ProHance 0.5mmol/ml solution for injection 10ml pre-filled syringes

Kraj: Wielka Brytania

Język: angielski

Źródło: MHRA (Medicines & Healthcare Products Regulatory Agency)

Składnik aktywny:

Gadoteridol

Dostępny od:

Bracco UK Ltd

Kod ATC:

V08CA04

INN (International Nazwa):

Gadoteridol

Dawkowanie:

.5mmol/1ml

Forma farmaceutyczna:

Solution for injection

Droga podania:

Intravenous

Klasa:

No Controlled Drug Status

Typ recepty:

Valid as a prescribable product

Podsumowanie produktu:

BNF:

Charakterystyka produktu

OBJECT 1
PROHANCE SYRINGES
Summary of Product Characteristics Updated 21-Dec-2017 | Bracco UK
Limited
1. Name of the medicinal product
ProHance 279.3 mg/ml, solution for injection in prefilled syringes
2. Qualitative and quantitative composition
Gadoteridol 279.3mg/ml (0.5M)
3. Pharmaceutical form
Sterile solution for intravenous injection
4. Clinical particulars
4.1 Therapeutic indications
This medicinal product is for diagnostic use only.
Using Magnetic Resonance Imaging (MRI), ProHance provides contrast
enhancement of the brain, spine
and surrounding tissues resulting in improved visualization (compared
with unenhanced MRI) of lesions
with abnormal vascularity or those thought to cause a disruption of
the normal blood-brain barrier.
ProHance can also be used for whole body MRI including the head, neck,
liver, breast, muscoloskeletal
system and soft tissue pathologies.
ProHance should be used only when diagnostic information is essential
and not available with
unenhanced magnetic resonance imaging (MRI).
4.2 Posology and method of administration
Posology
The lowest dose that provides sufficient enhancement for diagnostic
purposes 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_
The recommended dose of ProHance for imaging most brain and spinal
pathologies is 0.1 mmol/kg.
However, doses of 0.3 mmol/kg have been shown to be useful in patients
suspected of having cerebral
metastases or other poorly enhancing lesions.
The recommended dose for whole body MRI is 0.1 mmol/kg.
_Paediatric population _
_Children (2 years and above)_
The recommended dose of ProHance for brain imaging and spine
pathologies is 0.1 mmol/kg (0.2 ml/kg).
ProHance has been used in only a limited number of children aged
between 6 months and 2 years. If an
MRI procedure must be performed in this group, particular caution
should be exercised.
The safety and efficacy of doses higher than 0.1 mmol/kg and
sequent