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IOMERON 200 SOLUTION FOR INJECTION

Active substance(s): IOMEPROL

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09 OTT 2017

CROM
inFOTO s.n.c.
GRAFICA - FOTOCOMPOSIZIONE

FCI00SG08-PIL-IOME-200
Versione interna: 01

Via G. Tartini, 2 - 2 0 1 5 8 - M I L A N O
AZIENDA CERTIFICATA UNI EN ISO 9001:2008

Bracco s.p.a. via E. Folli, 50 - 20134 Milano - Italy

Impianto di proprietà della:

Patheon Italia S.p.A. viale G.B. Stucchi, 110 - 20900 Monza (MB) - Italy

Cliente:

BRACCO s.p.a.

Prodotto: IOMERON 200 (UK)
SPECIFICA
RIFERIMENTO: SF 0003 IS+P
Dimensioni:
Color i n°:

150 x 560 mm
Black

Materiale:

Codice Patheon:

Codice Patheon superato:

Codice Bracco:

Codice Bracco superato:

Istruzione

000000

258600

CI00SG08

CI00SG07

Stesa

Piegata

Pantone Green 347

Pre taglio

Bobina

Pantone Green 372

Pantone Blu 297

Passo di taglio a mm 00

CODICE LAETUS

Tipo Vernice

Pantone Red 185

01
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Apri nota
digitale
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Quality Assurance
Packaging Development. Italy

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Data Obsolescenza

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Status

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Definizione e colori non riflettono il risultato finale della produzione stampata.

FRONTE - Font size heading c.19 - Font size subheading c.11 - Font size main text c.10 - Font size line-spacing 10.5

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PACKAGE LEAFLET: INFORMATION FOR THE USER

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Iomeron 200 solution for injection
(Iomeprol)

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The name of your medicine is Iomeron 200 solution for injection, which will be
called Iomeron throughout this leaflet.

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Read all of this leaflet carefully before you start taking 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 your doctor or pharmacist.
- This medicine has been prescribed for you. Do not pass it on to others. It
may harm them, even if their symptoms are the same as yours.
- If you get any side effects, talk to your doctor, or pharmacist. This includes
any possible side effects not listed in this leaflet. See section 4.

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

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1. What Iomeron is and what it is used for

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Iomeron is a special dye (or contrast agent) which blocks X-rays because it
contains iodine. Iomeron works by helping your doctor to see the internal body
structures on an X-ray picture. Your doctor has prescribed Iomeron to help view
the blood vessels, urinary tract, bladder, spine, womb or joints using X-rays.
This medicine is for diagnostic use only.

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SENSO MACCHINA LETTURA CODICE

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

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You should not be given Iomeron if you:
- Are allergic to Iomeprol, or to any other ingredients of Iomeron (see list of
ingredients in Section 6).

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Warnings and precautions
Talk to your doctor or pharmacist before being given Iomeron if you have
any of the following conditions:
- A history of allergy or asthma;
- Blood clots, circulation problems, inflammation of the veins;
- An infection;
- Diabetes;
- Problems when you urinate;
- Sickle cell disease (your body produces abnormally shaped red blood
cells, which leads to anaemia);
- Heart problems;
- High blood pressure over a long period of time;
- Kidney or liver problems;
- Over-active or enlarged thyroid gland;
- Myasthenia gravis (a disease causing weak muscles);
- Stroke, mini-stroke, brain tumor or other brain diseases;
- A history of epilepsy;
- Alcoholism;
- Drug addiction;
- Phaeochromocytoma (a tumor of the adrenal gland);
- Multiple myeloma (a tumor of white blood cells);
- Paraproteinaemia (abnormal proteins in the blood).

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Particular care should be taken in children under 1 year of age and in the
elderly. These groups might be susceptible to adverse reactions.

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Tell your doctor if you have had thyroid function tests performed in the past.

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Other medicines and Iomeron
Please tell your doctor or pharmacist if you are taking, or have recently
taken, any other medicines, including medicines obtained without a
prescription. Especially tell your doctor if you are taking the following
medicines, as they may react with Iomeron:
- painkillers
- antiemetics (treatments that prevent vomiting)
- metformin (a treatment for diabetes)
- anti-epileptics (treatment for epileptic fits)
- drugs for psychiatric illness.

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Especially tell your doctor if you are taking the following medicines, as they
might increase the possibility that you will suffer from side effects:
- diuretics (a treatment for heart problems and high blood pressure)
- beta blockers (a treatment for heartbeat problems)
- ACE inhibitors (a treatment for high blood pressure)
- antidepressant
- interleukin-2 (a treatment for cancer).

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It may still be all right for you to be given Iomeron and your doctor will be able
to decide what is suitable for you.

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Taking Iomeron with food and drink
Unless otherwise instructed by the doctor, you should maintain a normal diet
on the day of the examination.

