver (70%) and spleen (10%).
Following subcutaneous administration, approximately 30-40% of the colloidal particles
of 99mTc-labelled albumin are filtered in the lymphatic capillaries, which have the principle
function of draining proteins from the interstitial fluid and returning them to the blood.
From here the particles are transported through the lymphatic vessels into the local
lymph nodes and main lymphatic vessels, and are finally trapped in the reticular cells of
the main lymph nodes.
A fraction of the injected dose is phagocytosed by the histiocytes at the injection site. A
fraction of the injected dose is transported in the blood and accumulates mainly in the
reticuloendothelial system (RES) of the liver, spleen and bone marrow, minimal traces are
eliminated through the kidneys. The maximum concentration in the liver and spleen is
reached after about 30 minutes, but in the bone marrow after only 6 minutes.
Organ uptake
The subcutaneous administration of the nanocolloid is followed by a rapid and massive
lymphatic drainage that makes it possible to trace the flow in the lymphatic vessels by
means of dynamic scanning, for at least 30 minutes. It is then possible to run a total body
scan or a Single photon emission computed tomography (SPECT). With regard to the
lymph nodes proximal to the injection site, it is possible to visualise them after 5 minutes
from administration.
Elimination
The metabolic degradation of Nanocoll is slow, and the half life in the body is about 32
hours, bearing witness to its stability in-vivo. Its elimination occurs through the kidneys
and to a lesser extent through the gastrointestinal system. The rate of excretion is not
influenced by administration of other pharmaceuticals, thus ensuring for the patient the
possibility of continuing any ongoing therapies at the time of the examination.
The metabolic degradation has a relatively low coefficient (1.5% per hour). This constitutes
a safe technical advantage, even in the case of late scans made possible by the good
in-vivo stability. However, this is associated with a relative disadvantage represented by
the larger radiation dose in the fixation sites.
A fraction of the injected dose is phagocytized by histiocytes at the injection site. Another
fraction appears in the blood and accumulates mainly in the RES of the liver, spleen and
bone marrow; faint traces are eliminated via the kidneys.
5.3 Preclinical safety data
No animal death and no gross pathological changes at necropsy were noted after
intravenous injection of 800 and 950 mg in mice and rats respectively.
No local reactions were observed in either mice or rats subcutaneously injected with
1g/kg.
These doses correspond to the contents of several tens of vials per kg body weight,
compared to the human albumin colloid dose of 7 micrograms /kg generally used in
nuclear medicine for diagnosis.
Mutagenicity studies and long-term carcinogenicity studies have not been carried out.
6

PHARMACEUTICAL PARTICULARS

6.1 List of excipients
Stannous chloride, dihydrate
Glucose, anhydrous
Poloxamer 238
Sodium phosphate, dibasic, anhydrous
Sodium phytate, anhydrous
6.2 Incompatibilities
This medicinal product must not be mixed with other medicinal products except those
mentioned in section 12.
6.3 Shelf life
1 year (12 months) from the date of manufacture.
The reconstituted product should be stored below 25°C. Do not refrigerate or freeze. It
should be used within 6 hours after labelling.
6.4 Special precautions for storage
Store in a refrigerator (2°C to 8°C).
For storage conditions of the reconstituted product, see section 6.3.
Storage of radiopharmaceuticals should be in accordance with national regulation on
radioactive materials.
6.5 Nature and contents of the container
10 ml, Type I Ph.Eur., glass vials sealed by bromobutyl rubber stoppers and metal flip off
caps.
Pack size: kit contains 5 vials.

6.6 Special precautions for disposal and other handling
Radiopharmaceuticals should be received, used and administered only by authorized
persons in designated clinical settings. Its receipt, storage, use, transfer and disposal are
subject to the regulation and/or appropriate licenses of local competent official
organisations.
Radiopharmaceuticals should be prepared in a manner which satisfies both radiation
safety and pharmaceutical quality requirements. Appropriate aseptic precautions should
be taken.
Contents of the vial are intended only for use in the preparation of 99m Tc-human
albumin nanocolloid and are not to be administered directly to the patient without first
undergoing the preparative procedure.
For instructions on reconstitution of the medicinal product before administration, see
section 12.

