TELEBRIX 30 MEGLUMINE

Israel - English - Ministry of Health

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Active ingredient:
MEGLUMINE IOXITALAMATE
Available from:
PROMEDICO LTD
ATC code:
P01CB01
Pharmaceutical form:
SOLUTION FOR INJECTION
Composition:
MEGLUMINE IOXITALAMATE 66.03 G / 100 ML
Administration route:
I.V, INTRAVASCULAR
Prescription type:
Required
Manufactured by:
GUERBET, FRANCE
Therapeutic group:
MEGLUMINE ANTIMONATE
Therapeutic area:
MEGLUMINE ANTIMONATE
Therapeutic indications:
For urograph, selective angiography, peripheral angiography, arthrography, hysterosalpingography and digestive exploration.
Authorization number:
027 67 21780 00
Authorization date:
2012-11-30

העדוה

לע

הרמחה

(

עדימ

ןולעב )תוחיטב

ל

אפור :ךיראת

5.2013

םש

רישכת

תילגנאב

רפסמו

( :םושירה

027-67-21780-00

)

Telebrix 30 Meglumine

םש

לעב

םושירה

:

Promedico LTD

ספוט

הז

דעוימ

טורפל

תורמחהה

דבלב

םיטרפ

לע

םי/יונישה

םי/שקובמה קרפ ןולעב טסקט

יחכונ טסקט

שדח

4.8.

Unde

sirabl

e

effect

s

Tabulated list of adverse reactions with TELEBRIX 30 Meglumine

or another form of TELEBRIX following non-enteral

administration:

System organ Class

Frequency: Adverse reaction

Immune system

disorder

Frequency not known: Anaphylactic shock,

anaphylactic reaction, anaphylactoid reaction,

hypersensetivity

Endocrine disorders

Frequency not known: Thyrotoxic crisis*,

hyperthyroidism*, thyroid disorder**

Psychiatric disorders

Frequency not known: Conusional state,

List summarising the undesirable effects reported with TELEBRIX 30

Meglumine or another form of TELEBRIX after intravascular

administration or instillation:

System Organ Class

Frequency:

undesirable effect

Immune system disorders

Unknown frequency: anaphylactic shock,

anaphylactic reaction, anaphylactoid reaction,

hypersensitivity

Endocrine disorders

agitation

Nervous system

disorders

Frequency not known: Coma,

loss of consciousness, syncope, convulsion,

paresis/paralysis, paresthesia, tremor,

dizziness, headache

Eye disorders

Frequency not known: Eyelid oedema

Ear and labyrinth

disorders

Frequency not known: Vertigo

Cardiac disorders

Frequency not known: Cardiac arrest,

myocardial infarction, angina pectoris,

arrhythmia, tachycardia, cyanosis

Vascular disorders

Frequency not known: Shock, hypertension,

hypotension, thrombophlebitis

, flushing,

pallor

Respiratory, thoracic

and mediastinal

disorders

Frequency not known: Respiratory arrest,

respiratory failure, laryngeal oedema,

laryngospasm, pulmonary oedema, dyspnoea,

bronchospasm, throat tightness, cough,

sneezing

Gastrointestinal

disorders

Frequency not known: Diarrhoea, nausea,

vomiting, abdominal pain

Skin and

subcutaneous tissue

disorders

Frequency not known:

Immediate: Angioedema, urticaria, pruritus,

erythema, hyperhidrosis

Delayed: Rash, rash maculo-papular,

dermatitis bullous

Musculoskeletal and

connective tissue

disorders

Frequency not known: Muscle spasm

Renal and urinary

disorders

Frequency not known: Renal failure acute,

anuria

General disorders and

Frequency not known: Oedema, face oedema,

System Organ Class

Frequency:

undesirable effect

Unknown frequency: thyrotoxic crisis*,

hyperthyroidism*, thyroid disorder*

Psychiatric disorders

Unknown frequency: confusional state,

agitation

Nervous system

disorders

Unknown frequency: coma, syncope,

convulsion, paresis/paralysis

paresthesiae, tremor, dizziness, headache

Cardiac disorders

Unknown frequency: cardiac arrest,

myocardial infarction, angina pectoris,

arrhythmia, tachycardia

Vascular disorders

Unknown frequency: hypotension,

thrombophlebitis, circulatory collapse

Respiratory, thoracic and

mediastinal disorders

Unknown frequency: respiratory arrest,

laryngeal œdema, laryngospasm,

pulmonary œdema,

bronchospasm, throat tightness, cough

Gastrointestinal

disorders

Unknown frequency: diarrhoea, nausea,

vomiting, abdominal pain

Skin and subcutaneous

tissue disorders

Unknown frequency:

Immediate: angiœdema, urticaria,

pruritus, erythema

Ear and labyrinth disorders

Hearing impaired

Cardiac disorders

Bradycardia

Respiratory, thoracic and mediastinal

disorders

Pneumonia aspiration

Gastrointestinal disorders

Pancreatitis

, ileus

enterocolitis

parotid

gland enlargement,

salivary hypersecretion

Reproductive system and breast disorders

Pelvic pain

Skin and subcutaneous tissue disorders

Stevens-Johnson

syndrome, toxic

epidermal necrolysis,

erythema multiforme,

eczema

Musculoskeletal and connective tissue

disorders

Arthralgia

Investigations

Electroencephalogram

abnormal,

blood amylase increased

in patients with swallowing impairment, oral route

following endoscopic retrograde cholangiopancreatography (ERCP)

following enteral administration

in the event of hysterosalpingography

in the event of arthrography

System Organ Class

Undesirable effect

Nervous system disorders

Brain œdema, amnesia,

speech disorder, somnolence,

dysgeusia

Eye disorders

Visual impairment, photophobia,

blindness transient

Ear and labyrinth disorders

Hearing impaired

Cardiac disorders

Bradycardia

Respiratory, thoracic and mediastinal

disorders

Pneumonia aspiration

, sneezing

Gastrointestinal disorders

Pancreatitis

, ileus

parotid gland enlargement,

salivary hypersecretion

Reproductive system and breast

disorders

Pelvic pain

Skin and subcutaneous tissue disorders

Stevens-Johnson

syndrome,

toxic epidermal

necrolysis,

erythema multiforme,

eczema

System Organ Class

Undesirable effect

Musculoskeletal and connective tissue

disorders

Arthralgia

Investigations

Electroencephalogram

abnormal,

blood amylase increased

in patients with swallowing disorders (oral route)

after endoscopic retrograde cholangio-pancreatography (ERCP)

after enteral administration

in the event of hysterosalpingography

in the event of arthrography

SUMMARY OF PRODUCT CHARACTERISTICS

1.

NAME OF THE MEDICINAL PRODUCT

TELEBRIX 30 MEGLUMINE (300 mg Iodine/mL), solution for injection

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION

For 100 mL of solution:

Meglumine ioxitalamate………………………………………………………. ....................... 66.03 g

Equivalent to iodine………………………………………………………………. ...................... 30 g

Iodine content per mL: 300 mg

Iodine mass per 30 mL vial: 9 g

Iodine mass per 50 mL vial: 15 g

Iodine mass per 100 mL bottle: 30 g

Excipient with known effect: Sodium (8.4 mg sodium per 100

For the full list of excipients, see section 6.1.

3.

PHARMACEUTICAL FORM

Solution for injection.

Viscosity at 20° C: 10.2 mPa.s

Viscosity at 37° C: 5.3 mPa.s

Osmolality: 1710 mOsm/kg

4.

CLINICAL PARTICULARS

4.1

Therapeutic indications

This medicinal product is for diagnostic use only.

Contrast medium for use in adults and children

via intra

-arterial and intravenous administration and by

instillation for:

Urograph, selective angiography, peripheral angiography, arthrography, hysterosalpingography and

digestive exploration.

4.2.

Posology and method of administration

Posology

dose

must

adapted according to

the patient’s age,

weight

, renal function, the type of

examination and the volume of the organ to be examined.

Indications

Average dose

mL/kg

Total volume

(min.-max.) mL

Intravenous urography

The standard dose is 1 to 2

ml/kg. In children under 20

kg, the dose is 2 to 3 ml/kg.

50 – 100 mL

Retrograde

urethrocystography

Dosage to be adapted to the

volume

organ

injected.

20 – 100 mL

Suprapubic cystography

Dosage to be adapted to the

volume

organ

injected.

