ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1.
QUADRAMET, solution for injection.
2.
Each ml of solution contains 1.3 GBq Samarium [
153
Sm] lexidronam pentasodium at the reference date
(corresponding to 20 to 46 µg/ml of samarium per vial)
Samarium specific activity is approximately 28 – 65 MBq/µg of samarium.
Each vial contains 2-4 GBq at the reference date.
Samarium-153 emits both medium-energy beta particles and an imageable gamma photon, and has a
period of 46.3 hours (1.93 days). The primary radiation emissions of samarium-153 are shown in
Table 1.
TABLE 1 : SAMARIUM-153 PRINCIPAL RADIATION EMISSION DATA
Radiation
Energy (keV)*
Abundance
Beta
640
30%
Beta
710
50%
Beta
810
20%
Gamma
103
29%
*
Maximum energies are listed for the beta emissions, the average beta particle energy is
233 keV.
For a full list of excipients, see section 6.1.
3.
Solution for injection.
Clear, colourless to light amber solution with pH ranging between 7.0 and 8.5.
4.
QUADRAMET is indicated for the relief of bone pain in patients with multiple painful osteoblastic
skeletal metastases which take up technetium [
99m
Tc]-labelled biphosphonates on bone scan.
The presence of osteoblastic metastases which take up technetium [
99m
Tc]-labelled biphosphonates
should be confirmed prior to therapy.
QUADRAMET should only be administered by physicians experienced in the use of
radiopharmaceuticals and after full oncological evaluation of the patient by qualified physicians.
The recommended dose of QUADRAMET is 37 MBq per kg body weight and is to be administered
by slow intravenous route through an established intravenous line over a period of one minute.
QUADRAMET should not be diluted before use.
2
Patients who respond to QUADRAMET generally experience the onset of pain relief within 1 week
after treatment. Relief of pain may persist for 4 weeks up to 4 months. Patients who experience a
reduction in pain may be encouraged to decrease their use of opioid analgesics.
Repeat administration of QUADRAMET should be based on an individual patient's response to prior
treatment and on clinical symptoms. A minimum interval of 8 weeks should be respected, subject to
recovery of adequate bone marrow function.
The data on the safety of repeated dosing are limited and based on compassionate use of the product.
QUADRAMET is not recommended for use in children below the age of 18 years due to a lack of data
on safety and efficacy.
4.3 Contra-indications
QUADRAMET is contra-indicated:
•
Hypersensitivity to the active substance (ethylenediaminetetramethylenephosphonate (EDTMP)
or similar phosphonates) or to any of the excipients.
•
in pregnant women
(See section 4.6).
•
in patients having received chemotherapy or hemi-body external radiation therapy in a
preceding period of 6 weeks.
QUADRAMET is used only as a palliative agent and should not be used concurrently with myelotoxic
chemotherapy as this may enhance myelotoxicity.
It should not be used concurrently with other biphosphonates if an interference is shown on the
technetium [
99m
Tc]-labelled biphosphonate bone scans.
In absence of clinical data, the injected activity should be adapted to the renal function.
Use of QUADRAMET in patients with evidence of compromised bone marrow reserve from previous
therapy or disease involvement is not recommended unless the potential benefit of the treatment
outweighs its risks.
Because of potential bone marrow suppression after administration, blood counts should be monitored
weekly for at least 8 weeks, beginning 2 weeks after administration of QUADRAMET, or until
recovery of adequate bone marrow function.
The patient should be encouraged to ingest (or receive by intravenous administration) a minimum of
500 ml of fluids prior to injection and should be encouraged to void as often as possible after injection
to minimise radiation exposure to the bladder.
The clearance of QUADRAMET being rapid, the precautions relating to the excreted urinary
radioactivity need not be taken after 6-12 hours following administration.
Special precautions, such as bladder catheterisation, should be taken during six hours following
administration to incontinent patients to minimise the risk of radioactive contamination of clothing,
bed linen, and the patient's environment. For the other patients the urine should be collected for at least
six (6) hours
.
Bladder catheterisation should be undertaken in patients with urinary obstruction.
