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UROGRAFIN 150 INFUSION

Active substance(s): MEGLUMINE AMIDOTRIZOATE / SODIUM AMIDOTRIZOATE

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Package leaflet: Information for the patient
UROGRAFIN®
Sodium amidotrizoate (sodium diatrizoate) and meglumine amidotrizoate (meglumine
diatrizoate)

Read all of this leaflet carefully before you are given this medicine because it contains
important information for you.
-

Keep this leaflet. You may need to read it again.
If you have any further questions, ask the doctor giving you Urografin (the
radiologist) or the X-ray department staff.
If you get any side effects, talk to your doctor or the X-ray department
staff/radiologist. This includes any possible side effects not listed in this leaflet.
See section 4.

What is in this leaflet
1.
2.
3.
4.
5.
6.

What Urografin is and what it is used for
What you need to know before you are given Urografin
How you will be given Urografin
Possible side effects
How to store Urografin
Contents of the pack and other information

1. What Urografin is and what it is used for
Urografin is an injectable contrast medium (a dye) which contains iodine. It is used to clearly
show on X-rays the area of your body that your doctor wants to investigate.
X-rays, like radio waves, can pass through objects and can be focused to make a picture.
When you have an X-ray, the beam of rays goes through your body where it is absorbed to
differing degrees by different tissues such as bones, muscles and organs. When the rays
come out on the other side they make a pattern of light and shade on a film. Urografin helps
to make this pattern clearer. The film is then examined by a specialist who will make a
diagnosis.
This medicine is for diagnostic use only.
2. What you need to know before you are given Urografin
Do not use Urografin





if you are allergic to sodium amidotrizoate, meglumine amidotrizoate, iodine or iodinecontaining contrast media or any of the other ingredients of this medicine (listed in
section 6)
if you have a condition caused by too much thyroid hormone (uncontrolled
thyrotoxicosis)
if you have severe heart insufficiency (causing oedema (swelling of areas of your body
e.g. ankles) or shortness of breath)
if you are pregnant or have inflammation of the pelvic cavity (symptoms include
stomach pain and tenderness, fever and irregular menstrual periods): you must not
have your uterus (womb) investigated with Urografin.

Warnings and precautions
Talk to your doctor or the X-ray department staff/radiologist before receiving Urografin

You must tell the X-ray department staff if you have any of the following:

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reduced liver or kidney function
epilepsy or a history of seizures
a disease of blood vessels in the brain (cerebral arteriosclerosis)
diabetes mellitus requiring treatment and/or associated with diabetic complications
damaged lungs (pulmonary emphysema)
poor general health
an overactive thyroid gland (hyperthyroidism) or a swollen neck due to an enlarged
thyroid gland (benign nodular goitre)
a disease of the bone marrow (multiple myeloma)
a history of allergy or a tendency to develop hypersensitivity reactions (for example if
you have hay fever, asthma or eczema), especially if you have taken a medicine like
Urografin (a contrast medium) before
poor heart function or blood circulation
previously had a reaction to any contrast media.

If any of these apply to you, you may be at a higher risk of having an allergic reaction or
becoming unconscious/fainting.
If you have a phaeochromocytoma (tumour of the adrenal gland) you may be given a medicine
called an alpha-receptor blocker before the investigation to prevent your blood pressure from
rising.
Urografin may affect the way the thyroid gland works for 6 weeks or more after being given it.
If you are going to have an iodine test for thyroid disease, tell your doctor or the laboratory
staff if you have been given Urografin recently.
Other medicines and Urografin
Tell your doctor or the X-ray department staff/radiologist if you are taking, have recently taken
or might take any other medicines. This is particularly important for:


beta-blockers (drugs used to treat heart or blood pressure), because they can make
allergic reactions worse



if you have been treated with a drug called interleukin, because there is a higher
chance of getting delayed reactions (e.g. fever flu-like symptoms, joint pain and
pruritus (itching))



if you have kidney disease due to diabetes (diabetic nephropathy) and are taking a
type of medicine called biguanides (metformin). You should inform your doctor who
will probably stop the biguanides 48 hours before the examination.

