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GADOPENTETATE INSIGHT 500 MICROMOL/ML SOLUTION FOR INJECTION

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PACKAGE LEAFLET: INFORMATION FOR THE USER

GADOPENTETATE INSIGHT 500 MICROMOL/ML SOLUTION FOR INJECTION
Gadopentetate dimeglumine

Read all of this leaflet carefully before you start using this medicine.


Keep this leaflet. You may need to read it again.



If you have any further questions, ask your doctor or your pharmacist.



This medicine has been prescribed for you personally and you should not pass it on to
others. It may harm them, even if their symptoms are the same as yours.



If any of the side effects get serious, or if you notice any side effects not listed in this
leaflet please tell your doctor or pharmacist.

In this leaflet:

1.

1.

What Gadopentetate Insight is and what it is used for

2.

Before you are given Gadopentetate Insight

3.

How to use Gadopentetate Insight

4.

Possible side effects

5.

How to store Gadopentetate Insight

6.

Further information

WHAT GADOPENTETATE INSIGHT IS AND WHAT IT IS USED FOR
Gadopentetate Insight contains gadopentetate dimeglumine, a product which enhances
contrast.
This medicine is for diagnostic use only.
Gadopentetate Insight is used in examinations with Magnetic Resonance Imaging (MRI).

Gadopentetate Insight is used during cranial (head), spinal and whole body MRI scans including
head and neck region, the chest including heart and female breast, the belly including pancreas
and liver, the kidneys, the pelvis including prostatic gland, bladder and womb, the muscles and
the bones.
It may be used to facilitate the visualization, detection and characterisation of several different
types of tumours (growths) or lesions in the head, spine and various sites of the body.
In addition the visualisation of all blood vessels (MR-angiography) is possible (with exception of
the arteries of the heart), especially for diagnosis of narrowing or obstructions of the vessels.
The blood supply to the heart muscle under stress conditions, for example induced by drugs,
can be measured and viability of the heart muscle can be diagnosed ("delayed enhancement").

2.

BEFORE YOU ARE GIVEN GADOPENTETATE INSIGHT
Do not take Gadopentetate Insight
-

if you are allergic (hypersensitive) to gadopentetate dimeglumine or any of the
other ingredients of Gadopentetate Insight

-

if you suffer from severe renal impairment (GFR < 30 ml/min/1.73 m2).

1

Take special care with Gadopentetate Insight
-

if you have a heart pacemaker, an iron-based (ferromagnetic) clip or an implant
or an insulin pump, please inform your radiologist/doctor about this. It is a
condition where MRI is not suitable.

-

because Gadopentetate Insight may trigger allergic or other specific individual
reactions that may have consequences on your heart, on your respiratory tract
or on your skin.

You should not be given Gadopentate Insight if you suffer from severe kidney
problems, or if you are a patient who is about to have or has recently had a liver
transplant, as use of Gadopentetate Insight 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 severe joint immobility, muscle weakness or may affect the normal working of
internal organs which may potentially be life threatening.
Gadopentetate Insight should also not be given to newborn babies up to age of 4
weeks.
Tell your doctor if:
• your kidneys do not work properly
• you have recently had, or soon expect to have, a liver transplant.

If an allergic reaction occurs, the radiologist/doctor will stop the administration
of the contrast medium at once and, if necessary, will start appropriate
treatment of the allergic reactions.
Therefore, it is recommended that you have a flexible in-dwelling catheter
during the examination, to enable immediate action in case of emergencies.
Very rarely severe reactions, including shock, may occur. Therefore, you
should read the following very carefully:
- if you have, or if you have ever had, bronchial asthma or other allergies or a
previous allergic reaction to contrast media you may be more likely to have
an allergic reaction during the examination. Tell your radiologist/doctor if you
suffer from these conditions. You may be given another medicine before the
examination to prevent them.
- if you are taking a beta-blocker (medicines used against high blood
pressure, heart problems and other conditions) you should tell your
radiologist/doctor. Patients treated with beta-blockers do not necessarily
respond to other medicines usually used for the treatment of allergic
reactions.
- if you have any heart problems (e. g. severe heart failure, coronary artery
disease) you are more susceptible to serious or even fatal outcomes of
severe allergic reactions.
- if you have fits or seizures you may have an increased risk of suffering from
one during the examination.
- if you suffer from moderate renal impairment (GFR 30-59 ml/min/1.73 m2)
you should tell your radiologist/doctor. Before you receive Gadopentetate
Insight, you will need to have a blood test to check how well your kidneys are
working.
Gadopentetate Insight should not be used in newborn babies up to the age of 4 weeks. As
kidney function is immature in infants up to 1 year of age, Gadopentetate Insight will only be
used in infants after careful consideration by the doctor.

