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CONRAY 280 INJECTION

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Product Summary
1.

NAME OF THE MEDICINAL PRODUCT
Conray™ 280 Injection

2.

QUALITATIVE AND QUANTITATIVE
COMPOSITION
Active substance: Iotalamic acid BP 45.6% w/v

Iodine containing contrast media may be hazardous in patients
with hyperthyroidism or with autonomous areas of the thyroid
gland. One should also be aware of the possibility of inducing
transient hypothyroidism in premature infants receiving contrast
media.

For excipients, see 6.1.
3.

PHARMACEUTICAL FORM
Injection

4.

CLINICAL PARTICULARS

4.1.

Extravasation of the contrast material may lead to serious
tissue injury including ulceration and compartment syndrome,
depending on the volume distributed. Surgical measures may be
required to control tissue damage after large-volume extravasation.

Therapeutic indications
This medicinal product is for diagnostic use only. X-ray contrast
medium used for the opacification of vascular and renal systems
and female genital tract. It does not normally possess any
pharmacological action.

4.2.

4.5.

Acute renal failure has been associated with lactic acidosis in
patients receiving metformin at the time of an X-ray examination
involving parenteral administration of iodinated contrast media.
Therefore, in diabetic patients taking metformin, if the serum
creatinine is normal, the examination should be performed and
intake of metformin stopped from the time of the examination.
The use of metformin should not be resumed for 48 hours,
and should only be restarted if renal function/serum creatinine
remains within the normal range.

Posology and method of administration
Route of administration: By intravenous, intra-uterine or intraarterial injection or injection directly into the chamber of the heart,
depending on the procedure.

Procedure

Dose

Intravenous urography

Adults: 40 - 80 ml
In the absence of preliminary
dehydration 40 - 100 ml may be used.
Infants and children:
Under 12 kg: 2 ml/kg body weight.
Over 12 kg: 1.5 ml/kg. Minimum of
24 ml.

The literature reports that patients who had been treated with
interleukin may develop a higher rate of adverse reactions as
described in the section “Undesirable Effects”. The reason has
not yet been clarified. According to the literature an increased or
delayed occurrence of these reactions within a period of 2 weeks
was observed after administration of interleukin.
4.6.

Cerebral angiography
(carotid and vertebral)

15 - 20 ml injected into the femoral
or iliac artery will provide excellent
visualisation of the arterial tree of
leg. A similar or smaller dose is
indicated for smaller arteries.
Average adult dose is 6 - 10 ml for
each injection. Exceptionally up to
10 injections of 8 ml each have been
made into the carotid artery.

Abdominal aortography
(direct puncture or
retrograde catheterisation)

Adults: 20 - 30 ml

Thoracic aortography

Often adequate in children. 0.5 - 1 ml/kg
body weight may be used as a test
dose in positioning catheter tip.

Angio cardiography

May be used as a test dose in
positioning catheter tip.
Volumes of up to 20 ml have
been used for this purpose prior
to the diagnostic dose of more
concentrated medium.

Splenography

Adults: 20 - 40 ml

Femoral venography
Inferior vena
cavography

Adults: 20 - 60 ml

Hysterosalpingography

About 10 ml are usually required,
administered by slow injection
into the uterine cervical canal via a
syringe or suitable cannula.

4.3.

4.7.

Effects on ability to drive and use machines
No effect on the ability to drive or operate machines is known.
However, due to the risk of early adverse reactions, driving or
operating machines is not advisable for 1 hour post injection.

4.8.

Undesirable effects
Adverse effects, which may occur in relation with the use of
Conray, are generally independent of the dose administered. They
are mild or moderate in the majority of cases, rarely severe or
life-threatening. However, even mild adverse events may be the
first indications of a serious, general reaction, which may occur in
rare cases after the use of any iodinated X-ray contrast medium.
The majority of reactions will occur within the first minutes post
injection. However, contrast medium-related hypersensitivity
reactions may also occur with a delay of some hours up to several
days. Common symptoms of delayed reactions are pruritus and
urticaria.
In the subsequent compilation, all symptoms are listed which have
been reported up to now in relation with the use of Conray, and
which are probably or possibly related to Conray.
Metabolic and nutritional disorders:
Very rare (< 0.01%):
thirst
Psychiatric disorders:
Very rare (< 0.01%):
Nervous system disorders:
Occasional (0.1% - 1%):
Rare (0.01% - 0.1%):

Contraindications
I).
II).
III).

4.4.

Pregnancy and lactation
There is inadequate evidence as to the safety of Conray in human
pregnancy. The pregnant female should not be submitted to X-rays
unless the radiologist considers it essential. Intravascular contrast
agents may cross the placenta and can potentially produce transient
fetal hypothyroidism. Lasting adverse effects on the fetus or
neonates have not been identified for Conray.