Ask the X-ray department staff if you are not sure.
Urografin with food and drink
If the procedure is to look at your abdomen, kidneys or bladder you may be asked to avoid
foods that cause flatulence (wind) for two days beforehand. These foods include:
peas, beans, lentils, salads, fruit
brown or granary bread
all kinds of uncooked vegetables.
You will be told not to eat after 6pm on the day before the examination, but you can still drink.
Babies and young children, however, must not fast. If you have a disorder of your body water
and body salts balance this will be corrected before the examination.
Do not reduce the amount you normally drink before the investigation, especially if you have
any of the following:


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multiple myeloma (disease of the bone marrow)

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diabetes mellitus



polyuria (production of large amounts of urine which is pale in colour)



oliguria (production of small amounts of urine)



gout.

Also, fluid intake must not be reduced in babies, young children, or in someone who is in a
very poor general state of health where their body tissues are wasting away.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a
baby, ask the doctor or X-ray department staff /radiologist for advice before receiving this
medicine.
Driving and using machines
You should not drive or operate machinery for 24 hours after the examination as you may
have a delayed reaction to Urografin.
Urografin contains sodium
This medicinal product contains 1.5 mg sodium per ml. To be taken into consideration by
patients on a controlled sodium diet.
3. How you will be given Urografin
The X-ray department staff will decide how much Urografin is needed for your particular
investigation. They will explain how everything works and what position you should lie in on the
X-ray table.
The dose of Urografin varies depending on the investigation and your weight. The dose range
is normally between 1 and 500 ml.
Once you lie down the Urografin will be injected into a vein. Sometimes, Urografin will be
injected into your muscles or anus (back passage). The staff in the X-ray department will
observe you for 30 minutes after the injection just in case you have any side effects.
If you receive more Urografin than you should
Overdosing is unlikely. If it does happen the radiologist will treat any symptoms that follow.
If you have any further questions on the use of this medicine, ask your doctor or the X-ray
department staff/radiologist for advice before receiving this medicine.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects you may get after being given a contrast medium like Urografin are usually mild
and do not last long.
However, as with similar contrast media, severe and life-threatening reactions, as well as
deaths, have been reported.
If you notice:
• itching of the skin, rash, wheals on the skin (urticaria)
• difficulty breathing, gagging, feeling of suffocation
• swelling of the face, neck or body
• itchy or watery eyes, tickling in the throat or nose, hoarseness, coughing or sneezing
• headache, dizziness, feeling faint
• feeling particularly hot or cold, sweating

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paleness or reddening of the skin
chest pain, cramp, tremor
feeling sick

Tell the radiologist or X-ray staff immediately as these may be the first signs of allergic
reaction or shock. Your investigation will need to be stopped, and you may need further
treatment.
Apart from the symptoms listed above the other possible side effects of Urografin are:





feeling sick or being sick
a sensation of pain and a general feeling of warmth
in rare cases your kidneys temporarily stop working
reddening or other reactions at the injection site if Urografin is not injected properly.

Very rarely severe or even life-threatening side-effects may occur and in some cases have
been fatal. These include:
lowered blood pressure
fainting (collapse)
circulatory failure
an irregular, rapid heart beat which may cause the heart to suddenly stop
beating altogether (cardiac arrest)
fits or other brain related symptoms
a build-up of water in the air spaces of the lung
anaphylactic shock (a very severe allergic reaction).
If you are having a procedure where Urografin will reach the brain, you may have
complications such as:
• coma, temporary confusion and drowsiness
• temporary weakness of the muscles
• disturbed vision or weakness of the facial muscles
• epileptic fits, especially in someone with epilepsy or brain damage.
Delayed reactions can occasionally occur, if you are concerned you should contact your
doctor.
Reporting of side effects
If you get any side effects, talk to your doctor, radiologist or X-ray department staff. This
includes any possible side effects not listed in this leaflet. You can also report side effects
directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Urografin
Keep this medicine out of the sight and reach of children.
Do not use Urografin after the expiry date which is stated on the label and carton after EXP.
The expiry date refers to the last day of that month.
Protect from light and secondary X-rays.

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6. Contents of the pack and other information
What Urografin contains

• The active substances are sodium amidotrizoate and meglumine amidotrizoate.
1 ml Urografin 150 contains 40 mg sodium amidotrizoate and 260 mg meglumine
amidotrizoate.
1 ml Urografin 150 for infusion contains 40 mg sodium amidotrizoate and 260 mg
meglumine amidotrizoate.

• The other ingredients are sodium calcium edetate (E 385) and water for injections.
What Urografin looks like and contents of the pack
Urografin 150 is available in packs of ten 10 ml ampoules or packs of ten 20 ml ampoules.
Urografin 150 for infusion is available in 250 ml or 500 ml bottles.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder: Bayer plc
Bayer House
Strawberry Hill
Newbury
Berkshire, RG14 1JA
Manufacturer:

BerliMed S.A
Madrid
Spain
.

