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MEDRONATE DRAXIMAGE 10 MG KIT FOR RADIOPHARMACEUTICAL PREPARATION

Active substance(s): MEDRONIC ACID

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ENGLISH
PACKAGE LEAFLET:
iNFORMATION FOR THE USER

SUMMARY OF THE PRODUCT CHARACTERISTICS

Medronate DraxImage 10 mg

1. NAME OF THE MEDICINAL PRODUCT
Medronate DRAXIMAGE 10 mg, kit for radiopharmaceutical preparation

Kit for radiopharmaceutical preparation
Medronic acid
Read all of this leaflet carefully before you are given this medicine 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 who will supervise the procedure.
–– If you get any side effects, talk to your Nuclear medicine doctor. This includes any possible side effects not listed in this
leaflet.
What is in this leaflet:
1. What Medronate DRAXIMAGE is and what it is used for
2. What you need to know before Medronate DRAXIMAGE is
used
3. How Medronate DRAXIMAGE is used
4. Possible side effects
5. How Medronate DRAXIMAGE is stored
6. Contents of the pack and other information
1. What Medronate DRAXIMAGE is and what is it used for
This medicine is a radiopharmaceutical product for diagnostic
use only.
Medronate DRAXIMAGE is used to make a scan to determine
whether there is an abnormality in the growth of your skeleton.
This medicine is a powder that, when mixed with a solution of
the radioactive substance sodium pertechnetate (Tc-99m), yields
an injection fluid containing technetium (99mTc)-medronate.
When technetium (99mTc) medronate is injected, it is taken up
temporarily by the bones. Since the product contains a small
amount of radioactivity, it can be visualised from outside the
body using special cameras, and an image can be taken (which
is known as a scan). This scan shows the distribution of the
radioactivity in the bones.
By means of a scan, your doctor can then determine whether
there is an abnormality in the growth of the skeleton.
The use of Medronate DRAXIMAGE does involve exposure to
small amounts of radioactivity. Your doctor and the Nuclear
medicine doctor have considered that the clinical benefit that
you will obtain from the procedure with radiopharmaceutical
outweighs the risk due to radiation.
2. What you need to know before Medronate DRAXIMAGE is used
Medronate DRAXIMAGE must not be used
–– if you are allergic to medronic acid (MDP, medronate) or any
of the other ingredients of this medicine (listed in section 6)
or to any of the components of the labelled radio­pharma­
ceutical
In case of doubt, it is important to consult your doctor before
this product is administered.
Warnings and precautions
Take special care with Medronate DRAXIMAGE
–– if you are pregnant or believe you may be pregnant
–– If you are breastfeeding
–– If you are under 18 years old
Before Medronate DRAXIMAGE administration you should:
–– drink plenty of water and to be well hydrated before the start
of the examination in order to urinate as often as possible
during the first hours after the study
–– avoid all important physical activity
Children and adolescents
Talk to your Nuclear medicine doctor if you are under 18 years
old. If you are under 18 years old, the radiation exposure is
higher, especially in growing bone. Your doctor will consider this.
Other medicines and Medronate DRAXIMAGE
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.
Please tell your physician if you are taking or have been administered, any of the following medicines/substances, since they
may interfere with your physician interpretation of the images:
–– compounds containing iron
–– single doses of bisphosphonate (to prevent loss of bone mass)
–– various anti-cancer medicines
–– medicines that suppress the immune system
–– aluminium-containing antacid
–– X-ray contrast media
–– antibiotics
–– anti-inflamatory agents
–– injections of calcium gluconate (to treat low blood levels of
calcium)
–– heparin calcium (to prevent blood clots)
–– gamma-aminocaproic acid
–– etidronate (to prevent loss of bone mass)
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant
or are planning to have a baby, ask your Nuclear medicine doctor
for advice before you are given this medicine.
You must inform the Nuclear medicine doctor before the administration of Medronate DRAXIMAGE if there is possibility you
might be pregnant, if you have missed your period or if you are
breastfeeding.
When in doubt, it is important to consult your Nuclear medicine
doctor who will supervise the procedure.
If you are pregnant
The Nuclear medicine doctor will only administer this product
during pregnancy if a benefit is expected which would outweigh
the risk.
If you are breastfeeding
Please ask your Nuclear medicine doctor when you can resume
breastfeeding.
Driving and using machines
It is considered unlikely that Medronate DRAXIMAGE will affect
your ability to drive or to operate machinery.
3. How Medronate DRAXIMAGE is used
There are strict laws on the use, handling and disposal of radio­
pharmaceutical products. Medronate DRAXIMAGE 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 will keep you informed of their actions.
The Nuclear medicine doctor supervising the procedure will
decide on the quantity of the Medronate DRAXIMAGE to be used
in your case. It will be the smallest quantity necessary to get the
desired information.
The quantity to be administered usually recommended for an
adult ranges from 300 to 740 MBq (MBq = Mega Becquerel, the
unit used to express radioactivity).
For very obese adult patients, the amount can vary from 11 to
13 MBq/kg.
Use in children and adolescents
In children and adolescents, the quantity to be administered will
be adapted to the child’s weight.
Administration of Medronate DRAXIMAGE and conduct of the
procedure
Medronate DRAXIMAGE is administered by injection in a vein.
–– A single dose is sufficient to give your doctor the information
desired. Before the scan is made you will be asked to urinate
in order to increase the quality of the scan.
–– The scans can be carried out any time after you have received
the injection. Precisely when the scan will be carried out
depends on the type of investigation.
–– So that the product can be used as efficiently as possible,
severe exertion immediately after the injection is discouraged
until a satisfactory image has been obtained.
Duration of the procedure
Your Nuclear medicine doctor will inform you about the usual
duration of the procedure.