Over 10 years of age: Lower range of
adult dosage.
Femoral and other
peripheral arteriography

Interactions with other medicinal products and other forms of
interaction

Conray injections must never be injected into the
subarachnoid space.
Use in proven or suspected hypersensitivity to iodine
containing media.
Use in patients with uncontrolled hyperthyroidism.

Very rare (< 0.01%):

Special warnings and precautions for use
Conray 280 is not indicated for myelography. Intrathecal use may
lead to convulsions and further life-threatening neurotoxic effects.
Following the use of any contrast medium of this type, there is the
possibility of severe sensitivity reactions occurring. When they do,
they tend to occur in the first few minutes following the injection.
Therefore the patient should be kept under close observation
for 15 minutes following the last injection. It is essential to have
immediately available emergency resuscitation equipment,
including appropriate drugs, oxygen and means of administration.
The patient should remain in the hospital environment (but not
necessarily in the radiology department) for one hour after time of
injection. The patient should return to the radiology
department if any symptoms develop.
Particular caution should be exercised in patients with a history
of allergy, atopy, asthma, cardiac disease or a previous adverse
reaction with any contrast medium as 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.

Eye disorders:
Rare (0.01% - 0.1%):
Very rare (< 0.01%):
Cardiac disorders:
Rare (0.01% - 0.1%):
Very rare (< 0.01%):

Vascular disorders:
Occasional (0.1% - 1%):
Rare (0.01% - 0.1%):
Very rare (< 0.01%):

INC280GB-0413

Caution must be exercised in patients with severely impaired renal
function, combined renal and hepatic disease, anuria, diabetes
mellitus, homozygotic sickle cell disease, or monoclonal gammopathy
(multiple myeloma, Waldenström’s macro-globulinaemia),
particularly when large doses are administered. Serious renal effects,
including acute renal failure, may occur in these patients. An effective
hydration prior to the administration of Conray is essential and may
decrease the risk of renal injury. Preparatory dehydration is dangerous
and may contribute to acute renal failure.

Conray 280-GB-PIL-04/2013

INC280GB-0413
Conray 280-GB-TL-04/2013

TECHNICAL LEAFLET

Package leaflet: Information for the user

Conray™ 280
Injection
Active substance: Iotalamic acid
Read all of this leaflet carefully before you start taking this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• 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 pharmacist.
In this leaflet:
1. What Conray is and what it is used for
2. Before you use Conray
3. How to use Conray
4. Possible side effects
5. How to store Conray
6. Further information
1. What Conray is and what it is used for
This medicine is for diagnostic use only. Conray is used for several types of
X-ray procedures including:
• imaging of vessels, both arteries and veins
• kidneys
• fallopian tube and urethra.
Conray is an X-ray contrast medium containing a special iodine compound.
The iodine blocks the X-rays, allowing vessels and the inner organs supplied
with blood to be seen.
2. Before Conray is used
Do not use Conray
• if you are allergic (hypersensitive) to contrast media substances containing
iodine or to any other Conray ingredients
• if you have an overactive thyroid gland which cannot be effectively treated
• for injection in certain spinal cord and brain areas, known as subarachnoid
space
Take special care with Conray
Inform your doctor if you have
• or previously had allergic reactions
• asthma, heart disease
• diabetes
• reduced urination, severely reduced kidney function
• combined kidney and liver disease
• problems with bone marrow, such as certain blood cancers known as
multiple myeloma, Waldenström’s macroglobulinaemia
• certain red blood cell abnormalities, known as sickle cell anaemia
• thyroid disease
• pain, swelling and/or blistering at the injection site after Conray
administration
Avoid dehydration to prevent some side effects.
Children younger than 18 years
Conray is used for imaging of arteries or kidneys within this age group.
However, it is not recommended for children in other X-ray procedures.
Using other medicines
Please tell your doctor or X-ray specialist if you are using or have recently
used any other medicines, including medicines obtained without a
prescription.
The following medicines can influence or be influenced by Conray:
• metformin: a medicine to treat diabetes
Your doctor will measure your kidney function before and after Conray use.
Metformin should be stopped before the investigation. It should not be restarted for at least 48 hours and only when your kidney function has returned
to normal.
• interleukin: medicines to treat certain tumours
Pregnancy and breast-feeding
• Pregnancy
Tell your doctor if you are pregnant or think you could be. Your doctor
will only administer Conray during pregnancy if it is absolutely necessary,
as it could harm the unborn child.

anxiety, somnolence

• Breast-feeding
Discuss this with your doctor or X-ray specialist before using Conray.