2

Using Gadopentetate Insight with food and drink
It is very important that you do not eat anything for 2 hours prior to the investigation.

Using other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other
medicines, including medicines obtained without a prescription.
Especially:

Beta blockers (medicines used for high blood pressure, heart problems and
other conditions)

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 Gadopentetate
Insight should not be used during pregnancy unless strictly necessary.
Breast-feeding
Tell your doctor if you are breast-feeding or about to start breast-feeding. Breast-feeding should
be discontinued for at least 24 hours after you receive Gadopentetate Insight.

Driving and using machines
Your injection is unlikely to affect your ability to drive a car or to operate machinery.
However, while driving vehicles or operating machinery you should take account that nausea or
low blood-pressure may incidentally occur.

3.

HOW TO USE GADOPENTETATE INSIGHT
Gadopentetate Insight will be given by an authorised healthcare professional directly into a vein

(intravenously).
Ideally you should be recumbent during administration, and you will be kept under supervision
for at least 30 minutes after the injection by your radiologist/doctor. This is the time where most
undesired reactions (e. g. allergic reactions) may occur. However, in rare cases, reactions may
occur after hours or days.
If this medicinal product is intended to be used with an automatic application system, its
suitability for the intended use has to be demonstrated by the manufacturer of the medical
device. Instructions for use of the medical device must be followed absolutely.
Adults, adolescents and children (over the age of two years)
The dose for cranial, spinal and whole body MRI used will depend on the type of lesion that is
being investigated but it is usually between 0.2 and 0.6 ml/kg body weight for adults and
between 0.2 and 0.4 ml/kg body weight for children.
Dosage in special patient groups
Neonates up to 4 weeks of age and infants up to 1 year of age
Gadopentetate Insight should not be used in newborn babies up to the age of 4 weeks.
As kidney function is immature in infants up to 1 year of age, infants should only receive one
dose of Gadopentetate Insight during a scan and should not receive a second injection for at
least 7 days.
3

In infants up to 1 year of age Gadopentetate Insight should only be used after careful
consideration because the proper function of the kidneys is not fully developed in this age group.
Toddlers (from 1 - 2 years)
The dose is 0.2 ml/kg body weight in children under the age of 2 years.
Elderly (aged 65 years and above)
It is not necessary to adjust your dose if you are 65 years of age or older but you will have a
blood test to check how well your kidneys are working.
Patients with impaired renal function
You should not be given Gadopentetate Insight if you suffer from severe kidney problems or if
you are a patient who is about to have or has recently had a liver transplant.
Patients with moderate renal impairment (if the value for assessment of renal function,
the GFR (glomerular filtration rate) is 30-59 ml/min/1.73 m2)
The use of Gadopentetate Insight must be carefully evaluated in patients with moderate renal
impairment. The medicine will remain longer in the body of those patients than in patients
without impaired renal function.
The doctor will screen you to see, if your kidneys are working properly.
If you have moderate kidney problems, you should only receive one dose of Gadopentetate
Insight during a scan and you should not receive a second injection for at least 7 days.

If you are given more Gadopentetate Insight than you should
This medicine will be given to you by a healthcare professional. If you think that you have
received too much medicine please tell your doctor or nurse immediately.
If you have any further questions on the use of this product, ask your doctor or radiographer or
pharmacist.

4.