100 – 250 mL

Special populations

Elderly patients

TELEBRIX 30 Meglumine should be administered with caution (see section 4.4), in well-hydrated

patients at the minimum effective dose.

Paediatric population

As with all other hyperosmolar contrast media, the use of this preparation should be carefully considered

in neonates, infants, and children. The administered dose should be reduced to the minimum.

Patients with renal impairment

In patients with renal failure, the dose is reduced and sufficient hydration must be ensured (see also

section 4.4.2.2. Precautions for use – Renal failure).

Method of administration

The product must be administered via intra-arterial and intravenous injection, or by instillation.

4.3.

Contraindications

Hypersensitivity to ioxitalamic acid or to any of the excipients listed in section 6.1.

History of major immediate or delayed skin reaction (see section 4.8) to TELEBRIX 30 Meglumine

(300 mg Iodine/mL), solution for injection;

Decompensated heart failure;

Manifest thyrotoxicosis;

Intrathecal or subarachnoid (or epidural) administration of TELEBRIX 30 Meglumine for

myelography, cerebral ventriculography or cisternography is contraindicated as severe and potentially

life-threatening neurotoxic reactions (e.g. myoclonus or epilepsy) can occur.

4.4.

Special warnings and precautions for use

Allergic reaction is possible regardless of the administration route and dose.

The intolerance risk is not univocal in the case of medicinal products administered locally for

opacification of bodily cavities:

a) Administration by certain specific routes (articular, biliary, intrathecal, intrauterine, etc.) leads to

considerable systemic passage: systemic effects may therefore be observed.

b) Administration by oral or rectal route generally leads to very limited systemic diffusion; if the gastro-

intestinal mucosa is normal, only 5% maximum of the dose administered is found in the urine, the

remainder being eliminated in the faeces. However, if the gastro-intestinal mucosa is altered, absorption is

increased; it becomes total and rapid in the event of perforation, with passage into the cavity of the

peritoneum. The medicinal product is then eliminated in the urine. The occurrence of any dose-dependent

systemic effects therefore depends on the condition of the gastro-intestinal mucosa.

c) The immuno-allergic mechanism is however not dose-dependent and always likely to be observed,

regardless of the administration route.

With respect to the prevalence and the intensity of adverse effects, the following therefore are antagonists:

Medicinal products administered by vascular route and by certain local routes

Medicinal products administered by intestinal route and little absorbed under normal conditions

4.4.1. Special warnings

4.4.1.1. Hypersensitivity

Any iodinated contrast medium can cause minor or major reactions that may be life-threatening. They

may be immediate (less than 60 minutes) or delayed (up to 7 days). They are often unpredictable.

The risk of major reaction requires the immediate availability of the means necessary for emergency

resuscitation.

Several mechanisms have been reported:

Direct toxicity affecting the vascular endothelium and tissue proteins.

Pharmacological action altering the concentration of certain endogenous factors

(histamine,

complement

fractions,

inflammation

mediators),

more

frequent

with

hyperosmolar products.

Immediate IgE-type allergy dependent on the contrast medium (anaphylaxis)

Cell-mediated allergic reactions (late onset cutaneous reactions)

Patients having previously suffered a reaction during administration of an iodinated contrast medium are

at increased risk of experiencing a renewed reaction during administration of the same, or another

iodinated contrast medium, and are therefore considered to be high risk subjects.

4.4.1.2. Iodinated contrast media and the thyroid (see 4.4.2.5. Precautions for use - Dysthyroidism)

Prior to administration of an iodinated contrast medium, it must be ensured that the patient is not to

undergo a scintigraphic exploration of the thyroid, or administration of radioactive iodine treatment.

Administration of iodinated contrast media, regardless of the route, disturbs hormone assays and iodine

fixation by the thyroid or thyroid cancer metastases until normalisation of urine iodine levels.

4.4.1.3. Extravasation

Extravasation is not an uncommon complication (0.04% to 0.9%) of intravenous injections of contrast

media. More frequent with high osmolarity contrast agents, most lesions are minor; however, severe

lesions such as skin ulceration, tissue necrosis and compartment syndrome may occur with all iodinated

contrast media. The factors of risk and/or seriousness are patient-related (poor vascular status or fragile

patient) and technique-related (use of a pressure injector, large volume administered). It is important to

identify these factors and optimise injection site and technique accordingly, and to monitor the patient

before, during and after the injection of TELEBRIX 30 Meglumine.

