Megaray Inj.

País: Armenia

Idioma: inglés

Fuente: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Ingredientes activos:

gadopentetic acid (meglumine gadopentetate)

Disponible desde:

DongKook Pharmaceutical Co.

Designación común internacional (DCI):

gadopentetic acid (meglumine gadopentetate)

Dosis:

469,01mg/ml

formulario farmacéutico:

solution for injection

tipo de receta:

Prescription

Información para el usuario

Megaray Inj. was developed as a contrast agent for diagnostic use in
magnetic resonance imaging (MRI). It can be
available for various MRI investigations from cranial and spinal MRI
to whole body MRI including facial skull, neck
region, thoracic and abdominal space, female breast, pelvis and
active, passive and locomotive apparatus.
Composition
Each mL
Gadopentetate Monomeglumine
…………………
371.4mg
Monomeglumine
..........………………………….…...
98.6mg
(As Gadopentetate Dimeglumine 469.01mg)
_Inactive Ingredients_
Pentetic Acid
……………………………………………
0.4mg
Water for Injection
..........…………………………….…...
q.s
Characteristics and Dosage form
Sterile, clear, colorless to slightly yellow aqueous solution for
injection
CLiniCAL pHARmACoLoGY
pharmacokinetics
The pharmacokinetics of intravenously administered gadopentetate
dimeglumine in normal subjects conforms to a
two compartment open-model with mean distribution and elimination
half-lives (reported as mean ± SD) of about 0.2
± 0.13 hours and 1.6 ± 0.13 hours, respectively.
Upon injection, the meglumine salt is completely dissociated from the
gadopentetate dimeglumine complex.
Gadopentetate is exclusively eliminated in the urine with 83 ± 14%
(mean ± SD) of the dose excreted within 6 hours
and 91 ± 13% (mean ± SD) by 24 hours, post-injection. There was no
detectable biotransformation or decomposition
of gadopentetate dimeglumine.
The renal and plasma clearance rates (1.76 ± 0.39 mL/min/kg and 1.94
± 0.28 mL/min/kg, respectively) of
gadopentetate are essentially identical, indicating no alteration in
elimination kinetics on passage through the
kidneys and that the drug is essentially cleared through the kidney.
The volume of distribution (266 ± 43 mL/kg) is
equal to that of extracellular water and clearance is similar to that
of substances which are subject to glomerular
filtration.
In vitro laboratory results indicate that gadopentetate does not bind
to human plasma protein. In vivo

Ficha técnica

THE SUMMARY OF THE PRODUCT CHARACTERISTICS
1.
Name of the medicinal product
Megaray Injection
2.
Qualitative and quantitative composition
Each mL contains
* Active Ingredients
Gadopentetate Monomeglumine (Company Spec.) 371.4mg
Meglumine (KP) 98.6mg
* Inactive Ingredients
Pentetic Acid (USP) 0.4mg
Water for Injection (KP) q.s.
3.
Pharmaceutical form
It is a sterile, clear colorless to slightly yellow aqueous solution
4.
Clinical particulars
4.1.
Therapeutic indications
_Central Nervous System: _
MEGARAY Injection is indicated for use with magnetic resonance imaging
(MRI)
in adults, and pediatric patients (2 years of age and older) to
visualize lesions
with
abnormal
vascularity
in
the
brain
(intracranial
lesions),
spine
and
associated tissues. MEGARAY Inj. has been shown to facilitate
visualization of
intracranial lesions including but not limited to tumors.
_ _
_Extracranial / Extraspinal Tissues:_
MEGARAY Injection is indicated for use with MRI in adults and
pediatric
patients (2 years of age and older) to facilitate the visualization of
lesions with
abnormal vascularity in the head and neck.
_ _
_Body: _
MEGARAY Injection is indicated for use in MRI in adults and pediatric
patients
(2 years of age and older) to facilitate the visualization of lesions
with abnormal
vascularity in the body (excluding the heart).
4.2.
Posology and method of administration
The following dosage guidelines apply to adults and children.
Recommended Dose : 0.2mL/kg
Route of Administration : Intravenous (into a large vein, if possible)
Rate of Administration : 10mL/min or as a bolus injection at
10ml/15sec.
Maximum Total Dose : 20mL
Dose and Duration of MEGARAY injection by
duration
Body weight
lb
kg
Total volume mL*
22
10
2
44
20
4
66
30
6
88
40
8
110
50
10
132
60
12
154
70
14
176
80
16
198
90
18
220
100
20
242
110
22
264
120
24
286
130
26
* Rate of injection : 10mL/15 sec
Special preparation of the patient for examination is not required:
however,
precautionary measures should be taken.
4.3.
Contraindications
1) The patient who has hy