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GADOPENTETATE DIMEGLUMINE 469 MG /ML SOLUTION FOR INJECTION

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PIL-524UK_GAD_V1.qxp

10/11/2010

16:56

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Gadopentetate dimeglumine 469 mg/ml
solution for injection
Gadopentetate dimeglumine
Read all of this leaflet carefully before you start taking this medicine
• Keep this leaflet. You may need to read it again.
• If you have further questions, please ask your doctor.
• This medicine has been prescribed for you. Do 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.
In this leaflet:
1. What Gadopentetate dimeglumine is and what it is used for
2. Before you are given Gadopentetate dimeglumine
3. How to use Gadopentetate dimeglumine
4. Possible side effects
5. How to store Gadopentetate dimeglumine
6. Further information

[Laetus code]

1.WHAT GADOPENTETATE DIMEGLUMINE IS AND WHAT IT IS USED FOR
Gadopentetate dimeglumine is used together with a technique called Magnetic Resonance Imaging (MRI)
to create artificial contrast to help make an MRI scan clearer. It is used during cranial (head), spinal and
whole body MRI scans including the 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 can be used to help detect and identify several different types of tumours (growths) or lesions in the
head, spine and various sites of the body. It can also help produce a clearer picture of blood vessels with
the exception of the arteries of the heart (called 'MR-angiography') and helps in the diagnosis of narrowing
or obstruction of the blood vessels. It can also help identify damaged heart muscle tissue.
This medicine is for diagnostic use only.
2.BEFORE YOU ARE GIVEN GADOPENTETATE DIMEGLUMINE
You should not be given Gadopentetate dimeglumine
• if you are allergic (hypersensitive) to Gadopentetate dimeglumine or any of the other ingredients of this
medicine.
• if you suffer from severe kidney problems (glomerular filtration rate, GFR, of less than 30ml/min/1.73m²)
or if you are about to have, or you have recently had a liver transplant, as use of this medicine 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 dimeglumine should not be given to newborn babies up to 4 weeks of age.

Take special care with Gadopentetate dimeglumine
• if you have recently had or soon expect to have a liver transplant. Tell your doctor if this applies to you.
• if you have a heart pacemaker, an iron-based (ferromagnetic) clip or an implant or an insulin pump.
Please inform your radiologist/doctor as these are conditions where MRI is not suitable.
• because Gadopentetate dimeglumine may trigger allergic or other specific individual reactions that may
have consequences on your heart, on your respiratory tract or on your skin.
• if an allergic reaction occurs. The radiologist/doctor will stop administering the contrast medium at once
and, if necessary, will start appropriate treatment of the allergic reaction. It is therefore recommended
that you have a flexible, in-dwelling catheter during the examination to enable immediate action in case
of emergencies.
Rarely severe reactions including shock may occur. Please 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 occurring.
• if you are taking a beta-blocker (medicines used for high blood pressure, heart problems and other
conditions) you should tell your radiologist/doctor. Patients treated with beta-blockers do not necessarily
respond to medicines that are 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 a fatal outcome if you have a severe allergic reaction.
• if you have fits or seizures you may have an increased risk of suffering from one during the examination.
• if your kidneys do not work properly, you will need to have a blood test to check how well your kidneys
are working before you are given Gadopentetate dimeglumine.
• if the child you are caring for is up to one year old, Gadopentetate dimeglumine should only be used
after careful consideration of the childs kidney function. It should not be used in newborn babies up to
4 weeks of age.

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 be aware that nausea or low
blood-pressure may occur.

Gadopentetate dimeglumine should not be injected into the fluid that surrounds the spinal cord (intrathecal).

Patients with liver and kidney problems
You should not be given this medicine if you have severe kidney problems or if you are about to have or
have recently had a liver transplant.

Newborns, infants and toddlers
In order to prevent overdosing, your doctor will inject your new-born infant or small child by hand, rather
than using a preset automatic injector.
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, in particular:
• Beta blockers (medicines used for high blood pressure, heart problems and other conditions).

3.HOW TO USE GADOPENTETATE DIMEGLUMINE
Gadopentetate dimeglumine will be given by a healthcare professional directly into a vein (intravenously).
Ideally you should be lying down during administration and you will be kept under observation for at least
30 minutes after the injection. This is the time when most undesired reactions (e.g. allergic reactions) may
occur. However, in rare cases, some reactions may occur a few hours or even days later.
If this medicine 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 head, spinal and whole body MRI will depend on the type of lesion that is being investigated
but it is usually between 0.2 and 0.6 ml/kg of body weight for adults and between 0.2 and 0.4 ml/kg of body
weight for children.
New-borns, infants and toddlers (aged from 4 weeks to 2 years)
In children from 4 weeks to 2 years of age 0.2 ml/kg of body weight is recommended.
As kidney function is immature in infants up to 1 year of age, infants should only receive one dose of
gadopentetate dimeglumine during a scan and should not receive a second injection for 7 days.
It should not be used in newborn babies up to 4 weeks of age.
In order to prevent an accidental overdose, the dose to be given to babies and small children should be
given by hand (see also notes on use in section 2).

