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OSTEOCIS

Active substance(s): SODIUM OXIDRONATE / SODIUM OXIDRONATE / SODIUM OXIDRONATE

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
OSTEOCIS®
Kit for the preparation of Technetium [99mTc] Oxidronate Injection

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION

OSTEOCIS®, kit for the preparation of Technetium [99mTc] Oxidronate Injection,
consists of 5 multidose vials, each containing the following sterile, pyrogen-free,
freeze-dried product under nitrogen :
Sodium oxidronate (I.N.N.) :
Stannous chloride dihydrate :
Ascorbic acid :
Sodium chloride
:

3.0
0.45
0.75
10.0

mg
mg
mg
mg

The product contains no antimicrobial preservative.
The product is to be used after reconstitution by the addition of sterile, pyrogen-free,
isotonic sodium pertechnetate [99mTc] injection, allowing the preparation of
Technetium [99mTc] Oxidronate Injection (technetium [99mTc] hydroxymethylene
diphosphonate, i.e. technetium [99mTc] HMDP).

3.

PHARMACEUTICAL FORM
Powder for injection.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
After reconstitution with sodium pertechnetate [99mTc] solution the agent may be used
for bone scintigraphy, where it delineates areas of altered osteogenesis.

4.2

Posology and method of administration
Posology
Adults and elderly population
The recommended activity for a patient of 70 kg average body weight is
500 MBq (i.e. 300-700 MBq) in a 50 to 70 kg adult. Other activities may be
justifiable. There is no special dosage regimen for the elderly patient.
Patients with high bone uptake and/or severe renal 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
activities to be administered to children and to adolescents may be calculated
according to the European Association of Nuclear Medicine (EANMMay 2008) guidelines, by using the formula corresponding to the indication
concerned and the relevant correction factor corresponding to the body mass
of the young patient (see Table 1).
Recommended activity [MBq] = 35 MBq x Factor (Table 1)

Mass
3 kg
4 kg
6 kg
8 kg
10 kg
12 kg
14 kg
16 kg
18 kg
20 kg

=
=
=
=
=
=
=
=
=
=

factor
1
1.14
1.71
2.14
2.71
3.14
3.57
4.00
4.43
4.86

Table 1
Mass
factor
22 kg = 5.29
24 kg = 5.71
26 kg = 6.14
28 kg = 6.43
30 kg = 6.86
32 kg = 7.29
34 kg = 7.72
36 kg = 8.00
38 kg = 8.43
40 kg = 8.86

Mass
42 kg
44 kg
46 kg
48 kg
50 kg
52-54 kg
56-58 kg
60-62 kg
64-66 kg
68 kg

=
=
=
=
=
=
=
=
=
=

factor
9.14
9.57
10.00
10.29
10.71
11.29
12.00
12.71
13.43
14.00

In very young children (up to 1 year) a minimum dose of 40 MBq is necessary
in order to obtain images of sufficient quality.
Method of administration
Multidose use.
This medicinal product should be reconstituted before administration to the
patient.
The radiolabelled solution is administered by a single intravenous injection.
For instructions on extemporaneous preparation of the medicinal product
before administration, see section 12.
For patient preparation, see section 4.4.
Image acquisition

Images obtained shortly after injection (e.g. in the so-called "3-phase bone
scan" procedure) will only partly reflect metabolic bone activity. Late phase
static scintigraphy should be performed not earlier than 2 hours after injection.
The patient should void before scanning.

4.3

Contra-indications

There are no specific contra-indications.
4.4

Special warnings and special precautions for use.

