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OMNISCAN INJECTION 0.5 MMOL/ML (287MG/ML)

Active substance(s): GADODIAMIDE

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1181158 GBR

Adults only
When brain metastases are suspected in patients
with equivocal scans after administration of the
0.1 mmol/kg b.w. injection, a second bolus injection
of 0.2 mmol/kg b.w. (equiv. to 0.4 ml/kg b.w.) up to
100 kg may be of additional diagnostic value when
administered within 20 minutes of the first injection.
Above 100 kg b.w. a second bolus injection of 40 ml
should be sufficient to provide diagnostically adequate
contrast.

1181158

SCIENTIFIC LEAFLET

GADODIAMIDE

Whole body
OMNISCANTM 0.5 mmol/ml Solution for Injection

QUALITATIVE AND QUANTITATIVE
COMPOSITION
Active ingredient
GADODIAMIDE
(GdDTPA-BMA)

Content pr ml
287 mg

Function
MRI-contrast
agent

equiv. 0.5 mmol
OMNISCAN Solution for injection is a non-ionic
paramagnetic contrast medium with the following
physicochemical properties:
Osmolality (mOsm/kg H20) at 37°C
780
Viscosity (mPa•s) at 20°C
2.8
Viscosity (mPa•s) at 37°C
1.9
Density at 20°C (kg/l)
1.15
Molar relaxivity
-1
-1
3.9
r1 (mM • s ) at 20 MHz and 37°C
r1 (mM-1 • s-1) at 10 MHz and 37°C
4.6
r2 (mM-1 • s-1) at 10 MHz and 37°C
5.1
pH
6.0-7.0
Gadodiamide is freely soluble in water.
Excipient(s) with known effect:
Omniscan also contains sodium 0.62mg/ml
For the full list of excipients, see list of excipients.

PHARMACEUTICAL FORM
Solution for injection, for intravenous use.
The product is a clear, colourless to slightly yellow
aqueous solution.

CLINICAL PARTICULARS
Therapeutic indications

Contrast medium for cranial and spinal magnetic
resonance imaging (MRI) and for general MRI of the
body after intravenous administration.
The product provides contrast enhancement and
facilitates visualisation of abnormal structures or
lesions in various parts of the body including the
CNS.
For cardiac MRI, the product is indicated for the
evaluation of coronary artery disease (CAD) by
myocardial perfusion imaging MRI (stress/rest and
late enhancement examination) for the detection
and localization of coronary artery disease (CAD)
and differentiation between areas of ischaemia and
infarction in subjects with known or suspected CAD.

Document: 1181158 GBR Version: 2 Draft: 3

Posology and method of administration
No special preparation of the patient is required.
OMNISCAN should be drawn into the syringe
immediately before use. Both the vial and the bottle
are intended for one patient only. Contrast medium
not used in one examination must be discarded.
For both adults and children the required dose
should be administered as a single intravenous
injection. To ensure complete injection of the
contrast medium, the intravenous line may be
flushed with sodium chloride injection 0.9%.

CNS
Dosage for adults and children
The recommended dosage is 0.1 mmol/kg body
weight (equivalent to 0.2 ml/kg b.w.) up to 100 kg.
Above 100 kg body weight 20 ml is usually sufficient
to provide diagnostically adequate contrast.

Dosage for adults and children from 2 years of age
The recommended dosage is 0.1 mmol/kg b.w.
(equiv. to 0.2 ml/kg b.w.) up to 100 kg.
Above 100 kg b.w. 20 ml is usually sufficient to
provide diagnostically adequate contrast.
OMNISCAN has also been used in a limited number of
children below 2 years of age.

CNS and Whole body only
Contrast-enhanced MRI should start shortly after
administration of the contrast medium, depending
on the pulse sequences used and the protocol
for the examination. Optimal enhancement is
observed within the first minutes after injection
(time depending on type of lesion/tissue).
Enhancement is generally lasting up to 45 minutes
after contrast medium injection. T1-weighted
scanning sequences are particularly suitable for
contrast-enhanced examinations with OMNISCAN.
In the investigated range of field strengths, from
0.15 Tesla up to 1.5 Tesla, the relative image contrast
was found to be independent of the applied field
strength.

