Ultravist 240

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Iopromide 498.72 mg/mL equivalent to 240 mg iodine

Available from:

Bayer New Zealand Limited

INN (International Name):

Iopromide 498.72 mg/mL (equivalent to 240 mg iodine)

Dosage:

240 mg/mL

Pharmaceutical form:

Solution for infusion

Composition:

Active: Iopromide 498.72 mg/mL equivalent to 240 mg iodine Excipient: Hydrochloric acid as 10% solution Sodium calcium edetate, hydrate Trometamol Water for injection

Units in package:

Bottle, glass, 50mL, 10 dose units

Class:

General sale

Prescription type:

General sale

Manufactured by:

Bayer AG

Therapeutic indications:

For intravascular use and use in body cavities. Contrast enhancement in computerised tomography (CT), arteriography and venography, intravenous/intra-arterial digital subtraction angiography (DSA), intravenous urography, use for ERCP, arthrography and examination of other body cavities. ULTRAVIST 240: Also for intrathecal use. ULTRAVIST 370: Especially for angiocardiography. ULTRAVIST 300/370: Not for intrathecal use.

Product summary:

Package - Contents - Shelf Life: Bottle, glass, 50mL - 10 dose units - 36 months from date of manufacture stored at or below 30°C - Vial, glass, 10mL - 1 dose units - 36 months from date of manufacture stored at or below 30°C - Vial, glass, 10mL - 10 dose units - 36 months from date of manufacture stored at or below 30°C

Authorization date:

1999-05-13

Patient Information leaflet

ULTRAVIST®
1
ULTRAVIST®
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.
1.
WHY AM I GIVEN ULTRAVIST?
ULTRAVIST contains the active ingredient iopromide. ULTRAVIST is a
contrast agent used during an X-ray examination.
For more information, see Section 1. Why am I given ULTRAVIST? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I AM GIVEN ULTRAVIST?
Do not use if you have ever had an allergic reaction to ULTRAVIST 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 OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I am
given ULTRAVIST? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with ULTRAVIST 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 ULTRAVIST?
ULTRAVIST is injected by the doctor, radiographer or nurse into
different parts of your body depending on the area of your
body to be examined.
More instructions can be found in Section 4. How am I given ULTRAVIST?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE RECEIVING ULTRAVIST?
THINGS YOU
SHOULD DO
Tell your doctor, radiographer or nurse if you have:
•
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
•
experience any asthma symptoms e.g. chest tightening.
DRIVING OR USING
MACHINES
Avoid driving a car or operating machinery for 24 hours after
receiving ULTRAVIST
LABORATORY TEST
ULTRAVIST can affect the results of some thyroid tests up to several
weeks after receiving it.
LOOKING AFTER
YOUR MEDICINE
The X-Ray unit will store ULTRAVIST

Summary of Product characteristics

220125 ULTRAVIST DS – CCDS v15 & v16
Page 1 of 21
NEW ZEALAND DATA SHEET
ULTRAVIST
® (IOPROMIDE)
1.
NAME OF THE MEDICINE
Iopromide
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Ultravist 240 solution for injection / infusion contains 499 mg of
iopromide per mL, equivalent
to 240 mg iodine
Ultravist 300 solution for injection/infusion contains 623 mg of
iopromide per mL, equivalent
to 300 mg iodine
Ultravist 370 solution for injection/infusion contains 769 mg of
iopromide per mL, equivalent
to 370mg iodine
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
ULTRAVIST solution for injection/infusion is a clear, colourless to
pale yellow solution, free of
particles and has a pH of 6.5 - 8.0. It contains no antimicrobial
preservatives.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
This medicine is for diagnostic use only.
For intravascular use and use in body cavities.
Contrast enhancement in computerised tomography (CT), arteriography
and venography,
intravenous/intra-arterial digital subtraction angiography (DSA),
intravenous urography, use
for ERCP, arthrography and examination of other body cavities.
ULTRAVIST 240: Also for intrathecal use.
ULTRAVIST 370: Especially for angiocardiography.
ULTRAVIST 300 / 370: Not for intrathecal use.
4.2
DOSE AND METHOD OF ADMINISTRATION
ADMINISTRATION TECHNIQUE
_VISUAL INSPECTION PRIOR TO USE _
Contrast media should be visually inspected prior to use and must not
be used in the
presence of particulate matter (including crystals), if discoloured,
or if the container is
defective in any way. As ULTRAVIST is a highly concentrated solution,
crystallisation
(evident as a milky-cloudy appearance and/or sediment or floating
crystals) may occur very
rarely.
220125 ULTRAVIST DS – CCDS v15 & v16
Page 2 of 21
_WARMING PRIOR TO USE _
Contrast media that are warmed to body temperature before
administration are better
tolerated and can be injected more easily because of reduced
viscosity.
ULTRAVIST
must
not
be
mixed
with
any
other
medicines,
su