POSSIBLE SIDE EFFECTS
Like all medicines, Gadopentetate Insight can cause side effects, although not everybody gets
them.
The most commonly reported undesirable effects with Gadopentetate Insight are nausea,
vomiting, headache, dizziness, pain and a feeling of warmth or coldness at the injection site or a
feeling of warmth in general.
There have been reports of nephrogenic systemic fibrosis (which causes hardening of the skin
and may affect also soft tissue and internal organs).
Other undesirable effects that may occur have been listed by organ system and frequency.
Frequencies are reported as:
Very common
(more than 1 in 10 people)
Common
(more than 1 in 100 people and less than 1 in 10 people)
Uncommon
(more than 1 in 1,000 people and less than 1 in 100 people)
Rare
(more than 1 in 10,000 people and less than 1 in 1,000 people)
Very rare
(less than 1 in 10,000 people)
Reactions for which no frequency rate can be provided due to lack of clinical data, have been
entered with “Not known”.

4

Organ system

Adverse reaction

Frequency

Blood Disorders

short term increase in blood iron

Rare

Nervous System
Disorders

dizziness, numbness (paraesthesia), headache

Uncommon

agitation, confusion, speech, or smelling
disturbance, fits, tremor, coma, sleepiness

Rare

Eye Disorders

eye pain, sight disturbance, eyes watering

Rare

Ear Disorders

pain of the ear, hearing disturbance

Rare

Heart Disorders

changes in heart rate or rhythm, blood pressure
changes, heart stops beating

Rare

Vascular Disorders

widening of the blood vessels and changes in
blood flow causing low blood pressure followed
by fainting, fast heart rate (tachycardia),
difficulties in breathing and turning blue possibly
leading to unconsciousness and shock

Rare

Respiratory, Thoracic and
Mediastinal Disorders

short term changes in breathing rate, shortness
of breath, difficulty in breathing, stopping
breathing, fluid in the lungs

Rare

Gastrointestinal
Disorders

nausea, vomiting

Uncommon

abdominal pain, diarrhoea, taste disturbance, dry
mouth, excess saliva

Rare

Hepatobiliary Disorders

short-term increase
bilirubine value

and

Rare

Skin Disorders

swelling of eyelids, face or lips, redness of the
skin, itchiness

Rare

Musculoskeletal
Disorders

back pain or joint pain

Rare

Kidney Disorders

urinary incontinence (urine leaking) or urgency,
short term changes in kidney function values or
acute renal failure in patients with disturbed
kidney function

Rare

General Disorders

sensation of heat

Uncommon

chest pain, chills, sweating, changes in body
temperature, fever;

Rare

and
Administration
Conditions

Site

in

liver

enzymes

pain at the administration site, feeling of
coldness or warmth, swelling, inflammation,
degeneration of tissue (tissue necrosis),
inflammation of the veins at the injection site

5

Organ system

Immune
Disorders

System

Adverse reaction

Frequency

cases of nephrogenic systemic fibrosis/
nephrogenic fibrosing dermophathy (a condition
in patients with kidney disease with hardening of
the skin and other organs)

Not known

Hypersensivity/anaphylactic reaction:
angiooedema, inflammation of the eye
(conjunctivitis), coughing, itching, runny nose,
sneezing, skin rashes (urticaria), wheeziness,
tightness of the voicebox (larynx), swelling of the
voice box (larynx) and the throat (pharynx), low
blood pressure, shock

Rare

Some people may find they have an allergic reaction to Gadopentetate Insight. Tell your doctor
immediately if any of the following rare severe allergy symptoms occur:
ƒ

Sudden wheeziness and tightness of the chest

ƒ

Swelling of eyelids, face or lips

ƒ

Skin rashes (urticaria), itchiness, fever

ƒ

Collapse

ƒ

Turning blue (cyanosis)

If any of the side effects get serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.

5.