!

After administration of Medronate DRAXIMAGE, you should:
–– Avoid any close contact with young children and pregnant
woman for 12 hours following the injection
–– Urinate frequently in order to eliminate the product from your
body. Your doctor may advise you to drink a lot to help the
traces of radioactivity leave your body more quickly.

213732.indd 1

2. Qualitative and Quantitative Composition
Each vial contains 10 mg of medronic acid.
The radionuclide is not part of the kit.
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Kit for radiopharmaceutical preparation.
To be reconstituted with sodium pertechnetate (99mTc) solution for injection (not included in this kit).
The medicinal product is a white freeze-dried plug that may break into powder.
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
This medicinal product is for diagnostic use only.
After radiolabeling with sodium (99mTc) pertechnetate solution, the solution obtained is
indicated in adults and children for bone scintigraphy for the detection of areas of altered
osteogenesis associated with:
Neoplasms:
"Staging
"
osteosarcoma
"The
" detection and follow up of bone metastases
Non-neoplastic lesions:
"As
" an aid in the evaluation of:
––Osteomyelitis
––Avascular necrosis
––Paget’s disease
––Stress fractures, shin splints
––Screening for loose or infected prosthesis when conventional radiography has been
performed and is not conclusive
––Reflex sympathetic syndrome
––Bone graft viability
Additional examinations in the setting of a positive bone scintigraphy may be necessary
to decrease the risk of false positives since areas of altered osteogenesis are potentially
detected with high sensitivity but low specificity.
4.2 Posology and method of administration
Posology
Adults: The optimal activity of technetium (99mTc) medronate injection has not been
systematically investigated. Injected activity may vary according to patient characteristics, imaging procedures, and imaging equipment.
The average activity administered by a single intravenous injection is 500  MBq (300740 MBq) as recommended by the EANM, 2003. Other activities may be justifiable. For
markedly obese adult patient, activity as high as 11 – 13 MBq/kg may be needed as recommended by SNM, 2003.
Newborns, infants, children and adolescents: The optimal paediatric activity has not
been systematically investigated. 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 adolescents may be calculated according to the following table:
EANM Paediatric Task Group Paediatric Activity Schedule
Weight
3 Kg
4 Kg
6 Kg
8 Kg
10 Kg
12 Kg
14 Kg
16 Kg
18 Kg
20 Kg

