Magnevist (pre-filled syringe)

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Meglumine gadopentetate 469 mg/mL (Formed from gadolinium oxide, diethylenetriamine pentetic acid & meglumine)

Available from:

Bayer New Zealand Limited

INN (International Name):

Meglumine gadopentetate 469 mg/mL (Formed from gadolinium oxide, diethylenetriamine pentetic acid & meglumine)

Dosage:

469 mg/mL

Pharmaceutical form:

Solution for injection

Composition:

Active: Meglumine gadopentetate 469 mg/mL (Formed from gadolinium oxide, diethylenetriamine pentetic acid & meglumine) Excipient: Meglumine Pentetic acid Water for injection

Units in package:

Syringe, glass, 10 mL

Class:

General sale

Prescription type:

General sale

Manufactured by:

Bayer AG

Therapeutic indications:

For diagnostic use by intravenous administration only. Cranial and Spinal Magnetic Resonance Imaging (MRI) In particular for the demonstration of tumours and for further differential-diagnostic clarification in suspected meningioma, (acoustic) neurinoma, invasive tumours (e.g. glioma) and metastases; for the demonstration of small and/or isointense tumours; in suspected recurrence after surgery or radiotherapy; for the differentiated demonstration of rare neoplasms such as haemangioblastomas, ependymomas and small pituitary adenomas; for improved determination of the spread of tumours not of cerebral origin. Additionally in spinal MRI: Differentiation of intra- and extramedullary tumours; demonstration of solid tumour areas in known syrinx; determination of intramedullary tumour spread. Whole Body MRI Including the facial skull, the neck region, the thoracic and abdominal space, the female breast, the pelvis and the active and passive locomotive apparatus and imaging of vessels throughout the body. In particular, Magnevist permits diagnostic information: · For the demonstration or exclusion of tumours, inflammation and vascular lesions; · For determination of the spread and demarcation of these lesions; · For the differentiation of the internal structure of lesions; · For assessment of the circulatory situation of normal and pathologically changed tissues; · For the differentiation of tumour and scar tissue after therapy; · For the recognition of recurrent prolapse of a disk after surgery. · For the semi-quantitative evaluation of the renal function combined with anatomical organ diagnosis.

Product summary:

Package - Contents - Shelf Life: Syringe, glass, 20mL - 5 dose units - 60 months from date of manufacture stored at or below 30°C - Syringe, glass, 15mL - 5 dose units - 60 months from date of manufacture stored at or below 30°C - Syringe, glass, 10mL - 5 dose units - 60 months from date of manufacture stored at or below 30°C - Syringe, plastic, Pre-filled 15mL fill in 20 mL - 5 dose units - 36 months from date of manufacture stored at or below 30°C. Do not freeze - Syringe, plastic, Pre-filled 10mL fill in 10 mL - 5 dose units - 36 months from date of manufacture stored at or below 30°C. Do not freeze

Authorization date:

1995-09-12

Patient Information leaflet

MAGNEVIST
®
(MAG·NE
⋅
VIST)
_DIMEGLUMINE GADOPENTETATE _
_ _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET
This leaflet answers some
common questions about
Magnevist. It does not contain
all the available information. It
does not take the place of talking
to your doctor.
All diagnostic agents have risks
and benefits. Your doctor has
weighed the risks of you using
Magnevist against the benefits
they expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
USING THIS DIAGNOSTIC AGENT, ASK
YOUR DOCTOR OR RADIOLOGIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT MAGNEVIST IS
USED FOR
Magnevist is used at the same
time as magnetic resonance
imaging (MRI) to aid in the
detection of abnormalities in the
brain, spinal cord, neck, chest,
abdomen, pelvis, bones and
muscles in adults; and in the
brain and spinal cord in children
and babies.
MRI is a form of medical
diagnostic imaging that forms
pictures after detecting water
molecules in normal and
abnormal tissues. This is done
using a complex system of
magnets and radiowaves.
Magnevist is a liquid that alters
the way in which the MRI
machine detects certain tissues
within the body. Magnevist often
makes the pictures clearer and
often shows things that may not
have been visible using MRI
alone.
Magnevist is only available at
MRI units for use in conjunction
with MRI
.
ASK YOUR DOCTOR IF YOU HAVE
ANY QUESTIONS ABOUT WHY
MAGNEVIST IS BEING USED IN YOU.
Your doctor may be using it for
another reason.
BEFORE YOU ARE
GIVEN MAGNEVIST
_WHEN YOU MUST NOT BE _
_GIVEN IT _
YOU MUST NOT BE GIVEN
MAGNEVIST IF YOU HAVE AN
ALLERGY TO:
• dimeglumine gadopentetate,
the active ingredient in
Magnevist
• any of the ingredients listed at
the end of this leaflet.
Some of the symptoms of an
allergic reaction may include:
• shortness of breath
• wheezing or difficulty
breathing
• swelling of the face, lips,
tongue or other parts of the body
• rash, itching or hives on the
skin.
YOU MUST NOT BE GIVEN
MAGNEVIST IF YOU HAVE SEVERE
DISTURBANCES OF KIDNEY
FUNCTION

Summary of Product characteristics

180916 MAGNEVIST DS
1
DATA SHEET
MAGNEVIST
DIMEGLUMINE GADOPENTETATE 469 MG/ML
1
PRODUCT NAME
MAGNEVIST (469 mg/mL solution for injection)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
MAGNEVIST contains dimeglumine gadopentetate 469 mg/mL as the active
ingredient.
MAGNEVIST (dimeglumine gadopentetate) solution for intravenous
injection is the
N-methylglucamine salt of the gadolinium complex of diethylenetriamine
pentaacetic
acid, and is an injectable contrast medium for magnetic resonance
imaging (MRI).
For the full list of excipients, see Section 6.1
.
3
PHARMACEUTICAL FORM
MAGNEVIST injection is a sterile, clear, colourless to slightly yellow
solution for
intravenous injection.
The physico-chemical properties of Magnevist are listed below:
Osmolality (Osm/kg H
2
O)
At 37
o
C
1.96
Viscosity (mPa·s)
At 20
o
C
At 37
o
C
4.9
2.9
pH - value
7.0 - 7.9
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For diagnostic use by intravenous administration only.
CRANIAL AND SPINAL MAGNETIC RESONANCE IMAGING (MRI)
In particular for the demonstration of tumours and for further
differential-diagnostic
clarification in suspected meningioma, (acoustic) neurinoma, invasive
tumours (e.g.
glioma) and metastases; for the demonstration of small and/or
isointense tumours; in
suspected recurrence after surgery or radiotherapy; for the
differentiated
demonstration of rare neoplasms such as haemangioblastomas,
ependymomas and
180916 MAGNEVIST DS
2
small pituitary adenomas; for improved determination of the spread of
tumours not of
cerebral origin.
Additionally in spinal MRI: Differentiation of intra- and
extramedullary tumours;
demonstration of solid tumour areas in known syrinx; determination of
intramedullary
tumour spread.
WHOLE BODY MRI
Including the facial skull, the neck region, the thoracic and
abdominal space, the
female breast, the pelvis and the active and passive locomotive
apparatus and
imaging of vessels throughout the body.
_ _
In particular, MAGNEVIST permits diagnostic information:
•
For the demonstration or exclusion of