DOTAREM gadoteric acid 279.32mg/mL injection 20 mL pre-filled syringe

Land: Australia

Språk: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv ingrediens:

gadoteric acid, Quantity: 279.32 mg/mL

Tilgjengelig fra:

Guerbet Australia Pty Ltd

INN (International Name):

Gadoteric acid

Legemiddelform:

Injection, solution

Sammensetning:

Excipient Ingredients: meglumine; water for injections

Administreringsrute:

Intravenous

Enheter i pakken:

10 (only for plastic syringe), 1

Resept typen:

Not scheduled. Not considered by committee

Indikasjoner:

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).

Produkt oppsummering:

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

Autorisasjon status:

Registered

Autorisasjon dato:

2010-08-26

Informasjon til brukeren

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

Preparatomtale

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