4.4.2. Precautions for use

4.4.2.1. Intolerance to iodinated contrast media:

Prior to the examination:

Identify subjects at risk via specific questioning concerning history.

Corticosteroids and H1-antihistamines were suggested as premedication in patients at the highest risk of

hypersensitivity reaction. However, they do not prevent serious or fatal anaphylactic shock to occur.

During the examination, the following must be ensured:

Medical supervision.

Maintenance of a venous access.

Necessary resuscitation equipment at hand.

After the examination:

Further to administration of a contrast medium, the patient must remain under observation for at least

30 minutes, as most adverse effects occur within this time.

The patient must be warned that late onset reactions may occur (up to 7 days later) (see section 4.8 –

Undesirable effects).

4.4.2.2 Renal failure

Iodinated contrast media may temporarily alter renal function or aggravate existing renal failure. The

preventive measures to be taken are as follows:

Identify high risk patients: dehydrated subjects, patients with renal failure, diabetes, severe heart

failure, monoclonal gammapathy (multiple myeloma, Waldenström’s disease), recent myocardial

infarction, intra-aortic balloon pump, low haematocrit , hyperuricaemia, or a history of renal failure

following administration of iodinated contrast media, children under one year and atheromatous

elderly subjects or with polymorbidity syndrome.

Initiate appropriate hydration by fluid and sodium solution where required.

Avoid combinations of nephrotoxic medicines (if such combinations are necessary, reinforce renal

biological

monitoring). The

medicinal

products

question

notably

angiotensin-converting

enzyme (ACE) inhibitors, aminoglycosides, organoplatins, high-dose methotrexate, pentamidine,

foscarnet

certain

antivirals

(aciclovir,

ganciclovir,

valaciclovir,

adefovir,

cidofovir,

tenofovir),

vancomycin,

amphotericin

non-steroidal

anti-inflammatory

drugs,

diuretics,

immunosuppressants such as ciclosporine or tacrolimus, ifosfamide.

Since renal elimination is reduced in the presence of renal dysfunction, the interval between two X-

ray examinations involving injection of an iodinated contrast medium must be as long as clinically

acceptable, especially in risk patients. For these patients, allow for a 48- to 72-hour interval. In the

event of renal failure following the first examination, any further examination should be deferred until

after initial renal function has been restored.

Prevent

lactic

acidosis

diabetic

patients

treated

with

biguanides

(metformin),

according

creatinine clearance. (see 4.5. Interactions - Antidiabetic drugs belonging to the biguanides family).

Haemodialysis patients may receive iodinated contrast media as these products are dialysable. The

haemodialysis department must first be consulted.

4.4.2.3. Liver failure

Special attention must be paid when a patient suffers both from liver failure and renal failure, as this

situation increases the risk of contrast medium retention.

4.4.2.4. Asthma

Asthma must be stabilized prior to injection of an iodinated contrast medium.

Special attention must be paid in cases of asthma attacks occurring 8 days prior to the examination, due to

the increased risk of bronchospasm.

4.4.2.5. Dysthyroidism

Following injection of an iodinated contrast medium, in particular in patients with goitre or with a history

of dysthyroidism, the risk of hyperthyroidism or induction of hypothyroidism also exists. Hypothyroidism

may also occur in newborns that have received, or whose mother has received an iodinated contrast

medium. Their thyroid function should be therefore evaluated and monitored.

4.4.2.6. Severe cardiovascular disease

event

existing

early

stage

heart

failure,

coronary

artery

disease,

pulmonary

arterial

hypertension

valvular

heart

disease,

risk

pulmonary

oedema,

myocardial

ischemia

arrhythmia or severe hemodynamic disorders is increased following administration of an iodinated

contrast medium.

4.4.2.7. Central nervous system disorders

The benefit/risk ratio must be estimated on a case per case basis:

due to the risk of worsening of neurological symptoms in patients presenting with transient ischemic

attack, acute cerebral infarction, recent intracranial haemorrhage, and cerebral oedema, idiopathic or

secondary epilepsy (tumour, scar).

during use by intra-arterial route in alcoholics (acute or chronic alcoholism) and users of other drugs.