3
Radiopharmaceuticals may be received, used and administered only by authorised persons in
designated clinical settings. Its receipt, storage, use, transfer and disposal are subject to the regulations
and the appropriate licences of the local competent official organisations.
Radiopharmaceuticals 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 Manufacturing Practice for pharmaceuticals.
Because of the potential for additive effects on bone marrow, the treatment should not be given
concurrently with chemotherapy or external beam radiation therapy. QUADRAMET may be given
subsequent to either of these treatments after allowing for adequate marrow recovery.
QUADRAMET is contra-indicated(see 4.3) in pregnancy. The possibility of pregnancy must strictly
be ruled out. Women of childbearing potential have to use effective contraception during the treatment
and the whole period of follow-up.
There are no available clinical data relating to the excretion of QUADRAMET in human milk. If
therefore QUADRAMET administration is deemed necessary, formula feeding should be substituted
for breast-feeding and the expressed feeds discarded.
No studies on the effects on the ability to drive and use machines have been performed.
Decreases in white blood cell and platelet counts and anaemia were observed in patients receiving
QUADRAMET.
In clinical trials white blood cell and platelet counts decreased to a nadir of approximately 40 % to
50 % of baseline 3 to 5 weeks after a dose, and generally returned to pre-treatment levels by 8 weeks
post treatment.
The few patients who experienced Grade 3 or 4 hematopoietic toxicity usually either had a history of
recent external beam radiation therapy or chemotherapy or had rapidly progressive disease with
probable bone marrow involvement.
Postmarketing reports of thrombocytopenia have included isolated reports of intracranial
haemorrhage, and cases in which the outcome was fatal.
A small number of patients have reported a transient increase in bone pain shortly after injection (flare
reaction). This is usually mild and self-limiting and occurs within 72 hours of injection. Such reactions
are usually responsive to analgesics.
Adverse drug reactions such as nausea, vomiting, diarrhoea and sweating were reported.
Hypersensitivity reactions including rare cases of anaphylactic reaction have been reported after
QUADRAMET administration.
A few patients experienced cord/root compressions, disseminated intravascular coagulation and
cerebrovascular accidents. The occurrence of these events may be linked to the patients’ disease
evolution. When there are spinal metastases at the cervico-dorsal level, an increased risk of spinal cord
compression cannot be excluded.
4
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 risks of the radiation are less than from the
disease itself.
The product should only be administered by qualified personnel in authorised settings. The possibility
of pharmacological overdose is therefore remote.
The risks to be expected are associated with the inadvertent administration of excess radioactivity.
Radiation dose to the body can be limited by promoting a diuresis and frequent voiding of urine.
5.
PHARMACOLOGIC PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Various pain palliation radiopharmaceuticals.
ATC Code: V10BX02
QUADRAMET has an affinity for skeletal tissue and concentrates in areas of bone turnover in
intimate association with hydroxyapatite; studies in rats have demonstrated that QUADRAMET is
cleared rapidly from the blood and localises to growing areas of bone matrix, specifically the layer of
osteoid undergoing mineralisation.
In clinical studies employing planar imaging techniques, QUADRAMET accumulates with a lesion-
to-normal bone ratio of approximately 5 and a lesion-to-soft tissue ratio of approximately 6. Thus,
areas of metastatic involvement can accumulate significantly greater amounts of QUADRAMET than
surrounding normal bone.
5.2 Pharmacokinetic properties
In patients, QUADRAMET is rapidly cleared from the blood. Thirty minutes after injection of the
agent to 22 patients, only 9.6 ± 2.8 % of the administered activity remained in plasma. At 4 and
24 hours, plasma radioactivity had decreased from 1.3 ± 0.7 % to 0.05 ± 0.03 %. Urinary excretion
occurred predominantly during the first 4 hours (30.3 ± 13.5 %). At 12 hours, 35.3 ± 13.6 % of the
administered activity had been excreted into the urine. Analysis of urine samples found the
radioactivity to be present as the intact complex. Less urinary excretion occurred in patients who had
extensive bony metastases, regardless of the amount of radiopharmaceutical administered. Total
skeletal uptake of QUADRAMET in studies of 453 patients with a variety of primary malignancies
was 65.5 ± 15.5 % of the administered activity. A positive correlation was found between skeletal
uptake and the number of metastatic sites. In contrast, skeletal uptake was inversely proportional to
plasma radioactivity at 30 minutes.