flushing
dizziness;
paraesthesia; taste
perversion
agitation; coma;
convulsions;
dyskinesia;
involuntary muscle
contractions;
paralysis; tremor;
urinary incontinence

Ask your doctor or pharmacist for advice before using any medicine

conjunctivitis
vision disorders

tachycardia;
ventricular fibrillation
arrhythmias;
bradycardia; cardiac
arrest; circulatory
failure; abnormal
ECG; heart block

hypotension
vasodilation; cyanosis
phlebitis

Respiratory, thoracic and mediastinal disorders:
Common (1% - 10%):
rhinitis
Occasional (0.1% - 1%):
coughing; dyspnoea
Rare (0.01% - 0.1%):
larynx oedema

Driving and using machines
Driving or operating machines is not advisable for up to 1 hour after injection.
In addition, symptoms such as dizziness, drowsiness and visual disturbances
have been reported. If this affects you, do not attempt any activities which
require concentration and the ability to react appropriately.
3. How to use Conray
Conray investigations will only be performed by a doctor or X-ray specialist,
who will also decide the dose. Lower doses are used for children.
Conray is injected into a blood vessel, into a heart cavity or into the uterus.
The dose depends on the specific procedure you are having and other factors
such as your health and age.
The lowest dose possible will be used to produce adequate X-ray images.
Patients should be kept under doctors’ observation for 15 minutes after
injection and stay for 1 hour in a medical environment.
If more Conray is given than it should
Overdoses are unlikely to occur, but an accidental overdose may affect your
heart and circulation system. Symptoms caused by an overdose include
difficult breathing and/or heart problems up to cessation of breathing and/or
of the heart beat. Inform your doctor or X-ray specialist immediately if you
notice any of these symptoms after receiving Conray. In addition, drink as
much as possible.
If you have any further questions on the use of this product, ask your doctor or
X-ray specialist.
4. Possible side effects
Like all medicines, Conray can cause side effects, although not everybody gets
them. Side effects associated with Conray are generally independent of the
dose given. In the majority of cases they are mild or moderate and very rarely
serious or life-threatening.

Serious effects or symptoms which require immediate attention by healthcare
personnel include cessation of the heartbeat or breathing, blue lips, fainting,
coma, sudden movements/convulsions, or acute kidney failure.

Very rare (< 0.01%):
Gastrointestinal disorders:
Common (1% - 10%):
Rare (0.01% - 0.1%):

If you experience any of the following, please consult your physician
immediately because you may have a serious allergic reaction: Allergic shock,
tightened airways/breathing difficulties, swollen face or eyes, swelling of the
voice box or tongue.

Very rare (< 0.01%):

apnoea; bronchospasm

nausea; vomiting
diarrhoea; dry mouth;
tongue oedema
dysphagia

Other symptoms of allergic reactions include cough, reddening of the face or
eyes, or rash. These are usually mild, but may also become serious. If you have
them and the symptoms become serious you should also consult your
physician immediately.

Skin and subcutaneous tissue disorders:
Common (1% - 10%):
pruritus; urticaria
Occasional (0.1% - 1%):
erythema; rashes
Rare (0.01% - 0.1%):
angioedema;
diaphoresis

Most side effects occur within the first minutes after injection. However,
allergic reactions to contrast media may occur within hours or may take up to
several days to occur.

Musculoskeletal, connective tissue and bone disorders:
Very rare (< 0.01%):
myalgia
Renal and urinary disorders:
Very rare (< 0.01%):

Side effects can occur with the following frequencies:
very common, occurs in more than 1 of 10 users
• hot flushes, pain
common, occurs in 1 to 10 per 100 users:
• sneezing and runny nose
• nausea, vomiting
• itching, hives
• allergy-like reactions

General disorders and administration
site conditions:
Very common (> 10%):
hot flushes; pain
Common (1% - 10%):
anaphylactoid
reactions
Occasional (0.1% - 1%):
chest pain;
face oedema;
periorbital oedema;
pharynx oedema
Rare (0.01% - 0.1%):
chills; injection site
reactions; malaise;
pallor; syncope
Very rare (< 0.01%):
abnormal crying;
anaphylactic shock;
headache; leg pain;
oedema