In infants and children particular attention should be paid to the relatively higher
radiation exposure of the epiphyses in growing bone.
Appropriate precautions should be taken concerning the activity which is eliminated
by the patients, to avoid any contamination. To reduce the radiation exposure to the
bladder wall, sufficient hydration of the patient and frequent voiding is recommended.
To avoid accumulation of tracer in the musculature it is advised that strenuous
exercise be discouraged immediately after injection until satisfactory bone imaging
has been effected.
Inadvertent or accidental subcutaneous administration of technetium [99mTc]
oxidronate should be avoided as perivascular inflammation has been described.
This radiopharmaceutical may be received, used and administered only by authorised
persons in hospitals. Its receipt, storage, use, transfer and disposal are subject to the
regulations and the appropriate licenses of the local competent official organisations.
Radiopharmaceuticals intended for administration to patients should be prepared by
the user in a manner which satisfies both radiation safety and pharmaceutical quality
requirements. Appropriate aseptic precautions should be taken, complying with the
requirements of Good Pharmaceutical Manufacturing Practice for pharmaceuticals.
4.5

Interaction with other medicaments and other forms of interaction.

The accumulation of technetium [99mTc] oxidronate in the skeleton, and thus the
quality of the scintigraphic procedure, may be decreased after medication with
chelates, with diphosphonates, after tetracycline or after iron containing drugs.
Regular medication with aluminium containing drugs (notably antacids) may lead to
abnormal high accumulation of 99mTc in the liver, presumably caused by formation of
labelled colloids.
4.6

Pregnancy and lactation

When it is necessary to administer radioactive medicinal products to women of
childbearing potential, information should always be sought about pregnancy. Any
woman who has missed a period should be assumed to be pregnant until proven
otherwise. Where uncertainty exists it is important that radiation exposure should be

the minimum consistent with achieving the desired clinical information. Alternative
techniques which do not involve ionising radiation should be considered.
Radionuclide procedures carried out on pregnant women also involve radiation doses
to the foetus. Only imperative investigations should be carried out during pregnancy
when likely benefit exceeds the risk incurred by mother and foetus. Administration of
700 MBq technetium [99mTc] oxidronate to a patient with normal bone uptake results
in an absorbed dose to the uterus of 4.27 mGy. The dose decreases to 2.03 mGy in
patients with high bone uptake and/or severely impaired kidney function. Doses above
0.5 mGy would be regarded as a potential risk for the foetus.
Before administering a radioactive medicinal product to a mother who is breast
feeding consideration should be given as to whether the investigation could be
reasonably delayed until the mother has ceased breast feeding and as to whether the
most appropriate choice of radiopharmaceutical has been made, bearing in mind the
secretion of activity in breast milk. If the administration is considered necessary, one
breast feed should be banked prior to injection and the subsequent one discarded after
injection. Breast feeding can be restarted 4 hours post injection.
4.7

Effects on ability to drive and use machines

Effects on the ability to drive or to operate machines have not been described.
4.8

Undesirable effects

Adverse drug effects are extremely rare following administration of technetium
(99mTc) oxidronate injection. Reports suggest an incidence of not more than one in
200 000 administrations. Symptoms of anaphylactoid reactions are rash, nausea,
hypotension and sometimes arthralgia. Onset of symptoms may be delayed 4 to
24 hours after administration.
Exposure to ionising radiation is linked with cancer induction and a potential for
development of hereditary defects.
As the effective dose is 4.0 mSv when the maximal recommended activity of
700 MBq is administered these adverse reactions are expected to occur with a low
probability.
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 the Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard.
4.9

Overdose

In the event of the administration of a radiation overdose with technetium [99mTc]
oxidronate the absorbed dose to the patient should be reduced where possible by
increasing the elimination of the radionuclide from the body by forced diuresis and
bladder voiding.

5.

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties

At the chemical concentrations of radiopharmaceutical and excipients used for
diagnostic procedures technetium [99mTc] oxidronate does not appear to exert any
pharmacodynamic effect.
5.2

Pharmacokinetic properties

Intravenously administered technetium [99mTc] oxidronate is rapidly distributed
throughout the extracellular space. Skeletal uptake begins almost immediately and
proceeds rapidly. 30 minutes post injection 10% of the initial dose is still present in
whole blood. At 1 hour, 2 hours, 3 hours and 4 hours after injection these values are
resp. 5%, 3%, 1.5% and 1%. Clearance from the body takes place via the kidneys. Of
the administered activity about 30% is cleared within the first hour, 48% within two
hours and 60% within 6 hours.