Angiography
Dosage for adults
The recommended dosage is 0.1 mmol/kg body
weight (equivalent to 0.2 ml/kg b.w.). The efficacy
and safety of OMNISCAN for use in angiography in
children under the age of 18 years has not been
established.
Imaging should be performed during the first pass
of the contrast agent, during and immediately after
injection, depending on the MR equipment used, to
obtain optimal contrast effect.

Mammography
Dosage for adults
The recommended dosage is 0.1 - 0.2 mmol/kg
body weight (equivalent to 0.2 - 0.4 ml/kg b.w.).
Above 100 kg b.w. 20 ml - 40 ml is usually sufficient
to provide diagnostically adequate contrast.

Coronary Artery Disease (CAD)
Dosage for adults
The recommended dosage for evaluation of
cardiac perfusion is 0.15 mmol/kg b.w.
(equiv. to 0.3 ml/kg b.w.) given as two separate doses
of 0.075 mmol/kg b.w. (equiv. to 0.15 ml/kg b.w.)
administered within an interval of ≥10 minutes; one
at pharmacological stress followed by one at rest.
For the intravenous bolus injection in cardiac MRI,
the use of a suitable injector is recommended at a
rate of up to 8 ml/sec.
An adequate pharmacological stress agent should be
administered via separate intravenous line. For the
evaluation of late enhancement only, a total dose of
0.15 mmol/kg b.w. is recommended.
The CAD indication has not been studied in children.

Special Populations
Renal impairment
Omniscan is contraindicated in patients with severe
renal impairment (GFR < 30 ml/min/1.73m2) or acute
kidney injury and in patients in the perioperative liver
transplantation period (see contra-indications).
Omniscan should only be used after careful
risk/benefit evaluation in patients with moderate
renal impairment (GFR 30-59 ml/min/1.73m2) at a

dose not exceeding 0.1 mmol/kg body weight
(see special warnings and precautions for use).
More than one dose should not be used during a
scan. Because of the lack of information on repeated
administration, Omniscan injections should not be
repeated unless the interval between injections is at
least 7 days.
Neonates up to 4 weeks of age and infants up to
1 year of age
Omniscan is contraindicated in neonates up to
4 weeks of age (see contra-indications).
Due to immature renal function in infants up to
1 year of age, Omniscan should only be used in these
patients after careful consideration at a dose not
exceeding 0.1 mmol/kg body weight.
More than one dose should not be used during a
scan. Because of the lack of information on repeated
administration, Omniscan injections should not be
repeated unless the interval between injections is at
least 7 days.
Elderly (aged 65 years and above)
No dosage adjustment is considered necessary.
Caution should be exercised in elderly patients
(see special warnings and precautions for use).

Contra-indications
OMNISCAN should not be used in patients known to
have hypersensitivity to OMNISCAN or its constituents.
Omniscan is contraindicated in patients with severe
renal impairment (GFR <30ml/min/1.73m2) or acute
kidney injury, in patients in the perioperative liver
transplantation period and in neonates up to 4 weeks
of age (see special warnings and precautions for use).

Special warnings and special precautions for use
The possibility of a reaction, including serious,
life-threatening, fatal, anaphylactoid or
cardiovascular reactions or other idiosyncratic
reactions should always be considered, especially in
those patients with a known clinical hypersensitivity
or a history of asthma or other allergic respiratory
disorders. A course of action should therefore be
planned in advance, with necessary drugs and
equipment available for immediate treatment should
a serious reaction occur.
Transitory changes in serum iron (within the normal
range in the majority of cases) have been observed
in some patients after administration of OMNISCAN.
The clinical significance of this, if any, is not known,
but all patients in whom this effect was observed
remained asymptomatic.
OMNISCAN interferes with serum calcium
measurements with some colorimetric
(complexometric) methods commonly used in
hospitals. It may also interfere with determinations of
other electrolytes (e.g. iron). Thus it is recommended
not to use such methods for 12-24 hours after
administration of OMNISCAN. If such measurements
are necessary, the use of other methods is
recommended.

