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UROGRAFIN 150 INFUSION

Active substance(s): MEGLUMINE AMIDOTRIZOATE / SODIUM AMIDOTRIZOATE

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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.
R Keep this leaflet. You may need to read it again.
R If you have any further questions, ask the doctor giving you
Urografin (the radiologist) or the X-ray department staff.
R 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. What Urografin is and what it is used for
2. What you need to know before you are given Urografin
3. How you will be given Urografin
4. Possible side effects
5. How to store Urografin
6. 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.

Do not use Urografin
R if you are allergic to sodium amidotrizoate, meglumine
amidotrizoate, iodine or iodine-containing contrast media or any
of the other ingredients of this medicine (listed in section 6).
R if you have a condition caused by too much thyroid hormone
(uncontrolled thyrotoxicosis)
R if you have severe heart insufficiency (causing
oedema (swelling of areas of your body e.g. ankles)
or shortness of breath)
R 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:
R reduced liver or kidney function
R epilepsy or a history of seizures
R a disease of blood vessels in the brain (cerebral arteriosclerosis)
R diabetes mellitus requiring treatment and/or associated with
diabetic complications
R damaged lungs (pulmonary emphysema)
R poor general health
R an overactive thyroid gland (hyperthyroidism) or a swollen neck
due to an enlarged thyroid gland (benign nodular goitre)
R a disease of the bone marrow (multiple myeloma)
R 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
R poor heart function or blood circulation
R 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:
R beta-blockers (drugs used to treat heart or blood pressure),
because they can make allergic reactions worse
R 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))
R 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:
R multiple myeloma (disease of the bone marrow)
R diabetes mellitus
R polyuria (production of large amounts of urine which is pale in
colour)
R oliguria (production of small amounts of urine)
R 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.

Please turn over B


The following information is intended for healthcare
professionals only:
Information for Healthcare Professionals

Urografin®

Contra-indications
Proven or suspected hypersensitivity to iodine-containing contrast
media, uncontrolled thyrotoxicosis and decompensated cardiac insufficiency.
Hysterosalpingography must not be carried out during pregnancy or
in patients with acute inflammatory conditions in the pelvic cavity.

Warnings
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 amidotri-zoate and
260mg meglumine amidotrizoate.
Excipients: Sodium calcium edetate (E Number 385), water for
injection.
Table 1
Medium

Ratio of
sodium:
meglumine amidotrizoate
Urografin 150 10:66

Exact Iodine Availability
concentration
mg/ml
146

Iodine
Viscosity
content (cp)
(g) per
container
20°C 37°C
10ml ampoule 1.46
2.2 1.4
20ml ampoule 2.92
250ml infu36.5
sion bottle
500ml infu73.0
sion bottle

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:
Bayer plc
Bayer House
Strawberry Hill
Newbury
Berkshire, RG14 1JA
Product licence numbers
Urografin 150 (30%) 00010/0569
Urografin 150 (30%) 00010/0568
for infusion
Urografin is manufactured by:
BerliMed S.A., Madrid, Spain.

Uses
X-ray contrast medium for the delineation of the vascular and renal systems.

85243926_02.indd 1

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, pulmo-nary emphysema, poor general health, latent
hyper-thyroidism, 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 reac-tion 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
sensi-tised to these substances in the meantime.
As with any contrast medium, the possibility of hyper-sensitivity
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 symp-toms 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 coagula-tion 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 procedurerelated 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 contrastmedium 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. 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 impair-ment
following intravascular contrast medium admin-istration. 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 betablockers.
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 inter-leukin.

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 admin-istration of
iodinated contrast media are rare. Never-theless, 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 licence 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.

20.05.2016 11:34:11

'

Urografin®

2. What you need to know before you are given Urografin

Packaging Technology Berlin sgqwx
page 1
Bayer Pharma AG
client: 138
material-no.: 85243926
PZ: 2664A-3
code-no.: 44
name: LEAFLET-UROGRAFIN 150/150 INF/325/370 GB
country: GB
colors: Black
version: 20.05.2016/02
approval:
dimension: 311 x 457 mm

Package leaflet: Information for the patient

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:
R itching of the skin, rash, wheals on the skin (urticaria)
R difficulty breathing, gagging, feeling of
suffocation
R swelling of the face, neck or body
R itchy or watery eyes, tickling in the throat or nose, hoarseness,
coughing or sneezing
R headache, dizziness, feeling faint
R feeling particularly hot or cold, sweating
R paleness or reddening of the skin
R chest pain, cramp, tremor
R 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:
R feeling sick or being sick
R a sensation of pain and a general feeling of
warmth
R in rare cases your kidneys temporarily stop
working
R 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:
R lowered blood pressure
R fainting (collapse)
R circulatory failure
R an irregular, rapid heart beat which may cause the heart to
suddenly stop beating altogether (cardiac arrest)
R fits or other brain related symptoms
R a build-up of water in the air spaces of the lung
R 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:
R coma, temporary confusion and drowsiness
R temporary weakness of the muscles
R disturbed vision or weakness of the facial muscles
R 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.

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 January 2016.
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.

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.


Table 2
Examination
Drip-infusion urography
Retrograde urography
Cystography

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

Overdosage
Acute symptoms of poisoning are unlikely with intra-vascular
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 inter-rupted. 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, urtic-aria, other kinds of skin eruption, oedema,
cramp, tremor, sneezing and lacrimation. These reactions, which can
occur irrespective of the amount adminis-tered 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.
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: January 2016

85243926

Urografin®

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.
R 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 lowtemperature stimulus and resultant ureteric spasms.
R 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.
R 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 elec-trolyte 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 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 pierc-ing the stopper
and drawing up the contrast medium (dedicated withdrawal
cannulas with a side hole, e.g. Nocore-Admix 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.
R 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 admin-istration of the contrast medium.
Insufficient contrast can necessitate later films.

85243926

85243926_02.indd 2

20.05.2016 11:34:28

Packaging Technology Berlin sgqwx
page 2
Bayer Pharma AG
client: 138
material-no.: 85243926
PZ: 2664A-3
code-no.: 44
name: LEAFLET-UROGRAFIN 150/150 INF/325/370 GB
country: GB
colors: Black
version: 20.05.2016/02
approval:
dimension: 311 x 457 mm

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.

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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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