5.3

Preclinical safety data

This agent is not intended for regular or continuous administration.Reproduction,
mutagenicity studies and long-term carcinogenicity studies have not been carried out.
Minimal liver abnormalities are seen at the level of 30 mg/kg in rats. In subacute
toxicity studies rats do not react to the administration of 10 mg/kg/day for 14 days,
dogs show histological changes in the liver (microgranuloma) after 3 and 10
mg/kg/day for 14 days. In dogs, treated for 14 consecutive days, long-lasting
indurations at the site of injection were observed.
Dosimetry
For this product the effective dose equivalent resulting from an administered activity
of 700 MBq (18.9 mCi) is typically 5.6 mSv (per 70 kg individual).
For an administered activity of 700 MBq (18.9 mCi) the typical radiation dose to the
target organ (bone) is 44.1 mGy and the typical radiation dose to the critical organ
(bladder wall) is 35 mGy.
In cases of high bone uptake and/or severely impaired kidney function, the effective
dose equivalent resulting from an administered activity of 700 MBq (18.9 mCi) of
technetium [99mTc] oxidronate is 5.7 mSv. The typical radiation dose to the target
organ is 84 mGy and the typical radiation dose to the critical organ (red marrow) is
12.6 mGy.
[99mTc] technetium disintegrates with the emission of gamma radiation with an energy
of 140 keV and a half life of 6 hours to [99Tc] technetium which can be regarded as
quasi stable.
The dosimetry data were quoted from ICRP publication 53 for phosphonates.

Radiation exposure (normal bone uptake)
as absorbed dose / injected activity (mGy/MBq)
Organ

Adult

Adrenals
Bladder wall
Bone surface
Breast
Stomach wall
Small intestine
Upper large intestine
Lower large intestine
Kidneys
Liver
Lungs
Ovaries
Pancreas
Red marrow
Spleen
Testes
Thyroid
Uterus
Other tissue

0.0019
0.050
0.063
0.00088
0.0012
0.0023
0.0020
0.0038
0.0073
0.0013
0.0013
0.0035
0.0016
0.0096
0.0014
0.0024
0.0010
0.0061
0.0019

Children (age in years)
15
10
0.0027
0.0039
0.062
0.090
0.082
0.13
0.00088
0.0014
0.0015
0.0025
0.0028
0.0044
0.0025
0.0038
0.0047
0.0072
0.0089
0.013
0.0016
0.0024
0.0016
0.0024
0.0046
0.0066
0.0020
0.0030
0.013
0.020
0.0018
0.0028
0.0033
0.0055
0.0016
0.0022
0.0076
0.012
0.0023
0.0033

Effective
dose equivalent
(mSv/MBq)

0.0080

0.010

0.015

5
0.0060
0.13
0.22
0.0022
0.0037
0.0066
0.0062
0.010
0.018
0.0038
0.0036
0.0097
0.0046
0.038
0.0043
0.0084
0.0035
0.017
0.0050

1
0.011
0.24
0.53
0.0042
0.0070
0.012
0.011
0.017
0.033
0.0070
0.0069
0.016
0.0085
0.075
0.0081
0.016
0.0056
0.028
0.0089

0.025

0.050

Radiation exposure (high bone uptake and/or severely impaired kidney function)
as absorbed dose / injected activity (mGy/MBq).