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Pregnancy and breast-feeding
If you are pregnant, you should only be given Iomeron if your doctor believes
it is clearly necessary. Tell your doctor if you are or believe you might be
pregnant.
Stopping breastfeeding is not necessary.
Ask your doctor or pharmacist for advice before taking any medicine.

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Patients with heart failure must not be given too much fluid.

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SENSO MACCHINA LETTURA CODICE

In all patients dehydration should be avoided and it might be necessary to
give fluids to ensure this.
Particular care should be taken in children and in the elderly, and in patients
with underlying conditions such as:
- diabetes
- abnormal production of urine (large or small amounts)
- gout
- liver and renal disorders
- sickle cell disease

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Driving and using machines
There is no known effect of Iomeron on the ability to drive or operate
machines.
However, it is not advisable you drive or operate machinery for 24 hours after
an injection to the spine.

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3. How you are given Iomeron

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Iomeron will be given to you by a doctor or a nurse in hospital or clinic. It will be
injected into an artery or a vein, or in the spine, or in a body cavity, or in a joint.

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Dosage
The recommended dose depends on which part of the body is being
X-rayed and is usually in the range 2-250ml. Your doctor may decide to vary
this dose or to repeat the dose if required.
The dose for children depends also on the age and the body size.
You will be kept under observation for at least 30 minutes after the
examination.

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

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If you are given more Iomeron than you should:
You should know that the hospital area or clinic where Iomeron is given to you
is well equipped to treat any effects of overdose.

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4. Possible side effects

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Like all medicines, Iomeron can cause side effects, although not everybody
gets them. They are usually mild to moderate and not prolonged. However,
severe and life-threatening reactions sometimes leading to death have
been reported. After administration by injection into a vein or artery, most
reactions occur within minutes, and after injection into body cavities or spine,
most reactions occur within a few hours or longer.

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09 OTT 2017

CROM
inFOTO s.n.c.
GRAFICA - FOTOCOMPOSIZIONE

FCI00SG08-PIL-IOME-200
Versione interna: 01

Via G. Tartini, 2 - 2 0 1 5 8 - M I L A N O
AZIENDA CERTIFICATA UNI EN ISO 9001:2008

Bracco s.p.a. via E. Folli, 50 - 20134 Milano - Italy

Impianto di proprietà della:

Patheon Italia S.p.A. viale G.B. Stucchi, 110 - 20900 Monza (MB) - Italy

Cliente:

BRACCO s.p.a.

Prodotto: IOMERON 200 (UK)
SPECIFICA
RIFERIMENTO: SF 0003 IS+P
Dimensioni:
Color i n°:

150 x 560 mm
Black

Materiale:

Codice Patheon:

Codice Patheon superato:

Codice Bracco:

Codice Bracco superato:

Istruzione

000000

258600

CI00SG08

CI00SG07

Stesa

Piegata

Pantone Green 347

Pre taglio

Bobina

Pantone Green 372

Pantone Blu 297

Passo di taglio a mm 00

CODICE LAETUS

Apri nota
digitale
se presente

Tipo Vernice

Pantone Red 185

01
Modifica rispetto la versione precedente:

CHANGE TO INCLUDE AGEP - ACUTE GENERALIZED EXANTHEMATOUS PUSTULOSIS

Quality Assurance
Packaging Development. Italy

Data Emissione

Data Obsolescenza

Archiviare almeno fino a:

Status

I colori su questa prova sono approssimativi, questa è una stampa a 600 dpi ottenuta con colori a base acqua CMYK.
Definizione e colori non riflettono il risultato finale della produzione stampata.

RETRO - Font size heading c.19 - Font size subheading c.11 - Font size main text c.10 - Font size line-spacing 10.5

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Tell your doctor straight away if you get any sudden wheeziness, difficulty in
breathing, swelling of the eyelids, face or lips, rash or itching (especially
affecting your whole body).

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The following side effects have been reported:
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Rare (in more than 1¬in 10,000, but less than 1¬in 1,000¬patients) :
fainting;
slow or rapid heartbeat, heart rhythm disorders;
decreased blood pressure;
rash;
back pain;
asthenia, stiffness, fever;
changes in some blood analysis.

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Uncommon (in more than 1¬in 1,000, but less than 1¬in 100¬patients):
headache;
dizziness;
increased blood pressure;
shortness of breath;
nausea, vomiting;
flushing, nettle rash, itching;
chest pain, warmth and pain at the injection site.

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Administration in a vessel
- Common (in more than 1¬in 100¬patients, but less than 1¬in 10¬patients):
- sensations of warmth.