% adult
activity
10%
14%
19%
23%
27%
32%
36%
40%
44%
46%

Weight
22 Kg
24 Kg
26 Kg
28 Kg
30 Kg
32 Kg
34 Kg
36 Kg
38 Kg
40 Kg

% adult
activity
50%
53%
56%
58%
62%
65%
68%
71%
73%
76%

Weight
42 Kg
44 Kg
46 Kg
48 Kg
50 Kg
52-54 Kg
56-58 Kg
60-62 Kg
64-66 Kg
68 Kg

% adult
activity
78%
80%
82%
85%
88%
90%
92%
96%
98%
99%

In children, a minimum activity of 20 – 40 MBq is necessary in order to obtain images of
sufficient quality.
Patients aged 65 and older: The need for dosage adjustments in geriatric populations has
not been systematically investigated. Decreased renal function (see below) and decreased
osteogenesis in the elderly may affect the uptake, distribution, or elimination of technetium (99mTc) medronate injection.
Patients with renal impairment: Careful consideration of the activity to be administered
is required since an increased radiation exposure is possible in these patients. The need
for dosage adjustments as a result of renal failure has not been systematically
investigated.
Patients with hepatic impairment: The need for dosage adjustments as a result of liver
failure has not been systematically investigated. Since technetium (99mTc) medronate is
almost exclusively eliminated by the kidneys, liver failure would not be expected to
require an adjustment to the activity administered.
Method of administration
This medicinal product should be reconstituted before administration to the patient.
This product is only for intravenous injection.
For patient preparation see section 4.4.
For instructions on reconstitution of the medicinal product before administration,
see section 12.
Because of potential tissue damage, extravasal injection of this radioactive product has
to be strictly avoided.
Image acquisition
Image acquisition parameters and procedures will vary depending upon the clinical question and the type of equipment available. The optimal time from dosing to imaging has
not been systematically investigated. Images may be obtained early after injection (in the
so-called 3-phase bone scintigraphy procedure) to search for abnormal blood flow supply
to a part of the skeleton, and some minutes later to evidence a potential rapid uptake by
some part of the skeleton. Images are generally acquired 2 to 5 hours after the administration of technetium (99mTc) medronate injection. Later images (6-24 h) result in a higher
target-to-background ratio and may permit better evaluation of the pelvis if this was
obscured by bladder activity on the routine (2-5 h) images. Six- to 24-hr delayed imaging
may be particularly helpful in patients with renal insufficiency or peripheral circulatory
disorders and those with urinary retention.
4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 or
to any of the components of the labelled radiopharmaceutical.

NOTE: a sodium fluoride (18F) bone PET will have the same limitations in osteoclastic
dominant lesion and the specificity considerations also apply to sodium fluoride (18F)
bone PET.
Caution is required when performing a bone scintigraphy in the interval after intervention
of radiation and especially medical oncologic therapy through at least several months. In
this interval, increased intensity of bone scintigraphy findings, in existing lesions, may
not represent worsening of disease or failed therapy but rather a ‘flare’ response due to
favourable osteoblastic reparative process secondary to successful intervention. Before
accepting the worsening of metastatic bone disease based on only increased bone scintigraphy intensity, close clinic correlation is required and a follow up bone scintigraphy
– either a MDP scintigraphy or sodium fluoride (18F) PET – is recommended. However, if
additional, new skeletal lesions are noted in the above circumstances this is an argument
favoring progression of bone metastases. Also, evidence of progression (new lesions)
may occur in the setting of improvement when focused radiation therapy of single or
specific lesions occurs.
Potential for hypersensitivity or anaphylactic reactions.
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.
Individual benefit/risk justification:
For each patient, the radiation exposure must be justifiable by the likely benefit. The
activity administered should in any case be as low as reasonably achievable to obtain the
required diagnostic information.
Renal impairment/Hepatic impairment
Careful consideration of the benefit risk ratio in these patients is required since an
increased radiation exposure is possible.
Paediatric population
For information on the use in paediatric population, see section 4.2 or 5.1. Careful consideration of the indication is required since the effective dose per MBq is higher than in
adults (see section 11).
Particular attention should be paid to the relatively higher radiation exposure of the
epiphyses in growing bone.
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.
Patients should be encouraged to increase oral fluids and urged to void as often as possible to reduce bladder radiation, especially after high activities e.g. for radionuclide
therapy. Patients with bladder voiding problems should be catheterized after high activity
administration.
To avoid accumulation of tracer in musculature, it is advised that strenuous exercise be
discouraged immediately after injection until satisfactory bone imaging has been
completed.
After the procedure
Close contact with infants and pregnant women should be restricted.
Precautions with respect to environmental hazard see section 6.6.
4.5 Interaction with other medicinal product and other forms of interaction
Potential interactions have been described. An increased extraosseous accumulation of
the radiotracer is reported for iron containing compounds, acute administration of
diphosphonate, several cytostatic and immunosuppressive medicinal products,
aluminium-containing antacids, X-ray contrast media, antibiotics, anti-inflammatory
substances, injections of calcium gluconate or heparin calcium and g-amino caproic acid.
As etidronate inhibits bone absorption of medronate, bone scintigraphy should be carried out before or earliest 2 – 4 weeks after etidronate administration.
Paediatric population
Interaction studies have only been performed in adults.
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 woman has missed a period, if the period is very
irregular, etc.), alternative techniques not using ionizing 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 the mother and foetus.
Based on published models, administration of 500 MBq technetium (99mTc) medronate
injection to a patient with normal bone uptake results in an absorbed dose to the uterus
of 3.15 mGy. The dose decreases to 1.45 mGy in patients with high bone uptake and/or
severely impaired kidney function. Published reports in pregnant patients have estimated
radiation doses to the foetus to have been 2.6 to 4.6 µGy/MBq (1.3 to 2.3 mGy/500 MBq).
Although this level of radiation is unlikely to present increased risk to the foetus, use of
Medronate DRAXIMAGE during pregnancy is not recommended unless clearly
necessary.
Breastfeeding
Before administering radiopharmaceuticals to a mother who is breastfeeding, consideration should be given to possibility of delaying the administration of radionuclide until the
mother has ceased breastfeeding, and to what is the most appropriate choice of radio­
pharmaceuticals, bearing in mind the secretion of activity in breast milk.
If the administration is considered necessary, breastfeeding should be interrupted for
12 hours and the expressed feeds discarded.
Close contact with infants should be restricted during this time.
4.7 Effects on the ability to drive and to use machines
No studies on the effects on the ability to drive and use machines have been
performed.
4.8 Undesirable effects
The following table presents how the frequencies are reflected in this section:
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)
Immune system disorders:
Very rare: hypersensitivity reactions, vasculitis, signs consistent with erythema multiforme, life-threatening anaphylaxis, 8 to 48 hours following the administration.
Nervous system disorders:
Very rare: headache
Vascular disorders:
Very rare: fall in blood pressure and hypotension symptoms, cutaneous vasodilatation
Respiratory, thoracic and mediastinal disorders:
Very rare: cough

