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PRIMOVIST 0.25MMOL/ML SOLUTION FOR INJECTION

Active substance: GADOXETIC ACID DISODIUM

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Primovist 0.25 mmol/ml,
solution for injection
Gadoxetate disodium

Primovist contains sodium
Primovist contains 82 mg of sodium per dose (based on the average
amount given to a 70 kg person). This should be taken into
consideration if you are on a sodium controlled diet.

3. How to use Primovist

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 your doctor giving
you Primovist (the radiologist) or the hospital/MRI-centre
personnel.
R If you get any side effects talk to your doctor or radiologist. This
includes any possible side effects not listed in this leaflet. See
section 4.
What is in this leaflet
1. What Primovist is and what it is used for
2. What you need to know before you are given Primovist
3. How to use Primovist
4. Possible side effects
5. How to store Primovist
6. Contents of the pack and other information

1. What Primovist is and what it is used for
Primovist is a contrast medium for magnetic resonance imaging
(MRI) of the liver. It is used to help detect and diagnose changes
that may be found in the liver. Abnormal signs within the liver can
be better evaluated (as to number, size, and distribution). Primovist
can also help the doctor determine the nature of any abnormalities,
thereby increasing the confidence one can have in the diagnosis.
It is provided as a solution for intravenous injection. This medicine
is for diagnostic use only.
MRI is a form of medical diagnostic imaging that forms pictures
after water molecules have been detected in normal and abnormal
tissues. This is done using a complex system of magnets and
radiowaves.

2. What you need to know before you are given Primovist
Do not use Primovist
R if you are allergic to gadoxetate disodium or any of the other
ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor before you are given Primovist if you
R have or have had allergy (e.g. hay fever, hives) or asthma
R had a previous reaction to contrast media
R have a poor kidney function
The use of some gadolinium-containing contrast agents in
patients with these conditions has been associated with a
disease called Nephrogenic Systemic Fibrosis (NSF). NSF is a
disease involving thickening of the skin and connective tissues.
NSF may result in debilitating joint immobility, muscle weakness
or impairment of the function of internal organs which may
potentially be life threatening.
R have a serious disease of the heart and blood vessels
R have low potassium levels
R or someone in your family, has ever had problems with the
electrical rhythm of the heart (long QT syndrome)
R have had changes to the rhythm or rate of your heartbeat after
taking medicines
Before you receive Primovist, tell your doctor if any of these applies
to you. Your doctor will decide whether the intended examination is
possible or not.
R Allergy-like reactions may occur after use of Primovist. Severe
reactions are possible. Delayed reactions may occur (after hours
or days) (see section 4 “Possible Side Effects”).
R Tell your doctor if you have a heart pacemaker or if there are any
implants or clips containing iron in your body.
Tell your doctor if:
R your kidneys do not work properly
R you have recently had, or soon expect to have, a liver transplant
Your doctor may decide to take a blood test to check how well your
kidneys are working before making the decision to use Primovist,
especially if you are 65 years of age or older.
Children and adolescents
The safety of Primovist in persons under 18 years has not yet been
tested. Therefore, use of Primovist in this patient group cannot be
recommended.
Other medicines and Primovist
Tell your doctor if you are taking, have recently taken or might take
any other medicines. These include especially:
R betablockers, medicines used to treat high blood pressure or
other heart conditions
R medicines that change the rhythm or rate of your heartbeat (e.g.
amiodarone, sotalol)
R rifampicin (medicine used to treat tuberculosis)
Pregnancy and breast-feeding
Pregnancy
You must tell your doctor if you think you are or might become
pregnant as Primovist should not be used during pregnancy unless
strictly necessary.
Breast-feeding
Tell your doctor if you are breast-feeding or about to start breastfeeding. Your doctor will discuss whether you should continue
breast-feeding or interrupt breast-feeding for a period of 24 hours
after you receive Primovist.

