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UROGRAFIN 370 INJECTION

Active substance: SODIUM AMIDOTRIZOATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
UROGRAFIN®
Sodium amidotrizoate (sodium diatrizoate) and meglumine amidotrizoate (meglumine
diatrizoate)

Read all of this leaflet carefully before you are given this medicine.
-

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 any of the side effects gets serious, or if you notice any side effects not listed in
this leaflet, please tell your doctor or the X-ray department staff/radiologist.

In this leaflet:
1.
2.
3.
4.
5.
6.

What Urografin is and what it is used for
Before you are given Urografin
How you will be given Urografin
Possible side effects
How to store Urografin
Further 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. Before you are given Urografin
Do not use Urografin if:





you are, or suspect you are, allergic (hypersensitive) to iodine or iodine-containing
contrast media or any of the other ingredients of Urografin (see Section 6: Further
Information)
you have a condition caused by too much thyroid hormone (uncontrolled
thyrotoxicosis)
you have severe heart insufficiency (causing oedema (swelling of areas of your body
e.g. ankles) or shortness of breath)
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.

Take special care with Urografin
You must tell the X-ray department staff if you have any of the following:
 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

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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.

Taking or using other medicines
Please tell the radiologist or X-ray department staff if you are taking or have recently taken
any other medicines, including medicines obtained without prescription. 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.

Using 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)



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
Tell the X-ray department staff if you are pregnant, think you may be pregnant, or are breast
feeding.
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.

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 500ml.
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.
4. Possible side effects
Like all medicines, Urografin 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
 paleness or reddening of the skin
 chest pain, cramp, tremor
 feeling sick

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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.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor or the X-ray department staff/radiologist.

5. How to store Urografin
Keep out of the reach and sight of children.
Do not use Urografin after the expiry date which is stated on the label. The expiry date refers
to the last day of that month.
Protect from light and secondary X-rays.

6. Further Information
What Urografin contains

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

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1ml Urografin 150 for infusion contains 40mg sodium amidotrizoate and 260mg
meglumine amidotrizoate.
1ml Urografin 370 contains 100mg sodium amidotrizoate and 660 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 10ml ampoules or packs of ten 20ml ampoules.
Urografin 150 for infusion is available in 250ml or 500ml bottles.
Urografin 370 is available in packs of ten 50 ml bottles or one 100ml bottle.

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 March 2013

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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

Urografin 370

00010/0570

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

-----------------------------------------------------------------------------------------------------------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 each medium
(see table 1).
1ml Urografin 150 contains 40mg sodium amidotrizoate and 260mg meglumine
amidotrizoate.
1ml Urografin 370 contains 100mg sodium amidotrizoate and 660mg meglumine
amidotrizoate.
Excipients: Sodium calcium edetate (E Number 385), water for injection.
Table 1
Medium

Ratio of
sodium:
meglumine
amidotrizoate

Exact Iodine
concentration
mg/ml

Availability

Iodine
Viscosity
content (g)
(cp)
per container
20°C

Urografin
150

10:66

146

10ml
ampoule

1.46

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37°C

2.2

1.4

6

20ml
ampoule
250ml
infusion
bottle
500ml
infusion
bottle
Urografin
370

10:66

370

2.92

20ml
ampoule
50ml bottle
100ml bottle

7.4

36.5

73.0

18.5

8.9

18.5
37.0

Package quantities
Urografin 150: Packs of 10x10ml ampoules and 10x20ml ampoules.
Urografin 150 for infusion: Packs of 1x250ml bottles and 1x500ml bottles.
Urografin 370: Packs of 10x20ml ampoules and 10x50ml bottles. In addition packs
of 1x100ml bottles.
Urografin is a contrast medium.
The product licence is held by:

Product licence numbers

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

Urografin 150 (30%)
Urografin 150 (30%) for infusion
Urografin 370 (76%)

Urografin is manufactured by:

00010/0569
00010/0568
00010/0570

BerliMed S.A., Madrid, Spain.

Uses
X-ray contrast media 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.
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 X-ray contrast media 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

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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 low osmolar radiocontrast media 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 sensitized 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 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 iodinated contrast media
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.

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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, X-ray
contrast media 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/media that the license holder suggests for each
investigation. These media 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

150

370

Intravenous
Up to 70mla
urography
Drip-infusion
2-4ml/kg body wt up
urography
to 250ml
Retrograde
5-10ml
urography
Cystography
Up to 500ml
Angiocardiography
30-50ml
Right heart
40-80ml
catheterisation
Left heart
40-60ml
catheterisation
Pulmonary
30-40ml
angiography
Coronary
4-8ml per arteryb
arteriography
Renal arteriography
5-8ml
Coeliac-axis
35-80ml
arteriography
Thoracic
30-60ml
aortography
Pelvic aortography
20-25ml
Translumbar
20-30ml
abdominal
aortography
Placentography
25ml
Splenoportography
40-50ml
Hysterosalpingo4-7ml
graphy
a If patients with cardiac insufficiency are given 100ml or more, an injection time of at
least 20-30 minutes is recommended.
b 100ml vials are available for coronary arteriography.
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 media are 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

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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.



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.



Angiography
Urografin 370 is suitable for angiographic investigations. It is preferred for those
angiographic investigations in which a high iodine concentration is of special
significance, e.g. aortography, angiocardiography, coronary arteriography.
2.

Children and neonates
Intravenous Urography
The fact that urograms of infants and young children generally show a lower contrast
density than those of adults is explained by the physiologically less effective function
of the immature nephron. Relatively high doses of media are therefore indicated.



up to 1 year
1-2 years
2-6 years
6-12 years
over 12 years

Urografin 370
7-10ml
10-12ml
12-15ml
15-20ml
adult dose



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



Angiocardiography
In neonates up to 5kg body weight, 8ml Urografin 370; Infants over 5kg body weight,
1ml/kg body weight up to 25ml per injection.



Right and left heart catheterisation
1-1.2ml/kg body weight of Urografin 370, with a maximum of 15ml per injection for
right heart and 25ml per injection for left heart.



Pulmonary angiography
0.5-0.6ml/kg body weight up to 8ml Urografin 370 per injection.

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.

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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 contrast media 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
piercing the stopper and drawing up the contrast medium (dedicated withdrawal
cannulas with a side hole, e.g. Nocore-Admix cannulas, are particularly suitable).
Contrast media 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.

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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.
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.

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Storage: Protect from light and X-rays.
Date of last revision of this leaflet: March 2013

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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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