MAGNEVIST gadopentetate dimeglumine 7.035 g/15mL injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

gadopentetate dimeglumine, Quantity: 469.01 mg/mL

Available from:

Bayer Australia Ltd

INN (International Name):

gadopentetate dimeglumine

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: pentetate meglumine; water for injections; meglumine

Administration route:

Intravenous

Units in package:

1x15mL

Prescription type:

Not scheduled. Not considered by committee

Therapeutic indications:

Using magnetic resonance imaging (MRI) dimeglumine gadopentetate provides contrast enhancement: . in intracranial and spinal lesions in adults and children with abnormal blood-brain barrier, or abnormal vascularity; . in whole body imaging in adult patients, including the neck region, the thoracic and abdominal space, the female breast, the pelvis and the musculoskeletal system. Note: reliable enhancement is not provided in imaging the pancreas and the male reproductive organs (prostate, testis and penis). INDICATIONS AS AT 30 AUGUST 1996: Using magnetic resonance imaging (MRI) dimeglumine gadopentetate provides contrast enhancement; in intracranial and spinal lesions in adults and children, including neonates and infants, with an abnormal blood-brain barrier, or abnormal vascularity; in whole body imaging in adult patients, including the neck region, the thoracic and abdominal space, the female breast, the pelvis and the musculoskeletal system. NOTE: reliable enhancement is not provided in imaging the pancreas and the male reproductive organs (prostate, testis and penis).

Product summary:

Visual Identification: A clear, colourless to slightly yellow solution.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 5 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Licence status A

Authorization date:

1994-05-04

Patient Information leaflet

1710 MAGNEVIST
®
CMI
1
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 O

Summary of Product characteristics

1710 Magnevist PI
1
PRODUCT INFORMATION
MAGNEVIST
®
NAME OF THE MEDICINE
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).
Magnevist Injection is a 0.5 mmol/mL solution of
1-deoxy-1-(methylamino)-D-glucitol
dihydrogen
[_N,N_-bis[2-[bis(carboxymethyl)amino]ethyl]glycinato-(5-)]gadolinate
(2-)
(2:1) with a molecular weight of 938 and has the following structural
formula:
Dimeglumine Gadopentetate (USAN)
Gadopentetate Dimeglumine (INN)
Molecular Formula: C
28
H
54
GdN
5
O
20
CAS Registry No.: 86050-77-3
DESCRIPTION
Magnevist Injection is a sterile, clear, colourless to slightly yellow
aqueous solution
for intravenous administration.
Each mL contains 469 mg dimeglumine gadopentetate, 530 micrograms
meglumine,
1.02 mg meglumine pentetate and water for injections. Magnevist
Injection contains
no antimicrobial preservative.
Magnevist Injection has a pH of 7.0-7.9. Magnevist Injection is
hypertonic under
conditions of use.
N
N
O
N
O
O
O
O
O
O
O
O
O
Gd
C
H
3
NH
2
+
O
H
O
H
H
O
H
H
OH
H
H
OH
2
1710 Magnevist PI
2
PHARMACOLOGY
PHARMACODYNAMICS
Mechanism of Action
Dimeglumine gadopentetate is a paramagnetic agent and, as such, it
develops a
magnetic moment when placed in a magnetic field. The relatively large
magnetic
moment produced by the paramagnetic agent results in a relatively
large local
magnetic field, which can enhance the relaxation rates of water
protons in the vicinity
of the paramagnetic agent.
In MRI, visualisation of normal and pathological tissue depends in
part on variations
in the radiofrequency signal intensity that occur with 1) changes in
proton density; 2)
alteration of the spin lattice or longitudinal relaxation time (T
1
); and 3) variation of the
spin-spin or transverse relaxation time (T
2
). When placed in a magnetic field,
dimeglumine gadopentetate decreases the T
1
and T
2
relaxation time in tissues wh