Patients with impaired renal function
Prior to administration of Omniscan, all patients
should be screened for renal dysfuncion by
obtaining laboratory tests.
There have been reports of nephrogenic systemic
fibrosis (NSF) associated with use of Omniscan
and some other gadolinium-containing contrast
agents in patients with acute or chronic severe
renal impairment (GFR < 30 ml/min/1.73m2) and/or
acute renal injury. Omniscan is contraindicated in
these patients (see contra-indications).
Caution should be exercised in use and dose
selection of OMNISCAN in patients with hepatorenal
syndrome. Patients undergoing liver transplantation
are at particular risk since the incidence of acute
renal failure is high in this group. Therefore
Omniscan must not be used in patients with severe

renal impairment, in patients in the perioperative
liver transplantation period and in neonates
(see contra-indications).
In addition, the risk for development of NSF
in patients with moderate renal impairment
(GFR 30–59 ml/min/1.73 m²) is unknown, therefore,
Omniscan should be only used after careful
risk-benefit evaluation in patients with moderate
renal impairment.
The elimination half-life of Omniscan is prolonged
in patients with impaired renal function. Because of
the lack of information on repeated administration
to these patients, Omniscan injections should not be
repeated unless the interval between injections is at
least 7 days.
Haemodialysis shortly after Omniscan administration
may be useful at removing Omniscan 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.
Patient with central nervous system disorders
In patients suffering from epilepsy or brain lesions
the likelihood of convulsions during the examination
may be increased. Precautions are necessary
when examining these patients (e.g. monitoring
of the patient) and the equipment and medicinal
products needed for the rapid treatment of possible
convulsions should be available.
Neonates and Infants:
Omniscan is contraindicated in neonates up to
4 weeks of age (see contra-indications). Due to
immature renal function in infants up to 1 year of
age, Omniscan should only be used in these patients
after careful consideration.
Elderly
As the renal clearance of gadodiamide may be
impaired in the elderly, it is particularly important
to screen patients aged 65 years and older for renal
dysfunction.
This medicinal product contains: 0.62 mg/ml of
sodium. This needs to be taken into consideration for
patients on a controlled sodium diet.

Interaction with other medicaments and
other forms of interaction
None known.

Fertility, pregnancy and lactation
Pregnancy
There are no data from the use of gadodiamide
in pregnant women. Animal studies have shown
reproductive toxicity at repeated high doses
(see preclinical safety data). Omniscan should not be
used during pregnancy unless the clinical condition
of the woman requires use of gadodiamide.
Breastfeeding
It is unknown whether gadodiamide is excreted
in human milk. Available data in animals have
shown excretion of gadodiamide in milk (for details
see preclinical safety data). A risk to the suckling
child cannot be excluded. Breast-feeding should
be discontinued for at least 24 hours after the
administration of Omniscan.

Effects on ability to drive and use machines
None known.

Undesirable effects
Adverse reactions have been reported in
approximately 6% of the patients in clinical trials.
Most events have been transient and the majority
of mild intensity. The most commonly reported
spontaneous adverse effects after Omniscan are
hypersensitivity reactions, nausea and vomiting.
Cases of nephrogenic systemic fibrosis (NSF) have
been reported with Omniscan (see Special warnings
and precautions for use).

