This drug is for diagnostic use only.

After labeling with sodium pertechnetate [99m Tc], the solution obtained is indicated in adults and children for the in vivo, in vitro or in vivo / in vitro labeling of red blood cells for scintigraphic exploration Of the compartment, blood.

The main indications are

· Angiocardioscintigraphy

O evaluation of ventricular ejection fraction

O study of cardiac parietal kinetics, global and regional

O cardiac imaging with phase analysis

· Diagnosis and localization of gastrointestinal haemorrhages, occult.

Dosage

After reconstitution of the complex, the recommended dose in children, adults and elderly subjects is 0.03 mL / kg body weight. >
Adult and elderly

After injection of the stannous medronate complex, injection of either sodium pertechnetate [99m Tc] (in vivo method) or 99m Tc (in vivo / in vitro method) was performed. In vitro incubation of the stannous medronate complex with the total or red blood cell fraction may also be performed prior to the addition of sodium pertechnetate (99m Tc) solution (in vitro method) and The reinjection to the patient of the red globules marked. The average activity administered is 800 MBq (750 to 950 MBq) in adult and elderly subjects.
Population, pediatric

Use in children and adolescents should be considered with caution, according to clinical needs and by evaluating the benefit / risk ratio in this group of patients. >
The activity to be injected into children and adolescents is a fraction of that used in adults, the fraction obtained by application of the coefficients below as a function of body mass
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Coefficients to apply to activity in adult

3kg '= 0.10

22kg; '= 0.50

42kg '= 0.78

4kg '= 0.14

24kg; '= 0.53

44kg '= 0.80

6kg '= 0.19

26kg; '= 0.56

46kg '= 0.82

8kg '= 0.23

28kg; '= 0.58

48kg '= 0.85

10kg; '= 0.27

30kg; '= 0.62

50kg '= 0.88

12kg '= 0.32

32kg '= 0.65

52-54kg '= 0.90

14kg '= 0.36

34kg '= 0.68

56-58kg '= 0.92

16kg '= 0.40

36kg '= 0.71

60-62kg '= 0.96

18kg '= 0.44

38kg '= 0.73

64-66kg '= 0.98

20kg '= 0.46

40kg '= 0.76

68kg '=; 0.99

E.A.N.M. (European Association of Nuclear Medicine)

In the very young child (less than 1 year), a minimum activity of 80 MBq is necessary for the obtaining of images of satisfactory quality.
Given the duration of fixation, stannous salts on red blood cells, it is advisable not to repeat the examination before a period of 3 months.
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Mode of administration

Intravenous administration

This medicinal product must be reconstituted before administration to the patient.
For the preparation of the patient, see Warnings and Precautions,

For instructions on the reconstitution of the medicinal product before administration and the labeling of erythrocytes, see section 12.
Methods of marking red blood cells

The stannous medronate complex (non-radioactive substance) is first reconstituted in 6 mL of sodium chloride isotonic solution for injectable preparation.
In vivo method

The administration of the stannous medronate complex is followed by an injection of sodium pertechnetate [99m Tc] 20 to 40 minutes later.
In vitro method

An appropriate amount of blood from the patient is taken. The reconstituted solution containing the stannous medronate complex is incubated in vitro with the collection of whole blood or the red blood cell (erythrocytes) fraction. The sodium pertechnetate (99mTc) solution is added 15 minutes, followed by reinjection to the patient of the labeled red blood cells
Modified in vivo (in vivo / in vitro) method

The reconstituted solution containing the stannous medronate complex is injected to obtain a "tin load" of the red blood cells in vivo. Then, on a blood sample, the red blood cell marking is carried out in vitro with pertechnetate [99m Tc] of sodium. The solution of labeled erythrocytes is then reinjected to the patient.

Pharmacotherapeutic group, radiopharmaceutical for diagnostic use

ATC code: V09GA06

No pharmacological action is expected from the radiopharmaceutical-labeled erythrocytes. The marking procedure comprises a first injection of stannous salts to "charge" the erythrocytes with this reducing agent so that the pertechnetate (99m Tc) injected in a second step is reduced and accumulated in the red cells 99m Tc in particular linked to the β chains of hemoglobin.

At the chemical concentrations used for diagnostic tests, the chemical entities involved in this process do not appear to have pharmacodynamic activity
Technetium-99m (99m Tc) is produced by means of a generator (99 Mo / 99m Tc) and disintegrates into technetium (99 Tc), emitting gamma radiation with an average energy of 140 keV and Half-life of 6.02 hours. Given its long half-life of 2.13 x 10 5 years, technetium (99 Tc) can be considered quasi-stable. >
The doses of radiation absorbed by an adult of 70 kg, after intravenous injection, of erythrocytes marked at 99m Tc are reported below (as calculated according to Publication 80 of the International Commission on Radiological Protection. Radiation doses to patients from radiopharmaceuticals, Pergamon, 1998).