4.4 Special warnings and precautions for use
Osteomyelitis:
In addition to other diagnostic imaging studies, careful correlation with the patient
physical examination findings is mandatory. The bone scintigraphy specificity increases
when the area of increased osteoblastic/osteogenic activity also corresponds to positive
physical examination finding particularly if consistent with infection (pain, redness,
swelling). Specificity will further improve by taking into account laboratory findings, that
is increased white blood cell leukocyte count, increased erythrocyte sedimentation rate
(ESR), or c-reactive protein (CRP). It is also strongly recommended to perform a 3-phase
bone scintigraphy (flow, immediate ‘blood pool’ and usual delayed images) when clinical
question is osteomyelitis or infection which has an improved sensitivity and specificity
when compared to single phase delayed protocols.

Gastrointestinal disorders:
Very rare: nausea, vomiting

Screening for loose or infected prosthesis:
Close correlation with the patient history of pain, physical examination and timing of
surgery is necessary prior to indicate bone scintigraphy. Caution in the diagnosis of a
loose or infected prosthesis is required in the immediate post operative period through
several months. As in all bone scintigraphy evaluations for infection or osteomyelitis, a
3-phase bone scintigraphy is strongly recommended.

Renal and urinary disorders:
Very rare: oliguria

Hepatobiliary disorders:
Very rare: jaundice
Skin and subcutaneous tissue disorders:
Very rare: local rash or generalized rash with itching and dermal irritation. Onset of the
reaction is commonly several hours post-injection and it may last up to 48 hours.
Treatment with a non-sedative histamine H1 antagonist is helpful.
Oedema in the extremities
Musculoskeletal and connective tissue disorders:
Very rare: chills, arthralgia, myalgias

General disorders and administration site conditions:
Very rare: fever, malaise

The detection and follow up of bone metastases:
Clinical and patient history correlation is required. As is known, sensitivity for osteogenic/osteoblastic activity is high while specificity for a specific disease diagnosis is
lower in the absence of correlative patient information or other diagnostic or physical
examination information. However specificity for general osteoblastic activity, in the setting of a positive study, is comparable to sensitivity.

Other disorders:
Exposure to ionizing radiation is linked with cancer induction and a potential for development of hereditary defects. The radiation dose resulting from therapeutic exposure
may result in higher incidence of cancer and mutations. In all cases it is necessary to
ensure that the risk of radiation is less than from the disease. As the effective dose
2.85 mSv (for an individual weighing 70kg) when the average recommended activity of
500  MBq is administered these adverse events are expected to occur with a low
probability.

Single photon bone scintigraphy is a highly sensitive diagnostic study for the evaluation
of metastatic bone disease but is not foolproof. A negative study in the absence of clinical
findings, e.g. pain, or other x-ray or CT findings has a very high likelihood of a true negative; however in the setting of focused, non-arthritic bone pain, other positive imaging
findings (lytic or sclerotic bone changes or PET with an appropriate radiopharmaceutical
if available) may be helpful.

4.9 Overdose
In the event of the administration of a radiation overdose with technetium (99mTc)medronate injection, 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
frequent bladder voiding. It might be helpful to estimate the effective dose that was
applied.