4.4.2.8. Pheochromocytoma

Patients suffering from phaechromocytoma may experience hypertension surge following intravascular

administration of a contrast medium and may require appropriate treatment prior to the procedure.

4.4.2.9. Myasthenia

Administration of a contrast medium may worsen myasthenia symptoms.

4.4.2.10. Enhanced side effects

Side effects related to administration of iodinated contrast media may be enhanced by pronounced states

of excitation, anxiety and pain. Appropriate treatment, and possibly sedation, may be necessary.

4.4.2.11. Warnings about excipients

This medicinal product contains less than 1 mmol sodium (23 mg) per 100 mL, so it is practically

sodium-free.

4.5.

Interaction with other medicinal products and other forms of interaction

4.5.1. Medicinal products

Antidiabetic in the biguanides group (metformin) (see also section 4.4.2.2. Precautions for use -

Renal failure)

1. In patients with normal renal function, biguanide treatment can be continued normally.

2. In patients with moderate renal insufficiency (estimated Glomerular Filtration Rate (eGFR) 30-59

mL/min/1.73m²):

Patients receiving intravenous contrast medium with eGFR equal to or greater than 45 mL/min/1.73 m²

can continue to take the biguanide normally.

Patients receiving intra-arterial contrast medium, and those receiving intravenous contrast medium with an

eGFR between 30 and 44 mL/min/1.73 m², should stop the biguanide 48 h before contrast medium and

should only restart the biguanide 48 hours after contrast medium if renal function has not deteriorated.

3. In patients with eGFR less than 30 mL/min/1.73 m² (Chronic Kidney Disease grade 4 and 5), or with

an intercurrent illness causing reduced liver function or hypoxia, the biguanide is contraindicated and a

careful risk/benefit assessment should precede the administration of any iodinated contrast media.

emergency

patients,

biguanide

should

stopped

from

time

contrast

medium

administration. After the procedure, the patient should be monitored for signs of lactic acidosis. The

biguanide should be restarted 48 h after contrast medium if serum creatinine/eGFR is unchanged from the

pre-imaging level.

Radiopharmaceuticals (see also section 4.4.1.1. Special warnings)

A risk of hyperthyroidism or induction of hypothyroidism exists in at-risk patients.

Iodinated contrast media disturb radioactive iodine uptake by thyroid tissue during several weeks, and this

may lead to poor fixation in the thyroid scintigraphy and reduced effectiveness of iodine 131 treatment.

Where

renal

scintigraphy

performed

injection of renal tubular secreted radiopharmaceuticals

planned, it is recommended to carry out this procedure prior to injection of the iodinated contrast medium.

Beta-blockers, vasoactive substances, angiotensin-converting enzyme inhibitors, angiotensin

receptor antagonists.

These medicinal products lead to a reduction in the

effectiveness

of cardiovascular

compensation

mechanisms in blood pressure disorders.

Hypersensitivity reactions may be aggravated in patients taking beta-blockers, particularly in the presence

of bronchial asthma. These patients may be refractory to standard treatment for hypersensitivity reactions

with beta-agonists. The doctor must be informed if the patient is taking such treatment prior to injection

of the iodinated contrast medium and dispose of the necessary resuscitation means.

Diuretics

Due to the risk of dehydration induced by diuretics, hydration is initially necessary for minimising the

risk of acute renal failure.

TELEBRIX 30 Meglumine may have an additive diuretic effect because of its hyperosmolar properties.

Interleukin- 2

Enhanced reaction to contrast media during treatment with interleukin- 2 (intravenous route) may occur:

rash, congestive flush, erythema, fever or flu-like symptoms, or more rarely hypotension, oliguria or even

renal failure.

Potentially nephrotoxic agents (see section 4.4.2.2. Precautions for use - Renal failure)

Fibrinolytic agents

It has been demonstrated that, in vitro, contrast media perturb the effects of fibrinolytic agents in a dose-

dependent manner. Given this enzyme inhibition, which varies between fibrinolytic agents, iodinated

contrast media should not be administered concomitantly.

