Medicinal Products

AMERSCAN ETAIN STANNEUX Ref106

Generic Drug Therapeutic Class: Diagnostic Products or Other Therapeutic Products
active ingredients: Stannous fluoride, Sodium medronate
laboratory: Mediam

IV injectable solution
Box of 5 vials of 6 ml diluted solution
All forms

Indication

This medicine is for diagnostic use only.

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

The main indications are:

· Angiocardioscintigraphy:

o evaluation of the ventricular ejection fraction,

o study of global and regional cardiac parietal kinetics,

o cardiac imaging with phase analysis.

· Diagnosis and localization of occult gastrointestinal hemorrhages.

Dosage AMERSCAN ETAIN STANNEUX Ref106 IV solution for injection Box of 5 vials of 6 ml of diluted solution

Dosage

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

Adult and elderly subject

After injection of the stannous medronate complex, an injection of either sodium pertechnetate [ 99m Tc] ( in vivo method) or 99m Tc-labeled red cells ( in vivo / in vitro method ) is performed. In vitro incubation of the stannous medronate complex with the whole blood sample or the red blood cell fraction may also be performed prior to the addition of the sodium pertechnetate [ 99m Tc] solution ( in vitro method) and reinjectin the patient red blood cells marked. The average activity administered is 800 MBq (750 to 950 MBq) in adults and the elderly.

Pediatric population

Use in children and adolescents should be considered with caution, based on clinical needs and assessing 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, a fraction obtained by applying the coefficients below according to body weight.

Coefficients to apply to activity in adults

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

EANM (European Association of Nuclear Medicine)

In very young children (under 1 year old), a minimum activity of 80 MBq is necessary to obtain images of satisfactory quality.

Given the duration of fixing stannous salts on red blood cells, it is advisable not to repeat the examination before a period of 3 months.

Administration mode

Intravenous administration.

This medicine must be reconstituted before administration to the patient.

For patient preparation, see Warnings and Precautions for Use .

For instructions on reconstitution of the drug before administration, and labeling of red blood cells, see section 12.

Methods for labeling red blood cells

The stannous medronate complex (non-radioactive substance) is first reconstituted in 6 mL of isotonic sodium chloride solution for injection.

In vivo method

Administration of the stannous medronate complex is followed by injection of sodium pertechnetate [ 99m Tc] 20 to 40 minutes later.

In vitro method

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

Modified method in vivo (in vivo / in vitro)

The reconstituted solution containing the stannous medronate complex is injected to obtain a "tin charge" of the red blood cells in vivo . Then, on a blood sample, the labeling of red blood cells is performed in vitro with sodium pertechnetate [ 99m Tc]. The solution of marked red blood cells is then reinjected to the patient.

Against indications

Hypersensitivity to the active substance (s) or to any of the excipients listed under Composition .

Undesirable effects Amerscan Tin Stanneux Ref106

Exposure to ionizing radiation can cause cancer or the development of inherited abnormalities. In the case of nuclear medicine diagnostic tests, it is recognized that the incidence of such adverse effects is low because of the activities involved. Since the effective dose is less than 20 mSv when the maximum recommended activity of 950 MBq is administered, these side effects are expected to occur with a low probability.

Intravenous administration of medronate may occasionally cause hypersensitivity reactions. Cases of local or generalized, pruriginous rashes with skin irritation have been reported. The reaction usually occurs a few hours after the injection and can last up to 48 hours. Non-sedating anti-histamine H 1 treatment may be considered.

Other side effects have also been reported: drop in blood pressure and symptoms of hypotension, nausea, vomiting, cutaneous vasodilation, headache, malaise, extremity edema and arthralgia.

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

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