UROGRAFIN 150 INFUSION

Active substance: SODIUM AMIDOTRIZOATE

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Transcript
In this leaflet:
1. What Urografin is and what it is used for
2. Before you are given Urografin
3. How you will be given Urografin
4. Possible side effects
5. How to store Urografin
6. 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.

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.

Please turn over




Information for Healthcare Professionals

Urografin®
Composition, availability and
viscosity

Warnings

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
Availability
Iodine
concentration
mg/ml

Iodine
Viscosity
content
(cp)
(g) per
container

146

10ml
ampoule

1.46

20ml
ampoule

Urografin 10:66
150

2.92

20°C 37°C
2.2 1.4

250ml infu- 36.5
sion bottle
500ml infu- 73.0
sion bottle
Urografin 10:66
370

370

20ml
ampoule

7.4

18.5 8.9

50ml bottle 18.5
100ml bottle 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:
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 370 (76%) 00010/0570
Urografin is manufactured by:
BerliMed S.A., Madrid, Spain.

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

81430543_02.indd 1

Contra-indications
Proven or suspected hypersensitivity to iodinecontaining 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.

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 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 sideeffects 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 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 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 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.
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 licence
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.

15.03.2013 13:13:30

Bayer Pharma AG
code-no.: 30
country: GB BPH
approval:

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.

PZ: 2512G-3

Sodium amidotrizoate (sodium diatrizoate)
and meglumine amidotrizoate
(meglumine diatrizoate)

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:
 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.

page 1

Urografin®

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
 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.

Packaging Technology Berlin DY
client: 138
itemno.: 81430543
name: Leaflet Urografin
colors: Black
version: 15.03.2013/02

Package Leaflet: information for the patient

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
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.

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.

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
Urografin 150 for
Infusion
Urografin 370

00010/0569
00010/0568
00010/0570

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



Table 2
Examination

Urografin 370
150

Intravenous urography
Drip-infusion urography
Retrograde urography
Cystography

370
Up to
70mla

2-4ml/kg
body wt up
to 250ml
5-10ml
Up to 500ml
30-50ml
40-80ml

Left heart
catheterisation

40-60ml

Pulmonary
angiography

30-40ml

Coronary arteriography

4-8ml per
arteryb
5-8ml

Coeliac-axis
arteriography

35-80ml

Thoracic aortography

30-60ml

Pelvic aortography

20-25ml

Translumbar
abdominal aortography

20-30ml

Splenoportography
Hysterosalpingography

25ml
40-50ml
4-7ml

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
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.
a

1-2 years

10-12ml

2-6 years

12-15ml
15-20ml

over 12 years

Right heart
catheterisation

Placentography

7-10ml

6-12 years

Angiocardiography

Renal arteriography

up to 1 year

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

81430543

81430543_02.indd 2

15.03.2013 13:13:39

Bayer Pharma AG
code-no.: 30
country: GB BPH
approval:

PZ: 2512G-3

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.
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

page 2

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.

Packaging Technology Berlin DY
client: 138
itemno.: 81430543
name: Leaflet Urografin
colors: Black
version: 15.03.2013/02

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.

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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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