Organ

Adult

Children (age in years)
15
10

5

1

Adrenals
Bladder wall
Bone surface
Breast
Stomach wall
Small intestine
Upper large intestine
Lower large intestine
Kidneys
Liver
Lungs
Ovaries
Pancreas
Red marrow
Spleen
Testes
Thyroid
Uterus
Other tissue

0.0035
0.0025
0.12
0.0021
0.0026
0.0031
0.0029
0.0034
0.0030
0.0027
0.0030
0.0029
0.0032
0.018
0.0026
0.0023
0.0024
0.0029
0.0030

0.0050
0.0035
0.16
0.0021
0.0032
0.0038
0.0036
0.0042
0.0037
0.0033
0.0037
0.0041
0.0040
0.023
0.0034
0.0027
0.0037
0.0037
0.0036

0.0072
0.0054
0.26
0.0032
0.0051
0.0057
0.0053
0.0065
0.0056
0.0049
0.0053
0.0059
0.0059
0.037
0.0051
0.0039
0.0054
0.0054
0.0053

0.011
0.0074
0.43
0.0051
0.0073
0.0085
0.0086
0.0096
0.0087
0.0075
0.0081
0.0089
0.0089
0.072
0.0078
0.0060
0.0083
0.0082
0.0081

0.021
0.015
1.0
0.0096
0.014
0.016
0.015
0.018
0.016
0.014
0.015
0.016
0.016
0.14
0.015
0.011
0.014
0.015
0.015

Effective
dose equivalent
(mSv/MBq)

0.0082

0.011

0.017

0.028

0.061

6.

PHARMACEUTICAL PARTICULARS

6.1

List of excipients

Stannous chloride dihydrate
Ascorbic acid
Sodium chloride

6.2

Incompatibilities

None known.
6.3

Shelf life

The expiry date for this kit is 12 months from the day of manufacture. The expiry date
is indicated on the outer packaging and on each vial.
The expiry date for the labelled product is 8 hours after labelling.
6.4
Special precautions for storage
This kit must be stored at a temperature ranging between +2°C and +8°C.
The labelled product must be stored at a temperature ranging between +2°C and
+8°C.
6.5

Nature and contents of container

15 ml, colourless, European Pharmacopoeia type I, drawn glass vials, closed with
rubber stoppers and aluminium capsules.
6.6

Special precautions for disposal

-

Method of preparation
Usual precautions regarding sterility and radioprotection should be respected.

Take a vial from the kit and put it in an appropriate lead shielding.
Using a hypodermic syringe, introduce through the rubber stopper 2 to 10 ml of sterile and
pyrogen-free sodium pertechnetate [99mTc] injection, radioactivity varying as a function of the
volume from 0.74 to maximum 11.1 GBq (from 20 to maximum 300 mCi). Sodium
pertechnetate [99mTc] injection should comply with European Pharmacopoeia specifications.
Do not use a breather needle as the contents are under nitrogen: after introduction of the
volume of sodium pertechnetate [99mTc] injection, without removing the needle, withdraw an
equivalent volume of nitrogen in order to avoid excess pressure in the vial.

Shake for about 2 minutes and allow to rest 15 minutes at room temperature.
The obtained preparation is a clear and colourless solution, with a pH ranging between 5.0
and 7.0.
Limpidity of the solution after preparation, pH, radioactivity and gamma spectrum should be
checked before use.
The vial should never be opened and must be kept inside its lead shielding. The solution
should be removed aseptically through the stopper with a sterile lead protected syringe .
-

Quality control

The quality of labelling (radiochemical purity) could be checked according to the following
procedure.
Method
Paper chromatography
Materials and reagents
1.
Adsorbent
2 Whatman 17 Chr paper strips (A and B) for paper chromatography. Trace a starting
line 2.5 cm from one of the ends of each strip.
2.
Solvents
Solvent A: 0.9% sodium chloride solution
Solvent B: methanol-water (85/15 V/V)
3.
Small developing tanks with cover
Appropriate tanks. Keep the containers stoppered before use.
4.
Miscellaneous
Forceps, scissors, syringes, needles, appropriate counting apparatus.
Procedure
Do not let air enter the vial to be tested and store all vials containing radioactive solution in
lead shieldings.
1.
Introduce respectively in tanks A and B a layer of 2 cm of solvent A and B.
2.
Apply a drop of the preparation to the starting line of strip A using a syringe and
needle. Apply another drop of the preparation to the starting line of strip B. Note the time.
3.
Using forceps, introduce each strip vertically into the corresponding developing tank
(i.e. container with solvent A for strip A and container with solvent B for strip B), with the
starting line downward. Stopper the containers.
4.
When the solvent has reached the top of the strips, use the forceps to remove each
strip and allow to dry in the air.
5.

