Gadovist 1.0

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Gadobutrol 604.72mg equivalent to 1 mmol/mL

Available from:

Bayer New Zealand Limited

INN (International Name):

Gadobutrol 604.72 mg (equivalent to 1 mmol/mL)

Dosage:

1 mmol/mL

Pharmaceutical form:

Solution for injection

Composition:

Active: Gadobutrol 604.72mg equivalent to 1 mmol/mL Excipient: Calcobutrol Hydrochloric acid Trometamol Water for injection

Units in package:

Syringe, 5mL prefilled syringes, 5 dose units

Class:

General sale

Prescription type:

General sale

Manufactured by:

Bayer AG

Therapeutic indications:

Gadovist 1.0 is indicated in adults and children of all ages including full-term newborns for: · Contrast enhancement in cranial and spinal magnetic resonance imaging (MRI). For spinal MRI this includes: Differentiation of intra- and extramedullary tumours, demonstration of solid tumour areas in known syrinx, determination of intramedullary tumour spread. Gadovist 1.0 is especially suited for high dose indications, such as cases where the exclusion or demonstration of additional foci may influence the therapy or patient management, for detection of very small lesions and for visualisation of lesions that do not readily take up contrast media. Gadovist 1.0 is also indicated for perfusion studies such as the diagnosis of stroke, the detection of focal cerebral ischaemia and tumour perfusion. · Contrast enhancement in whole body MRI including head and neck region, thoracic space, breast, abdomen (pancreas, liver and spleen), pelvis (prostate, bladder and uterus), retroperitoneal space (kidney), extremities and musculoskeletal system. · Contrast enhancement in magnetic resonance angiography (CE MRA). · Contrast enhancement in cardiac MRI including assessment of rest and pharmacological stress perfusion and delayed enhancement.

Product summary:

Package - Contents - Shelf Life: Syringe, glass, 10 mL prefilled syringe - 5 dose units - 36 months from date of manufacture stored at or below 30°C 24 hours opened stored at or below 25°C - Syringe, glass, 5 mL prefilled syringes - 5 dose units - 36 months from date of manufacture stored at or below 30°C 24 hours opened stored at or below 25°C - Syringe, glass, 7.5 mL in 10 mL prefilled syringes - 5 dose units - 36 months from date of manufacture stored at or below 30°C 24 hours opened stored at or below 25°C - Syringe, plastic, 20 mL prefilled syringe - 5 dose units - 36 months from date of manufacture stored at or below 30°C 24 hours opened stored at or below 25°C - Syringe, plastic, 15 mL prefilled syringe - 5 dose units - 36 months from date of manufacture stored at or below 30°C 24 hours opened stored at or below 25°C - Syringe, plastic, 10 mL prefilled syringe - 5 dose units - 36 months from date of manufacture stored at or below 30°C 24 hours opened stored at or below 25°C - Syringe, plastic, 7.5 mL in 10 mL prefilled syringe - 5 dose units - 36 months from date of manufacture stored at or below 30°C 24 hours opened stored at or below 25°C - Syringe, plastic, 5 mL prefilled syringe - 5 dose units - 36 months from date of manufacture stored at or below 30°C 24 hours opened stored at or below 25°C - Vial, glass, 2 mL vials - 1 dose units - 60 months from date of manufacture stored at or below 30°C 24 hours opened stored at or below 25°C - Vial, glass, 2 mL vials - 3 dose units - 60 months from date of manufacture stored at or below 30°C 24 hours opened stored at or below 25°C - Vial, glass, 15 mL vials - 10 dose units - 36 months from date of manufacture stored at or below 30°C 24 hours opened stored at or below 25°C

Authorization date:

1970-01-01

Patient Information leaflet

GADOVIST® 1.0
1
GADOVIST® 1.0
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 GADOVIST 1.0?
GADOVIST 1.0 contains the active ingredient gadobutrol. GADOVIST 1.0
is a contrast agent used during a magnetic resonance
imaging (MRI) examination.
For more information, see Section 1. Why am I given GADOVIST 1.0? in
the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I AM GIVEN GADOVIST 1.0?
Do not use if you have ever had an allergic reaction to GADOVIST 1.0
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 GADOVIST 1.0? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with GADOVIST 1.0 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 GADOVIST 1.0?
GADOVIST 1.0 is injected into your vein by a doctor, radiographer or
nurse immediately before or during your MRI
examination.
It is recommended that you do not eat for 2 hours before you are given
GADOVIST 1.0.
More instructions can be found in Section 4. How am I given GADOVIST
1.0? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE RECEIVING GADOVIST 1.0?
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
•
have very poor kidney function or severe kidney problems
•
had a liver transplant,

Summary of Product characteristics

210730 GADOVIST 1.0 DS
Page 1 of 20
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
GADOVIST
®
1.0 (1.0 mmol/mL) Solution for Intravenous Injection.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Gadobutrol 604.72 mg/mL (1.0 mmol/mL)
GADOVIST 1.0 is available as a 1.0 mmol/mL solution and each mL of
GADOVIST 1.0
contains 604.72 mg gadobutrol.
GADOVIST 1.0 M is a solution containing 604.72 mg/mL gadobutrol.
Excipient with known effect: Each mL contains 0.00056 mmol (equivalent
to 0.013 mg) of
sodium. Based on the average amount given to a 70 kg person, this
medicinal product
contains less than 1 mmol sodium (23 mg) per dose (see section 4.4).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for Intravenous Injection in prefilled syringe or vial.
TABLE 1: PHYSICO-CHEMICAL PROPERTIES OF GADOVIST 1.0
Contrast Medium Concentration
GADOVIST 1.0
(mg/mL)
(mmol/mL)
604.72
1.0
Osmolarity at 37º C
(mOsm/L solution)
1117
Osmolality at 37º C
(mOsm/kg H
2
O)
1603
Viscosity at 37º C (mPa.s)
4.96
GADOVIST 1.0 solution has a pH of 6.6 to 8.0
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
This medicinal product is for diagnostic use only.
GADOVIST 1.0 is indicated in adults and children of all ages including
full-term newborns for:
CONTRAST ENHANCEMENT IN CRANIAL AND SPINAL MAGNETIC RESONANCE IMAGING
(MRI).
For
spinal
MRI
this
includes:
Differentiation
of
intra-
and
extramedullary
tumours,
demonstration of solid tumour areas in known syrinx, determination of
intramedullary tumour
spread.
210730 GADOVIST 1.0 DS
Page 2 of 20
GADOVIST 1.0 is especially suited for high dose indications, such as
cases where the
exclusion
or
demonstration
of
additional
foci
may
influence
the
therapy
or
patient
management, for detection of very small lesions and for visualisation
of lesions that do not
readily take up contrast media.
GADOVIST 1.0 is also indicated for perfusion studies such as the
diagnosis of stroke, the
detection of focal cerebral ischaemia and tumour perfusion.
Contrast enhancement in whole body MRI inclu