Primovist is injected by a doctor via a small needle into a vein.
Primovist will be administered immediately before your MRI
examination.
After the injection you will be observed for at least 30 minutes.
The recommended dose
The actual dosage of Primovist that is right for you will depend on
your body weight:
0.1 ml Primovist per kg body weight.
Dosage in special patient groups
The use of Primovist is not recommended in patients with severe
kidney problems and patients who have recently had, or soon
expect to have, a liver transplant. However if use is required you
should only receive one dose of Primovist during a scan and you
should not receive a second injection for at least 7 days.
Elderly
It is not necessary to adjust your dose if you are 65 years of age or
older but you may have a blood test to check how well your kidneys
are working.
Further information regarding the administration and handling of
Primovist is given at the end of the leaflet.
If you receive more Primovist than you should
Overdosing is unlikely. If it does happen, the doctor will treat any
symptoms that follow.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although
not everybody gets them.
Most of the side effects are mild to moderate.
The most frequently observed side effects in patients receiving
Primovist (may affect 5 or more in 1,000 users) are nausea (feeling
sick), headache, feeling hot, increased blood pressure, back pain and
dizziness.
The most serious side effect in patients receiving Primovist is
anaphylactoid shock (a severe allergy-like reaction).
As with other contrast media, in rare cases allergy-like reactions
may occur, including severe reactions (shock) in very rare cases, that
may need immediate medical intervention.
Mild swelling of the face, lips, tongue or throat, coughing, itching,
runny nose, sneezing and hives (nettle-type rash) may be the first
signs that a severe reaction is happening. Tell the MRI department
staff immediately if you experience any of these signs or have
difficulty in breathing.
Delayed reactions hours to days after the administration of
Primovist may occur. If this should happen to you, tell your doctor
or radiologist.
Below we list the reported/experienced side effects by frequency:
Common:
may affect up to
1 in 10 people

Headache
Nausea (feeling
sick)

Not known:
Rare:
may affect up to frequency cannot
1 in 1,000 people be estimated
from the
available data
Incapability to sit Fast heartbeat
Sensation of
Restlessness
whirling (vertigo) or stand still
Hypersensitivity/
Tremor
Dizziness
Abnormally strong allergy-like
Numbness and
or rapid heartbeat reaction (e.g.
tingling
shock, low blood
(palpitation)
Problems with
pressure, swelling
Irregular
sense of taste
in the tongue or
heartbeat (signs
Problems with
throat, hives
of heart block)
sense of smell
Discomfort of the (nettle-type rash),
Flushing
swelling of the
mouth
Blood pressure
face, runny nose,
Increased
increased
conjunctivitis,
Breathing difficul- production of
stomach pain,
saliva
ties
Red skin rash with reduced feeling or
Vomiting
pimples or spots sensitivity in the
Dry mouth
skin, sneezing,
Increased
Skin rash
cough, itching,
sweating
Severe itching*
pale skin)
Feeling of
Back pain
discomfort
Chest pain
Injection site reac- Generally feeling
unwell
tions**
Feeling hot
Chills
Tiredness
Feeling abnormal

Uncommon:
may affect up to
1 in 100 people

* Severe itching (Generalized itching, Itching of the eye)
** Injection site reactions (various kinds) comprise the following
terms: involuntary leakage of the contrast agent and bleeding
into the adjacent tissue at the injection site, Injection site
burning, Injection site coldness, Injection site irritation, Injection
site pain
The following side effects have been life-threatening or fatal in
some cases: shock and breathing difficulties.
Changed laboratory values may occur shortly after you have been
given Primovist. Therefore inform the health personnel that you
have recently undergone an examination with Primovist if you take
blood or urine samples.
There have been reports of nephrogenic systemic fibrosis (which
causes hardening of the skin and may affect also soft tissue and
internal organs) associated with use of other gadoliniumcontaining contrast agents.

84324280

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Packaging Technology Berlin pewi
page 1
Bayer Pharma AG
client: 0021
item-no.: 84324280
PZ: 2698O-3
code-no.:
name: LF-OUTS-Primovist VL
country: GB/-/BPH
colors: Black
version: 13.10.2014/02
approval:
dimension: 210 x 462 mm

Package leaflet: Information for the user

Sophia
Hillebrand

Digitally signed by Sophia
Hillebrand
DN: o=Bayer Group,
ou=SignCert,
0.9.2342.19200300.100.1.1=gfd
xo, cn=Sophia Hillebrand
Date: 2014.10.15 16:55:19
+02'00'

5. How to store Primovist
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
vial and outer carton label after EXP. The expiry date refers to the
last day of that month.
This medicine does not require any special storage conditions.
This medicine should be used immediately after opening.
This medicine is a clear, colourless to pale yellow solution. It should
be visually inspected before use. This medicine should not be used
in case of severe discoloration, the occurrence of particulate matter
or a defective container.
Do not throw away any medicines via wastewater or household
waste. Ask your pharmacist how to throw away medicines you no
longer use. These measures will help protect the environment.

