Omniscan 287mg/ml (0,5mmol/ml) solution for i/v injection

Страна: Армения

Язык: английский

Источник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Активный ингредиент:

gadodiamide

Доступна с:

GE Healthcare Ireland Limited

код АТС:

V08CA03

ИНН (Международная Имя):

gadodiamide

дозировка:

287mg/ml (0,5mmol/ml)

Фармацевтическая форма:

solution for i/v injection

Штук в упаковке:

(1) glass vial 20ml, (10) glass vials 20ml

Тип рецепта:

Prescription

Статус Авторизация:

Registered

Дата Авторизация:

2018-07-31

Характеристики продукта

1
LOCAL SUMMARY OF PRODUCT CHARACTERISTICS
1
PRODUCT NAME
Omniscan
®
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of solution contains: gadodiamide 287 mg (equivalent to 0.5 mmol)
Excipients with known action:
Total sodium: 0.62 mg/ml
For a complete list of excipients, see section 6.1.
3
DOSAGE FORM
Solution for intravenous administration.
Transparent, colorless to pale-yellow liquid.
Osmolality at 37 °C: 780 (mOsm/kg H
2
O)
pH: 6.0–7.0
4
CLINICAL DATA
4.1
INDICATIONS
The product is for diagnostic use only.
Omniscan
®
is a gadolinium-based linear non-ionic contrast agent for brain and
spinal MRI
(magnetic resonance imaging). Omniscan
®
is also indicated for whole body imaging, including
the head and the neck, the chest, which included the heart, limbs,
abdominal and pelvic organs
(prostate and bladder), the mammary gland in women, the abdominal
cavity (liver and pancreas),
retroperitoneal
space
(kidneys),
musculoskeletal
system
and
blood
vessels
(angiography).
Omniscan
®
is for intravenous use.
Gadolinium-based contrast agents should only be used in cases where
diagnostic information is
critical and cannot be obtained via non-contrast MRI.
Omniscan
®
provides a better visualization of abnormal structures or lesions and
helps identify
differences between healthy and pathological tissue.
4.2
DOSAGE AND METHOD OF ADMINISTRATION
Dosage
Omniscan
®
should be drawn into the syringe immediately before use. All
recommended doses
can be administered as bolus intravenous injections. In order to
ensure a full-volume injection of
Omniscan
®
the intravenous catheter, through which the drug is administered, can
be washed with
5 ml of a 9 mg/ml (0.9%) sodium chloride solution for injection after
the injection.
The lowest effective dose should be used. The dose is calculated
taking into account the patient’s
body weight. Do not exceed the recommended dose per kilogram of body
weight.
_CNS examination_
The recommended dose is 0.2 ml/kg body weight (equivalent to 0.1
mmol/kg body weight) for
adults and children with