Measure bar should be 150mm at 100% scale

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Clearly mark any amendments on one proof and return to MPS

Warning! We cannot accept responsibility for any errors
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Customer

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Description

Nanocoll P724GB Technical leaflet

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Date

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Artwork No.

604585

Keyline

Pharma
Code

1202

The content of the kit before reconstitution is not radioactive. However, after Sodium
Pertechnetate (99mTc) Injection Ph. Eur. is added, adequate shielding of the final preparation
must be maintained.
The administration of radiopharmaceuticals creates risks for other persons from external
radiation or contamination from spills of urine, vomiting, etc. Radiation protection
precautions in accordance with national regulations must therefore be taken.
Normal safety precautions for handling radioactive materials should be observed. After use,
all materials associated with the preparation and administration of radiopharmaceuticals,
including any unused product and its container, should be decontaminated or treated as
radioactive waste and disposed of in accordance with the conditions specified by the local
competent authority. Contaminated material must be disposed of as radioactive waste via
an authorised route.

7 MARKETING AUTHORIZATION HOLDER
GE Healthcare S.r.l.
Via Galeno, 36
20126 - Milan
Italy
8 MARKETING AUTHORIZATION NUMBERS
PL 16991/0001

9 DATE OF FIRST AUTHORIZATION / RENEWAL OF THE AUTHORIZATION
Date of first authorisation: 15 June 1998
Date of the last renewal: 09 May 2002

10 DATE OF REVISION OF THE TEXT
08/04/2015
11 DOSIMETRY
Technetium (99mTc) is produced by means of a (99Mo/99mTc) generator and decays with the
emission of gamma radiation with a mean energy of 140 keV and a half-life of 6.02 hours to
technetium (99Tc) which, in view of its long half-life of 2.13 x 105 years can be regarded as
quasi stable.
The radiation dose estimation for a number of organs is based on MIRD reference man and
MIRD S values, and has been calculated from biological data of organ uptake and blood
clearance.
The radiation doses absorbed by a patient weighing 70 kg, after intravenous injection of
technetium-99m human albumin colloidal particles, are reported hereafter.
Organ
Liver
Urinary bladder (wall)
Spleen
Bone marrow (red)
Ovaries
Testes
Whole body

Absorbed dose (µGy/MBq)
78
25
18
14
3.2
1.1
5.1

For this product the effective dose resulting of an administered activity of 500 MBq is 2.5
mSv (per 70 kg individual).
For an administered activity of 500 MBq the typical radiation dose to the critical organ (liver)
is 39 mGy and the typical radiation dose to the target organ (red bone marrow) is 7.0 mGy.
The radiation doses absorbed by a patient weighing 70 kg, after subcutaneous injection of
technetium-99m human albumin colloidal particles, are reported hereafter.
Organ
Injection site
Lymph nodes
Liver
Urinary bladder (wall)
Spleen
Bone marrow (red)
Ovaries
Testes
Whole body

