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MAGNEVIST 2 MMOL/L SOLUTION FOR INJECTION

Active substance: GADOPENTETIC ACID DIMEGLUMINE SALT

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Magnevist 2 mmol/l is used together with a technique called
Magnetic Resonance Imaging (MRI) to create artificial contrast
or enhancement to help make an MRI scan of your joints
clearer.
MRI is a modern scanning technique which produces very high
quality pictures of various parts of your body without using
X-rays. The use of MRI can provide a quick, early and accurate
diagnosis.
The scanner uses a strong magnetic field and radiowaves to
measure the magnetic properties of body tissues. Using a
computer, this information is converted into a black and white
picture which can help your doctor see and investigate the
differences between normal and abnormal tissue.
Sometimes MRI is used in areas where it cannot produce a clear
black and white picture. This is when Magnevist 2 mmol/l is
used. Magnevist 2 mmol/l produces a clearer image and allows
the doctor to see the area of interest better. Sometimes several
scans will be taken before Magnevist 2 mmol/l is injected and
then further scans taken after the injection.
This medicine is for diagnostic use only.

1. What Magnevist 2 mmol/l is and what it is
used for

What is in this leaflet
1. What Magnevist 2 mmol/l is and what it is used for
2. What you need to know before you are given Magnevist
2 mmol/l
3. How you will be given Magnevist 2 mmol/l
4. Possible side effects
5. How to store Magnevist 2 mmol/l
6. Contents of the pack and other information

Do not use Magnevist 2 mmol/l:
R if you are allergic to dimeglumine gadopentetate or any of
the other ingredients of this medicine (listed in section 6)
R if you have a heart pacemaker or if there are any implants or
clips containing iron inside your body. (This is not because of
an interaction with Magnevist 2 mmol/l but because if you
have any of these, you should not be placed in a strong
magnetic field).
Warnings and precautions
Talk to your radiologist or MRI-centre staff before receiving
Magnevist 2 mmol/l
Your doctor will need to take special care when giving you
Magnevist 2 mmol/l if:
R you have a history of allergy (e.g. hay fever, hives), asthma,
or have had a reaction to another type of contrast media.
This is because you may be more likely to have an allergic
reaction. If you have had any of these in the past, tell the
radiologist or MRI-centre staff.
R you have an infected joint.
Before you receive Magnevist 2 mmol/l, you must tell the
radiographer or MRI-centre staff if any of these apply to you.
Other medicines and Magnevist 2 mmol/l
Tell the radiologist or MRI-centre staff if you are taking, have
recently taken or might take any other medicines.

2. What you need to know before you are given
Magnevist 2 mmol/l

3. How you will be given Magnevist 2 mmol/l

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You will be asked to sit or lie down and Magnevist 2 mmol/l will
be injected into the joint which is being investigated. Scanning
may start immediately after the Magnevist 2 mmol/l injection.
The MRI staff will observe you for at least 30 minutes after the
injection just in case you have any side effects.
Adults:
The dose of Magnevist 2 mmol/l varies depending on which
joint is investigated. For most joints, 20 ml is used, but up to
50 ml may be used for the knee joint. The doctor will decide
how much Magnevist 2 mmol/l is needed for your investigation.
Children:
Magnevist 2 mmol/l is not recommended for use in children.
If you receive more Magnevist 2 mmol/l than you should
Overdosing is unlikely. If this does occur no serious ill-effects
are expected.
If you have any further questions on the use of this medicine, ask
the MRI-centre staff.

Volume required
15-20 ml
~ 10 ml
4 ml
1-2 ml
10-20 ml
25-50 ml
12-20 ml
Paediatric population:
The safety and efficacy of Magnevist 2 mmol/l in children aged
up to 18 years has not yet been established. No data are
available. Magnevist 2 mmol/l is not recommended in the
paediatric age group until further data become available.
Method of administration
The dose required is administered via intraarticular injection
under strict aseptic technique and according to the instructions
provided in section 6.6.
Contrast-enhanced MRI can be commenced immediately
afterwards.
4.3 Contraindications
Hypersensitivity to the active substance or to any of the
excipients listed in section 6.1.