If you have moderate kidney problems, you should only receive one dose of Gadopentetate dimeglumine
during a scan and you should not receive a second injection for at least 7 days,
Elderly patients
It is not necessary to adjust your dose if you are 65 years or older but you will have a blood test to check
how well your kidneys are working.

Using Gadopentetate dimeglumine with food and drink
It is very important that you do not eat anything for 2 hours before the examination.

Gadopentetate dimeglumine will be given by a healthcare professional directly into a vein
(i.e. intravenous use). It should only be drawn up into the syringe immediately before it is used.

Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine.
You must tell your doctor if you think you are pregnant as Gadopentetate dimeglumine should not
be used during pregnancy unless clearly necessary.
Tell your doctor if you are breast-feeding or about to start breastfeeding.
You should not breast-feed for at least 24 hours after you receive this medicine.

If you have been given more Gadopentetate dimeglumine than you should have been
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.

INFORMATION FOR HEALTHCARE PROFESSIONALS
Prior to administration of Gadopentetate dimeglumine, 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 dimeglumine 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 dimeglumine must not be used in patients with
severe renal impairment or in patients in the peri-operative liver
transplantation period.
Gadopentetate dimeglumine 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/1.73m2) is unknown therefore Gadopentetate dimeglumine
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.
No more than one dose should be used during a scan. Because of the lack
of information on repeated administration, Gadopentetate dimeglumine
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
dimeglumine should only be used in these patients after careful consideration
at a dose not exceeding 0.2 ml/kg body weight. No more than one dose
should be used during a scan. Because of the lack of information on repeated
administration, Gadopentetate dimeglumine injections should not be repeated
unless the interval between injections is at least 7 days. Gadopentetate
dimeglumine should not be given to newborn babies up to the 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 administration may be
useful at removing Gadopentetate dimeglumine 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 dimeglumine should not be used during pregnancy unless the
clinical condition of the woman requires use of this medicinal product.
Breast-feeding should be discontinued for at least 24 hours after
administration.

Method of administration and MRI examination
The required dose should only be administered by intravenous injection.
A bolus injection is possible.
Gadopentetate dimeglumine should be drawn into the syringe immediately
before use. If it is intended to be used with an automatic application system,
its suitability for the intended use must be demonstrated by the manufacturer
of the medical device. Instructions for use of the medical device must be
followed absolutely.
Regardless of the field strength of the magnet, the recommended magnetic flux
density for Gadopentetate dimeglumine is between 0.14 Tesla and 1.5 Tesla.
The MRI examination should start shortly after administration of Gadopentetate
dimeglumine depending on the pulse sequences used and the protocol for the
examination. Optimal enhancement is observed within the first minutes after
injection, where the time depends on the type of lesion/tissue. Enhancement
generally lasts for up to 45 minutes after contrast medium injection.
T1-weighted scanning sequences are particularly suitable for contrast
enhanced examinations with Gadopentetate dimeglumine.
For single use only.
The vial/bottle should not be used if its integrity is compromised or if any
signs of deterioration (such as particles in the solution or fissures in the
vial/bottle) are visible.
Dietary recommendations
Nausea and vomiting are known side effects when using MRI contrast
agents. The patient should therefore refrain from eating for 2 hours prior to
the investigation.
Anxiety
Pronounced tension, anxiety or pain may increase the risk of side effects or
can aggravate the reactions caused by contrast agents. Sedatives may be
given to these patients.

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4.POSSIBLE SIDE EFFECTS

Organ system

Adverse reaction

Frequency

5HOW TO STORE GADOPENTETATE DIMEGLUMINE

Like all medicines, Gadopentetate dimeglumine can cause side effects, although not
everybody gets them.

Nervous System Disorders

dizziness, numbness (paraesthesia), headache

Uncommon

Keep out of the reach and sight of children.

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

Rare

Do not use Gadopentetate dimeglumine after the expiry date which is stated on the label. The expiry date
refers to the last day of that month.

Eye Disorders

eye pain, sight disturbances, eyes watering

Rare

Other side effects that may occur have been listed by organ system and frequency.
Frequencies are reported as:
very common: affects more than 1 in 10 patients
common: affects 1 to 10 patients in every 100
uncommon: affects 1 to 10 patients in every 1,000
rare: affects 1 to 10 patients in every 10,000
very rare: affects less than 1 patient in every 10,000
not known: frequency cannot be estimated from the available data

Ear Disorders

ear pain, hearing disturbances

Rare

Heart Disorders

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

Rare

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.

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

6.FURTHER INFORMATION

Some people may find they have an allergic reaction to Gadopentetate dimeglumine.
Tell your doctor immediately if any of the following rare symptoms occur:
• Sudden wheezing and tightness of the chest
• Swelling of eyelids, face or lips
• Skin rashes (urticaria), itchiness, fever
• Collapse
• Turning blue (cyanosis).