After identifying the strips, cut strip A at Rf = 0.15 and strip B at Rf = 0.4.

6.
Separately count each section of the strips and record the obtained values (use an
appropriate detection apparatus with a constant counting time, and known geometry and
background noise).
7.
Calculations
Correct the counting data for background noise.
Calculate the percentage of hydrolysed technetium [99mTc] from counting data for the A strip :

% hydrolysed 99mTc = activity of strip A for Rf 0.0 - 0.15 / total activity of strip A × 100
Calculate the percentage of free technetium [99mTc] from counting data for the B
strip :
% free 99mTc = activity of strip B for Rf0.4 - 1.0 / total activity of strip B × 100
Calculate the percentage of bound technetium [99mTc] (radiochemical purity) :
% bound 99mTc = 100% - (% hydrolysed 99mTc + % free 99mTc)
8.
The percentage of bound 99mTc (radiochemical purity) should be more than 95 % and
the percentage of total hydrolysed 99mTc and free 99mTc should be less than 5 %.

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.
Radioactive waste must be disposed of in conformity with the relevant national and
international regulations.

7

MARKETING AUTHORISATION HOLDER
CIS bio international
B.P. 32
91192 Gif-sur-Yvette Cedex
FRANCE

8

Tel.

: +33-(0)1.69.85.70.70

Fax

: +33-(0)1.69.85.70.71

MARKETING AUTHORISATION NUMBER(S)
PL 11876/0006

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
31/05/2006

10

DATE OF REVISION OF THE TEXT
24/08/2016

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 data listed below are from ICRP publications 53 and 80 for phosphonates and are
calculated according to the following assumptions:
The main uptake is in bone, with a further small uptake in kidneys, and the excretion is via the
renal system. It is assumed that a fraction of 0.5 of the injected activity is taken up by bone
with a half-time of 15 min, and retained there with halftimes of 2 hr (0.3) and 3 d (0.7). In
children the uptake is predominantly in the metaphyseal growth zones.
The kidney uptake is set at 0.02 with a retention identical to that of the total body, having
half-times (with fractional retention) of 0.5 hr (0.3), 2 hr (0.3) and 3 d (0.4).
In pathological cases there may be higher uptake and/or longer retention in bone, especially in
kidney diseases. The 24 hr total body retention, which normally amounts to 30%, has been
reported as 40% in osteomalacia, 50% in primary hyperparathyroidism, 60% in Paget's
disease and 90% in renal osteodystrophia. For absorbed dose calculations in pathological
cases an average bone uptake of 70% is assumed, with no excretion.
Organ absorbed doses and effective doses for normal bone uptake were recalculated in
Publication 80.

Radiation exposure (normal bone uptake)
ICRP 80
Absorbed dose per unit activityadministered (mGy/MBq)
Organ
Adult

