DOTAREM gadoteric acid 279.32mg/mL injection 15 mL pre-filled syringe

Страна: Австралия

Язык: английский

Источник: Department of Health (Therapeutic Goods Administration)

Активный ингредиент:

gadoteric acid, Quantity: 279.32 mg/mL

Доступна с:

Guerbet Australia Pty Ltd

ИНН (Международная Имя):

Gadoteric acid

Фармацевтическая форма:

Injection, solution

состав:

Excipient Ingredients: meglumine; water for injections

Администрация маршрут:

Intravenous

Штук в упаковке:

10 (only for plastic syringe), 1

Тип рецепта:

Not scheduled. Not considered by committee

Терапевтические показания :

Dotarem is indicated, in adults and children, for use with magnetic resonance imaging to provide contrast enhancement for intracranial and spinal lesions with abnormal blood brain barrier or abnormal vascularity, and for whole body imaging (see clinical studies).

Обзор продуктов:

Visual Identification: Clear, colourless to yellow solution.; Container Type: Syringe; Container Material: PP; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Статус Авторизация:

Registered

Дата Авторизация:

2010-08-26

тонкая брошюра

1(12)
AUSTRALIAN PRODUCT INFORMATION
DOTAREM
® (GADOTERIC ACID) SOLUTION FOR INJECTION
1
NAME OF THE MEDICINE
Gadoteric acid.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
DOTAREM (gadoteric acid) paramagnetic contrast media for Magnetic
Resonance Imaging (MRI).
Each vial or pre-filled syringe contains the active ingredient
gadoteric acid 279.32 mg/mL
(equivalent to 0.5 mmol/mL). Gadoteric acid is a complex of the
paramagnetic ion gadolinium
oxide 90.62 mg/mL with DOTA
(1,4,7,10–tetraazacyclododecane–N,N’,N’’,N’’’–tetraacetic
acid)
202.46 mg/mL.
Chemical characteristics of the formulation:
Osmolality:1350 mOsm.kg-1,
Viscosity at 20°C: 3.2 mPa.s,
Viscosity at 37°C: 2.0 mPa.s,
pH: 6.5 – 8.0.
For the full list of excipients see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Solution for injection.
DOTAREM is a clear, colourless to yellow solution available in vials
or pre-filled syringes intended
for intravenous injection.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
DOTAREM is indicated, in adults and children, for use with magnetic
resonance imaging to
provide contrast enhancement for intracranial and spinal lesions with
abnormal blood brain
barrier or abnormal vascularity, and for whole body imaging (see
Section 5.1 Pharmacodynamic
properties - Clinical trials,).
4.2
D
OSE AND METHOD OF ADMINISTRATION
DOSAGE
The lowest effective dose should be used. The dose should be
calculated based on the patient’s
body weight and should not exceed the recommended dose per kilogram of
body weight detailed
in this section.
ADULTS (≥ 18 YEARS)
The maximum recommended dose is 0.1 mmol/kg, i.e. 0.2 mL/kg for
adults.
2(12)
PAEDIATRICS (0 TO 18 YEARS)
The maximum recommended dose is 0.1 mmol/kg, i.e. 0.2 mL/kg for
children and infants.
METHOD OF ADMINISTRATION
DOTAREM is intended for intravenous administration only.
Volumes required for doses of 0.1 mmol/kg are shown below.
WEIGHT (KG)
VOLUME (ML) REQUIRED FOR A DOSE OF 0.1 MMOL/KG
10
2
20
4
30
6
40
8
50
10
60
12
70
14
80
16
90
18
100
20
If DOTA

Характеристики продукта

1(12)
AUSTRALIAN PRODUCT INFORMATION
DOTAREM
® (GADOTERIC ACID) SOLUTION FOR INJECTION
1
NAME OF THE MEDICINE
Gadoteric acid.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
DOTAREM (gadoteric acid) paramagnetic contrast media for Magnetic
Resonance Imaging (MRI).
Each vial or pre-filled syringe contains the active ingredient
gadoteric acid 279.32 mg/mL
(equivalent to 0.5 mmol/mL). Gadoteric acid is a complex of the
paramagnetic ion gadolinium
oxide 90.62 mg/mL with DOTA
(1,4,7,10–tetraazacyclododecane–N,N’,N’’,N’’’–tetraacetic
acid)
202.46 mg/mL.
Chemical characteristics of the formulation:
Osmolality:1350 mOsm.kg-1,
Viscosity at 20°C: 3.2 mPa.s,
Viscosity at 37°C: 2.0 mPa.s,
pH: 6.5 – 8.0.
For the full list of excipients see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Solution for injection.
DOTAREM is a clear, colourless to yellow solution available in vials
or pre-filled syringes intended
for intravenous injection.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
DOTAREM is indicated, in adults and children, for use with magnetic
resonance imaging to
provide contrast enhancement for intracranial and spinal lesions with
abnormal blood brain
barrier or abnormal vascularity, and for whole body imaging (see
Section 5.1 Pharmacodynamic
properties - Clinical trials,).
4.2
D
OSE AND METHOD OF ADMINISTRATION
DOSAGE
The lowest effective dose should be used. The dose should be
calculated based on the patient’s
body weight and should not exceed the recommended dose per kilogram of
body weight detailed
in this section.
ADULTS (≥ 18 YEARS)
The maximum recommended dose is 0.1 mmol/kg, i.e. 0.2 mL/kg for
adults.
2(12)
PAEDIATRICS (0 TO 18 YEARS)
The maximum recommended dose is 0.1 mmol/kg, i.e. 0.2 mL/kg for
children and infants.
METHOD OF ADMINISTRATION
DOTAREM is intended for intravenous administration only.
Volumes required for doses of 0.1 mmol/kg are shown below.
WEIGHT (KG)
VOLUME (ML) REQUIRED FOR A DOSE OF 0.1 MMOL/KG
10
2
20
4
30
6
40
8
50
10
60
12
70
14
80
16
90
18
100
20
If DOTA