Organ

Adult

15 years old

10 years

5 years

1 year

Adrenals
0.0099

0,012

0.020

0.030

0.056

Bladder wall

0.0085

0.011

0.014

0.017

0.031

Bone Surfaces

0.0074

0,012

0.019

0.036

0.074

Brain

0.0036

0.0046

0.0075

0,012

0.022

Breasts

0.0035

0,0041

0.0070

0.011

0.019

Gallbladder

0.0065

0.0081

0.013

0.020

0.030

Gastrointestinal tract

Stomach wall

0.0046

0.0059

0.0097

0.014

0.025

Small Intestine

0.0039

0.0049

0.0078

0,012

0.021

Colon

0.0037

0.0048

0.0075

0,012

0.020

Large intestine

0.0040

0.0051

0.0080

0.013

0.022

Lower large intestine

0.0034

0.0044

0.0069

0.010

0.018

Heart

0.023

0.029

0.043

0.066

0.11

Kidney

0.018

0.022

0.036

0.057

0.11

Liver

0.013

0.017

0.026

0.040

0.072

Lungs

0.018

0.022

0.035

0.013

0.11

Muscles

0.0033

0.0040

0.0061

0.0094

0.017

Esophagus

0.0061

0.0070

0.0098

0.015

0.023

Ovaries

0.0037

0.0048

0.0070

0.011

0.019

Pancreas

0.0066

0.0081

0.013

0.019

0.033

Bone marrow

0.0061

0.0076

0,012

0.020

0.037

Skin
0.0020

0.0024

0.0038

0.0062

0,012

After marking with sodium pertechnetate [99m Tc], the solution obtained is indicated in adults and children for in vivo, in vitro or in vivo labeling In vitro red blood cells for scintigraphic exploration of the blood compartment The main indications are: Angiocardioscintigraphy Evaluation of ventricular ejection fraction Study of cardiac parietal kinematics Global and regional • Cardiac imaging with phase analysis • Diagnosis and localization of gastrointestinal haemorrhage, occult.

Rate

0.014

0.017

0.027

0.043

0.081

Testicles

0.0023

0.0030

0.0044

0.0069

0.013

Thymus

0.0061

0.0070

0.0098

0.015

0.023

Thyroid

0.0057

0.0071

0,012

0.019

0.036

Uterus

0.0039

0.0049

0.0074

0.011

0.019

Other fabrics

0.0035

0.0045

0.0073

0.013

0.023

Effective dose (mSv / MBq)

0.0070

0.0089

0.014

0.021

0.039

The effective dose resulting from the administration of a maximum (recommended) activity of 950 MBq for an adult weighing 70 kg is about 6.7 mSv.

For an administered activity of 950 MBq the dose of radiation to the target organ (the heart) is 23 mGy.
Stannous tin Mediam has no known influence on the ability to drive and use machines

Hypersensitivity to the active substance (s) or to any of the excipients mentioned in section Composition.
Risks of hypersensitivity or anaphylactic reactions.

Justification: individual benefit / risk

For each patient, exposure to radiation should be justified by the expected benefit. The activity administered should in all cases be as low as possible to obtain the diagnostic information necessary

Pediatric population

For more information on use, see pediatric population Dosage and mode of administration

In the newborn and the child, it is necessary to ensure that the diagnostic benefit of the examination justifies the risk of irradiation incurred since the effective dose per MBq is higher than in adults; See section 11).

Patient preparation

The patient should be well hydrated before beginning the examination and prompted to urinate as often as possible within the first few hours after examination to reduce radiation

After the procedure

Close contact with infants and pregnant women should be limited within the first few hours following the administration of a radiopharmaceutical ..
Precautions, special

This medicine contains 1.42 mg sodium per vial (before reconstitution). To be taken into account in patients under strict low-sodium diet.

It is recommended that the examination be performed with 99m Tc-labeled erythrocytes before any administration of iodinated contrast media, as the cell-marking efficiency may be affected. >

Hazard precautions, for the environment see section Instructions for use, handling and disposal

A decrease in the marking efficiency was observed in the presence of the following substances: heparin, tin, aluminum, prazosin, methyldopa, hydralazine, digitalis, quinidine, β adrenergic blockers (eg propanolol), calcium antagonists (eg verapamil , Nifedipine), nitrates (eg trinitrin), anthracyclines, iodinated contrast media, teflon catheters (stannous tin, Sn 2+ capable of reacting with the catheter).

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

In the case of overdosage, the absorbed dose can hardly be reduced insofar as the elimination of the bound technetium depends entirely on the physiological renewal of the red blood cells. The dose absorbed in excess pertechnetate (99mTc) must be Reduced as much as possible by promoting the elimination of the radionuclide from the body by increasing the frequency of urination and by a forced diuresis. It may be useful to estimate the dose actually applied.

Women in childbearing age

When administering a radiopharmaceutical to a woman of childbearing age, it is important to verify that the pregnant woman is not pregnant. Any delay in menstruation should suggest the possibility of pregnancy until proven otherwise. In case of doubt, it is important to limit exposure to radiation to the minimum compatible with obtaining clinical information. The use of alternative techniques, not using ionizing radiation, should be considered.

Pregnancy

The radionuclides used in pregnant women also deliver doses of radiation to the fetus. During pregnancy, only essential tests should be performed where the potential benefit is far greater than the risks to the mother and the fetus.

Breastfeeding

Before administering a radiopharmaceutical to a lactating woman, consideration should be given to the possibility of delaying the administration of radionuclides until breastfeeding is completed. Otherwise, account should be taken of the activity likely to pass through maternal milk to select the most appropriate radiopharmaceutical. If the administration is deemed necessary, the milk will be drawn before injection and retained for use, and breastfeeding must be discontinued for 12 hours and the milk produced during this period must be discarded. Code>
Exposure to ionizing radiation can cause cancer or the development of hereditary abnormalities. In the case of nuclear medicine diagnostic examinations it is recognized that the incidence of such undesirable effects is low due to the activities involved. Since the effective dose is less than 20 mSv when l The recommended maximum activity of 950 MBq is administered, these undesirable effects are expected to occur with a low probability.
Intravenous administration of medronate may occasionally cause hypersensitivity reactions. Cases of local or generalized eruptions, pruriginous, with irritation of the skin have been reported. The reaction usually occurs a few hours after the injection and may last up to 48 hours. A non-sedative anti-histamine H 1 treatment may be considered.

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Isolated cases of allergic or vagal reactions have been observed after administration of technetium-99m-labeled red cells but have not been reported in detail. >