4.5.2. Other forms of interaction

High concentrations of iodinated contrast media in plasma and urine may interfere with in vitro bilirubin,

protein and inorganic substance assay (iron, copper, calcium and phosphate); it is therefore recommended

to not perform assay of these substances during the 24 hours following the procedure.

4.6

Pregnancy and lactation

Pregnancy

Given that exposure to radiation should generally be avoided, during pregnancy, whether a contrast

agent is used or not, the benefit of a radiological examination must be carefully assessed.

Embryotoxicity

Studies conducted in animals have not shown any teratogenic effects.

In the absence of teratogenic effects in animals, no malformation in humans is expected. To date, the

substances causing malformations in humans have been found to be teratogenic in animals in well

conducted studies in two species.

Foetotoxicity

Occasional iodine overload following administration of the medium in the mother may lead to foetal

dysthyroidism if the examination is carried out after 14 weeks' amenorrhea. The thyroid function of

neonates exposed in utero must be examined and monitored.

However, reversibility of this effect and the expected maternal benefit indicate that occasional

administration of an iodinated contrast medium should not be delayed where the indication for

radiological examination in pregnant women is carefully assessed.

Fertility

Toxicological studies conducted on reproduction function did not show any effects on reproduction,

fertility or foetal or post-natal development.

Breastfeeding

Small quantities of iodinated contrast media are excreted in breast milk. Occasional administration in

mothers therefore bears a low risk of causing adverse effects in infants. It is advisable to suspend

breastfeeding for 24 hours following administration of an iodinated contrast medium.

4.7.

Effects on ability to drive and use machines

No study on the effect on the ability to drive and use machines has been conducted.

Given the pharmacological properties of

TELEBRIX 30 Meglumine

itself, any effect on the ability to

drive and use machines is unlikely.

4.8.

Undesirable effects

Since marketing, the most frequently reported undesirable effects after administration of all forms of

TELEBRIX

are:

hypersensitivity

particularly

anaphylactic

reaction,

anaphylactoid

reaction

anaphylactic shock), urticaria, rash particularly erythema and maculopapular rash) and reactions at the

injection site (such as oedema, pain and inflammation).

Hypersensitivity reactions are usually immediate (occurring during administration or within the hour

following the start of administration), but they may be delayed (from one hour to several days after

administration), and are seen as undesirable cutaneous reactions.

Immediate reactions

consist in

or several,

successive

concomitant

effects,

usually

cutaneous reactions, respiratory and/or cardiovascular disorders, which may be the early signs of

shock. They are rarely fatal.

The undesirable effects are presented in the table below according to System Organ Class; frequency

is unknown (cannot be estimated from

available data).

List summarising the undesirable effects reported with TELEBRIX 30 Meglumine or another form of

TELEBRIX after intravascular administration or instillation:

System Organ Class

Frequency: undesirable effect

Immune system disorders

Unknown

frequency:

anaphylactic

shock,

anaphylactic

reaction,

anaphylactoid reaction, hypersensitivity

Endocrine disorders

Unknown

frequency:

thyrotoxic

crisis*,

hyperthyroidism*,

thyroid

disorder*

Psychiatric disorders

Unknown frequency: confusional state, agitation

Nervous system

disorders

Unknown

frequency:

coma,

syncope,

convulsion,

paresis/paralysis,

paresthesiae, tremor, dizziness, headache

Cardiac disorders

Unknown frequency: cardiac arrest, myocardial infarction, angina

pectoris, arrhythmia, tachycardia

Vascular disorders

Unknown frequency: hypotension, thrombophlebitis, circulatory

collapse

Respiratory, thoracic and

mediastinal disorders

Unknown frequency: respiratory arrest, laryngeal œdema,

laryngospasm, pulmonary œdema, bronchospasm, throat tightness,

cough

Gastrointestinal

disorders

Unknown frequency: diarrhoea, nausea, vomiting, abdominal pain

Skin and subcutaneous

tissue disorders

Unknown frequency:

Immediate: angiœdema, urticaria, pruritus, erythema

Delayed:rash maculo-papular

Renal and urinary

disorders

Unknown frequency: renal failure acute, anuria

General disorders and

administration site

conditions

Unknown frequency: œdema, face oedema, pain, feeling hot, malaise,

injection

site

extravasation,

injection

site

pain,

injection

site

inflammation, injection site oedema, injection site necrosis

Investigations

Unknown frequency: Blood creatinine increased

in the event of extravasation

* See section 4.4.1.2. Iodinated contrast media and the thyroid

The following undesirable effects have been reported with other iodinated contrast media or with

TELEBRIX via a different route of administration.