This leaflet was last revised in December 2015.

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To listen to or request a copy of this leaflet in Braille, large print or audio please
call, free of charge:

0800 198 5000 (UK only)
Please be ready to give the following information:
Product name

Reference number

Urografin 150

00010/0569

Urografin 150 for Infusion

00010/0568

This is a service provided by the Royal National Institute of the Blind.

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-----------------------------------------------------------------------------------------------------------The following information is intended for healthcare professionals only:
Information for Healthcare Professionals
UROGRAFIN®
Composition, availability and viscosity
The Urografin range contains sodium and meglumine amidotrizoate in various ratios. The
numerical suffix gives the approximate iodine concentration of the medium (see table 1).
1ml Urografin 150 contains 40mg sodium amidotrizoate and 260mg meglumine amidotrizoate.

Excipients: Sodium calcium edetate (E Number 385), water for injection.
Table 1
Medium

Urografin
150

Ratio of sodium:
meglumine
amidotrizoate

Exact Iodine
concentration
mg/ml

10:66

146

Availability

10ml
ampoule
20ml
ampoule
250ml
infusion bottle
500ml
infusion bottle

Iodine content
(g) per
container

Viscosity (cp)

20°C

37°C

2.2

1.4

1.46
2.92
36.5
73.0

Package quantities
Urografin 150: Packs of 10x10ml ampoules and 10x20ml ampoules.
Urografin 150 for infusion: Packs of 1x250ml bottles and 1x500ml bottles.

Urografin is a contrast medium.
The product licence is held by:

Product licence numbers

Urografin is manufactured by:

Bayer plc
Bayer House
Strawberry Hill
Newbury
Berkshire, RG14 1JA

Urografin 150 (30%)
Urografin 150 (30%) for infusion

00010/0569
00010/0568

BerliMed S.A., Madrid, Spain.

Uses
X-ray contrast medium for the delineation of the vascular and renal systems.
Contra-indications
Proven or suspected hypersensitivity to iodine-containing contrast media, uncontrolled
thyrotoxicosis and decompensated cardiac insufficiency.

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Hysterosalpingography must not be carried out during pregnancy or in patients with acute
inflammatory conditions in the pelvic cavity.
Warnings
For patients with severe impairment of hepatic or renal function, cerebral arteriosclerosis,
epileptic conditions, diabetes mellitus requiring drug treatment and/or associated with diabetic
complications, pulmonary emphysema, poor general health, latent hyperthyroidism, multiple
myeloma or benign nodular goitre the need for examination with an X-ray contrast medium
merits careful consideration.
This also applies to patients with a history of allergy, atopy, bronchial asthma, endogenous
eczema, cardiac or circulatory insufficiency or a previous adverse reaction with any contrast
medium since experience shows that they may be at higher risk from developing anaphylaxis
or cardiovascular collapse. Consideration should be given to the use of a low osmolar
radiocontrast medium in such patients.
The patient should be recumbent during the administration of Urografin. Thereafter, the
patient must be kept under close observation for at least 30 minutes, since about 90% of all
severe incidents occur within that time. If the administration does not take place on the X-ray
table, any patient with a labile circulation should be brought to the X-ray machine sitting or
lying down.
Particular caution should be exercised in allergic persons who have previously tolerated an
injectable iodine-containing contrast medium without any complication because they may have
become sensitised to these substances in the meantime.
As with any contrast medium, the possibility of hypersensitivity must always be considered. If
marked side-effects or suspected allergic reactions occur during injection and do not
disappear, or even get worse, when the injection is briefly interrupted, it is probable that the
patient is hypersensitive and the investigation must be abandoned. Even relatively minor
symptoms such as itching of the skin, sneezing, violent yawns, tickling in the throat,
hoarseness or attacks of coughing may be early signs of a severe reaction and, therefore,
merit careful attention.
Ionic iodinated contrast media inhibit blood coagulation in vitro more than non-ionic contrast
media. Nevertheless medical personnel performing vascular catheterisation procedures
should pay meticulous attention to the angiographic technique and catheter flushing so as to
minimise the risk of procedure-related thrombosis and embolisation.
In patients with multiple myeloma, diabetes mellitus requiring drug treatment, polyuria, oliguria
or gout, and in infants, young children and marasmic patients the fluid supply should not be
restricted. Existing disturbances of the balance of water and electrolytes must be corrected
before the administration of a hypertonic contrast-medium solution.
Premedication with an alpha-blocker is recommended in patients with phaeochromocytoma,
because of the risk of hypertensive crisis.
If iodine isotopes are to be administered for the diagnosis of thyroid disease, it should be
borne in mind that after the administration of an iodinated contrast medium which are excreted
via the kidneys, the capacity of the thyroid tissue to take up iodine will be reduced for 2 weeks,
and sometimes up to 6 weeks.
Experience shows that pronounced states of excitement, anxiety and pain can be the cause of
side effects or intensify contrast medium-related reactions. They can be counteracted by calm
management of the patient and the use of suitable drugs.
Pregnancy and lactation
X-ray examinations should if possible be avoided during pregnancy. It has not yet been
proved beyond question that Urografin may be used without hesitation in pregnant patients.