Joint
Shoulder
Elbow
Wrist
Finger joint
Hip
Knee
Ankle

4.1 Therapeutic indications
For contrast enhancement in direct magnetic resonance
arthrography.
This medicinal product is for diagnostic use by intraarticular
administration only.
4.2 Posology and method of administration
The usual precautions for MRI (e.g. exclusion of cardiac
pacemakers and other ferro-magnetic objects including
vascular clips etc) must be observed.
Posology
The recommendations for the use of Magnevist 2 mmol/l apply
to a field strength between 0.2 Tesla and 1.5 Tesla.
Intraarticular administrations of contrast agents are to be
given with the patient lying or sitting. After the end of the
injection, the patient should be kept under supervision for at
least half an hour.
Adults:
In general, for all joints the administration of up to 20 ml (knee
joint up to 50 ml) Magnevist 2 mmol/l is sufficient for good
opacification and to answer all the relevant clinical questions.
A volume leading to a slight distension of the joint capsule
should be injected. Only so much contrast medium should be
injected until discrete resistance is felt and/or the patient
experiences a mild feeling of pressure.
Guidelines on volumes to be administered:

4. CLINICAL PARTICULARS

Solution for injection.

3. PHARMACEUTICAL FORM

1 ml aqueous solution contains 1.876 mg gadopentetic acid,
dimeglumine salt as active ingredient (equivalent to
0.002 mmol gadopentetic acid, dimeglumine, containing
0.32 mg gadolinium).
Excipient with known effect: sodium chloride
Magnevist 2 mmol/ contains 3.4 mg sodium per ml.
For the full list of excipients, see section 6.1.

2. QUALITATIVE AND QUANTITATIVE
COMPOSITION

Magnevist 2 mmol/l solution for injection

1. NAME OF THE MEDICINAL PRODUCT

4.4 Special warnings and precautions for use
Strict aseptic technique is required to prevent infection.
Fluoroscopic control should be used to ensure proper needle
placement and prevent extracapsular injection. Undue pressure
should not be exerted during injection.
Intraarticular injections of Magnevist 2 mmol/l should be
avoided in infected joints.
R Hypersensitivity
Severe systemic hypersensitivity reactions cannot be totally
excluded (see section 4.8).
Mild angioedema, conjunctivitis, coughing, pruritus, rhinitis,
sneezing and urticaria, which can occur irrespective of the
amount administered and the mode of administration, may be
the first signs of incipient state of shock.
As with other contrast agents, delayed reactions may occur
(hours later or up to several days).
As with other contrast enhanced diagnostic procedures, postprocedure observation of the patient is recommended.
Medication for the treatment of hypersensitivity reactions as
well as readiness for institution of emergency measures are
necessary. Appropriate drugs and instruments
(e.g. endotracheal tube and ventilator) must be readily
available.
The risk of hypersensitivity reactions is higher in case of:
P previous reaction to contrast media,
P history of bronchial asthma,
P history of allergic disorders
The decision to use Magnevist 2 mmol/l must be made after
particularly careful evaluation of the risk-benefit-ratio in
patients with an allergic disposition.
R Magnevist 2 mmol/l contains sodium
This medicinal product contains 3.4 mg sodium per ml. To be
taken into consideration by patients on a controlled sodium diet.
4.5 Interaction with other medicinal products and other
forms of interaction
As for all other gadolinium containing contrast media, no
interactions with other medicaments have been observed.
Formal drug interaction studies have not been carried out. See
also section 6.2.
Magnevist should be administered without the addition of
iodinated contrast media as iodinated contrast media reduce
the level of contrast achievable with Magnevist (see section 6.6).
4.6 Fertility, pregnancy and lactation
R Pregnancy
For gadopentetic acid, dimeglumine no clinical study data on
exposed pregnancies are available. Animal studies do not
indicate direct or indirect harmful effects with respect to
embryonal / foetal development (see section 5.3).
Caution should be exercised using Magnevist 2 mmol/l in
pregnant women.
R Breast-feeding
No data exist concerning intra-articular administration in
lactating women. After intravascular use minimal amounts of
gadopentetic acid, dimeglumine salt (a maximum of 0.04%) of
the intravenously administered dose enters the breast milk.
From experience gained so far, harm to the breast-fed infant is
considered unlikely.
4.7 Effects on ability to drive and use machines
No effects of Magnevist 2 mmol/l on driving ability and use of
machinery can be expected. However, joint effusion may affect
the ability to drive due to a limited joint mobility.

dimeglumine gadopentetate

dimeglumine gadopentetate

Read all of this leaflet carefully before you are given this
medicine because it contains important information for you.
R Keep this leaflet. You may need to read it again.
R If you have any further questions, please ask the doctor
giving you Magnevist 2 mmol/l (the radiologist) or the
hospital/MRI-centre staff.
R If you get any side effects, talk to your doctor, radiologist or
the hospital/MRI-centre staff. This includes any possible side
effects not listed in this leaflet. See section 4.