13-06-05 7:55 AM

Pharmacodynamic effects
When administered in usual doses Medronate DRAXIMAGE 10 mg shows no pharmacodynamic effects detectable clinically or/and analytically.
5.2 Pharmacokinetic properties
In the first 3 minutes after injection of technetium (99mTc) medronate injection, there is
soft tissue uptake and renal accumulation. With increasing clearance from these compartments, progressive accumulation in the skeletal system is seen, initially in the lumbar
vertebrae and the pelvic region. Blood clearance proceeds in 3 phases: 1 – rapid phase
(T1/2=3.5 min.), 2 – medium phase (T1/2=27 min.) and 3 – slow phase (T1/2=144 min.). The
rapid phase represents the transfer of the radioactive substance from the circulation into
the extravascular system, the medium phase involving skeletal uptake. The slow phase is
probably associated with the release of the technetium (99mTc) medronate injection
complex from a protein bound complex.
About 50% of the activity injected accumulates in the skeleton. Maximum bone accumulation is reached 1 hour after injection and remains practically constant up to 72 hours.
The circulating unbound complex is eliminated via the kidneys. The peak of activity
through the kidneys is reached after approximately 20 minutes. Within 1 hour, with normal renal function, around 32% of the total quantity of unbound complex has undergone
glomerular filtration, within 2 hours 47.5% and within 6 hours 60%. The quantity of
phosphonate, within the recommended activity range, has no effect on renal excretion.
The quantity eliminated via the intestines is insignificant.
The level of accumulation in the skeletal system depends on the circulation and the
extent of regeneration of basic bone material. Whole body retention of 31.6 ± 5% is
reported in healthy individuals, 38.2 ± 7% in those with extensive metastases, 49 ± 11%
in primary hyper-parathyroidism and 45% in osteoporosis.
5.3 Preclinical safety data
Adverse events in animals after intravenous administration of medronate complex were
only observed at doses sufficiently in excess of therapeutic doses in humans. Repeated
administration of very high doses of diphosphonates can cause mineralization disorders.
Mutagenicity studies and long-term carcinogenicity studies have not been carried out.

6.2 Incompatibilities
The technetium-99m labeling reaction involved in preparing 99mTc-methylene diphosphonate complex depends on the maintenance of some tin in the divalent state. The
presence of oxidizing compounds in the pertechnate (99mTc) solution may adversely
affect labeling.
This medicinal product must not be mixed with other medicinal products except those
mentioned in section 12.
6.3 Shelf life
2 years
After radiolabeling: 12 hours
Reconstituted product: Do not store above 25°C. Do not refrigerate or freeze.
6.4 Special precautions for storage
Lyophilized product: Do not refrigerate or freeze.
For storage conditions after radiolabeling of the medicinal product, see section 6.3.
The medicinal product should not come into contact with air.
Storage of radiopharmaceuticals should be in accordance with national regulations on
radioactive materials.
6.5 Nature and contents of container
One vial contains 13.33 mg of powder.
10 ml Type I multidose glass vial closed with a butyl rubber stopper Type I. Medronate
DRAXIMAGE 10 mg is supplied as 5, 10, 30 or 100 vials in a carton.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal and other handlings
General warnings
Inadvertent or accidental subcutaneous administration of technetium (99mTc) medronate
should be avoided as perivascular inflammation has been described for technetium
(99mTc) diphosphonates.
Radiopharmaceuticals should be received, used and administered only by authorized
persons in designated clinical settings. Their receipt, storage, use, transfer and disposal
are subject to the regulations and/or appropriate licenses of the local competent official
organization.
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 technetium (99mTc)
medronate injections 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.
If at any time in the preparation of this product the integrity of the vial is compromised it
should not be used.
Administration procedures should be carried out in a way to minimize risk of contamination of the medicinal product and irradiation of the operators. Adequate shielding is
mandatory.
The content of the kit before extemporary preparation is not radioactive. However, after
sodium pertechnetate (99mTc) solution for injection 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 spill of urine, vomiting etc. Radiation protection precautions in accordance with national regulations must therefore be taken.
This preparation is likely to result in a relatively high radiation dose to most patients. The
administration of Medronate DRAXIMAGE may result in significant environmental hazard. This may be of concern to the immediate family of those individuals undergoing
treatment or the general public depending on the level of activity administered.
Suitable precautions in accordance with national regulations should be taken concerning
the activity eliminated by the patients in order to avoid any contaminations.
Any unused medicinal product or waste material should be disposed of in accordance
with local requirements.
7. MARKETING Authorization HOLDER
DRAXIMAGE (UK) Limited
125 Old Broad Street, 26th floor,
London, EC2N 1AR
United Kingdom
8. MARKETING Authorization NUMBER(S)
PL 29620/0002