5.3 Preclinical safety data
The radiolysis products of Sm-EDTMP showed a renal toxicity in rats and dogs with a no effect level
of 2.5 mg/kg.
Repeated dose administration of samarium [
153
Sm]-EDTMP to dogs indicated a slightly longer time
for depressed bone marrow and peripheral haematological parameters to recover when compared to
recovery following only single dose administration.
Radioactive Sm-EDTMP has not been tested for mutagenicity/carcinogenicity but due to the radiation
dose resulting from therapeutic exposure it should be regarded as presenting a genotoxic/carcinogenic
risk.
5
Non-radioactive Sm-EDTMP showed no mutagenic potential in a battery of
in vivo
and
in vitro
tests.
The same results were observed for Sm-EDTMP enriched with radiolysis degradants.
In a carcinogenic potential study of EDTMP, osteosarcomas occurred in rats at high doses. In the
absence of genotoxic properties, these effects can be assigned to the EDTMP chelatant properties
leading to osseous metabolism disturbances.
No studies have been performed to assess the effect of QUADRAMET on reproduction.
6.
6.1 List of excipients
Total EDTMP (as EDTMP.H2O)
Calcium-EDTMP sodium salt (as Ca)
Total sodium (as Na)
Water for Injections
6.2 Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with the other
medicinal products.
6.3 Shelf-life
1 day from the activity reference time stated on the label.
Use within 6 hours of thawing. After thawing, do not freeze again.
6.4 Special precautions for storage
QUADRAMET is delivered frozen in dry ice.
Store in a freezer at -10°C to -20°C in the original package.
Storage procedures should be in accordance with local regulations for radioactive substances.
6.5 Nature and contents of container
15 ml colourless European Pharmacopoeia Type I drawn glass vial closed with Teflon-coated
chlorobutyl/natural rubber stopper and aluminium flip-off overseal.
Each vial contains 1.5 ml (2 GBq at calibration) to 3.1 ml (4 GBq at calibration) of solution for
injection.
6.6 Special precautions for disposal and other handling
The administration of radiopharmaceuticals creates risks to 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.
Any unused product or waste material should be disposed of in accordance with local requirements.
6
7.
CIS bio international
Boîte Postale 32
F-91192 GIF-SUR-YVETTE Cedex
FRANCE
8.
EU/1/97/057/001
9.
Date of the first authorisation: 05.02.1998
Date of the last renewal: 05.02.2003
11. DOSIMETRY
The estimated absorbed radiation doses to an average adult patient from an intravenous injection of
QUADRAMET are shown in Table 2. The dosimetry estimates were based on clinical biodistribution
studies using methods developed for radiation dose calculations by the Medical Internal Radiation
Dose (MIRD) Committee of the Society of Nuclear Medicine.
Because QUADRAMET is excreted in the urine, radiation exposure was based on a urinary voiding
interval of 4.8 hours. Radiation dose estimates for bone and marrow assume that radioactivity is
deposited on bone surfaces, in accordance with autoradiograms of bone samples taken from patients
who received QUADRAMET.
7
Radiation dose to specific organs, which may not be the target organ of therapy, may be influenced
significantly by pathophysiological changes induced by the disease process. This should be taken into
consideration when using the following information:
TABLE 2 : RADIATION ABSORBED DOSES
Organ
Absorbed dose per injected activity (mGy/MBq)
Adrenals
0.009
Brain
0.011
Chest
0.003
Gallbladder
0.004
Ascending colon wall
0.005
Descending colon wall
0.010
Small intestine
0.006
Myocardial wall
0.005
Kidneys
0.018
Liver
0.005
Lungs
0.008
Muscle
0.007
Ovaries
0.008
Pancreas
0.005
Red marrow
1.54
Bone surfaces
6.76
Skin
0.004
Spleen
0.004
Stomach
0.004
Testes
0.005
Thymus
0.004
Thyroid
0.007
Urinary bladder wall
0.973
Uterus
0.011
Effective dose
(mSv/MBq)
0.307
For this product the effective dose resulting from an injected activity of 2 590 MBq is 796 mSv.