HOW TO STORE GADOPENTETATE INSIGHT
Keep out of the reach and sight of children.
Do not use Gadopentetate Insight after the expiry date that is stated on the label. The expiry
date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
Chemical and physical in-use stability has been demonstrated 24 hours at 25°C. From a
microbiological point of view, the product should be used immediately. If not used immediately,
in-use storage times and conditions prior to use are the responsibility of the user and would
normally not be longer than 24 hours at 2 to 8°C.
Do not use Gadopentetate Insight if you notice any visible signs of deterioration (such as
particles in the solution or fissures in the vial).
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 Gadopentetate Insight contains
- The active substance is gadopentetate dimeglumine.
- 1 ml Gadopentetate Insight solution for injection contains 469 mg of gadopentetate
dimeglumine (corresponding to 500 micromol, corresponding to 78.63 mg gadolinium).
- The other ingredients are pentetic acid, meglumine and water for injection

What Gadopentetate Insight looks like and contents of the pack
Solution for injection.

6

Your medicinal product comes in a clear glass vial with a rubber stopper and aluminium cap that
is packed into a carton along with this patient information leaflet (package leaflet).
The vial contains a clear, particle free solution for injection.
Gadopentetate Insight is presented in the following packs:
1 vial with 5, 10, 15, 20, 30 and 100 ml solution for injection
10 vials with 5, 10, 15, 20, 30 and 100 ml solution for injection
Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer
Marketing authorisation holder:
Agfa HealthCare Imaging Agents GmbH
Am Coloneum 4
50829 Köln
Germany
Tel: + 49 221 5717-660
Fax: + 49 221 5717-1051
E-mail: imagingagents@agfa.com
Manufacturer:
Biokanol Pharma GmbH
Kehler Straße 7
76437 Rastatt
Germany

This leaflet was last approved in 12/2011
This medicinal product is authorised in the Member States of the EEA under the
following names:
Name of the Member State: / Name of Gadopentetate dimeglumine:
Germany:

Gadopentetat Insight 500 Mikromol/ml Injektionslösung

Italy:

Gadopentetat Insight 500 micromol/ml soluzione iniettabile

Spain:

Gadopentetato de dimeglumina Insight 500 micromol/ml solución
inyectable

United Kingdom: Gadopentetate Insight 500 micromol/ml solution for injection

7

The following information is intended for medical or healthcare professionals only:
Prior to administration of Gadopentetate Insight, all patients should be screened for renal
dysfunction by obtaining laboratory tests.
There have been reports of nephrogenic systemic fibrosis (NSF) associated with use of
Gadopentetate Insight and some other gadolinium-containing contrast agents in patients with
acute or chronic severe renal impairment (GFR < 30 ml/min/1.73m2). Patients undergoing liver
transplantation are at particular risk since the incidence of acute renal failure is high in this
group. Therefore Gadopentetate Insight must not be used in patients with severe renal
impairment, in patients in the perioperative liver transplantation period.
Gadopentetate Insight should also not be given to newborn babies up to the age of 4 weeks.
The risk for development of NSF in patients with moderate renal impairment (GFR 30–59
ml/min/1.73 m2) is unknown, therefore, Gadopentetate Insight should be only used after careful
risk-benefit evaluation in patients with moderate renal impairment at a dose not exceeding
0.2 ml/kg body weight. More than one dose should not be used during a scan. Because of the
lack of information on repeated administration, Gadopentetate Insight injections should not be
repeated unless the interval between injections is at least 7 days.
Due to immature renal function in infants up to 1 year of age, Gadopentetate Insight should only
be used in these patients after careful consideration at a dose not exceeding 0.2 ml/kg body
weight. More than one dose should not be used during a scan. Because of the lack of
information on repeated administration, Gadopentetate Insight injections should not be repeated
unless the interval between injections is at least 7 days. Gadopentetate Insight should not be
given to newborn babies up to age of 4 weeks.
As the renal clearance of gadopentetate dimeglumine may be impaired in the elderly, it is
particularly important to screen patients aged 65 years and older for renal dysfunction.
Haemodialysis shortly after Gadopentetate Insight administration may be useful at removing
Gadopentetate Insight 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.
Gadopentetate Insight should not be used during pregnancy unless the clinical condition of the
woman requires use of gadopentetate dimeglumine.
Breast-feeding should be discontinued for at least 24 hours after the administration of
Gadopentetate Insight.
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.

8

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