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PRIMOVIST 0.25 MMOL/ML SOLUTION FOR INJECTION PREFILLED SYRINGE

Active substance(s): GADOXETIC ACID DISODIUM

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Primovist 0.25 mmol/ml, solution for injection, pre-filled syringe
Gadoxetate, disodium
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 and efficacy of Primovist have not been established in
patients under 18 years old as there is limited experience on its
use. Further information regarding the use of Primovist in
children is given at the end of the leaflet.
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 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
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: Uncommon:
may affect may affect up to
up to 1 in 1 in 100 people
10 people

Rare:
may affect up
to 1 in 1,000
people

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

* 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.
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
Website: www.medicinesauthority.gov.mt/adrportal

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 syringe 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, colorless 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.

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, Croatia,
Cyprus, Czech Republic, Estonia, Finland, Germany, Greece,
Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,
Netherlands, Norway, Poland, Portugal, Slovak Republic, Slovenia,
Spain, Sweden, United Kingdom.
This leaflet was last revised in November 2015.
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 Paediatric population
An observational study was performed in 52 paediatric patients
(aged > 2 months and < 18 years). Patients were referred for
Primovist enhanced liver MRI to evaluate suspected or known
focal liver lesions. Additional diagnostic information was
obtained when combined unenhanced and enhanced liver MR
images were compared with unenhanced MR images alone.
Serious adverse events were reported, however none were
assessed by the investigator to be related to Primovist. Due to the
retrospective nature and small sample size of this study, no
definitive conclusion can be made regarding efficacy and safety
in this population.
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 discolouration, 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).
P Patient should be observed for at least 30 minutes after the
injection.
P Primovist must not be mixed with other medicinal products.
P Intramuscular injection must be strictly avoided.
R Handling
Primovist is ready to use.
The prefilled syringe should be prepared for the injection
immediately before the examination. The tip cap should be
removed from the prefilled syringe immediately before use.
Any solution not used in one examination is to be discarded in
accordance with local requirements.
The peel-off tracking label on the syringes 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.
Glass syringe only:

1. Open the package

2. Screw the plunger on the
syringe

3. Break the protective cover

4. Remove the protective cover

5. Remove the rubber stopper

6. Remove the air in the syringe

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 prefilled syringe with 5.0 ml contains 907 mg gadoxetate
disodium,
1 prefilled syringe with 7.5 ml contains 1361 mg gadoxetate
disodium [glass syringe only],
1 prefilled syringe 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 prefilled syringes with 5.0 ml solution for injection (in
10-ml glass prefilled syringes)
1, 5, or 10 prefilled syringes with 7.5 ml solution for injection (in
10-ml glass prefilled syringes) [glass syringe only]
1, 5, or 10 prefilled syringes with 10.0 ml solution for injection (in
10-ml glass prefilled syringes)
Not all pack sizes may be marketed.

Further information regarding the use of Primovist is given in
section 3 of the leaflet.

85017187

85017187_02.indd 1

24.11.2015 14:17:28

Packaging Technology Berlin sgmgj
page 1
Bayer Pharma AG
client: 0021
material-no.: 85017187
PZ: 2589C-3
code-no.: 95
name: LF-INS-Primovist 0,25MMOL/ML PFS
country: GB/-/BPH
colors: Black
version: 24.11.2015/02
approval:
dimension: 297 x 594 mm

Package leaflet: Information for the user

85017187

Primovist® 0.25 mmol/ml
Solution for injection,
pre-filled syringe

85017187_02.indd 2

24.11.2015 14:17:44
Packaging Technology Berlin sgmgj
page 2
Bayer Pharma AG
client: 0021
material-no.: 85017187
PZ: 2589C-3
code-no.: 95
name: LF-INS-Primovist 0,25MMOL/ML PFS
country: GB/-/BPH
colors: Black
version: 24.11.2015/02
approval:
dimension: 297 x 594 mm

Primovist 0.25 mmol/ml, solution for injection, pre-filled syringe
Gadoxetate, disodium
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 and efficacy of Primovist have not been established in
patients under 18 years old as there is limited experience on its
use. Further information regarding the use of Primovist in
children is given at the end of the leaflet.
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 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
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.

84863521_04.indd 1

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: Uncommon:
may affect may affect up to
up to 1 in 1 in 100 people
10 people

Rare:
may affect up
to 1 in 1,000
people

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

* 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.
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
Website: www.medicinesauthority.gov.mt/adrportal

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 Paediatric population
An observational study was performed in 52 paediatric patients
(aged > 2 months and < 18 years). Patients were referred for
Primovist enhanced liver MRI to evaluate suspected or known
focal liver lesions. Additional diagnostic information was
obtained when combined unenhanced and enhanced liver MR
images were compared with unenhanced MR images alone.
Serious adverse events were reported, however none were
assessed by the investigator to be related to Primovist. Due to the
retrospective nature and small sample size of this study, no
definitive conclusion can be made regarding efficacy and safety
in this population.
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 discolouration, 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).
P Patient should be observed for at least 30 minutes after the
injection.
P Primovist must not be mixed with other medicinal products.
P Intramuscular injection must be strictly avoided.
R Handling
Primovist is ready to use.
The prefilled syringe should be prepared for the injection
immediately before the examination. The tip cap should be
removed from the prefilled syringe immediately before use.
Any solution not used in one examination is to be discarded in
accordance with local requirements.
The peel-off tracking label on the syringes 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.
Plastic syringe only:
Hand injection

Injection with a power injector

1. Open the package

1. Open the package

2. Take out the syringe and
plunger rod

2. Take out the syringe

3. Turn the plunger rod clockwise into the syringe

3. Open the cap with a twist

4. Open the cap with a twist

4. Connect the tip of the syringe
to the tubing system by
turning it clock-wise. Proceed
according to the instructions
for the device

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 syringe 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, colorless 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 prefilled syringe with 5.0 ml contains 907 mg gadoxetate
disodium,
1 prefilled syringe 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 prefilled syringes with 5.0 ml solution for injection (in
10-ml plastic prefilled syringes)
1, 5, or 10 prefilled syringes with 10.0 ml solution for injection (in
10-ml plastic prefilled syringes)
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, Croatia,
Cyprus, Czech Republic, Estonia, Finland, Germany, Greece,
Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,
Netherlands, Norway, Poland, Portugal, Slovak Republic, Slovenia,
Spain, Sweden, United Kingdom.
This leaflet was last revised in November 2015.
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.

5. Remove the air in the syringe
Further information regarding the use of Primovist is given in
section 3 of the leaflet.

84863521

19.11.2015 08:25:30

Packaging Technology Berlin sgmgj
page 1
Bayer Pharma AG
client: 0021
material-no.: 84863521
PZ: 2589C-3
code-no.: 313
name: LF-INS-Primovist 0,25MMOL/ML PFSP
country: GB/-/BPH
colors: Black
version: 19.11.2015/04
approval:
dimension: 297 x 594 mm

Package leaflet: Information for the user

84863521

Primovist® 0.25 mmol/ml
Solution for injection,
pre-filled syringe

84863521_04.indd 2

19.11.2015 08:26:01
Packaging Technology Berlin sgmgj
page 2
Bayer Pharma AG
client: 0021
material-no.: 84863521
PZ: 2589C-3
code-no.: 313
name: LF-INS-Primovist 0,25MMOL/ML PFSP
country: GB/-/BPH
colors: Black
version: 19.11.2015/04
approval:
dimension: 297 x 594 mm

Expand view ⇕

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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