Download PRIMOVIST® 0.25 MMOl/Ml BAYER MIDDLE EAST

08-15
Primovist® 0.25 mmol/mL
BAYER MIDDLE EAST
solution for injection
prefilled syringe
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 in order to better
recognise and diagnose possible changes in the liver.
Liver abnormalities can be better assessed (number,
size and distribution). Beyond that, the doctor can
use Primovist to determine the type of a possible
abnormality, consequently increasing the reliability
of the diagnosis.
The contrast agent is available as a solution for
intravenous injection. This medicinal product is for
diagnostic use only.
MRI is a type of medical-diagnostic imaging process, that utilises a complex system of magnetic
fields and radio waves to recognise and make visible water molecules in healthy and morbid tissue.
2. BEFORE YOU ARE GIVEN PRIMOVIST
Do not use PRIMOVIST
• if you are hypersensitive (allergic) to gadoxetic
acid, disodium or one of the other components of
Primovist. The other constituents are listed in section 6 ‘What Primovist contains’.
Take special care with PRIMOVIST
• if you have or have ever had an allergy (e.g. hay
fever, hives) or asthma.
• if you have ever had a reaction following the use of
contrast agents.
• if your kidney function is seriously impaired. There
have been cases of nephrogenic systemic fibrosis
(NSF) observed in patients with advanced renal
malfunction following the administration of contrast
agents containing gadolinium. NSF is a disease
that causes thickening of the skin and of the connective tissue and can result in impaired mobility of
joints, myasthenia or impaired function of the internal organs, which can be life threatening.
• if you have a serious disease of the heart and
blood vessels.
• if your potassium values are low.
• if you or a member of your family have ever had
problems with the electrical activity of the heart, i.e.
the heart‘s rhythm (Long QT syndrome)
• if your heart‘s rhythm or your heart beat has ever
changed after taking medicinal products If one of
these criteria applies to you, inform your doctor
before being given Primovist. Your doctor will then
decide, whether the planned examination can take
place or not.
•A
llergy-like, even severe reactions can result from
the use of Primovist. Delayed reactions (after
hours or days) cannot be ruled out (see section 4.
‘Possible side effects’).
• Inform your doctor, if you wear a cardiac pacemaker or if you have implants or clips containing iron in
your body.
•T
he use of Primovist in patients under 18 years of
age is not recommended, since there are no clinical data available with respect to this age group.
Using PRIMOVIST with other medicines
Please inform your doctor, if you are taking or have
recently taken any other medicines, even if they are
nonprescription medicines. Of primary concern are:
• b eta blockers, which are used for the treatment of
high blood pressure and other heart diseases;
•m
edicines, that change the heart rhythm or the
heart frequency (such as, amiodarone, sotalol);
• r ifampicin or rifamycin, which are used in treating
tuberculosis.
Using PRIMOVIST with food and drink
Since contrast agents, such as Primovist. can cause
nausea and vomiting, you are advised not to eat
anything for 2 hours prior to the examination.
Pregnancy and breast-feeding
Tell your doctor, if you are or could be pregnant,
since Primovist should only be used during pregnancy, if it is compellingly necessary.
BAYER-PRIMOVIST 0.25 mmol/mL - p.1/3
BAYER-PRIMOVIST 0.25 mmol/mL - p.2/3
Inform your doctor, if you are presently or intending
to breast feed, since Primovist should only be used
after careful examination in these circumstances. It
is advisable for you to discontinue breast feeding
for a period of 24 hours after the administration of
Primovist.
Important information about some of the ingredients of PRIMOVIST
Primovist contains 82 mg sodium in each dose
(based on the average dose for someone weighing
70 kg).
Take this into consideration, if you are on a low-sodium diet.
3. HOW TO USE PRIMOVIST
Using a small hollow needle, a doctor will inject
Primovist into a vein, just before your MRI examination.
After the injection, you will be monitored for at least
30 minutes.
The dose of Primovist suitable for you depends on
your body weight:
0.1 mL Primovist per kg body weight.
Further information concerning the administration and
handling of Primovist is located at the end of this leaflet.
If you receive more Primovist than you should An
overdose is unlikely. In the event of an overdose,
your doctor will treat the symptoms, that arise as a
consequence.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Primovist can cause side effects,
although not everybody gets them.
As can be found in other contrast agents, rare cases
of allergy-like reactions can occur, in very rare
cases, even severe reactions (shock), that require
immediate medical treatment.
The first signs of a severe reaction can take the
form of slight swelling in the face, lips, tongue or
throat, coughing, itching, runny nose, sneezing
and hives (skin rash). Inform the MRI department
staff immediately, if you experience any of these
signs or have difficulty in breathing.
