PRIMOVIST disodium gadoxetate 181.43 mg/mL (0.25M) 7.5mL injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

disodium gadoxetate, Quantity: 181.43 mg/mL

Available from:

Bayer Australia Ltd

INN (International Name):

Disodium gadoxetate

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: trisodium caloxetate; sodium hydroxide; trometamol; water for injections; hydrochloric acid

Administration route:

Intravenous

Units in package:

10 x 7.5mL vials, 1 x 7.5mL vial, 5 x 7.5mL vials

Prescription type:

Not scheduled. Not considered by committee

Therapeutic indications:

This medicinal product is for diagnostic use only. PRIMOVIST is indicated for use in adults for the enhancement of magnetic resonance imaging (MRI) of focal liver lesion

Product summary:

Visual Identification: Clear solution in a colourless glass vial, fitted with black rubber stopper with bordered cup.; Container Type: Vial; Container Material: Glass; Container Life Time: 5 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2004-07-02

Patient Information leaflet

PRIMOVIST®
1
PRIMOVIST®
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
WARNING: Important safety information is provided in a boxed warning
in the full CMI. Read before using this medicine.
1.
WHY AM I GIVEN PRIMOVIST?
PRIMOVIST contains the active ingredient disodium gadoxetate.
PRIMOVIST is a contrast agent used during a magnetic
resonance imaging (MRI) examination of the liver in adults.
For more information, see Section 1. Why am I given PRIMOVIST? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I AM GIVEN PRIMOVIST?
Do not use if you have ever had an allergic reaction to PRIMOVIST or
any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR, RADIOGRAPHER OR NURSE IF YOU HAVE ANY OTHER
MEDICAL CONDITIONS, TAKE ANY OTHER MEDICINES, OR ARE
PREGNANT OR PLAN TO BECOME PREGNANT.
It is recommended that you do not eat for 2 hours before you are given
PRIMOVIST.
For more information, see Section 2. What should I know before I am
given PRIMOVIST? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with PRIMOVIST and affect how it works. A
list of these medicines is in Section 3. What if I am
taking other medicines? in the full CMI.
4.
HOW AM I GIVEN PRIMOVIST?
PRIMOVIST is injected into your vein by a doctor, radiographer or
nurse during your MRI examination.
More instructions can be found in Section 4. How am I given PRIMOVIST?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE RECEIVING PRIMOVIST?
THINGS YOU
SHOULD DO
Tell your doctor, radiographer or nurse if you:
•
experience any of the severe symptoms of loss of consciousness or
heart attack, increase in heart
rate, difficulty breathing, low blood pressure and swelling of the
face, lips or tongue leading to
severe breathing difficulties and shock
•
have very poor kidney function or severe kidney problems
•
had a liver transplant, impaired liver function or liver cirrhosis
•
have severe he

Summary of Product characteristics

2002 PRIMOVIST PI
Page 1 of 16
AUSTRALIAN PRODUCT INFORMATION
PRIMOVIST
® (DISODIUM GADOXETATE)
1.
NAME OF THE MEDICINE
Disodium gadoxetate
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 mL of the magnetic resonance imaging (MRI) contrast agent
Primovist contains 0.25
mmol disodium gadoxetate (equivalent
to
181.43 mg
disodium gadoxetate
as the active
ingredient).
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Solution for injection.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
This medicinal product is for diagnostic use only.
Primovist is indicated for use in adults for the enhancement of
magnetic resonance imaging
(MRI) of focal liver lesions.
4.2
DOSE AND METHOD OF ADMINISTRATION
GENERAL INFORMATION
The usual safety rules for magnetic resonance imaging must be
observed, e.g. exclusion of
cardiac pacemakers and ferromagnetic implants.
Primovist is for use as a single dose in one patient only. Discard any
remaining content.
DOSAGE
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 through a large-bore
needle or indwelling
catheter (18-20 gauge is recommended). After the injection of the
contrast
medium the
intravenous cannula should be flushed using physiological saline
solution.
The recommended dose of Primovist is:
Adults
0.1 mL/kg body weight Primovist (equivalent to 25 µmol/kg body
weight).
Imaging
After bolus injection of Primovist, dynamic imaging during arterial,
portovenous, and equilibrium
2002 PRIMOVIST PI
Page 2 of 16
phases utilises the different temporal enhancement pattern of
different liver lesion types to
obtain information about their classification (benign/malignant) and
the specific characterisation.
It further improves visualization of hypervascular liver lesions.
The delayed (hepatocyte) phase starts at about 10 minutes post
injection (in confirmatory
studies most of the data were obtained at 20 minutes post injection)
with an imaging window
last