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Therefore, an examination with a contrast medium during pregnancy should be carried out
only if considered absolutely necessary by the physician.
Renally eliminated contrast media such as Urografin enter the breast milk in only very small
amounts.
Limited data suggest that the risk to the suckling infant of administering salts of diatrizoic acid
to its mother is low.
Drug Interactions
Diabetic nephropathy may predispose to renal impairment following intravascular contrast
medium administration. This may precipitate lactic acidosis in patients who are taking
biguanides. As a precaution, biguanides should be stopped 48 hours prior to the contrast
medium examination and reinstated only after adequate renal function has been regained.
Hypersensitivity reactions can be aggravated in patients on beta-blockers.
The prevalence of delayed reactions (e. g. fever, rash, flu-like symptoms, joint pain and
pruritus) to contrast media is higher in patients who have received interleukin.
Incompatibilities
Some radiologists give an antihistamine or a corticoid prophylactically to patients with a
history of allergy. However, because of the possibility of precipitation, the X-ray contrast
medium and prophylactic agents must not be administered mixed together.
Effects on ability to drive and to use machines
Delayed reactions following intravascular administration of iodinated contrast media are rare.
Nevertheless, driving or operating machinery is not advisable for the first 24 hours.
Dosage and administration
1.
Adults only
Table 2 shows the medium that the license holder suggests for each investigation. This
medium may be used at the discretion of the radiologist for other established permutations of
medium and examination which, for the sake of simplicity, have been omitted from the table.

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Table 2
Examination
Drip-infusion
urography
Retrograde urography
Cystography

Dose regimen
2-4ml/kg body wt up to
250ml
5-10ml
Up to 500ml

Other indications include: high dose urography, pelvic venography, venacavography,
arthrography, selective visceral angiography, limb venography, jugular venography,
vesiculography, sialography, sinusography, amniography, lymphangiography, intramuscular
urography, operative and percutaneous cholangiography, fistulography, oesophageal and anal
atresia.
Urografin medium is not suitable for myelography.
Urodynamic studies
Urografin 150 (a 30% solution) can be diluted with normal saline to obtain the desired density.
The pH is not significantly affected by dilution.
• Retrograde urography
A 30% solution (Urografin 150) is generally sufficient for retrograde urography. It is advisable
to warm the contrast medium to body temperature to avoid low-temperature stimulus and
resultant ureteric spasms.



Infusion urography
The rapid infusion of large amounts of a contrast medium in low concentration produces
increased urine formation while retaining a high concentration of the contrast medium in the
urine.
This method can provide complete visualisation of the renal pelvis and calyces as well as the
entire course of the ureters. The nephrographic effect is also intensified, and is prolonged for
up to 15-30 minutes after the termination of the infusion.



Drip infusion urography
Dosage of Urografin 150 should not exceed 4ml/kg body weight.

3. General
In the case of abdominal angiography and urography, the diagnostic yield is increased if the
bowels are emptied of faecal matter and gas. On the two days prior to the examination,
patients should therefore avoid flatulent food, in particular peas, beans and lentils, salads,
fruit, brown or granary bread and all kinds of uncooked vegetables. On the day before
examination, patients should refrain from eating after 6pm. Moreover, it can be appropriate to
administer a laxative in the evening.
The patient must attend for examination fasting but adequately hydrated. Disorders of the
water and electrolyte balance must be corrected. This applies in particular to patients who are
predisposed to such disturbances.
In babies and young children, however, prolonged fasting and the administration of a laxative
before the examination are contraindicated.
Intravascular administration of the contrast medium should, if possible, be done with the
patient lying down. After the administration, the patient should be kept under observation for
at least 30 minutes, since experience shows that the majority of all severe incidents occur