Absorbed dose (µGy/MBq)
12,000
590
16
9.7
4.1
5.7
5.9
3.5
4.6

For this product the effective dose equivalent resulting of an administered activity of 110
MBq is 0.44 mSv (per 70 kg individual).
For an administered activity of 110 MBq the typical radiation dose to the target organ
(lymph nodes) is 65 mGy and to the critical organ (injection site) 1320 mGy.
12 INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS
Method of preparation
- Place a vial containing the albumin colloidal particles in a convenient lead shield.
- Aseptically introduce into the vial 1-5 ml Sodium Pertechnetate (99mTc) Injection Ph. Eur.
with a radioactivity ranging from 185 to 5550 MBq (5 to 150 mCi).
- In children, it is possible to dilute the product up to 1:50 with sodium chloride for
injection.
- Do not use a breather needle.
- Relieve the excess of pressure in the vial by simply withdrawing an equal volume of
gas in the syringe.
- Invert carefully a few times to dissolve the contents of the vial.
- For paper chromatography allow to stand for 5-10 minutes at room temperature
(15°C -25°C).
- For chromatography on TLC-SA allow to stand for 30 minutes at room temperature
(15°C -25°C).
- Shake before withdrawing a dose.
- In no case should the preparation be left in contact with air.
The disposal of waste should be in accordance with national and international guidelines.
Quality control
RCP by ascending paper chromatography:
Support: paper Whatman No. 1
Solvent: methanol : water 85 : 15 v/v
Time: 1 hour
99m
Tc (nanocolloid): ≥ 95%
Rf [99mTc (nanocolloid)]: 0.0%
Free 99m-Tc pertechnetate migrate with Rf 0.7 + 10%
B - RCP by ascending chromatography on TLC-SA:
Support: TLC-SA (2 x 12 cm strips; dispose a small drop of preparation at 2.5 cm of the
bottom)
Solvent : methanol: water 85 : 15 v/v
Time: 25-30 minutes (approximately at 7 cm from the origin; remove strip from the tank and
allow it to dry)
99m
Tc (nanocolloid): ≥ 95%
Rf [99mTc (nanocolloid)]: 0.0 – 0.1
Free 99m-Tc pertechnetate and other Technetium-hydrophilic complexes migrate with
Rf 0.8 – 1.0
Do not use material if the radiochemical purity is less than 95%
13 OTHER INFORMATION
Manufacturer
GIPHARMA S.r.l.
Via Crescentino
13040 Saluggia (VC)
ITALY
GE and the GE Monogram are trademarks of General Electric Company.

Page 2 of 5

GE Healthcare

HEALTHCARE PROFESSIONAL
INFORMATION

NANOCOLL

500 micrograms
kit for radiopharmaceutical
preparation
Human albumin colloidal
particles

P724GB

1 1 8 2 9 6 6

L/5957/05
CODE READS
R-L

Measure bar should be 150mm at 100% scale

artwork.leicester@multipkg.com

Clearly mark any amendments on one proof and return to MPS

Warning! We cannot accept responsibility for any errors
in this proof after approval. Whilst we take extreme care
at all times to ensure accuracy to our clientʼs brief,
the final responsibility must be taken by our client.
IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING
FULL APPROVAL OF DESIGN AND TEXT.

Customer

GI Pharma

Colours Used

Description

Nanocoll P724GB Technical leaflet

Process Black

Item Code

L/5957/05-1182966

Profile

n/a

Size

384 x 440mm

Min. Point Size

7.6pt

Market

UK

Language

English

Proof By

louise.heel

Proof No.

4

Date

16.10.2015

Artwork No.

604585

Keyline

Pharma
Code

1202

PACKAGE LEAFLET: INFORMATION FOR THE USER
NANOCOLL 500 micrograms kit for
radiopharmaceutical preparation
Human albumin colloidal particles
(called Nanocoll in this leaflet)
Read all of this leaflet carefully before you are given
Nanocoll, 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.
• If any of your 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. See section 4.

In this leaflet:
1. What Nanocoll is and what it is used for
2. What you need to know before you are given Nanocoll
3. How Nanocoll is given
4. Possible side effects
5. How to store Nanocoll
6. Contents of the pack and other information
1. What Nanocoll is and what it is used for
This medicine is for diagnostic use only. It is used only to
help identify illness. It is not a treatment for your illness.

• The scan can help your nuclear medicine doctor
see your bone marrow and the lymphatic system.
The lymphatic system is a network of glands, tubes
(like veins), and nodes (connections) that are found
throughout your body.
• If you have cancer, Nanocoll can be injected to help
your doctor see if the cancer has spread to 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
Nanocoll has found the sentinel lymph nodes, they
can be removed and checked to see there are any
cancer cells present
• Some other people are given this medicine to see
swelling (inflammation) of glands and vessels
(like veins), that are found throughout the body,
responsible for draining fluid caused by inflammation.
Your doctor or nurse will explain which part of your body
will be scanned.
The use of Nanocoll does involve exposure to small
amounts of radioactivity. Your doctor and the nuclear
medicine doctor have considered the clinical benefit
that you will obtain from the procedure with the
radiopharmaceutical outweighs the risk due to radiation.
Ask your nuclear doctor if have any questions.
2. What you need to know before you are given
Nanocoll

• Nanocoll is a ‘radiopharmaceutical’ medicine. Before it
is used, the powder in the vial which contains human
albumin colloidal particles is mixed with a radioactive
medicine called technetium. This contains a small
amount of radioactivity and can make parts of the
body visible to doctors during tests.
• Once injected it can be seen from outside your body
by a special camera used in the scan.

