MYOVIEW FOR INJECTION 0.23 mgvial

Krajina: Singapur

Jazyk: angličtina

Zdroj: HSA (Health Sciences Authority)

Aktívna zložka:

Tetrofosmin (as Tetrofosmin Sulphosalicylate)

Dostupné z:

GE HEALTHCARE PTE. LTD.

ATC kód:

V09GA02

Dávkovanie:

0.23 mg/vial

Forma lieku:

INJECTION, POWDER, FOR SOLUTION

Zloženie:

Tetrofosmin (as Tetrofosmin Sulphosalicylate) 0.23 mg/vial

Spôsob podávania:

INTRAVENOUS

Typ predpisu:

Prescription Only

Výrobca:

GE HEALTHCARE AS (OSLO SITE)

Stav Autorizácia:

ACTIVE

Dátum Autorizácia:

2002-02-25

Príbalový leták

1175797 SGP_1175797 SGP  06.01.12  09.41  Side 1 

ORGAN

ABSORBED RADIATION  DOSE

(ΜGY/MBQ)

EXERCISE

REST

Gall bladder   wall 
Upper large intestine 
Lower large  intestine 
Urinary bladder  wall 
Small intestine

Kidney

Salivary glands

Ovaries

Uterus

Bone surface 
Thyroid 
Pancreas 
Stomach 
Adrenals

Red Marrow 
Heart wall 
Spleen 
Muscle 
Testes

Liver 
Thymus 
Brain 
Lungs 
Skin 
Breasts

Total body

33.2

20.1

15.3

15.6

12.1

10.4

8.0

7.9

7.3

6.2

4.3

5.0

4.6

4.3

4.1

4.1

4.1

3.5

3.4

3.2

3.1

2.7

2.3

2.2

2.2

3.8

48.6

30.4

22.2

19.3

17.0

12.5

11.6

9.6

8.4

5.6

5.8

5.0

4.6

4.1

4.0

4.0

3.8

3.3

3.1

4.2

2.5

2.2

2.1

1.9

1.8

3.7

D
o
c
u
m
e
n
t:
 1
1
7
5
7
9
7
 SG
P 
Ve
rs
io
n
: 
2
 D
ra
ft
: 
1

6.    Cut the  strip into 3 pieces at  the  marked cutting positions  and  measure the 
activity on  each  using  suitable  counting equipment.  Try  to  ensure  similar 
counting geometry for each piece and minimize equipment  dead time losses.

7.    Calculate the radiochemical purity from:

%
99m
Tc-tetrofosmin =        Activity of centre piece          x 100

Total activity  of all 3 pieces

NOTE: Free [
99m
Tc] pertechnetate runs to the top piece of the strip.

99m
Tc-tetrofosmin    runs  to  the  centre  piece  of  the  strip.    Reduced 
hydrolysed-

99m
Tc  and  any  hydrophilic  complex  impurities  remain at  the  origin  in the  bottom 
piece of the strip.

Do not use material  if the radiochemical  purity is less than 90%.

OVERDOSE

In cases of overdosage of radioactivity frequent micturition and defaecation should 
be encouraged  in order to minimize rad

Súhrn charakteristických

facial oedema, hypotension and dyspnoea. Some reactions were delayed
by several
hours following administration of
99m
Tc-tetrofosmin. Transient rises in white blood
cell counts have also been reported in a small number of patients.
Isolated cases of
serious reactions have been reported, including anaphylactic reaction
(0.001%) and
severe allergic reaction (single report).
In
case
of
side-effects
following
administration
of
radiopharmaceuticals,
users
should
ensure
the
availability
of
appropriate
medical
treatment
at
the
time
of
administration of any radiopharmaceutical to the patient. Users are
requested to
report to GE Healthcare Limited any instances of suspected adverse
drug reactions or
side-effects associated with the use of this product.
For each patient, exposure to ionising radiation must be justifiable
on the basis of
likely benefit. The activity administered must be such that the
resulting radiation dose
is as low as reasonably achievable bearing in mind the need to obtain
the intended
diagnostic result. Exposure to ionising radiation is linked with
cancer induction and a
potential for development of hereditary defects. For diagnostic
nuclear medicine
investigations the current evidence suggests that these adverse events
will occur
with negligible frequency because of the low radiation dose incurred.
For
most
diagnostic
investigations
using
a
nuclear
medicine
procedure
the
radiation dose (ED or using the previous nomenclature, EDE) delivered
is less than
20mSv. Higher doses may be justified in some clinical circumstances.
PHARMACODYNAMIC PROPERTIES
Pharmacotherapeutic
group:
Diagnostic
radiopharmaceutical
for
cardiovascular
system imaging, ATC Code : V09G A 02.
Pharmacological
effects
are
not
expected
following
intravenous
administration
of
reconstituted Myoview at the recommended dosage. Studies in animals
have shown
that myocardial uptake of
99m
Tc-tetrofosmin is linearly related to coronary blood flow,
confirming the effectiveness of the complex as a myocardial perfusion
imaging agent.
Limited data i