Delayed reactions are also possible; these can
occur anywhere from several hours to several days
after the administration of Primovist. If you notice
delayed reactions, inform your doctor or radiologist.
Side effects, that were reported / actually occurred
are listed below categorically according to their frequency:
The adverse reactions listed under ‘uncommon’
refer to 1 to 10 in 1,000 patients.
The adverse reactions listed under ‘rare’ refer to
less than 1 in 1,000 patients.
Adverse reactions, that were observed in clinical
studies, prior to the marketing authorisation of
Primovist:
Uncommon
Headaches
Vertigo
Sensations of numbness
and tingling
Dysgeusia (problems with
the sense of taste)
Olfactory dysfunction
(problems with the sense
of smell)
Flushed face
Rise in blood pressure
Difficulties in breathing
Vomiting
Nausea (feeling sick)
Skin rash
Strong itching *
Chest pain
Reactions at the injection
site**
Sensation of heat
Rare
Dizziness (vertigo)
Restlessness
Trembling
Strong and/or quickened
heartbeat (palpitation)
Arrhythmia (irregular
heartbeat) (sign of a heart
block)
Dry mouth
Mouth complaints
Increased saliva formation
Rash with blisters and
splotchy skin
Increased sweating
Chills
Back pain
Feeling of uneasiness
Generally not feeling well
Tiredness
Malaise
* Strong itching (generalised itching, itchy eyes)
**Reactions at the injection site (varying kinds), which includes the following
terms: extravasation of the contrast agent and bleeding into the tissue surrounding the injection site, burning sensation at the injection site, sensation of
cold at the injection site, irritation at the injection site, pain at the injection site
Post-marketing spontaneous reporting of additional adverse reactions to Primovist:
Accelerated heartbeat (tachycardia) and restlessness occurred in rare cases.
Laboratory test results can change soon after the use
of Primovist. If you have blood or urine samples taken,
please inform the healthcare professionals that you
recently underwent an examination using Primovist.
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.
BAYER-PRIMOVIST 0.25 mmol/mL - p.3/3
5. STORING PRIMOVIST
Do not store above 30°C.
Keep out of the reach and sight of children.
Do not use the medicinal product after the expiry
date stated on the label. The expiry date refers to
the last day of the month indicated.
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.
The following information is intended for medical or healthcare professionals only:
• Before the injection
Primovist is a clear, colourless to faintly yellow solution, which is free of visible particles. Visually examine prior to use, and do not use, if the solution exhibits any strong discolouration, if particles are present,
or if the container is damaged.
• Administration
Administer Primovist undiluted as an intravenous
bolus injection with a flow speed of approximately
6. FURTHER INFORMATION
2 mL per second. Afterwards, flush the intravenous
cannula with physiological saline solution (9 mg/mL).
What PRIMOVIST contains:
he patient should lie down and remain under
•T
he active substance is gadoxetic acid, disodium - T
observation for at least 30 minutes after the injection.
181.43 mg/mL, equivalent to 0.25 mmol/mL.
o not mix Primovist with other medicinal products.
• The other constituents are caloxetic acid, trisodi- - D
Absolutely
avoid intramuscular injection.
um; trometamol, sodium hydroxide, hydrochloric
acid and water for injection.
• Handling
1 prefilled syringe with 5.0 mL solution contains Primovist is ready to use.
Prepare the prefilled syringe for injection directly
907 mg gadoxetic acid, disodium salt.
1 prefilled syringe with 7.5 mL solution contains before the examination. Remove the tip cap only
just before using the prefilled syringe.
1361 mg gadoxetic acid, disodium salt.
1 prefilled syringe with 10.0 mL solution contains 1 Any unused contrast-agent solution remaining
from any one examination should be disposed of in
814 mg gadoxetic acid, disodium salt.
accordance with local requirements.
What PRIMOVIST looks like and contents of the 1. Open the package.
pack:
2. Screw the plunger onto the syringe.
Primovist is a clear, colourless to faintly yellow liq- 3. Break off the tip cap.
uid, which is free of visible particles. The packs 4. Remove the tip cap.
contain:
5. Remove the rubber stopper.
1, 5 or 10 prefilled syringes with 5.0 mL solution for 6. Remove the air from the syringe.
injection (in 10-mL prefilled syringes)
1, 5 or 10 prefilled syringes with 7.5 mL solution for
injection (in 10-mL prefilled syringes)
1, 5 or 10 prefilled syringes with 10.0 mL solution for
injection (in 10-mL prefilled syringes) Not all pack
sizes may be marketed.
Manufacturer:
Bayer Schering Pharma AG
Müllerstrasse 178
D – 13342 Berlin, Deutschland
Telephone: +49 30 468-1111
This leaflet was last approved in June 2008