Children (age in years)
15

10

5

1

Adrenals

0.0021

0.0027

0.0039

0.0058

0.011

Bladder

0.048

0.060

0.088

0.073

0.13

Bone surfaces

0.063

0.082

0.13

0.22

0.53

Brain

0.0017

0.0021

0.0028

0.0043

0.0061

Breast

0.00071

0.00089

0.0014

0.0022

0.0042

Gall bladder

0.0014

0.0019

0.0035

0.0042

0.0067

Stomach

0.0012

0.0015

0.0025

0.0035

0.0066

Small intestine

0.0023

0.0029

0.0044

0.0053

0.0095

Colon

0.0027

0.0034

0.0053

0.0061

0.011

Upper large intestine

0.0019

0.0024

0.0039

0.0051

0.0089

Lower large intestine

0.0038

0.0047

0.0072

0.0075

0.013

Heart

0.0012

0.0016

0.0023

0.0034

0.0060

Kidneys

0.0073

0.0088

0.012

0.018

0.032

Liver

0.0012

0.0016

0.0025

0.0036

0.0066

Lungs

0.0013

0.0016

0.0024

0.0036

0.0068

Muscles

0.0019

0.0023

0.0034

0.0044

0.0079

Oesophagus

0.0010

0.0013

0.0019

0.0030

0.0053

Ovaries

0.0036

0.0046

0.0066

0.0070

0.012

Pancreas

0.0016

0.0020

0.0031

0.0045

0.0082

Red marrow

0.0092

0.010

0.017

0.033

0.067

Skin

0.0010

0.0013

0.0020

0.0029

0.0055

Spleen

0.0014

0.0018

0.0028

0.0045

0.0079

Testes

0.0024

0.0033

0.0055

0.0058

0.011

Thymus

0.0010

0.0013

0.0019

0.0030

0.0053

Thyroid

0.0013

0.0016

0.0023

0.0035

0.0056

Uterus

0.0063

0.0076

0.012

0.011

0.018

Remaining organs

0.0019

0.0023

0.0034

0.0045

0.0079

Effective dose
(mSv/MBq)

0.0057

0. 0070

0.011

0.014

0.027

GI-tract

The effective dose resulting from the administration of an activity of 700 MBq of technetium
(99mTc)-oxidronate for an adult weighing 70 kg is about 4.0 mSv.

For an administered activity of 700 MBq the typical radiation dose to the target organ (bone)
is 44.1 mGy and the typical radiation dose to the critical organ (bladder wall) is 33.6 mGy.
Radiation exposure (high bone uptake and/or severely impaired kidney function)
ICRP 53
Absorbed dose per unit activity
administered (mGy/MBq)

Organ
Adult

Children (age in years)
15

10

5

1

Adrenals

0.0035

0.0050

0.0072

0.011

0.021

Bladder wall

0.0025

0.0035

0.0054

0.0074

0.015

Bone surface

0.12

0.16

0.26

0.43

1.0

Breast

0.0021

0.0021

0.0032

0.0051

0.0096

Stomach wall

0.0026

0.0032

0.0051

0.0073

0.014

Small intestine

0.0031

0.0038

0.0057

0.0085

0.016

Upper large intestine

0.0029

0.0036

0.0053

0.0086

0.015

Lower large intestine

0.0034

0.0042

0.0065

0.0096

0.018

Kidneys

0.0030

0.0037

0.0056

0.0087

0.016

Liver

0.0027

0.0033

0.0049

0.0075

0.014

Lungs

0.0030

0.0037

0.0053

0.0081

0.015

Ovaries

0.0029

0.0041

0.0059

0.0089

0.016

Pancreas

0.0032

0.0040

0.0059

0.0089

0.016

Red marrow

0.018

0.023

0.037

0.072

0.14

Spleen

0.0026

0.0034

0.0051

0.0078

0.015

Testes

0.0023

0.0027

0.0039

0.0060

0.011

Thyroid

0.0024

0.0037

0.0054

0.0083

0.014

Uterus

0.0029

0.0037

0.0054

0.0082

0.015

Other tissue

0.0030

0.0036

0.0053

0.0081

0.015

Effective dose
equivalent (mSv/MBq)

0.0082

0.011

0.017

0.028

0.061

In cases of high bone uptake and/or severely impaired kidney function, the effective dose
equivalent resulting from an administered activity of 700 MBq of technetium (99mTc)
oxidronate is 5.7 mSv.
The typical radiation dose to the target organ is 84 mGy and the typical radiation dose to the
critical organ (red marrow) is 12.6 mGy.