Weight
70
80

E
(mSv)
3.47
3.04

Effective Dose (mSv/MBq) for children
1y
5y
10 y
0.0263
0.0142
0.00904

15 y
0.0059

The effective dose per MBq will be higher in patients with reduced renal function and in
patients with high bone uptake.
The target organ is the bone surface (0.063 mGy/MBq). For an administered activity of
600 MBq, the radiation dose to the bone surface is 37.8 mGy.
The critical organ is the bladder wall (0.048 mGy/MBq). For an administered activity of
600 MBq, the radiation dose to the bladder wall is 28.8 mGy.
The table below shows the dosimetry as calculated according to Publication 80 of the
ICRP (International 1999).

213732.indd 2

0.0012
0.0023
0.0027
0.0019
0.0038
0.0012
0.0073
0.0012
0.0013
0.0019
0.0010
0.0036
0.0016
0.0092
0.0010
0.0014
0.0024
0.0010
0.0013
0.0063
0.0019

0.0018
0.0029
0.0034
0.0024
0.0047
0.0016
0.0088
0.0016
0.0016
0.0023
0.0013
0.0046
0.0020
0.01
0.0013
0.0018
0.0033
0.0013
0.0016
0.0076
0.0023

0.0025
0.0044
0.0053
0.0039
0.0072
0.0023
0.012
0.0025
0.0024
0.0034
0.0019
0.0066
0.0031
0.017
0.0020
0.0028
0.0055
0.0019
0.0023
0.012
0.0034

0.0035
0.0053
0.0061
0.0051
0.0075
0.0034
0.018
0.0036
0.0036
0.0044
0.0030
0.0070
0.0045
0.033
0.0029
0.0045
0.0058
0.0030
0.0035
0.011
0.0045

0.0066
0.0095
0.011
0.0089
0.013
0.0060
0.032
0.0066
0.0068
0.0079
0.0053
0.012
0.0082
0.067
0.0055
0.0079
0.011
0.0053
0.0056
0.018
0.0079

0.0057

0.0070

0.0110

0.0140

0.0270

12. INSTRUCTION FOR PREPARATION OF RADIOPHARMACEUTICALS
As with any pharmaceutical products, if at any time in the preparation of this product
the integrity of this vial is compromised it should not be used.
Before reconstituting a vial, it should be inspected for cracks and/or a melted plug or any
other indication that the integrity of the pressure differential (inside/outside the vial)
has been lost.
The medicinal product should not come into contact with air.
Method of preparation
NOTE: Use aseptic procedures throughout and take precautions to minimize radiation
exposure by use of suitable shielding. Use waterproof gloves during the following preparation procedure.
To prepare technetium (99mTc) medronate injection:
a) Remove the protective disc from a reaction vial and swab the closure with either an
alcohol swab or a suitable bacteriostatic agent.
b) Place the reaction vial in a suitable lead vial shield (minimum wall thickness 1/8 inch)
which has a fitted lead cap. Obtain 2 to 10 mL of sterile, non-pyrogenic sodium
pertechnetate 99mTc injection Ph. Eur. using a shielded syringe.
c) Using a shielded syringe, aseptically introduce 740 to 18500 MBq (20 to 500 mCi) of
sodium pertechnetate (99mTc) to a reaction vial. Sodium pertechnetate 99mTc
solutions containing an oxidizing agent are not suitable for use.
d) Place the lead cap on the reaction vial shield and swirl the shielded reaction vial until
the contents are completely dissolved. The solution must be clear and free of particulate matter before proceeding.
e) Assay the product in a suitable calibrator, record the radioassay information on the
label with radiation warning symbol, and apply it to the reaction vial.
f) The radiochemical purity of the finished preparation should be determined prior to
patient administration. The radiochemical purity should not be less than 95%.
g) Withdrawals for administration must be made aseptically using a shielded sterile
syringe and needle. Since the reaction vials contain nitrogen, they should not be
vented. If repeated withdrawals are made, the replacement of the contents of the vial
with air should be minimized.
h) Do not keep the labeled product above 25°C, in the refrigerator or the freezer. Use the
labeled product within 12 hours. It should also be stored during its life in a suitable
lead shield.
When reconstituted with sodium pertechnetate (99mTc), the clear isotonic solution has a
pH of 6.5 to 7.5.
Quality control
The following procedure describes a series of simple steps for running chromatograms.
Steps h and i describe two methods, one for determining free pertechnetate in a mixture
of chelated and reduced technetium and the other for determining reduced technetium
in a mixture of chelated technetium and pertechnetate. The TLC procedure requires the
following:
Solid phase:  ITLC-SG
Solvant A: 136 mg/mL sodium acetate for determination of reduced technetium
Solvant B: Methylethylketon for determination of pertechnetate
a) Add 1 mL of the required solvent to an 18 mm x 150 mm test tube. Stopper the test
tube and allow the atmosphere to equilibrate for 1 minute.
b) Place a drop (approximately 0.02 mL) of the radioactive solution on a 1 cm x 10 cm
chromatographic strip at a pencil mark 1 cm from one end of the strip, which is the
origin. A simple way to do this is to use a standard 1 mL tuberculin syringe with
a 25 gauge needle and dispense one small drop. Discard the needle and syringe after
use. Instead of a tuberculin syringe, a 20 microlitres disposable micropipette
(e.g. Fisher Scientific 21-164-2D) can also be used to dispense 0.02 mL.
c) Immediately dry the spot using a gentle stream of nitrogen gas. Do not use compressed air since this tends to cause pertechnetate formation.
d) Develop the chromatogram by placing it, with the origin down into the solvent, in the
previously equilibrated test tube. Stopper the test tube. The test tube should be kept
upright, ideally in a test tube rack. Development requires about 10 minutes for ITLCSG strips.
e) When the solvent front has climbed to the top of the strip, remove it with a forceps
and allow it to dry. The strips can be dried by placing them radioactive side up on a
disposable non-porous pad at room temperature.
f) In the sodium acetate (136 mg/mL) system, reduced 99mTcO2 stays at the origin
or  Rf = 0, while the bound and free technetium 99mTcO4- move to the front
(Rf = 0.85-1.0).
g) In the methylethylketon system, the bound and reduced fractions stay at the origin
while free pertechnetate 99mTcO4- migrates to the front (Rf = 0.85-1.0).
h) Method A – Determination of reduced technetium, using sodium acetate (136 mg/mL)
solvent:
Cut the dried strip 3 cm from the origin. The short piece is marked as Part I and the
long piece is marked as Part II. Count the pieces in a suitable counter and determine
the percentage of reduced technetium according to the following formula:

If you have been given more Medronate DRAXIMAGE than you
should
An overdose is unlikely because you will only receive a single
dose of Medronate DRAXIMAGE precisely controlled by the
specialist physician supervising the procedure. However, in the
case of an overdose, you will receive the appropriate treatment.
Should you have any further questions on the use of Medronate
DRAXIMAGE, please ask the Nuclear medicine doctor who
supervises the procedure.
4. P  ossible side effects
Like all medicines, Medronate DRAXIMAGE can cause side
effects, although not everybody gets them.
This administered radiopharmaceutical will deliver low amount
of ionising radiation with very low risk of cancer and hereditary
abnormalities.
Cases of local rash or generalised rash with itching and skin
irritation have been observed a few hours after the injection.
Very rarely (in less than 1 in 10,000 patients) severe, lifethreatening allergic (hypersensitivity) reactions may occur.
The following side effects may appear in rare cases: a drop in
blood pressure and symptoms that accompany low blood
pressure, nausea, vomiting, headache, malaise, swelling of the
fingers and toes and pain in the joints.
If you get any side effects, or if you notice any of the side effects
not listed in this leaflet, talk to your Nuclear medicine doctor.
5. H
 ow Medronate DRAXIMAGE is stored
You will not have to store this medicine. This medicine is stored
under the responsibility of the specialist in appropriate premises.
Storage of radiopharmaceuticals will be in accordance with
national regulations on radioactive materials.
The following information is intended for the specialist only.
Medronate DRAXIMAGE must not be used after the expiry date
which is stated on the label. The expiry date refers to the last day
of the month.
If at any time in the preparation of this product the integrity of
the vial is compromised it should not be used.
6. Contents of the pack and other information
What Medronate DRAXIMAGE contains
–– The active substance is medronic acid, each vial contains
10 milligrams of medronic acid.
–– The other ingredients are: p-aminobenzoic acid, tin (II)
chloride dihydrate, sodium hydroxide, and hydrochloric
acid 1N under nitrogen.
What Medronate DRAXIMAGE looks like and the contents of
the pack
Medronate DRAXIMAGE 10 mg, is a kit for radiopharmaceutical
preparation.
This medecinal product is a white freeze-dried plug that may
break into powder.
It has to be reconstituted with sodium pertechnetate (99mTc)
solution for injection (not included in this kit). Once reconstituted, the medicinal product is a clear solution.
This medicinal product is supplied as a 10 mL colourless multidose glass vial containing 10 milligrams of medronic acid
Pack sizes: 5, 10, 30 or 100 vials.
Not all pack size may be marketed
Marketing authorization holder
DRAXIMAGE (UK) Limited
125 Old Broad Street, 26th floor,
London, EC2N 1AR
United Kingdom
Diagnostic Imaging Limited (DIL)
Elkington Lodge
Welford
Northamptonshire NN6 6HE
United Kingdom
Manufacturer(s) responsible for batch release
Diagnostic Imaging Limited (DIL)
Elkington Lodge
Welford
Northamptonshire, NN6 6HE
United Kingdom
This leaflet was last approved in April 2012

®DRAXIMAGE is a Registered Trademark of Jubilant DraxImage Inc.