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within this time. If the administration does not take place on the X-ray table, any patient with a
labile circulation should be brought to the X-ray machine sitting or lying down.
Experience shows that contrast medium is tolerated better if it is warmed to body temperature.
The contrast medium solution should not be drawn into the syringe or the infusion bottle
attached to the infusion set until immediately before the examination.
Vials containing contrast medium solutions are not intended for the withdrawal of multiple
doses. The rubber stopper should never be pierced more than once. The use of cannulas
with a long tip and a maximum diameter of 18G is recommended for piercing the stopper and
drawing up the contrast medium (dedicated withdrawal cannulas with a side hole, e.g. NocoreAdmix cannulas, are particularly suitable).
Contrast medium not used in one investigation must be discarded.
If diagnostic clarification necessitates several high single doses, the patient should be given
the opportunity between injections to compensate for the increased serum osmolality by the
influx of interstitial fluid.
To achieve this, a period of 10-15 minutes is necessary in adequately hydrated patients. The
intravascular administration of water and electrolytes is indicated if more than 300ml contrast
medium are required for a single examination.
• Filming times after injection
The renal parenchyma can be demonstrated best when the film is taken immediately after the
end of the administration.
For visualisation of the renal pelvis and urinary tract, the first film is taken 3-5 and the second
10-12 minutes after the administration of the contrast medium. The earlier time should be
chosen for younger patients and the later time for older patients.
In babies and young children it is advisable to take the first film as early as about 2 minutes
after the administration of the contrast medium.
Insufficient contrast can necessitate later films.
Overdosage
Acute symptoms of poisoning are unlikely with intravascular administration. On inadvertent
overdosage or in greatly impaired renal function, the contrast medium may be removed by
dialysis, and the balance of water and electrolytes should be corrected.
Acute toxicity studies do not suggest a risk of acute intoxication.
Side effects
Mild subjective symptoms, such as a feeling of heat and nausea, occur very seldom and
disappear rapidly when the injection is slowed down or briefly interrupted. Transient pain may
occur, in particular during the examination of peripheral vascular regions.
Other symptoms which may occur are:
Chills, fever, sweating, headache, dizziness, blanching, weakness, gagging and a feeling of
suffocation, gasping, a rise or fall of blood pressure, itching, urticaria, other kinds of skin
eruption, oedema, cramp, tremor, sneezing and lacrimation. These reactions, which can
occur irrespective of the amount administered and the mode of administration, may be the first
signs of incipient shock. Administration of the contrast medium must be discontinued
immediately and - if necessary - specific therapy instituted intravenously. It is therefore
advisable to use a flexible indwelling cannula for intravenous contrast medium administration.

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Very rarely, severe or even life-threatening side-effects such as severe hypotension and
collapse, circulatory failure, ventricular fibrillation, cardiac arrest, pulmonary oedema,
anaphylactic shock or other allergic manifestations, convulsions, or other cerebral symptoms
may occur. In some cases these have proved fatal.
To permit immediate countermeasures to be taken in emergencies, appropriate drugs, an
endotracheal tube and a ventilator should be ready to hand.
Experience shows that hypersensitivity reactions occur more frequently in patients with an
allergic disposition.
Paravascular administration of the contrast medium rarely leads to severe tissue reactions.
Delayed reactions can occasionally occur.
Neurological complications such as coma, temporary states of confusion and somnolence,
transient paresis, disturbed vision or facial muscle paresis and epileptic fits may occur after
cerebral angiography and other procedures in
which the contrast medium reaches the brain
with the arterial blood. In very rare cases the induction of fits has been observed after
intravenous
administration of Urografin in epileptics and patients with focal brain damage.
However, a causal relationship seems to be questionable.
Temporary renal failure may occur in rare cases.
Suggestions for the treatment of contrast medium incidents
It is very important in order to be able to take prompt action in the event of contrast medium
incidents to have all drugs and instruments for emergency therapy readily available and to be
familiar with the practice of emergency measures. Please refer to the Royal College of
Radiologists guidelines “Advice on the management of reactions to intravenous contrast
media”.

Expiry date: The expiry date is printed on the label. The contrast medium should not be
used after this date.
Storage: Protect from light and X-rays.
Date of last revision of this leaflet: December 2015

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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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