For an administered activity of 2 590 MBq, the typical radiation dose to the target organ, skeletal
metastases, is 86.5 Gy and the typical radiation doses to the critical organs are: normal bone surfaces
17.5 Gy, red marrow 4.0 Gy, urinary bladder wall 2.5 Gy, kidneys 0.047 Gy and ovaries 0.021 Gy.
8
12. INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS
Allow the product to thaw at room temperature before administration.
The solution for injection should be visually inspected before use. It should be clear without particles.
The operator should be careful to protect the eyes while inspecting the solution for clarity.
The activity should be measured by a dose calibrator immediately before administration. Verification
of the dose to be administered and patient identification are necessary prior to administration of
QUADRAMET.
For radiation safety reasons, the patient should be treated in a facility with the appropriate agreement
for the therapeutic use of radioactive non-sealed sources. He/she will be released when exposure rates
comply with the limits prescribed by the regulations in force.
Any unused product or waste material should be disposed of in accordance with local requirements.
Detailed information on this medicinal product is available on the website of the European Medicines
Agency (EMEA)
http://www.emea.europa.eu/
9
ANNEX II
A. MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE
B. CONDITIONS OF THE MARKETING AUTHORISATION
10
A. MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE
Name and address of the manufacturer responsible for batch release
CIS bio international
Boîte Postale 32
F-91192 Gif-sur-Yvette cedex
France
B. CONDITIONS OF THE MARKETING AUTHORISATION
•
Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product
Characteristics, section 4.2)
•
CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND
EFFECTIVE USE OF THE MEDICINAL PRODUCT
Not applicable
•
OTHER CONDITIONS
Pharmacovigilance system
The MAH must ensure that the system of pharmacovigilance, as described in version 7
presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and
functioning before and whilst the product is on the market.
11
ANNEX III
LABELLING AND PACKAGE LEAFLET
12
A. LABELLING
13
PARTICULARS TO APPEAR ON THE OUTER PACKAGING
{ METALLIC BOX / LEADPOT }
1.
QUADRAMET, solution for injection
2.
STATEMENT OF THE ACTIVE SUBSTANCE(S)
Samarium [
153
Sm] lexidronam pentasodium
:
1.3 GBq/ml at reference date.
(Corresponding to 20 to 46 µg/ml of samarium)
3.
LIST OF EXCIPIENTS
Total EDTMP (as EDTMP.H2O)
Calcium-EDTMP sodium salt (as Ca)
Total sodium (as Na)
Water for injections
4.
Solution for injection in a single-dose vial.
ml
GBq/vial,
(12 h CET)
5.
METHOD AND ROUTE OF ADMINISTRATION
Read package leaflet before use
For intravenous use
6.
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT
OF THE REACH AND SIGHT OF CHILDREN
Keep out of reach and sight of children
7.
OTHER SPECIAL WARNING
8.
EXPIRY DATE
EXP: DD/MM/YYYY (12 h CET)
14
9.
SPECIAL STORAGE CONDITIONS
Store in a freezer at -10°C to -20°C in the original package
Use within 6 hours of thawing
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF
APPROPRIATE
Dispose of as radioactive waste in accordance with local law
CIS bio international,
Boîte Postale 32,
91192 GIF-SUR-YVETTE Cedex,
FRANCE
12. MARKETING AUTHORISATION NUMBER
EU/1/97/057/001
13. BATCH NUMBER
Batch :
14. GENERAL CLASSIFICATION FOR SUPPLY
Medicinal product subject to medical prescription
15.
INSTRUCTIONS ON USE
16.
INFORMATION IN BRAILLE
<Justification for not including Braille accepted>
15
MINIMUM PARTICULARS TO APPEAR ON SMALL INTERMEDIATE PACKAGING
UNITS
GLASS VIAL
1.
QUADRAMET, solution for injection
Samarium [
153
Sm] lexidronam pentasodium
For intravenous use
2.
METHOD OF ADMINISTRATION
3.