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- Not known (cannot be estimated from the available data):
- reduction in blood platelets, which increases risk of bleeding or bruising;
- Haemolytic anaemia (abnormal breakdown of red blood cells, which may
cause fatigue, rapid heart rate and shortness of breath);
- serious allergic reaction which causes difficulties in breathing or dizziness;
- anxiety, confusion;
- coma, temporary problems in blood supply to the brain, with few or no
residual after-effects (TIA), paralysis, syncope, fits, loss of consciousness,
difficulties in speaking, abnormal sensations (tingling, itching), memory loss,
drowsiness, taste disorders;
- temporary blindness, impaired eyesight, eye irritation, eye watering, light
sensitivity;
- cardiac arrest, myocardial infarction, heart failure, chest pain, irregular
heartbeat, heart conduction disturbances, heart palpitations, blue
discolouration of the skin and mucous membranes;
- blood circulation failure (circulatory collapse) or shock (sharp drop in
blood pressure, pallor, restlessness, weak rapid pulse, clammy skin,
reduced consciousness) caused by sudden and severe dilation of the
blood vessels, hot flushes, redness, pallor;
- respiratory arrest, acute shortness of breath (acute respiratory distress
syndrome), fluid on the lungs, swelling of the throat, sudden constriction of
the airways (bronchospasm), asthma, cough, shallow and rapid breathing
(hyperventilation), throat discomfort, inflammation of the nasal lining,
characterised by blocked nose, sneezing and discharge (rhinitis),
hoarseness (dysphonia);
- diarrhoea, abdominal pain, excessive saliva flow, difficulties in swallowing,
enlarged salivary glands;
- serious allergic reactions which cause a widespread pustular rash with fever
or swelling of the face or throat, cold sweat, increased sweat production;
- joint pain;
- kidney failure;
- reaction at the site of injection including pain and swelling, localised
feelings of coldness, fatigue, generally feeling ill (malaise), thirst,
development of circular skin blisters (the centre of which is often paler in
colour) (erythema multiforme), possibly with ulceration and blistering of the
mucous membranes (especially of the mouth, lips, eyes and genitals) and
high fever (Stevens-Johnson syndrome), with detachment of the skin in the
most severe cases (toxic epidermal necrolysis (Lyell’s syndrome);
- abnormal electrocardiogram heart tracing.

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Common (in more than 1 in 100 patients, but less than 1 in 10 patients):
dizziness;
increased blood pressure;
nausea, vomiting;
back pain, pain in the extremities;
reaction at the injection site, including pain, discomfort, feeling of warmth.

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Administration in the cerebrospinal fluid
- Very common (in more than 1 in 10 patients):
- headache.

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not known (cannot be estimated from the available data):
serious allergic reaction which causes difficulties in breathing or dizziness;
epilepsy;
rash.

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-

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- Uncommon (in more than 1 in 1,000, but less than 1 in 100 patients):
- loss of consciousness, sensation of paralysis of the lower limbs, abnormal
sensations or lack of sensation, somnolence;
- decreased blood pressure, redness;
- sweating increased, itching;
- muscle stiffness, neck pain;
- hot sensation, fever.

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Administration in body cavities
- abnormal blood analysis (examination of the pancreas);
- local irritation in case of arthrography and fistulography;
- allergic reactions; serious allergic reaction which causes difficulties in
breathing or dizziness cannot be excluded;
- like other iodine-containing preparations, pelvic pain and malaise may
occur after examination of the cervix, fallopian tubes and ovaries.

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If you have any other questions not answered in this leaflet please ask the
medical staff.

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If you get any side effects, talk to your doctor. This includes any possible side
effects not listed in this leaflet. You can also report side effects directly via the
Yellow Card Scheme, website: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety
of this medicine.

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5. How to store Iomeron

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You will not be required to store the medicine yourself. Your doctor or hospital
pharmacist will know how to store Iomeron.
Keep this medicine out of the sight and reach of children, stored below 30 °C
and protected from light.
Do not use this medicine after the expiry date stated on the label. The expiry
date refers to the last day of that month.
Iomeron should be given to you immediately once drawn up into the syringe.
Do not throw away any medicine via wastewater or household waste. These
measures will help protect the environment.

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6. Contents of the pack and other information

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What Iomeron contains
One ml of Iomeron 200 contains 40.82% of the active substance Iomeprol
corresponding to 200 mg iodine.
The other ingredients are trometamol, hydrochloric acid and water.

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What Iomeron looks like and contents of the pack
Iomeron is supplied in glass bottles containing: 20, 30, 50, 75, 100, 150, 200 or
250 ml of solution.
Not all packs sizes may be marketed.

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Marketing Authorisation Holder and Manufacturer
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Marketing Authorisation Holder
Bracco U.K. Ltd, Unit 15, Valley Business Centre, Gordon Road, High Wycombe,
Buckinghamshire HP13 6EQ, United Kingdom

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Manufacturers
Patheon Italia S.p.A., 2° Trav. SX Via Morolense 5, 03013 Ferentino (FR), Italy
Bracco Imaging S.p.A., Bioindustry Park, Via Ribes 5, 10010 Colleretto Giacosa (TO), Italy
BIPSO GmbH, Robert-Gerwig-Strasse 4, 78224 Singen, Germany

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This leaflet was last revised in
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CI00SG08 - 000000

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+ Expand Transcript

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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