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IOMERON 300 SOLUTION FOR INJECTION

Active substance(s): IOMEPROL

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Impianto di proprietà della:

Bracco s.p.a. via E. Folli, 50 - 20134 Milano - Italy
Prodotto: IOMERON 300 - UK

SPECIFICA
RIFERIMENTO:
Dimensioni:
Colori n°:

Materiale:

Codice cliente:
Pa
Codice

Leaflet

215001
0000000

148 x 600

Codice cliente superato:

Codice nuovo:

Codice superato:

CLB6001

Fustella

Eurolaser
CODICE LAETUS

NERO

1
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NEW PACKAGING FOR BIPSO PRODUCTION

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iomeron 250 50 ml

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.

11/03/2016

C. 04514/6

FRONTE - Font size heading c.19 - Font size subheading c.11 - Font size main text c.11 - Font size line-spacing c.12,5

PACKAGE LEAFLET: INFORMATION FOR THE USER

Iomeron 300 solution for injection
(Iomeprol)

The name of your medicine is Iomeron 300 solution for injection, which
will be called Iomeron throughout this leaflet.
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.
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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CODE

1. What Iomeron is and what it is used for
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, or urinary tract or bladder,
spine or breast and salivary ducts using X-rays.
This medicine is for diagnostic use only.

3. How you are given Iomeron
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.
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.
If you have any further questions on the use of this product, ask your
doctor or pharmacist.
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.
4. Possible side effects
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.
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).
The following side effects have been reported:
Administration in a vessel
- Common (in more than 1 in 100 patients, but less than 1 in 10 patients):
- sensations of warmth.

LAETUS
CODE

2. What you need to know before you are given Iomeron
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).
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).
Particular care should be taken in children under 1 year of age and
in the elderly. These groups might be susceptible to adverse reactions.
Tell your doctor if you have had thyroid function tests performed in the
past.
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.
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).
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.
Taking Iomeron with food and drink
You should maintain a normal diet until 2 hours before your X-ray
examination and then avoid eating until after the examination is
complete.
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.
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.

Impianto di proprietà della:

Bracco s.p.a. via E. Folli, 50 - 20134 Milano - Italy
Prodotto: IOMERON 300 - UK

SPECIFICA
RIFERIMENTO:
Dimensioni:
Colori n°:

Materiale:

Codice cliente:
Pa
Codice

Leaflet

215001
0000000

148 x 600

Codice cliente superato:

Codice nuovo:

Codice superato:

CLB6001

Fustella

Eurolaser
CODICE LAETUS

NERO

1
Modifica rispetto la versione precedente:

NEW PACKAGING FOR BIPSO PRODUCTION

Quality Assurance
Packaging Development, Italy

Traduzione braille:

Data Emissione

Data Obsolescenza

Archiviare almeno fino a:

Status

iomeron 250 50 ml

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.

11/03/2016

C. 04514/6

LAETUS
CODE

RETRO
FRONTE - Font size heading c.19 - Font size subheading c.11 - Font size main text c.11 - Font size line-spacing c.12,5

5. How to store Iomeron
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.
6. Contents of the pack and other information
What Iomeron contains
One ml of Iomeron 300 contains 61.24% of the active substance Iomeprol
corresponding to 300 mg iodine.
The other ingredients are trometamol, hydrochloric acid and water.
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.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Bracco U.K. Ltd, Unit 15, Valley Business Centre, Gordon Road, High
Wycombe, Buckinghamshire HP13 6EQ, United Kingdom
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
This leaflet was last revised in April 2016
CLB6001
UK F.1/0000000

LAETUS
CODE

- 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.
- Rare (in more than 1 in 10,000, but less than 1 in 1,000 patients) :
- fainting;
- slow or rapid heartbeat;
- decreased blood pressure;
- rash;
- back pain;
- asthenia, stiffness, fever;
- changes in some blood analysis.
- Not known (cannot be estimated from the available data):
- reduction in blood platelets, which increases risk of bleeding or bruising;
- 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 rhythm disorders,
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 reaction which causes 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.
Administration in the cerebrospinal fluid
- Very common (in more than 1 in 10 patients):
- headache.
- 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.
- 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.
- not known (cannot be estimated from the available data):
- serious allergic reaction which causes difficulties in breathing or
dizziness;
- epilepsy;
- rash.
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.
If you have any other questions not answered in this leaflet please ask
the medical staff.
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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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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