EXPIRY DATE
EXP: DD/MM/YYYY (12 h CET)
4.
BATCH NUMBER
Batch:
5.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
ml
GBq/vial,
(12 h CET)
6.
OTHER
Manufacturer: CIS bio international.
16
B. PACKAGE LEAFLET
17
PACKAGE LEAFLET: INFORMATION FOR THE USER
QUADRAMET, solution for injection
Samarium [
153
Sm] lexidronam pentasodium.
Read all of this leaflet carefully before you start taking this medicine.
-
If you have any further questions, ask your doctor or your pharmacist.
-
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor or your pharmacist.
In this leaflet:
1.
What QUADRAMET is and what it is used for
2.
Before you take QUADRAMET
4.
Possible side effects
5.
How to store QUADRAMET
6.
Further information
1.
WHAT QUADRAMET IS AND WHAT IT IS USED FOR
QUADRAMET is a medicinal product for therapeutic use only.
This radiopharmaceutical is used for the treatment of bone pain due to your disease.
QUADRAMET has a high affinity for skeletal tissue. Once injected it concentrates in bone lesions.
Because QUADRAMET contains small amounts of a radioactive element, samarium-153, radiations
are delivered locally to the bone lesions, allowing to develop the palliative action on bone pain.
2.
BEFORE YOU TAKE QUADRAMET
Do not take QUADRAMET:
•
If you are hypersensitive (allergic) to ethylene diamine tetramethylene phosphonic acid
(EDTMP) or similar phosphonate compounds,
•
If you are pregnant,
•
If you have received chemotherapy or hemibody field external radiation therapy in a preceding
period of 6 weeks.
Take special care with QUADRAMET:
QUADRAMET is not recommended for use in children below 18 years of age.
Your doctor will take blood samples weekly for at least 8 weeks to check your platelets, white and red
blood cell counts which may slightly decrease due to the therapy.
During 6 hours following the injection of QUADRAMET, your physician will encourage you to drink
and void as often as possible. He will decide at which time you will be authorised to leave the nuclear
medicine department.
18
-
Keep this leaflet. You may need to read it again.
3.
How to take QUADRAMET
In the case of urine incontinence or urinary obstruction you will get a urine catheter for about 6 hours.
For the other patients the urine should be collected for at least 6 hours.
If your renal function is decreased, the amount of product will be adapted.
Taking other medicines:
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines
including medicines obtained without a prescription.
Pregnancy and breast-feeding:
QUADRAMET must not be administered to pregnant women.
If QUADRAMET administration to a breastfeeding woman is deemed necessary, breastfeeding should
be stopped.
Ask your doctor or pharmacist for advice before taking any medicine.
3.
HOW TO TAKE QUADRAMET
Your doctor will want to carry out a special scan before administering QUADRAMET to ascertain
whether you are likely to benefit from QUADRAMET.
Dosage
One single dose of 37 megabecquerel (Becquerel is the unit in which radioactivity is measured) of
QUADRAMET per kilogram of body weight is to be injected.
If you have the impression that the effect of QUADRAMET is too strong or too weak, talk to your
doctor or pharmacist.
Method and route of administration
QUADRAMET is to be administered by slow injection into a vein.
Frequency of administration
This medicinal product is not intended to be injected on a regular or continuous basis. The
administration can however be repeated after 8 weeks following injection, subject to the evolution of
your disease.
Duration of treatment
You will be authorised to leave the nuclear medicine department after a dosimetric follow-up
(generally within 6 hours following QUADRAMET injection).
If you take more QUADRAMET than you should
QUADRAMET being supplied as a single-dose vial, an accidental overdose is unlikely to occur.
Radiation dose to the body can be limited by increasing fluid intake and frequent voiding of urine.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
19
4.
POSSIBLE SIDE EFFECTS
Like all medicines, QUADRAMET can have side effects, although not everybody gets them.
The undesirable effects due to QUADRAMET administration are linked with a decrease of red and
white blood cells, and platelets. Cases of bleeding have been reported, some of which have been
serious.
This is the reason why your blood counts will be monitored strictly for a few weeks following
QUADRAMET injection.
