ProHance, 279.3 mg/ml, Solution for Injection, 10 ml vial

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

Gadoteridol

Tilgjengelig fra:

Bracco International B.V.

ATC-kode:

V08CA; V08CA04

INN (International Name):

Gadoteridol

Dosering :

279.3 milligram(s)/millilitre

Legemiddelform:

Solution for injection

Resept typen:

Product subject to prescription which may not be renewed (A)

Terapeutisk område:

Paramagnetic contrast media; gadoteridol

Autorisasjon status:

Marketed

Autorisasjon dato:

1993-02-23

Informasjon til brukeren

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
PROHANCE 279.3 MG/ML
SOLUTION FOR INJECTION
Gadoteridol
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if their
symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell
your doctor or pharmacist.
IN THIS LEAFLET:
1. What ProHance is and what it is used for
2. Before you use ProHance
3. How to use ProHance
4. Possible side effects
5. How to store ProHance
6. Further information
1. WHAT PROHANCE IS AND WHAT IT IS USED FOR
ProHance is a magnetic resonance contrast medium in the form of a
solution for injection. It is used for
Magnetic Resonance Examinations to provide a better picture of the
brain, spine and surrounding tissues in
case of lesions involving the blood flow.
2. BEFORE YOU USE PROHANCE
DO NOT USE PROHANCE
• if you are allergic (hypersensitive) to Gadoteridol or any of the
other ingredients of ProHance (see section
6) or other gadolinium based contrast media.
• if you are under 18 years of age
TAKE SPECIAL CARE WITH PROHANCE
• In some cases ProHance may cause changes in serum iron (the amount
of iron in your blood) with no
significant effects.
• The allergic reactions which have been seen occasionally after the
administration of similar products might
also happen with ProHance. Therefore emergency measures must be
readily available.
Tell your doctor if:
- If you have a history of allergy
- your KIDNEYS do not work properly
- you have recently had, or soon expect to have, a LIVER TRANSPLANT
- You have a history of epilepsy or brain lesions
YOUR DOCTOR MAY DECIDE TO TAKE A BLOOD TEST TO CHECK HOW WELL YOUR
KIDNEYS ARE WORKING BEFORE
MAKING THE DECISION TO USE PROHANCE ESPECIALLY IF YOU ARE 65 YEARS OF
AGE OR OLDER.
TA

Preparatomtale

Health Products Regulatory Authority
07 November 2018
CRN008JWP
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
ProHance, 279.3 mg/ml, Solution for Injection, 10 ml vial
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Gadoteridol 279.3 mg per ml (0.5 mmol) 2793 mg per 10 ml.
For excipients, see 6.1.
3 PHARMACEUTICAL FORM
Solution for injection.
A clear colourless to pale yellow sterile solution for intravenous
use.
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
visualisation
(compared with unenhanced MRI) of lesions with abnormal vascularity or
those
thought to cause a disruption of the normal blood-brain barrier.
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 (0.2 ml/kg). However, in patients suspected of having
cerebral
Health Products Regulatory Authority
07 November 2018
CRN008JWP
Page 2 of 10
metastases or other poorly enhancing lesions 0.3 mmol/kg (0.6 ml/kg)
is
recommended.
To ensure complete injection of the contrast medium, the injection
should be
followed by a 5ml normal saline flush. The imaging procedure should be
completed
within 1 hour after injecting ProHance.
CAUTION DURING INJECTION OF ANY CONTRAST MEDIA IS NECESSARY TO AVOID
EXTRAVASATION.
_Paediatric population _
_Children_
The safety and effectiveness of ProHance in children have not been
established.
SPECIAL POPULATION