PRIMOVIST 0.25MMOL/ML SOLUTION FOR INJECTION

Active substance: GADOXETIC ACID DISODIUM

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Read all of this leaflet carefully before you are given this
medicine.
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 any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or
radiologist.
In this leaflet:
1. What PRIMOVIST is and what it is used for
2. Before you are given PRIMOVIST
3. How to use PRIMOVIST
4. Possible side effects
5. How to store PRIMOVIST
6. Further 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. BEFORE YOU ARE GIVEN PRIMOVIST
Do not use PRIMOVIST
R if you are allergic (hypersensitive) to gadoxetate disodium or any
of the other ingredients of Primovist listed in section 6 “What
Primovist contains”.
Take special care with PRIMOVIST
R if you have or have had allergy (e.g. hay fever, hives) or asthma
R if you had a previous reaction to contrast media
R if you have a poor kidney function. The use of some gadoliniumcontaining 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 if you have a serious disease of the heart and blood vessels
R if you have low potassium levels
R if you, or someone in your family, has ever had problems with
the electrical rhythm of the heart (long QT syndrome)
R if you 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.

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 usual 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 have received
Overdosing is unlikely. If it does happen, the doctor will treat any
symptoms that follow.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Primovist 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: affects 1 to 10 users in 100
Uncommon: affects 1 to 10 users in 1,000
Rare: affects 1 to 10 users in 10,000
Not known: frequency cannot be estimated from the available data

81499845

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Bayer Pharma AG
code-no.: 0
country: GB BPH
approval:

Gadoxetate disodium

PZ: 2698O-3

Solution for injection

page 1

Primovist 0.25 mmol/ml

Using other medicines
Please tell your doctor if you are taking or have recently taken any
other medicines, including medicines obtained without a
prescription. 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 (medicines used to treat tuberculosis).
Pregnancy and breast-feeding
Ask your doctor for advice before taking any medicine.
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.
Important information about some of the ingredients of
PRIMOVIST
Primovist contains 82 mg of sodium per dose of Primovist (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.

Packaging Technology Berlin DY
client: 0021
itemno.: 81499845
name: LF-OUTS-Primovist VL
colors: Black
version: 10.12.2012/01

PACKAGE LEAFLET: INFORMATION FOR THE USER

* Severe itching (Generalised 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.
If any of the side effects gets serious, or if you notice any side effects
not listed in this leaflet, please tell your doctor or radiologist.
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.

5. HOW TO STORE PRIMOVIST
Keep out of the reach and sight of children.
Do not use Primovist 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 the month.
This medicinal product does not require any special storage
conditions.
Primovist should be used immediately after opening.
This medicinal product is a clear, colourless to pale yellow solution.
It should be visually inspected before use. Primovist should not be
used in case of severe discolouration, the occurrence of particulate
matter or a defective container.
Medicines should not be disposed of via wastewater or household
waste. Ask your pharmacist how to dispose of medicines no longer
required. These measures will help to protect the environment.

6. FURTHER 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 5.0ml contains 907mg gadoxetate disodium,
1 injection vial with 7.5ml contains 1361mg gadoxetate disodium,
1 injection vial with 10.0ml contains 1814mg 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 and Manufacturer
Marketing Authorisation Holder:
Bayer plc
Bayer House
Strawberry Hill
Newbury
Berkshire
RG14 1JA
Manufacturer:
Bayer Pharma AG
Müllerstrasse 178
D- 13342 Berlin, Germany
Telephone: +49 30 468- 1111
This medicinal product is authorised under the name Primovist in
the following Member States of the EEA: Austria, Belgium, 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 December 2012

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approval:

-----------------------------------------------------------------------------The following information is intended for medical or 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
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).
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.

Bayer Pharma AG
code-no.: 0
country: GB BPH

Not known
Fast heartbeat
Restlessness
Hypersensitivity
/ allergy-like
reaction (e.g.
shock, low
blood pressure,
swelling in the
tongue or
throat, hives
(nettle-type
rash), swelling
of the face,
runny nose,
conjunctivitis,
stomach pain,
reduced feeling
or sensitivity in
the skin,
sneezing,
cough, itching,
pale skin)

PZ: 2698O-3

Rare
Incapacity to sit
or stand still
Tremor
Abnormally
strong or rapid
heartbeat
(palpitation)
Irregular
heartbeat
(signs of heart
block)
Discomfort of
the mouth
Increased
production of
saliva
Red skin rash
with pimples or
spots
Increased
sweating
Feeling of
discomfort
Generally
feeling unwell

page 2

Uncommon
Sensation of
whirling (vertigo)
Dizziness
Numbness and
tingling
Problems with
sense of taste
Problems with
sense of smell
Flushing
Blood pressure
increased
Breathing
difficulties
Vomiting
Dry mouth
Skin rash
Severe itching*
Back pain
Chest pain
Injection site
reactions**
Feeling hot
Chills
Tiredness
Feeling
abnormal

Packaging Technology Berlin DY
client: 0021
itemno.: 81499845
name: LF-OUTS-Primovist VL
colors: Black
version: 10.12.2012/01

Common
Headache
Nausea
(feeling sick)

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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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