You may exceptionally feel a slight increase in bone pain a few days after QUADRAMET injection.
You should not be alarmed at this; in such case, your pain medicine will be slightly increased. This
effect is moderate and brief and will disappear after some hours.
Adverse drug reactions such as nausea, vomiting, diarrhoea and sweating were reported.
Hypersensitivity reactions including rare cases of anaphylactic reaction have been reported after
QUADRAMET administration.
In rare cases, the following undesirable effects have been observed: neuralgia, coagulation disorders,
cerebrovascular accidents. These effects were deemed to be related to the progression of the disease.
If you experience back pain or sensory abnormalities, please inform your physician as soon as
possible.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please
tell your doctor or pharmacist.
5.
HOW TO STORE QUADRAMET
Keep out of the reach and sight of children.
Do not use QUADRAMET after the expiry date which is stated on the label.
QUADRAMET expires 1 day from the activity reference time stated on the label.
Store at –10°C to –20°C in a freezer in its original packaging.
QUADRAMET should be used within 6 hours of thawing. After thawing, do not freeze again.
The product label includes the appropriate storage conditions and the expiry date for the batch of
product. Hospital personnel will ensure that the product is stored correctly and not administered to you
after the stated expiry date.
Storage procedures should be in accordance with national regulations for radioactive materials.
6.
FURTHER INFORMATION
What QUADRAMET contains
The active substance is samarium [
153
Sm] lexidronam pentasodium.
Each ml of solution contains 1.3 GBq Samarium [
153
Sm] lexidronam pentasodium at the reference date
(corresponding to 20-46 µg/ml of samarium per vial).
The other ingredients are Total EDTMP (as EDTMP.H2O), calcium-EDTMP sodium salt (as Ca),
20
total sodium (as Na), water for injections.
What QUADRAMET looks like and contents of the pack
QUADRAMET is a solution for injection.
This medicinal product is a clear, colourless to light amber solution which is packed in a 15 ml
colourless European Pharmacopoeia Type I drawn glass vial closed with Teflon-coated
chlorobutyl/natural rubber stopper and aluminium flip-off overseal.
Each vial contains 1.5 ml (2 GBq at reference) to 3.1 ml (4 GBq at reference) of solution for injection.
Marketing authorisation holder and manufacturer
CIS bio international
Boîte Postale 32
F-91192 Gif-sur-Yvette cedex
France
The leaflet was last approved on ().
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web
The following information is intended for medical or healthcare professionals only:
For detailed information refer to the Summary of Product Characteristics of QUADRAMET.
INSTRUCTIONS FOR USE, HANDLING AND DISPOSAL
Read directions for use thoroughly before starting the preparation procedure.
All procedures should be conducted using aseptic techniques and standard precautions for handling
radionuclides.
Use of radiopharmaceutical agents
Radiopharmaceuticals should only be used by qualified personnel with the appropriate government
authorisation for the use and handling of radionuclides. This radiopharmaceutical may be received,
used and administered only by authorised persons in designated clinical settings. Its receipt, storage,
use, transfer and disposal are subject to the regulations and/or appropriate licences of the local
competent official organisations.
Radiopharmaceuticals should be prepared by the user in a manner which satisfies both radiation safety
and pharmaceutical requirements. Appropriate aseptic precautions should be taken, complying with
the requirements of Good Manufacturing Practice for pharmaceuticals.
Method of preparation
Allow the product to thaw at room temperature before administration.
The solution for injection should be visually inspected before use. It should be clear without particles.
The operator should be careful to protect the eyes while inspecting the solution for clarity.
21
The activity should be measured by a dose calibrator immediately before administration. Verification
of the dose to be administered and patient identification are necessary prior to administration of
QUADRAMET.
Usual precautions regarding sterility and radioprotection should be respected.
The administration of radiopharmaceuticals creates risks to 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.
For radiation safety reasons, the patient should be treated in a facility with the appropriate agreement
for the therapeutic use of radioactive non-sealed sources. He will be released when exposure rates
comply with the limits prescribed by the regulations in force.
Radioactive waste must be disposed of in conformity with the relevant national and international
regulations.
22
Source: European Medicines Agency
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