12

INSTRUCTIONS FOR PREPARATION OF
RADIOPHARMACEUTICALS
Usual precautions regarding sterility and radioprotection must be respected.

Withdrawals should be performed under aseptic conditions. The vial must not
be opened and must be kept inside the lead shielding. After disinfection of the
stopper, the solution should be withdrawn via the stopper using a single dose
syringe fitted with suitable protective shielding and a disposable sterile needle
or using an authorised automated application system.
If the integrity of this vial is compromised, the product should not be used.
Method of preparation
Take a vial from the kit and put it in an appropriate lead shielding.
Using a hypodermic syringe, introduce through the rubber stopper 2 to 10 ml
of sterile and pyrogen-free sodium pertechnetate (99mTc) injection,
radioactivity varying as a function of the volume from 0.74 to maximum 11.1
GBq. Sodium pertechnetate (99mTc) injection should comply with European
Pharmacopoeia specifications.
Do not use a breather needle as the contents are under nitrogen: after
introduction of the volume of sodium pertechnetate (99mTc) injection, without
removing the needle, withdraw an equivalent volume of nitrogen in order to
avoid excess pressure in the vial.
Shake for about 2 minutes and allow to rest 15 minutes at room temperature.
The solution of technetium (99mTc)-oxidronate obtained is a clear and
colourless solution, with a pH ranging between 5.0 and 7.0.
Limpidity of the solution after preparation, pH, radioactivity and gamma
spectrum should be checked before use.
Quality control
The quality of labelling (radiochemical purity) could be checked according to
the following procedure.
Method
Paper chromatography
Materials and reagents
1.
Adsorbent
Whatman 17 Chr paper strips (A and B) for paper chromatography. Trace a
starting line 2.5 cm from one of the ends of each strip.
2.
Solvents
Solvent A : 0.9% sodium chloride solution
Solvent B : methanol-water (85/15 V/V)
3.
Small developing tanks with cover
Appropriate tanks. Keep the containers stoppered before use.
4.
Miscellaneous
Forceps, scissors, syringes, needles, appropriate counting apparatus.
Procedure
Do not let air enter the vial to be tested and store all vials containing
radioactive solution in lead shieldings.
1.
Introduce respectively in tanks A and B a layer of 2 cm of solvent A
and B.
2.
Apply a drop of the preparation to the starting line of strip A using a
syringe and needle. Apply another drop of the preparation to the starting line
of strip B. Note the time.
3.
Using forceps, introduce each strip vertically into the corresponding
developing tank (i.e. container with solvent A for strip A and container with
solvent B for strip B), with the starting line downward. Stopper the containers.

4.
When the solvent has reached the top of the strips, use the forceps to
remove each strip and allow to dry in the air.
5.
After identifying the strips, cut strip A at Rf = 0.15 and strip B at Rf =
0.4.
6.
Separately count each section of the strips and record the obtained
values (use an appropriate detection apparatus with a constant counting time,
and known geometry and background noise).
7.
Calculations
Correct the counting data for background noise.
Calculate the percentage of hydrolysed technetium [99mTc] from counting data
for the A strip:
% hydrolysed 99mTc = activity of strip A for Rf 0.0 - 0.15
total activity of strip A

× 100

Calculate the percentage of free technetium [99mTc] from counting data for the
B strip:
% free 99mTc = activity of strip B for Rf 0.4 - 1.0
total activity of strip B

× 100

Calculate the percentage of bound technetium [99mTc] (radiochemical purity):
% bound 99mTc = 100% - (% hydrolysed 99mTc + % free 99mTc)
8.
The percentage of bound 99mTc (radiochemical purity) should be more
than 95 % and the percentage of total hydrolysed 99mTc and free 99mTc should
be less than 5 %.

Any unused medicinal product or waste material should be disposed of in
accordance with local requirements.

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Source: Medicines and Healthcare Products Regulatory Agency

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