Pamiray 370 Injection

Maa: Armenia

Kieli: englanti

Lähde: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktiivinen ainesosa:

iopamidol

Saatavilla:

DongKook Pharmaceutical Co.

INN (Kansainvälinen yleisnimi):

iopamidol

Annos:

370mg iodine/ml

Lääkemuoto:

solution for injection

Prescription tyyppi:

Prescription

Pakkausseloste

Pamiray 300, 370 Injection
(Iopamidol)
DESCRIPTION
Pamiray 300 Injection contains iopamidol 0.612 g per mL (300 mg as
iodine) and Pamiray 370 Injection contains iopamidol
0.7552 g per mL (370 mg as iodine). Pamiray 300 and 370 Injection also
contain 1.0 mg/mL of tromethamine, 0.39 mg/mL of
edetate calcium disodium, hydrochloric acid, and water for injection.
INDICATIONS
1. Pamiray 300 Injection :
1) X-ray contrast media for neuroradiology (ventriculography,
basilarography, myelography)
2) Angiography (arteriography, venography)
3) Urography
4) Computer tomography (CAT Scanning)
2. Pamiray 370 Injection :
1) X-ray contrast media for angiography : coronary arteriography,
thoracic aortography, abdominal aortography,
angiocardiography, selective visceral arteriography, peripheral
arteriography
2) Urography
3) Computer tomography (CAT Scanning)
DOSAGE AND ADMINISTRATION
Pamiray is injected intravenously or infused with catheter insertion
or direct centesis in accordance with doctor
'
s directions.
1. Pamiray 300 Injection
1) Neuroradiology
Ventriculography and basilarography : 3 - 15 mL
Myelography : 5 - 15 mL
2) Angiography
Cerebral arteriography : 5 - 10 mL
Venography : 30 - 50 mL
Peripheral arteriography : 40 - 50 mL
3) Urography : 40 - 100 mL
4) Computer tomography (CAT Scanning) : 0.5 - 2.0 mL/kg
2. Pamiray 370 Injection
1) Angiography
Coronary arteriography : 8 - 15 mL
Thoracic aortography : 1.0 - 1.2 mL/kg
Abdominal aortography : 1.0 - 1.2 mL/kg
Angiocardiography : 1.0 - 1.2 mL/kg
Selective visceral arteriography : Administer in accordance with
doctor
'
s directions.
Peripheral arteriography : 40 - 50 mL
2) Urography : 20 - 100 mL
3) Computer tomography (CAT Scanning) : 0.5 - 2.0 mL/kg
CONTRAINDICATIONS
Proven or suspected hypersensitivity to iodine containing preparations
of this type.
WARNINGS
As with all other contrast media this product may provoke anaphylaxis
or other manifestations of allergy with nausea,
vomiting, dyspnea, erythema, urticaria and hypotension. A positive
history of allergy, asthma or unto

Valmisteyhteenveto

THE SUMMARY OF THE PRODUCT CHARACTERISTICS
1.
Name of the medicinal product
Pamiray Injection
2.
Qualitative and quantitative composition
Each mL contains
PAMIRAY 300 Injection
Each ml contains
Active ingredient :
Iopamidol (USP)
0.612 g
(300mg as iodine)
Inactive ingredient :
Edetate calcium disodium (USP)
0.39 mg
Tromethamine (USP)
1.0 mg
Hydrochloric acid (KP)
q. s.
Water for injection (USP)
q. s.
PAMIRAY 370 Injection
Each ml contains
Active ingredient :
Iopamidol (USP)
0.7552 g
(370mg as iodine)
Inactive ingredient :
Edetate calcium disodium (USP)
0.39 mg
Tromethamine (USP)
1.0 mg
Hydrochloric acid (KP)
q. s.
Water for injection (USP)
q. s.
3.
Pharmaceutical form
It is a sterile, clear colorless solution
4.
Clinical particulars
4.1.
Therapeutic indications
1. Pamiray 300 Injection :
①
X-ray contrast media for neuroradiology (ventriculography,
basilarography,
myelography)
②
Angiography (arteriography, venography)
③
Urography
④
Computer tomography (CAT Scanning)
2. Pamiray 370 Injection :
①
X-ray contrast media for angiography : coronary arteriography,
thoracic
aortography,
abdominal
aortography,
angiocardiography,
selective
visceral
arteriography, peripheral arteriography
②
Urography
③
Computer tomography (CAT Scanning)
4.2.
Posology and method of administration
Pamiray is injected intravenously or infused with catheter insertion
or direct
centesis in accordance with doctor's directions.
1. Pamiray 300 Injection
①
Neuroradiology
Ventriculography and basilarography : 3 - 15 mL
Myelography : 5 - 15 mL
②
Angiography
Cerebral arteriography : 5 - 10 mL
Venography : 30 - 50 mL
Peripheral arteriography : 40 - 50 mL
③
Urography : 40 - 100 mL
④
Computer tomography (CAT Scanning) : 0.5 - 2.0 mL/kg
2. Pamiray 370 Injection
①
Angiography
Coronary arteriography : 8 - 15 mL
Thoracic aortography : 1.0 - 1.2 mL/kg
Abdominal aortography : 1.0 - 1.2 mL/kg
Angiocardiography : 1.0 - 1.2 mL/kg
Selective
visceral
arteriography
:
Administer
in
accordance
with
doctor's
directions.
Peripheral arteriography : 4