DOTAREM gadoteric acid 279.32mg/mL injection 10mL vial

Država: Avstralija

Jezik: angleščina

Source: Department of Health (Therapeutic Goods Administration)

Aktivna sestavina:

gadoteric acid, Quantity: 279.3 mg/mL

Dostopno od:

Guerbet Australia Pty Ltd

Farmacevtska oblika:

Injection, solution

Sestava:

Excipient Ingredients: water for injections; meglumine

Pot uporabe:

Intravenous

Enote v paketu:

1 X 10mL

Tip zastaranja:

Not scheduled. Not considered by committee

Terapevtske indikacije:

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

Povzetek izdelek:

Visual Identification: Clear, colourless to yellow solution.; Container Type: Vial; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Status dovoljenje:

Licence status A

Datum dovoljenje:

2000-12-11

Navodilo za uporabo

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

Lastnosti izdelka

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