Nanocoll must not be used:
• If you are allergic (hypersensitive) to the active
ingredient or any other ingredient. (Listed in Section 6).
• For a scan of the lymphatic system (involving the
pelvis), if you are pregnant or think you might be
pregnant.
Do not have Nanocoll if any of the above apply to you.
If you are not sure talk to your nuclear medicine doctor
or nurse.

Code Reads
L-R

Warnings and precautions
Check with your nuclear medicine doctor or nurse before
having Nanocoll if:
• You are pregnant or think you may be pregnant.

• You have been told by a doctor that there is
a blockage in your lymphatic system.
• You have a liver or kidney problem.
• You are on a low sodium diet.
• You have already had surgery to the affected
area before
Before administration of Nanocoll you should:
• Drink plenty of water before the start of the
examination in order to urinate as often as possible
during the first hours after the scan.
Children and adolescents
Talk to your nuclear medicine doctor if you are under
18 years old.
Other medicines and Nanocoll
Please tell your nuclear medicine doctor, who will
supervise the procedure, if you are taking or have
recently taken any other medicines, including medicines
obtained without a prescription. This includes herbal
medicines. This is because some medicines can affect the
way Nanocoll works.
If you are having a scan of the lymphatic system, tell
your nuclear medicine doctor if you are taking any of the
types of medicine below. This is because they may affect
the results of your scan:
• Medicines given in hospital for x-rays or scans
(iodinated contrast media).
If you are not sure if the above applies to you, talk to your
nuclear medicine doctor before having Nanocoll.
Pregnancy and breast-feeding
You should not be given Nanocoll for a scan of the
lymphatic system (involving the pelvis), if you are
pregnant or think you may be pregnant. This is because it
may affect the baby.
For other scans, you must tell your nuclear medicine
doctor if you are pregnant or think that you may be
pregnant. Your doctor will only use this product if it is
considered that the benefit outweighs the risk.
Do not breast-feed if you are given Nanocoll. This is
because small amounts of ‘radioactivity’ may pass into
the mother’s milk. If you are breast-feeding, your nuclear

Page 4 of 5
medicine doctor may wait until you have finished breastfeeding before using Nanocoll. If it is not possible to wait
your doctor will ask you to:
• stop breast-feeding for 13 hours after the injection,
and
• use formula feed for your child, and
• express (remove) breast milk and throw away the milk.
Your nuclear medicine doctor will let you know when you
can start breast-feeding again.

Driving and using machines
Ask your nuclear medicine doctor if you can drive or use
machines after you have been given Nanocoll.
Important information about Nanocoll
Nanocoll contains 0.24mg/ml Sodium. This needs to be
considered for people on a low sodium diet.
3. How Nanocoll is given
There are strict laws on use, handling and disposal of
radiopharmaceutical products. Nanocoll will only be
used in special controlled areas. This product will only
be handled and given to you by people who are trained
and qualified to use it safely. These persons will take
special care for the safe use of this product and keep you
informed of their actions.
• Nanocoll will always be used in a hospital or clinic.
• They will tell you anything you need to know for its
safe use.
Your nuclear medicine doctor will decide on the dose that
is best for you. It will be the smallest dose necessary to
get the desired information.
The quantity to be administered usually recommended
for an adult ranges from 5 to 400 MBq (megabequerel,
the unit to express radioactivity) for a scan of the
lymphatic system and sentinel lymph nodes, and
from 185 to 500 MBq for a bone marrow scan and for
swelling. For a scan of the lymphatic system and
sentinel nodes:
• The dose may be divided up into smaller amountsthis means the doctor can make more than one
injection into the area around the tumour.
turn over