In clinical trials with Omniscan, adverse reactions
have been reported with the frequencies given below
(very common ≥1/10; common (≥1/100, <1/10);
uncommon (≥1/1000, < 1/100); rare (≥1/10,000,
<1/1000). Reactions for which no frequency rate can
be provided due to lack of clinical data, have been
entered with “Not known”.
Immune system disorders
Uncommon: Allergy-like skin and mucous
membrane reactions, hypersensitivity
Not known: Anaphylactic/anaphylactoid reactions*
Psychiatric disorders
Rare:
Anxiety
Nervous system disorders
Common:
Headache
Uncommon: Dizziness, paraesthesia, transient
perverted sensation of taste
Rare:
Convulsions, tremor, somnolence,
transient perverted sensation of smell
Eye disorders
Rare:
Visual disturbance
Cardiac disorders
Not known: Tachycardia
Vascular disorders
Uncommon: Flushing
Respiratory, thoracic and mediastinal disorders
Rare:
Dyspnoea, coughing
Not known: Sneezing, throat irritation,
bronchospasm, respiratory distress
Gastrointestinal disorders
Common:
Nausea
Uncommon: Vomiting, diarrhoea
Skin and subcutaneous disorders
Uncommon: Pruritus
Rare:
Rash, urticaria, oedema including face
swelling and angioneurotic oedema
Not known: Nephrogenic systemic fibrosis (NSF)
Musculoskeletal and connective tissue disorders
Rare:
Arthralgia
Renal and urinary system disorders
In patients with pre-existing severe renal
insufficiency;
Rare:
Acute renal failure
Not Known: Increase in blood creatinine
General disorders and administration site conditions
Common:
Transient sensation of warmth,
coolness or local pressure in connection
with injection. Transient sensation of
pain at the injection site
Rare:
Chest pain, fever, shivering
*Anaphylactic/anaphylactoid reactions which may
occur irrespective of the dose given and the method
of administration, may be the first signs of an
incipient shock.
Late adverse reactions can occur hours to days after
administration of Omniscan.

Reporting of suspected adverse reactions
Reporting suspected adverse reactions after
authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk
balance of the medicinal product. Healthcare
professionals are asked to report any suspected
adverse reactions via the Yellow Card Scheme.
Website: www.mhra.gov.uk/yellowcard

Overdose
Clinical consequences of overdose have not been
reported and acute symptoms of toxicity are
unlikely in patients with a normal renal function.
Treatment is symptomatic. There is no antidote for
this contrast medium. Omniscan can be removed
by haemodialysis. However there is no evidence
that haemodialysis is suitable for prevention of
nephrogenic systemic fibrosis (NSF).

1181158 GBR
1181158

PACKAGE LEAFLET:
INFORMATION FOR THE USER

GADODIAMIDE

Omniscan 0.5 mmol/ml solution for injection
Gadodiamide

Read all of this leaflet carefully before you
are given Omniscan because it contains
important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor.
• If you get any side effects, talk to your doctor.
This includes any possible side effects not listed in
this leaflet. See section 4.

In this leaflet:
1. What Omniscan is and what it is used for
2. What you need to know before you are given
Omniscan
3. How Omniscan is given
4. Possible side effects
5. How to store Omniscan
6. Contents of the pack and other information

1. What Omniscan is and what it is
used for
This medicine is for diagnostic use only.
Omniscan is a contrast medium which is used in
Magnetic Resonance Imaging (MRI) examinations of
the brain, spine and for whole body examinations.
Omniscan is used only for identifying (diagnosing) an
illness. Omniscan is used when the brain, spine or
whole body are examined with a MRI scanner. It can
help the doctor see some medical conditions more
clearly. This can increase the amount of information
the doctor has to identify the illness (make a diagnosis).

2. What you need to know before you
are given Omniscan
Do not have Omniscan
• if you are allergic (hypersensitive) to gadodiamide
the active substance of Omniscan or to any of its
other ingredients (listed in section 6)
• If you suffer from severe kidney problems and/or
acute kidney injury.
• if you are a liver transplant patient.
as use of Omniscan in patients with these conditions
has been associated with a disease called
Nephrogenic systemic fibrosis (NSF). NSF is a disease
which causes discolouration and thickening of the
skin and may be painful and result in reduced joint
mobility, muscle weakness or impairment of the
function of the internal organs.