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 disturbances, dry mouth,
excess saliva

Rare

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

Rare

cases of nephrogenic systemic fibrosis/ nephrogenic fibrosing
dermophathy (which causes hardening of the skin and may also
affect soft tissue and internal organs)

Not known

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 kidney failure in
patients with kidney problems

Rare

feeling hot

Uncommon

chest pain, chills, sweating, changes in body temperature, fever;
pain at the administration site, feeling cold or warm, swelling,
inflammation, degeneration of tissue (tissue necrosis),
inflammation of the veins at the injection site

Rare

Immune System Disorders
Allergic reactions:

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

The required dose of Gadopentetate dimeglumine should be administered
by hand to avoid accidental overdose and must not be administered with
an autoinjector in children of up to two years.

Laboratory values

Short term increase in blood iron levels, liver enzyme levels
and bile pigment (bilirubin) levels.

Rare

Summary of Dosage recommendations/maximum dose:
0.2 ml/kg body weight Normal dose in adults, adolescents and children for
cranial, spinal and whole body MRI. Maximum
dose in children <2 years

The most commonly reported side effects are nausea, vomiting, headache, dizziness, pain
and a feeling of warmth or cold at the injection site, or a feeling of warmth in general.

Skin Disorders

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.

General Disorders and
Administration Site Conditions

Store the vials/bottles in the outer carton in order to protect from light.
Do not store above 30°C.

What Gadopentetate dimeglumine contains:
The active substance is: Gadopentetate dimeglumine
Each ml of solution for injection contains 469 mg Gadopentetate dimeglumine (equivalent to 500 micromole,
equivalent to 79 mg gadolinium).
The other ingredients are pentetic acid, meglumine, water for injections
What Gadopentetate dimeglumine looks like and contents of the pack
Your medicine comes in a clear glass vial or bottle with a rubber stopper and aluminium cap that is packed
into a carton along with this patient information leaflet (package leaflet).
The vial or bottle contains a clear, particle free solution for injection.
Gadopentetate dimeglumine is presented in the following packs:
1 vial with 5, 10, 15, 20 and 30 ml solution for injection
10 vials with 5, 10, 15, 20 and 30 ml solution for injection
1 and 10 bottles with 100 ml solution for injection
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Bowmed Limited, Unit 2, Eastman Way, Stevenage, Herts SG1 4SZ, U.K.
Manufacturer
Bowmed Ibisqus Ltd, Brynkinalt Business Centre, Chirk, Wrexham, LL14 5NS, U.K.
This leaflet was last approved in 11/2010.

INFORMATION FOR HEALTHCARE PROFESSIONALS (CONT.)
Posology
Adults, adolescents and children (over the age of two years)
In general, 0.2 ml/kg body weight is sufficient to provide diagnostically
adequate contrast to answer clinical questions for cranial and spinal MRI
as well as for MRI of other regions.
In special cases, e.g. if a strong clinical suspicion of a lesion persists
despite a normal scan or in lesions with poor vascularisation and/or a small
extracellular space, an additional 0.2-0.4 ml/kg body weight for adults within
30 minutes, followed by MRI, may be necessary for an adequate contrast,
especially with less heavily T1-weighted scanning sequences.
For the exclusion of metastases or tumour recurrence in adults, an initial
0.6 ml/kg body weight may lead to a higher diagnostic confidence.
Depending on the investigation technique and the region to be investigated,
the maximum dose may be necessary in adults to visualize blood vessels
(e.g. angiography).
Maximum dose: 0.6 ml/kg body weight in adults or 0.4 ml/kg body weight in
children.
New-borns, infants and toddlers (under the age of two years)
Gadopentetate dimeglumine is contraindicated in neonates up to 4 weeks
of age.
Due to immature renal function in infants up to 1 year of age, Gadopentetate
dimeglumine 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 dimeglumine injections should not be repeated
unless the interval between injections is at least 7 days.
In children under 2 years of age 0.2 ml/kg body weight is recommended.
Only limited experience has been gained from applying whole-body MRI
to children under 2 years of age.

0.4 ml/kg body weight Maximum dose in children
0.6 ml/kg body weight Maximum dose in adults

Renal impairment
Gadopentetate dimeglumine is contraindicated in patients with severe renal
impairment (GFR < 30 ml/min/l.73m2) and in patients in the perioperative
liver transplantation period. Gadopentetate dimeglumine should only be
used after careful risk/benefit evaluation in patients with moderate renal
impairment (GFR 30-59 ml/min/1.73 m2) at a dose not exceeding 0.2 ml/kg
body weight. No more than one dose should be used during a scan.
Because of the lack of information on repeated administration, Gadopentetate
dimeglumine injections should not be repeated unless the interval between
injections is at least 7 days.
Shelf-life
Chemical and physical in-use stability has been demonstrated for 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 dimeglumine if you notice any visible signs of
deterioration (such as particles in the solution or fissures in the vial/bottle).

Expand Transcript

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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