Hence, they may occur during administration of TELEBRIX.

System Organ Class

Undesirable effect

Psychiatric disorders

Hallucinations, anxiety

Nervous system disorders

Brain œdema, amnesia, speech disorder, somnolence,

dysgeusia

Eye disorders

Visual impairment, photophobia, blindness transient

Ear and labyrinth disorders

Hearing impaired

Cardiac disorders

Bradycardia

Respiratory,

thoracic

mediastinal

disorders

Pneumonia aspiration

, sneezing

Gastrointestinal disorders

Pancreatitis

ileus

parotid

gland

enlargement,

System Organ Class

Undesirable effect

salivary hypersecretion

Reproductive system and breast

disorders

Pelvic pain

Skin and subcutaneous tissue disorders

Stevens-Johnson

syndrome,

toxic

epidermal

necrolysis, erythema multiforme, eczema

Musculoskeletal and connective tissue

disorders

Arthralgia

Investigations

Electroencephalogram

abnormal,

blood

amylase

increased

in patients with swallowing disorders (oral route)

after endoscopic retrograde cholangio-pancreatography (ERCP)

after enteral administration

in the event of hysterosalpingography

in the event of arthrography

Undesirable effects in children

The known nature of undesirable effects associated with TELEBRIX 30 Meglumine is the same as that

of effects reported in adults. Their frequency cannot be estimated from available data.

4.9.

Overdose

Overdose increases the risk of kidney disease and may cause diarrhoea, dehydration, electrolyte

imbalance, haemodynamic and cardiovascular disorders.

With very high doses, fluid and electrolyte losses must be compensated by appropriate rehydration. Renal

function must be monitored during at least three days. Haemodialysis may be carried out if necessary.

5.

PHARMACOLOGICAL PROPERTIES

5.1.

Pharmacodynamic properties

Pharmacotherapeutic group: IODINATED CONTRAST MEDIUM (V: miscellaneous)

ATC Code: V08AA05

TELEBRIX 30 MEGLUMINE (300 mg Iodine/mL), solution for injection is an ionic, nephrotropic, water

soluble uro-angiographic contrast medium with an osmolality of 1710 mOsm/kg.

5.2.

Pharmacokinetic properties

Injected by vascular route, ioxitalamic acid is distributed to the intravascular compartment and the

interstitial space. The elimination half life is 1.1 hour, the distribution volume 194 mL/kg and total

clearance 120 mL/min on average. It is mainly eliminated by renal route (glomerular filtration without re-

absorption or tubular secretion) in unchanged form. The osmotic diuresis effect induced by TELEBRIX

30 MEGLUMINE is related to the osmolality and volume of the medium injected.

In the event of renal failure, heterotropic renal elimination takes place by biliary, salivary, sudoral and

colic route. The substance is dialysable.

5.3

Preclinical safety data

Effects have only been observed in animals at a level of exposure significantly higher than the maximum

dose in humans, and are therefore of little clinical significance.

6.

PHARMACEUTICAL DATA

6.1

List of excipients

Meglumine, sodium calcium edetate, sodium dihydrogen phosphate dihydrate, water for injections.

6.2.

Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal

products.

6.3.

Shelf- life

3 years.

6.4.

Special precautions for storage

Store below 25°C.

Keep protected from light.

6.5.

Nature and contents of container

colourless

glass

vials/bottles

(type

with

elastomer

stoppers

(chlorobutyl).

Not all pack sizes may be marketed.

6.6.

Special precautions for disposal and other handling

Any unused product or waste material should be disposed of in accordance with local requirements.

7.

MANUFACTURER

Guerbet

BP 57400

F-95943 ROISSY CDG CEDEX

FRANCE

8.

MARKETING AUTHORISATION NUMBER(S)

027-67-21780-00

9.

REGISTRATION HOLDER

Promedico LTD

6 Hashiloach St.

Petach-Tikva

10.

DATE OF APPROVAL/

REVISION

The format of this leaflet has been defined by the MOH and its content has been checked and

approved, June 2013

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