• Nanocoll is injected under the skin, or in or around the
tumour. The place depends upon the tumour.
• Injections may be given immediately prior to a scan,
or can be some hours, or the day before.
• Injections may sometime be given using ultrasound as
a guide.
• Antibiotics may sometimes be given for some days
after you receive the injection
• A swab may be used to cover the area immediately
after injection
• For injections in the mouth you may be asked to rinse
your mouth out afterwards
For a bone marrow scan and for swelling, the usual
dose is:
• One single injection into a vein (‘intravenous’ injection).
Use in Children
In children the quantity administered will be adapted to
the child’s body mass.
Duration of the procedure
Your nuclear medicine doctor will inform you about the
usual duration of the procedure.
The nuclear medicine doctor will inform you if you need to
take any special precautions after receiving this medicine.
Contact the doctor if your have any questions.
If you have been given more Nanocoll than you should
An overdose is unlikely, because you will receive a single
dose of Nanocoll precisely controlled by the nuclear
medicine doctor supervising the procedure. However,
in the case of overdose, you will receive the appropriate
treatment.
4. Possible side effects
Like all medicines, Nanocoll can cause side effects,
although not everybody gets them.
This radiopharmaceutical will deliver low amounts
of ionising radiation with the least risk of cancer and
hereditary abnormalities.

Allergic Reactions
If you have an allergic reaction when you are in hospital
or a clinic having the scan, tell the doctor or nurse
straight away. The signs may include:
• skin rash, itching or flushing
• swelling of the face
• difficulty in breathing.
In more serious cases reactions may include:
• passing out (unconsciousness), feeling dizzy or
lightheaded.
If any of the side effects above happen after you leave
the hospital or clinic, you should go or be taken straight
to the casualty department of your nearest hospital.
Reporting of side effects
If you get any side effects, talk to your nuclear medicine
doctor. This includes any possible side effects not listed
in this leaflet. You can also report side effects directly via
the Yellow card scheme at www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more
information on the safety of this medicine.

Page 3 of 5

What Nanocoll looks like and contents of the pack
Nanocoll is supplied as a kit for radiopharmaceutical
preparation. The kit contains five vials. Each vial contains
500 micrograms of human albumin colloidal particles.

GE Healthcare
PATIENT
INFORMATION

Marketing Authorisation Holder
GE Healthcare S.r.l.
Via Galeno, 36
20126 Milan
Italy

NANOCOLL
500 micrograms kit for
radiopharmaceutical
preparation
Human albumin
colloidal particles

Manufacturer
GIPHARMA S.r.l.
Via Crescentino
13040 Saluggia (VC)
Italy

P724GB

This leaflet was last revised in 03/2015.
Marketing Authorisation UK: PL 16991/0001

1 1 8 2 9 6 7

GE and the GE Monogram are trademarks of
General Electric Company.

P/5958/04

5. How to store Nanocoll
Nanocoll is kept out of sight and reach of children.
The product label includes the correct storage conditions
and the expiry date for the batch. Hospital staff will
ensure that the product is stored and disposed of
correctly and not used after the expiry date stated on the
label.
6. Contents of the pack and other information
What Nanocoll contains
• The active ingredient is human albumin colloidal
particles. Each vial of Nanocoll contains 500
micrograms of human albumin colloidal particles.
• The other ingredients are stannous chloride dihydrate,
glucose anhydrous, poloxamer 238, sodium phosphate
dibasic anhydrous and sodium phytate anhydrous.
Code Reads
R-L

Page 5 of 5

Measure bar should be 150mm at 100% scale

artwork.leicester@multipkg.com

Clearly mark any amendments on one proof and return to MPS

Warning! We cannot accept responsibility for any errors
in this proof after approval. Whilst we take extreme care
at all times to ensure accuracy to our clientʼs brief,
the final responsibility must be taken by our client.
IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING
FULL APPROVAL OF DESIGN AND TEXT.

Customer

GI Pharma

Colours Used

Description

Nanocoll P724GB Patient information leaflet

Process Black

Item Code

P/5958/04-1182967

Profile

N/A

Size

400 x 190mm

Min. Point Size

10.4pt

Market

UK

Language

English

Proof By

louise.heel

Proof No.

4

Date

16/10/2015

Artwork No.

604613

Pharma
Code

Keylines

1203

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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