Warnings and precautions
Talk to you doctor before using Omniscan
• if you have or have had any allergies
(e.g. allergies to seafood, hay fever, nettle rash).
• if you have asthma or other breathing problems
caused by an allergy.
• if you have a history of epilepsy, brain lesions or if
you have ever had fits or seizures.
• if you have any kidney problems.
• if you are going to have a blood test between
12-24 hours after having the Omniscan injection.
This is because Omniscan may affect how
accurately the blood test shows the level of iron or
calcium (electrolytes) in your blood.

You should not be given Omniscan 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 Omniscan 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.
Omniscan should also not be given to newborn babies
up to age of 4 weeks.
Before you receive Omniscan, you will need to have
a blood test to check how well your kidneys are
working.

Children and adolescents
Omniscan 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, Omniscan will only be
used in infants after careful consideration by the
doctor.

Other medicines and Omniscan
Tell your doctor if you are taking or have recently
taken any other medicines, including medicines
obtained without a prescription.

Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may
be pregnant or are planning to have a baby, ask your
doctor for advice before you are given Omniscan,
as Omniscan should not be used during pregnancy
unless strictly necessary.
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
Omniscan.

Driving and using machines
No effects are known on the ability to drive and use
machines.
This medicinal product contains 0.62mg/ml of sodium.
To be taken into consideration if you are on a low
sodium diet

3. How to use Omniscan
Dosage and administration
• Omniscan will be given to you by injection into one
of your veins. This is usually as a single injection
before or during your MRI scan.
• Sometimes a second injection of Omniscan is given
to help the doctor identify (diagnose) the condition.
The amount injected will depend on your weight and
what part of your body is being examined.
• The usual amount is 0.2 ml for each kilogram of
body weight.
• Sometimes the amount given is up to 0.6 ml for
each kilogram of body weight.
You will not normally receive more than
20 ml Omniscan, even if you weigh more than
100 kilograms. However, for identifying (diagnosing)
some conditions you may need to have 60 ml
Omniscan.
Dosage in special patient groups
You should not be given Omniscan 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.
Omniscan should also not be used in newborn babies
up to the age of 4 weeks.
If you have moderate kidney problems, you should
only receive one dose of Omniscan during a scan and
you should not receive a second injection for at least
7 days.
As kidney function is immature in infants up to
1 year of age, infants should only receive one dose
of Omniscan during a scan and should not receive a
second injection for at least 7 days.



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.
If you have any further questions on the use of this
Omniscan, ask your doctor.

4. Possible side effects
There have been reports of nephrogenic systemic
fibrosis (which causes hardening of the skin and may
affect also soft tissue and internal organs).
Like all medicines, Omniscan can cause side effects,
although not everybody gets them.
If any of the side effects gets serious, or if you notice
any side effects not listed in this leaflet, please tell
your doctor.

Document: 1181158 GBR Version: 2 Draft: 3

If you get any of the following during or after
the examination:
• Allergic reactions:
- wheeziness, difficulty in breathing or tightness
or pain in the chest.
- skin rash, lumps or itchy spots.
• A decrease in the amount or urine you pass, or a
change in its colour.
• Nephrogenic systemic fibrosis (NSF), which causes
discolouration and thickening of the skin and may
be painful and result in reduced joint mobility,
muscle weakness or impairment of the function of
the internal organs.
You should tell the doctor straight away.
This is a list of side effects which may occur during or
after the examination:
Common (affects less than 1 in 10 people)
• An uncomfortable feeling of warmth, coolness,
pressure or pain may occur in the area around
where injection is given. This lasts for only a short
time.
• Headache.
• Nausea (feeling sick).
Uncommon (affects less than 1 in 100 people)
• Allergic-like reactions of skin and mucous
membrane (mouth and throat).
• Feeling dizzy.
• Tingling sensations.
• Vomiting.
• Diarrhoea.
• Flushing.
• Itching.
• A momentary change in your sense of taste.
Rare (affects less than 1 in 1,000 people)
• A momentary change in your sense of smell.
• Fits or seizures.
• Feeling drowsy.
• Difficulty in breathing.
• Pain in the joints.
• Shaking or tremors.
• Feeling anxious.
• Disturbance of vision.
• Chest pain.
• Acute kidney failure
• Coughing
• Rash and hives
• Swelling, including face swelling, mouth or throat.
• Fever.
• Shivering.
Unknown (the number of people affected is unknown)
• Allergic (hypersensitive) reactions, including allergic
shock, see “Allergic reactions” above for other
signs.
• Nephrogenic systemic fibrosis (NSF), which causes
discolouration and thickening of the skin and may
be painful and result in reduced joint mobility,
muscle weakness or impairment of the function of
the internal organs.
• Very fast heart beat.
• Irritation in the throat.