6. Contents of the pack and other information
What Primovist contains
R The active substance is gadoxetate, disodium. Each ml of solution for injection contains 0.25 mmol gadoxetate disodium
(equivalent to 181.43 mg gadoxetate disodium).
R The other ingredients are caloxetate trisodium; trometamol,
sodium hydroxide (for pH adjustment), hydrochloric acid (for pH
adjustment), and water for injections.
1 injection vial with 5.0 ml 907 mg gadoxetate disodium,
1 injection vial with 7.5 ml contains 1361 mg gadoxetate disodium,
1 injection vial with 10.0 ml contains 1814 mg gadoxetate
disodium.
What Primovist looks like and contents of the pack
Primovist is a clear, colourless to pale yellow liquid free from visible
particles. The contents of the packs are:
1, 5, or 10 injection vials with 5.0 ml solution for injection (in 6-ml
injection vial)
1, 5, or 10 injection vials with 7.5 ml solution for injection (in 10-ml
injection vial)
1, 5, or 10 injection vials with 10.0 ml solution for injection (in
10-ml injection vial)
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Bayer plc
Bayer House
Strawberry Hill
Newbury
Berkshire
RG14 1JA
Manufacturer
Bayer Pharma AG
Müllerstrasse 178
D - 13353 Berlin, Germany
Telephone: +49 30 468-1111
This medicine is authorised under the name Primovist in the
following Member States of the EEA: Austria, Belgium, Czech
Republic, Finland, Germany, Hungary, Ireland, Italy, Luxembourg,
Malta, Norway, Poland, Portugal, Slovak Republic, Sweden, United
Kingdom.
This leaflet was last revised in
2014-10-20

The following information is intended for healthcare professionals
only:
R Renal impairment
Prior to administration of Primovist, it is recommended that all
patients are screened for renal dysfunction by obtaining
laboratory tests.
There have been reports of nephrogenic systemic fibrosis (NSF)
associated with use of some gadolinium-containing contrast agents
in patients with acute or chronic severe renal impairment
(GFR< 30ml/min /1.73 m2). Patients undergoing liver
transplantation are at particular risk since the incidence of acute
renal failure is high in this group. As there is a possibility that NSF
may occur with Primovist, it should therefore be avoided in patients
with severe renal impairment and in patients in the perioperative
liver transplantation period unless the diagnostic information is
essential and not available with non-contrast enhanced MRI. If use
of Primovist cannot be avoided, the dose should not exceed
0.025 mmol/kg body weight. More than one dose should not be
used during a scan. Because of the lack of information on repeated
administration, Primovist injections should not be repeated unless
the interval between injections is at least 7 days.
As the renal clearance of gadoxetate may be impaired in the elderly,
it is particularly important to screen patients aged 65 years and
older for renal dysfunction.
Haemodialysis shortly after Primovist administration may be useful
at removing Primovist from the body. There is no evidence to
support the initiation of haemodialysis for prevention or treatment
of NSF in patients not already undergoing haemodialysis.
R Pregnancy and breast-feeding
Primovist should not be used during pregnancy unless the clinical
condition of the woman requires use of gadoxetate.
Continuing or discontinuing breast feeding for a period of 24 hours
after administration of Primovist, should be at the discretion of the
doctor and lactating mother.
R Before injection
Primovist is a clear, colourless to pale yellow solution free from
visible particles. The contrast medium should be inspected visually
before use. Contrast media should not be used in case of severe
discoloration, the occurrence of particulate matter or a defective
container.
R Administration
Primovist is to be administered undiluted as an intravenous bolus
injection at a flow rate of about 2 ml/sec. After the injection the
intravenous cannula/ line should be flushed using physiological
saline solution (9 mg/ml).
R Patient should be observed for at least 30 minutes after the
injection.
R Primovist must not be mixed with other medicinal products.
R Intramuscular injection must be strictly avoided.
R Handling
Primovist is ready to use.
Vials containing contrast media are not intended for the withdrawal
of multiple doses. Primovist should only be drawn into the syringe
immediately before use.
The rubber stopper should never be pierced more than once.
Any solution not used in one examination is to be discarded in
accordance with local requirements.
Further information regarding the use of Primovist is given in
section 3 of the leaflet.
The peel-off tracking label on the vials should be stuck onto the
patient record to enable accurate recording of the gadolinium
contrast agent used. The dose used should also be recorded. If
electronic patient records are used, the name of the product, the
batch number and the dose should be entered into the patient
record.

84324280

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Packaging Technology Berlin pewi
page 2
Bayer Pharma AG
client: 0021
item-no.: 84324280
PZ: 2698O-3
code-no.:
name: LF-OUTS-Primovist VL
country: GB/-/BPH
colors: Black
version: 13.10.2014/02
approval:
dimension: 210 x 462 mm

Reporting of side effects
If you get any side effects, talk to your doctor or radiologist. This
includes any possible side effects not listed in this leaflet. You can
also report side effects directly (see details below). By reporting side
effects you can help provide more information on the safety of this
medicine.
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
Malta
ADR Reporting
The Medicines Authority
Post-Licensing Directorate
203 Level 3, Rue D’Argens
GŻR - 1368 Gżira
Website: www.medicinesauthority.gov.mt
e-mail: postlicensing.medicinesauthority@gov.mt

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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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