Magnevist® 2 mmol/l solution for injection

Magnevist® 2 mmol/l solution for injection
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant
or are planning to have a baby, ask the MRI-centre staff for
advice before receiving this medicine. A very small amount of
Magnevist enters the breast milk, but this isn’t likely to cause
any harm.
Driving and using machines
The volume of Magnevist 2 mmol/l injected into your joint may
limit your movement. Do not drive if your movement is
affected.
Magnevist 2 mmol/l contains sodium
This medicinal product contains 3.4 mg sodium per ml. To be
taken into consideration by patients on a controlled sodium diet.

Summary of Product Characteristics

Digitally signed by Claudia
Majcherek
DN: o=Bayer Group,
ou=SignCert,
0.9.2342.19200300.100.1.1=s
gpfv, cn=Claudia Majcherek
Date: 2015.07.16 10:21:31
+02'00'

Claudia
Majchere
k

Package Leaflet: Information for the user

Injection site
pain/
Injection site
(joint)
pressure
sensation

Common
(≥1/100 to
<1/10)

Uncommon Rare
(≥1/1,000 to (≥1/10,000
<1/100)
to <1/1,000)
Headache
Dizziness
Vasovagal
reaction
Nausea
Vomiting

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5.1 Pharmacodynamic properties
Pharmacotherapeutic group: paramagnetic contrast media,
ATC code: V08CA01
Magnevist 2 mmol/l is a paramagnetic contrast agent for
magnetic resonance imaging. The contrast-enhancing effect is
mediated by the di-N-methylglucamine salt of gadopentetic
acid, dimeglumine - the gadolinium complex of pentetic acid
(diethylene triamine pentaacetic acid = DTPA). When a suitable
scanning sequence (e.g. T1-weighted spin-echo technique) is
used in proton magnetic resonance imaging, the gadolinium
ion-induced shortening of the spin-lattice relaxation time of
excited atomic nuclei leads to an increase of the signal
intensity and, hence, to an increase of the image contrast of
certain tissues.

5. PHARMACOLOGICAL PROPERTIES

The most appropriate MedDRA term is used to describe a
reaction and its synonyms and related conditions.
R Immune system disorders/Hypersensitivity/Allergic reaction
Systemic hypersensitivity may occur rarely in the form of skin
reactions. The possibility of a severe hypersensitivity reaction
cannot be totally excluded (see section 4.4).
R General disorders and administration site conditions
Injection of Magnevist 2 mmol/l into the joint is commonly
associated with transient discomfort, e.g. pressure and pain due
to the injected volume. Severe pain may often result from
undue use of pressure or the injection of large volumes.
Other adverse reactions commonly known from intravenous
injection of gadolinium chelates were so far not observed with
Magnevist 2 mmol/l, due to the low dose and the topical
administration.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the
medicinal product is important. It allows continued monitoring
of the benefit/risk balance of the medicinal product. Healthcare
professionals are asked to report any suspected adverse reactions
via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
4.9 Overdose
No signs of intoxication secondary to an overdose have so far
been observed or reported on clinical use.

Nervous system
disorders
Vascular
disorders
Gastrointestinal
disorders
General
disorders and
administration
site conditions

System Organ
Class

4.8 Undesirable effects
Frequency of adverse reactions from clinical trial data
Based on experience in more than 4,900 patients, the
undesirable effects listed below have been observed and
classified by investigators as drug-related.
Adverse reactions with the use of Magnevist 2 mmol/l are usually
of mild to moderate intensity.
The most frequently reported reactions were local injection site
reactions, i.e. injection site pain and joint pressure sensations
which are mainly related to the procedure itself.
The table below reports adverse reactions by MedDRA system
organ classes (MedDRA SOCs).