Counts in Part I X 100
Counts in Part I + Part II

Percent 99mTcO4- =

Counts in Part IV X 100
Counts in Part III + Part IV

NOTE: THE STRIPS ARE CUT IN DIFFERENT POSITIONS FOR METHODS A AND B.
j) Determine the amount of bound technetium according to the following formula:
Percent Chelated 99mTc = 100 — %99mTcO4- — %99mTcO2
k) Store all waste radioactive strips for 48 hours before disposing of them as nonradioactive waste. Store used chromatographic solvents in a similar fashion.
Medicines Agency, http://www.ema.europa.eu>

®DRAXIMAGE is a Registered Trademark of Jubilant DraxImage Inc.

213732

#

11. DOSIMETRY
Technetium (99mTc) is produced by means of a (99Mo/99mTc) generator and decays with
the emission of gamma radiation with 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 2.13x105 years can
be regarded as quasi stable.
The effective dose (E) of technetium (99mTc) medronate injection is 0.00619 mSv/MBq for
females and 0.00475 mSv/MBq for males. The usual adult activity of 8 MBq/kg in a 70-kg
female will result in an effective dose of 3.5 mSv; in an 80-kg male, it will result in an
effective dose of 3.0 mSv.

0
0.0631

Absorbed dose per activity administered (mGy/MBq)
Adult
15 years 10 years
5 years
1 year
0.0021
0.0027
0.0039
0.0058
0.011
0.048
0.060
0.088
0.073
0.13
0.063
0.082
0.13
0.22
0.53
0.0017
0.0021
0.0028
0.0043
0.0061
0.00071
0.00089
0.0014
0.022
0.0042
0.0014
0.0019
0.0035
0.0042
0.0067

The Nuclear medicine doctor will inform you if you need to take
any special precautions after receiving this medicine. Contact
your Nuclear medicine doctor if you have any questions.

i) Method B – Determination of pertechnetate, using methylethylketon:
Cut the dried strip 2 cm from the solvent front end. The short piece is marked Part IV
and the long piece is marked Part III. Count the pieces in a suitable counter and
determine the percentage of free pertechnetate according to the following formula:

10. DATE OF REvISION OF THE TExT
Date/Day of procedure: 11 February 2014/D60

Women
Men

Organ
Adrenals
Bladder wall
Bone surfaces
Brain
Breast
Gall Bladder
GI tract
Stomach wall
Small intestine
Colon
Upper large intestine
Lower large intestine
Heart
Kidneys
Liver
Lungs
Muscles
Oesophagus
Ovaries
Pancreas
Red Marrow
Skin
Spleen
Testes
Thymus
Thyroid
Uterus
Remaining organ
Effective dose
(mSv/MBq)

Percent 99mTcO2 =

9. DATE OF FIRST Authorization/RENEWAL OF Authorization
Date of first Authorization: 21 February 2008
Date of latest renewal: 27 November 2013

Adult Effective Dose
E
(mSv/MBq)
0.00619
0.00475

Absorbed radiation doses:

99mTc-phosphate and phosphonate (mGy/MBq)

For Medronate DRAXIMAGE, the effective dose from the administration of 500  MBq
technetium (99mTc) medronate is 2.85 mSv (for an individual weighing 70 kg).
The radiation dose to the target organ, bone surface, is 31.5 mGy/500 MBq.
For this activity of 500 MBq, the radiation doses delivered to the target organ (bone surfaces) is 31.5  mGy/500  MBq and the typical radiation dose to the critical organ, the
bladder wall is 24.0 mGy/500 MBq.

6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
p-Aminobenzoic acid
Stannous Chloride Dihydrate
Hydrochloric acid 1N (for pH adjustment)
Sodium hydroxide (for pH adjustment)

Dose
(MBq/kg)
8
8

#

5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Diagnostic radiopharmaceuticals; skeleton; Technetium
[99mTc] compounds, ATC code: V09B A02

213732

13-06-05 7:55 AM

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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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