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NANOCOLL 500 MICROGRAMS KIT FOR RADIOPHARMACEUTICAL PREPARATION

Active substance(s): HUMAN ALBUMIN COLLOIDAL PARTICLES / HUMAN ALBUMIN COLLOIDAL PARTICLES / HUMAN ALBUMIN COLLOIDAL PARTICLES

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P724GB
PACKAGE LEAFLET: INFORMATION FOR HEALTHCARE PROFESSIONAL
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:
CODE READS
L-R

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.
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:
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 (cervix and vulvar) cancer.

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.
•• 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.

4.2. Posology and method of administration

4.3 Contraindications

Posology

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 99mTc-human albumin
colloidal particles is contraindicated in persons with a history of
hypersensitivity to products containing human albumin.

Adults
Bone Marrow and Inflammation Imaging
Recommended activities in adults are as follows:
Bone marrow scanning: 185 - 500 MBq

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 imperative 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.

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

4.7 Effects on ability to drive and use machines

Stannous chloride, dihydrate
Glucose, anhydrous
Poloxamer 238
Sodium phosphate, dibasic, anhydrous
Sodium phytate, anhydrous

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

6.2 Incompatibilities

4.8 Undesirable effects

This medicinal product must not be mixed with other medicinal products
except those mentioned in section 12.

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)

Lymphoscintigraphy and Sentinel Lymph Node Imaging

Immune system disorders

Store at 2°C to 25°C.

Recommended activities in adults are as follows:

4.4 Special warnings and precautions for use

Not known: Hypersensitivity, anaphylaxis

For storage conditions of the reconstituted product, see section 6.3.

Lymphoscintigraphy: The recommended activity by single or multiple
subcutaneous (interstitial) injection 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.

Paediatric population

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.

Storage of radiopharmaceuticals should be in accordance with national
regulation on radioactive materials.

••
••
••
••
••
••

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:
o cervical (stage Ia2/Ib1, IIa1): 110 MBq
o  
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
o  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:
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

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

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
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.

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.
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

rare

The reconstituted product should be stored below 25°C. Do not
refrigerate or freeze. It should be used within 6 hours after labelling.

Occasionally hypersensitivity reactions
life-threatening anaphylaxis) may occur.

Paediatric population, see section 4.2.

very

2 years (24 months) from the date of manufacture.

During pregnancy, lymphoscintigraphy, including sentinel node
detection, involving the pelvis is strictly contraindicated due to the
accumulation in lymph nodes.

Inflammation imaging: 370 - 500 MBq.

(including

6.3 Shelf life

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

6.4 Special precautions for storage

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.
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 AUTHORISATION HOLDER

GE Healthcare S.r.l.
Via Galeno, 36
20126 - Milan
Italy
8

MARKETING AUTHORIZATION NUMBERS

PL 16991/0001

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.

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
May 2017
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.

GE Healthcare

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

HEALTHCARE PROFESSIONAL
INFORMATION

NANOCOLL

500 micrograms
kit for radiopharmaceutical
preparation

For this product the effective dose resulting of an administered activity
of 500 MBq is 2.5 mSv (per 70 kg individual).

Human albumin colloidal
particles

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

P724GB

9999999

CODE READS
R-L
L/5957/06

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

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.

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

Expand Transcript

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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