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Packaging Technology Berlin sgmgj
page 1
Bayer Pharma AG
client: 0021
item-no.: 84618314
PZ: 2589C-3
code-no.: 292
name: LF-INS-Magnevist 2MMOL PFS
country: GB/-/BPH
colors: Black
version: 10.07.2015/04
approval:
dimension: 297 x 594 mm

1.01
1.00
4.8-8.0

1.03
0.71

0.29

1.88

5.2 Pharmacokinetic properties
The pharmacokinetic properties of gadopentetic acid,
dimeglumine have been extensively studied after intravenous
and oral administration in doses exceeding the amount injected
intraarticularly.
After intraarticular injection the compound distributes in the
synovial fluid and diffuses into the interstitial space. Marginal
uptake into the cartilage is completely reversible.
After distribution in the extracellular space primarily through
diffusion controlled processes, the gadopentetic acid,
dimeglumine is eliminated unmetabolised via the kidneys by
glomerular filtration.
5.3 Preclinical safety data
Non-clinical data reveal no special hazard for humans based on
conventional studies of systemic toxicity, genotoxicity,
carcinogenic potential, toxicity to reproduction and contact
sensitising potential.
R Local tolerance
Experimental local tolerance studies with gadopentetic acid,
dimeglumine (at a concentration of 500 mmol/l) following
single subcutaneous and intramuscular administration in
animals indicated that slight local intolerance reactions could
occur at the injection site after inadvertent administration.

Contrast medium concentration
(mg/ml)
Osmolality (Osm/kg H2O)
At 37°C
Viscosity (mPa·s)
At 20°C
At 37°C
Density (g/ml)
At 20°C
At 37°C
pH-value

Magnevist 2 mmol/l

Gadopentetic acid, dimeglumine is a highly paramagnetic
compound which leads to distinct shortening of relaxation
times, even in low concentrations. The paramagnetic efficacy,
the relaxivity (determined from the influence on the spin-lattice
relaxation time of protons) is 3.67 in water and about
4.95 l/mmol/sec in plasma, and displays only slight
dependency on the strength of the magnetic field.
The concentration of Magnevist 2 mmol/l corresponds to 1/250 of
the concentration used for i.v. administration. This concentration
is sufficient to allow adequate imaging efficacy even after further
dilution with joint effusion. If the joint cavity is filled with
gadolinium-containing fluid, the signal in the cavity increases on
use of T1-weighted sequences, i.e. it becomes bright and contrasts
clearly with all structures with a weak or intermediate signal (i.e.
all intraarticular structures: hyaline and fibrous cartilage, all
ligaments, tendons and the joint capsule). While normal, or even
increased, joint fluid does not differ in its signal behaviour in
T1-weighted images from all the other anatomical structures
apart from fibrocartilage, the intraarticular administration of
Magnevist 2 mmol/l leads to distinctly improved contrast
situations.
DTPA forms a firm complex with the paramagnetic gadolinium
ion with extremely high in vivo and in vitro stability
(log K = 22 - 23). The dimeglumine salt of gadopentetic acid,
dimeglumine is a highly water-soluble, extremely hydrophilic
compound with a distribution coefficient between n-butanol and
buffer at pH 7.6 of about 0.0001. The substance does not display
any particular protein binding or inhibitory interaction with
enzymes (e.g. myocardial Na+ and K+ ATPase). Magnevist 2 mmol/l
does not activate the complement system and, therefore,
probably has a very low potential for inducing anaphylactoid
reactions.
Based on clinical experience, impairment of hepatic, renal or
cardiovascular function is not expected.
The physico-chemical properties of Magnevist 2 mmol/l listed
below are:

4. Possible side effects

to be updated once the variation is approved
Legal category: POM

10. DATE OF REVISION OF THE TEXT

01 May 2008/23 February 2009

9. DATE OF FIRST AUTHORISATION / RENEWAL OF
THE AUTHORISATION

PL 00010/0544

8. MARKETING AUTHORISATION NUMBER

Bayer plc
Bayer House
Strawberry Hill
Newbury
Berkshire
RG14 1JA

7. MARKETING AUTHORISATION HOLDER

Like all medicines, this medicine can cause side effects, although
not everybody gets them.
Side effects you may get after being given a contrast medium
like Magnevist 2 mmol/l are usually mild to moderate.
If you notice:
R itching of the skin, rash, wheals on the skin (urticaria)
R difficulty breathing, gagging, feeling of suffocation
R swelling of the face, neck or body
R itchy or watery eyes, tickling in the throat or nose,
hoarseness, coughing or sneezing
R headache, dizziness, feeling faint
R feeling particularly hot or cold, sweating
R paleness or reddening of the skin
R chest pain, cramp, tremor
R feeling sick
Tell the radiologist or MRI staff immediately as these may be
the first signs of allergic reaction or shock. Your investigation
will need to be stopped and you may need further treatment.
Apart from the symptoms listed above, these are the possible
side effects of Magnevist 2 mmol/l, starting with the more
common ones:
Common
may affect up to 1 in 10 people
R sensations or reactions at the injection site (such as pain,
joint pressure and temporary discomfort)
Uncommon
may affect up to 1 in 100 people
R feeling sick
R dizziness
R headache
Rare
may affect up to 1 in 1,000 people
R being sick
R slowed heartbeat; lowered blood pressure; fainting
R allergic-type skin reactions including itching, redness,
wheals on the skin

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients
pentetic acid
meglumine
sodium chloride
water for injections
6.2 Incompatibilities
In the absence of compatibility studies, this medicinal product
must not be mixed with other medicinal products.
6.3 Shelf life
3 years
6.4 Special precautions for storage
None
6.5 Nature and contents of container
Colourless Type I, glass pre-filled syringe with chlorinated butyl
rubber stopper and combined luer lock adapter, tip cap
(chlorobutyl rubber), safety cap.
Pack size: syringe containing 20 ml of Magnevist solution;
individual syringe is blister packaged, with one syringe per carton.
6.6 Special precautions for disposal and other handling
The prefilled syringe must be taken from the pack and prepared
for the injection immediately before the examination and
injected under sterile conditions.
The tip cap should be removed from the prefilled syringe
immediately before use.
Any contrast medium solution not used in one examination
must be discarded.
Mixture of Magnevist 2 mmol/l with X-ray contrast media
before injection is not recommended as it may reduce efficacy.
The minimal amount of X-ray contrast medium required for
control of the needle position in the joint may be separately
injected prior to the administration of Magnevist 2 mmol/l
(0.5 ml to a maximum of 1.0 ml).
What Magnevist 2 mmol/l contains
R The active substance is dimeglumine gadopentetate.
1 ml Magnevist 2 mmol/l contains 1.876 mg of the
dimeglumine salt of gadopentetic acid.
R The other ingredients are meglumine, pentetic acid,
sodium chloride and water for injections.
What Magnevist 2 mmol/l looks like and contents of
the pack
Magnevist 2 mmol/l is available in 20 ml pre-filled
syringes.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Bayer plc
Bayer House
Strawberry Hill
Newbury
Berkshire
RG14 1JA
Manufacturer:
Bayer Pharma AG
Berlin
Germany

6. Contents of the pack and other information

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on
the label after EXP. The expiry date refers to the last day of that
month.

5. How to store Magnevist 2 mmol/l

Delayed reactions can occur (after hours or days), if you are
concerned you should contact your doctor.
Reporting of side effects
If you get any side effects, talk to your radiologist or MRI-centre
staff. This includes any possible side effects not listed in this
leaflet. You can also report side effects directly via the Yellow
Card Scheme at: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information
on the safety of this medicine.

Reference number

84618314

84618314

Magnevist® 2 mmol/l
solution for injection

00010/0544
MAGNEVIST® 2 mmol/l
solution for injection
This is a service provided by the Royal National Institute of the
Blind.

Product name

Please be ready to give the following information:

0800 198 5000 (UK only)

To listen to or request a copy of this leaflet in Braille, large
print or audio please call, free of charge:

This leaflet was last revised in April 2015.

10.07.2015 11:36:57
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Packaging Technology Berlin sgmgj
page 2
Bayer Pharma AG
client: 0021
item-no.: 84618314
PZ: 2589C-3
code-no.: 292
name: LF-INS-Magnevist 2MMOL PFS
country: GB/-/BPH
colors: Black
version: 10.07.2015/04
approval:
dimension: 297 x 594 mm

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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