Primovist 0.25mmol/ml solution for injection 10ml pre-filled syringes

Țară: Regatul Unit

Limbă: engleză

Sursă: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredient activ:

Gadoxetate disodium

Disponibil de la:

Bayer Plc

Codul ATC:

V08CA10

INN (nume internaţional):

Gadoxetate disodium

Dozare:

.25mmol/1ml

Forma farmaceutică:

Solution for injection

Calea de administrare:

Intravenous

Clasă:

No Controlled Drug Status

Tip de prescriptie medicala:

Valid as a prescribable product

Rezumat produs:

BNF: ; GTIN: 5016703008699

Prospect

V027
Page 1 of 9
Due to regulatory changes, the content of the following Patient
Information Leaflet may vary from the one found in your medicine pack.
Please compare the 'Leaflet prepared/revised date' towards the end of
the leaflet to establish if there have been any changes.
If you have any doubts or queries about your medication, please
contact
your doctor or pharmacist.
_ _
_ _
PACKAGE LEAFLET: INFORMATION FOR THE USER
PRIMOVIST 0.25 MMOL/ML, SOLUTION FOR INJECTION, PRE-FILLED SYRINGE
Gadoxetate, disodium
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE
BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, please ask your doctor giving you
Primovist (the radiologist) or
the hospital/MRI-centre personnel.
-
If you get any side effects talk to your doctor or radiologist. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Primovist is and what it is used for
2.
What you need to know before you are given Primovist
3.
How to use Primovist
4.
Possible side effects
5.
How to store Primovist
6.
Contents of the pack and other information
1.
WHAT PRIMOVIST IS AND WHAT IT IS USED FOR
Primovist is a contrast medium for magnetic resonance imaging (MRI) of
the liver. It is used to help detect
and diagnose changes that may be found in the liver. Abnormal signs
within the liver can be better evaluated
(as to number, size, and distribution). Primovist can also help the
doctor determine the nature of any
abnormalities, thereby increasing the confidence one can have in the
diagnosis.
It is provided as a solution for intravenous injection. This medicine
is for diagnostic use only.
MRI is a form of medical diagnostic imaging that forms pictures after
water molecules have been detected in
normal and abnormal tissues. This is done using a complex system of
magnets and radiowaves.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN PRIMOVIST
DO NOT USE PRIMOVIST
-
if yo

Caracteristicilor produsului

OBJECT 1
PRIMOVIST 0.25 MMOL/ML, SOLUTION FOR INJECTION,
PREFILLED SYRINGE
Summary of Product Characteristics Updated 16-Jan-2018 | Bayer plc
1. Name of the medicinal product
Primovist 0.25 mmol/ml, solution for injection, pre-filled syringe
2. Qualitative and quantitative composition
Each ml contains 0.25 mmol gadoxetate disodium (Gd-EOB-DTPA disodium),
equivalent to 181.43 mg
gadoxetate disodium.
1 prefilled syringe with 5.0 ml contains 907 mg gadoxetate disodium,
1 prefilled syringe with 7.5 ml contains 1361 mg gadoxetate disodium,
1 prefilled syringe with 10.0 ml contains 1814 mg gadoxetate disodium.
Excipients with known effect: 11.7 mg sodium/ ml
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Solution for injection, prefilled syringe:
Clear, colourless to pale yellow liquid free from visible particles.
4. Clinical particulars
4.1 Therapeutic indications
Primovist is indicated for the detection of focal liver lesions and
provides information on the character of
lesions in T1-weighted magnetic resonance imaging (MRI).
Primovist should be used only when diagnostic information is essential
and not available with
unenhanced magnetic resonance imaging (MRI) and when delayed phase
imaging is required.
This medicinal product is for diagnostic use by intravenous
administration only_._
4.2 Posology and method of administration
METHOD OF ADMINISTRATION
Primovist is a ready-to-use aqueous solution to be administered
undiluted as an intravenous bolus
injection at a flow rate of about 2 ml/sec. After the injection of the
contrast medium the intravenous
cannula/ line should be flushed using sterile 9 mg/ml (0.9 %) saline
solution.
For detailed imaging information refer to section 5.1.
For additional instructions see section 6.6.
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.
The rec