Primovist

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Gadoxetate disodium 181.43 mg/mL (Manufactured in-situ from gadolinium oxide and ethoxybenzyl DTPA)

Available from:

Bayer New Zealand Limited

INN (International Name):

Gadoxetate disodium 181.43 mg/mL (Manufactured in-situ from gadolinium oxide and ethoxybenzyl DTPA)

Dosage:

181.43 mg/mL

Pharmaceutical form:

Solution for injection

Composition:

Active: Gadoxetate disodium 181.43 mg/mL (Manufactured in-situ from gadolinium oxide and ethoxybenzyl DTPA) Excipient: Hydrochloric acid As 3.6% w/w aqueous solution Caloxetate complexing agent Sodium hydroxide Trometamol Water for injection

Units in package:

Syringe, Pre-filled, unit dose 10 ml syringe, 1 dose unit

Class:

General sale

Prescription type:

General sale

Manufactured by:

Bayer AG

Therapeutic indications:

For use in adults for the enhancement of magnetic resonance imaging (MRI) of focal liver lesions

Product summary:

Package - Contents - Shelf Life: Syringe, glass, Pre-filled, 10 ml syringe - 1 dose units - 60 months from date of manufacture stored at or below 30°C - Syringe, plastic, Pre-filled, 10 mL in 10 mL syringe - 1 dose units - 36 months from date of manufacture stored at or below 30°C - Syringe, plastic, Pre-filled, 5 mL in 10 mL syringe - 1 dose units - 36 months from date of manufacture stored at or below 30°C - Syringe, plastic, Pre-filled, 10 mL in 10 mL syringe - 5 dose units - 36 months from date of manufacture stored at or below 30°C - Syringe, plastic, Pre-filled, 5 mL in 10 mL syringe - 5 dose units - 36 months from date of manufacture stored at or below 30°C - Syringe, plastic, Pre-filled, 10 mL in 10 mL syringe - 10 dose units - 36 months from date of manufacture stored at or below 30°C - Syringe, plastic, Pre-filled, 5 mL in 10 mL syringe - 10 dose units - 36 months from date of manufacture stored at or below 30°C

Authorization date:

2011-06-07

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

180916 PRIMOVIST DS
1
DATA SHEET
PRIMOVIST
Gadoxetate disodium 181.43 mg/mL
1
PRODUCT NAME
PRIMOVIST (181.43 mg/mL solution for injection)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
PRIMOVIST contains gadoxetate disodium 181.43 mgl/mL as the active
ingredient.
Each 1 mL of the MRI contrast agent PRIMOVIST contains 0.25 mmol
disodium
gadoxetate (equivalent to 181.43 mg disodium gadoxetate as the active
ingredient).
Each mL contains 0.511 mmol (equivalent to 11.755 mg) of sodium (See
Section 4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE).
PRIMOVIST contains no antimicrobial preservative.
For the full list of excipients, see Section 6.1.
3
PHARMACEUTICAL FORM
PRIMOVIST is a clear, colourless to pale yellow solution for injection
The physico-chemical properties of PRIMOVIST are listed below:
Osmolality at 37°C (mOsm/kg H
2
O)
688
Density at 37°C (g/mL)
1.0881
Viscosity at 37°C (mPa·s)
1.19
pH
6.8 – 8.0
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.
180916 PRIMOVIST DS
2
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.
Dose
The lowest effective dose should be used.
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
mL/kg body weight PRIMOVIST (equivalent to 25 µmol/kg body weight).
Imaging
After bolus injection of PRIMOVIST, dynamic imaging during arterial,
portovenous,
and eq