• Sneezing.
• Severe difficulty in breathing.
• Increase in levels of creatinine in your blood.
(creatinine level is used as a measure of how your
kidneys are functioning)

PHARMACOLOGICAL PROPERTIES
Pharmacodynamic properties

6. Contents of the pack and other
information

Pharmacotherapeutic group: Paramagnetic contrast
media.
ATC code: V08C A03
The paramagnetic properties of Omniscan provide
contrast enhancement during MRI.
There were no clinically significant deviations from
preinjection values in haemodynamic and blood and
urine laboratory parameters following intravenous
injection of gadodiamide in healthy volunteers.
However, a minor transient change in serum iron
levels 8 to 48 hours after gadodiamide injection was
observed.
OMNISCAN does not cross the intact blood-brain
barrier. Administration of OMNISCAN causes signal
enhancement from areas where blood-brain barrier
dysfunction has been induced by pathological
processes, and may provide greater diagnostic yield
than unenhanced MRI. Lack of enhancement need
not indicate absence of pathology since some types
of low grade malignancies or inactive MS-plaques fail
to enhance; it can be used for differential diagnosis
between different pathologies.

What Omniscan contains

Pharmacokinetic properties

• The active substance is gadodiamide (287 mg of
gadodiamide in each ml, equivalent to 0.5 mmol in
each ml).
• The other ingredients are caldiamide sodium
and sodium hydroxide or hydrochloric acid
(for pH adjustment) and water for injections.

GE Healthcare AS
Nycoveien 1-2
P.O. Box 4220 Nydalen
NO-0401 Oslo, Norway

Gadodiamide is rapidly distributed in the
extracellular fluid. The volume of distribution is
equivalent to that of extracellular water.
The distribution half-life is approximately 4 minutes
and the elimination half-life is approximately
70 minutes. In patients with impaired renal function
(GFR < 30 ml/min) the elimination half-life will be
prolonged to an extent inversely proportional to GFR.
Gadodiamide is excreted through the kidneys by
glomerular filtration. In patients with normal renal
function approximately 85% of the administered
dose is recovered in the urine by 4 hours and
95-98% by 24 hours after intravenous injection.
The renal and total clearance rates of gadodiamide
are nearly identical, and are similar to that of
substances excreted primarily by glomerular
filtration.
No dose dependent kinetics have been observed
after injection of 0.1 and 0.3 mmol/kg.
No metabolites have been detected. No protein
binding has been observed.

Manufacturer

Preclinical safety data

Reporting of side effects
If you get any side effects, talk to your doctor.
This includes any possible side effects not listed
in this leaflet. You can also report side effects
directly via the Yellow Card Scheme,
Website: www.mhra.gov.uk/yellowcard

5. How to store Omniscan
• Keep out of the sight and reach of children.
• Store in the outer carton in order to protect from
light.
• Do not freeze.
• Do not use Omniscan after the expiry date which is
stated on the label.
• If electronic patient records are used, the name of
the product, the batch number and the dose should
be entered into the patient record.

What Omniscan looks like and contents of
the pack
Omniscan is a solution for injection. It is a clear,
watery (aqueous) solution, colourless to slightly
yellow.