uncommon, occurs in 1 to 10 per 1,000 users:
• flushing
• low blood pressure
• cough, breathlessness
• skin redness, rash
• chest pain
• swollen face or eyes
• throat tightening
rare, occurs in 1 to 10 per 10,000 users:
• dizziness
• tingling skin, taste disturbances
• red eyes
• racing pulse, serious irregular heart beat
• blood vessel dilation (widening of the blood vessels, which could for example
cause redness of the skin)
• low oxygen in the blood, shown as blue lips
• swelling of the voice box or tongue
• diarrhoea, dry mouth
• swelling of the skin and of e.g. eye lids, lips, tongue, the inner lining of the
oral cavity/throat and of other mucous membranes
• increased sweating, chills
• injection site reactions
• feeling unwell, paleness
• fainting
very rare, occurs in fewer than 1 per 10,000 users:
• thirst
• anxiety, drowsiness, excitement
• movement disorders, convulsions
• coma
• muscle cramps, paralysis
• shakiness
• involuntary loss of urine
• sight problems
• irregular heart beats, slow pulse
• cardiac arrest (cessation of the heartbeat), circulatory failure (failure or
cessation of the normal blood circulation)
• heart activity changes measured using ECG (changes in the electrical activity
of the heart, which can be observed in an electrocardiogram), heart blockage
• vein inflammation
• narrowing of the airways, temporary cessation of breathing
• swallowing difficulties
• acute kidney failure or decreased kidney function
• leg or muscle pain, headache
• allergic shock
• tissue swelling
• abnormal crying

acute renal failure;
decrease in renal
function

4.9.

Overdose
Overdose is unlikely in clinical practice, but in the event of
inadvertent overdosage, it is important to keep the patient well
hydrated, otherwise, treatment should be symptomatic with
particular reference to the cardiovascular system.

5.

PHARMACOLOGICAL PROPERTIES

5.1.

Pharmacodynamic properties
Pharmacotherapeutic group: Watersoluble, nephrotropic, high
osmolar, iodinated X-ray contrast media
ATC code: V08AA04
Conray does not normally possess any pharmacological action.

5.2.

Pharmacokinetic properties
If renal function is not impaired, Conray is rapidly excreted
unchanged by glomerular filtration.

5.3.

Preclinical safety data
None stated

6.

PHARMACEUTICAL PARTICULARS

6.1.

List of excipients
Meglumine, Sodium calcium edetate dihydrate, Sodium
dihydrogen phosphate monohydrate, Water for injections

6.2.

Incompatibilities
Apart from water for injections and dextrose saline, Conray should
not be mixed with any other substance.

6.3.

Shelf life
60 months

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 X-ray specialist.

6.4.

Keep out of the reach and sight of children. Protect from X-rays.
Keep container in the outer carton in order to protect from light.

5. How to store Conray
Keep out of reach and sight of children.
Do not use Conray after the expiry date which is stated on the label. The expiry
date refers to the last day of that month.

6.5.

Nature and contents of container
Conray 280 is packaged in uncoloured vials and bottles composed
of type I glass (European Pharmacopoeia). Bottles are fitted with
32mm latex-free bromobutyl rubber closures and aluminium cap
seals. Vials are fitted with 20mm latex-free bromobutyl rubber
closures and aluminium cap seals.

Keep the container in the outer carton in order to protect from light. Protect
from X-rays.
6. Further information
What Conray contains
• The active substance is Iotalamic acid.
One millilitre of Conray contains 45.6% w/v Iotalamic acid, which is equal to
280 mg iodine.
• The other ingredients are: meglumine, sodium calcium edetate dihydrate,
sodium dihydrogen phosphate monohydrate, water for injections.
What Conray looks like and contents of the pack
Conray is an aqueous solution for injection. It is a clear colourless to pale
yellow solution.
Conray is packaged in uncoloured vials and bottles. Bottles are fitted with
32 mm, vials with 20 mm bromobutyl rubber closures, both sealed with
aluminium cap seals.

Special precautions for storage

Glass ampoule or glass bottle sealed with a white rubber plug.
Pack size:
Box of 10 x 20 ml vials
Box of 10 x 50 ml bottles
6.6.

Instruction for use, handling and disposal
Not stated

Administrative Data
7.

Pack size:
Box of 10 x 20 vials
Box of 10 x 50 bottles

MARKETING AUTHORISATION HOLDER
Mallinckrodt UK Commercial Ltd.
4500 Parkway, Whiteley, Fareham
Hampshire PO15 7NY, United Kingdom

Not all pack sizes and box sizes may be marketed in all countries.

8.

MARKETING AUTHORISATION NUMBER: P.L. 41744/0001

Marketing Authorisation Holder and Manufacturer
• Marketing Authorisation Holder
Mallinckrodt UK Commercial Ltd., 4500 Parkway, Whiteley, Fareham, Hampshire
PO15 7NY, United Kingdom, Tel: +44(0)1329224477, Fax: +44(0)1329224442
• Manufacturer
Mallinckrodt Medical Imaging Ireland, Damastown, Mulhuddart,
Dublin 15, Ireland

9.

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION: 01/0

10.

DATE OF REVISION OF THE TEXT: 11/2012

This leaflet was last approved in 04/2.013

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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