Omniscan is supplied as:
Glass vials of 5 ml, 10 ml, 15 ml and 20 ml
Pre-filled syringe of 10ml, 15ml and 20ml
Not all pack sizes may be marketed.

Marketing Authorisation Holder

GE Healthcare AS
Nycoveien 1-2
P.O. Box 4220 Nydalen
NO-0401 Oslo, Norway
Or
GE Healthcare Ireland
IDA Business Park
Carrigtohill
Co. Cork, Ireland

Local Representative:
GE Healthcare Limited
Little Chalfont, Buckinghamshire HP7 9 NA

This leaflet was last approved in
June 2015

Omniscan is a trademark of GE Healthcare
GE and the GE monogram are trademarks of General
Electric Company.

Non-clinical data reveal no special hazard for
humans based on conventional studies of safety
pharmacology, repeated dose toxicity, genotoxicity
and local tolerance.
Toxicological studies have demonstrated a high
acute tolerance of gadodiamide. The common finding
after high single dose or repeated dose toxicology
studies was proximal tubular vacuolation, which was
reversible, and was not associated with altered renal
function.
Gadodiamide had no effects on fertility, reproductive
performance or peri- post-natal development in rats,
or in teratology studies in rats and rabbits at doses
not associated with paternal or maternal toxicity.
In pregnant rabbits reduced fetal weights and
skeletal anomalies were observed after repeated
administration of doses of 0.5 mmol/kg/day and
above (approximately 2 times the maximum human
cumulative dose of 0.3 mmol/kg based on a mmol/kg
comparison). The transfer of maternally administered
gadodiamide into milk was small in lactating rats
injected intravenously with gadodiamide.

PHARMACEUTICAL PARTICULARS
List of excipients

The following excipients are included:
Caldiamide sodium, sodium hydroxide 1 M or
hydrochloric acid 1 M, water for injections.

Incompatibilities
OMNISCAN should not be directly mixed with other
drugs. A separate syringe and needle should be used.

Shelf life
3 years

Special precautions for storage
OMNISCAN in glass vials should be stored below
30ºC and protected from light and freezing. The vial
is intended for one patient only. Any unused portions
must be discarded.

Nature and content of containers
The product is filled in injection vials with a fill
volume of 5 ml, 10 ml, 15 and 20 ml. The vials are
made of colourless highly resistant borosilicate glass
(Ph.Eur. Type I) and are closed with latex free rubber
stoppers, sealed with complete tear off capsules of
aluminium with coloured plastic “flip-off” tops.
The product is supplied as:
1 vial of 5 ml
10 vials of 5 ml
10 vials of 10 ml
10 vials of 15 ml
10 vials of 20 ml

Special precautions for disposal and other
handling
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. If electronic
patient records are used, the name of the product,
the batch number and the dose should be entered
into the patient record.

MARKETING AUTHORISATION
HOLDER
GE Healthcare AS
Nycoveien 1-2
P.O. Box 4220 Nydalen
NO-0401 Oslo, Norway

Local representative
GE Healthcare Limited
Amersham Place
Little Chalfont
Buckinghamshire HP7 9NA

Manufacturer
GE Healthcare AS
or GE Healthcare Ireland,
Nycoveien 1-2
IDA Business Park
P.O.Box 4220 Nydalen
Carrigtohill Co. Cork
NO-0401 OSLO, NORWAY
Ireland
Telephone: +47 23 18 50 50
Telephone: +353 21 88 33 66
Telefax:
+47 23 18 60 00
Telefax:
+353 21 88 33 25

Legal category
POM

MARKETING AUTHORISATION
NUMBER
PL 00637/0015

DATE OF THE FIRST AUTHORISATION
OR RENEWAL
25th September 1992 in UK / 10 June 2005

DATE OF REVISION OF THE TEXT
April 2015

Omniscan is a trademark of GE Healthcare.
GE and the GE monogram are trademarks of General
Electric Company.

1181158 GBR

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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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