Biliscopin For Infusion 10.5g/100mL injection bottle

Nazione: Australia

Lingua: inglese

Fonte: Department of Health (Therapeutic Goods Administration)

Principio attivo:

iotroxate meglumine, Quantity: 105.46 mg/mL

Commercializzato da:

Bayer Australia Ltd

INN (Nome Internazionale):

iotroxate meglumine

Forma farmaceutica:

Injection, solution

Composizione:

Excipient Ingredients: sodium calcium edetate; sodium bicarbonate; sodium chloride; water for injections

Via di somministrazione:

Intravenous

Confezione:

1 x 100mL, 100mLx10

Classe:

Medicine Registered

Tipo di ricetta:

Not scheduled. Not considered by committee

Indicazioni terapeutiche:

Biliscopin for infusion is indicated for radiological examination of hepatic and biliary ducts and gallbladder when examination by oral technique is unsuccessful or inappropriate.

Dettagli prodotto:

Visual Identification: Clear solution, < colour reference solution y5 or by5.; Container Type: Bottle; Container Material: Glass Type II Clear; Container Life Time: 5 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Stato dell'autorizzazione:

Licence status A

Data dell'autorizzazione:

1995-06-20

Foglio illustrativo

BILISCOPIN®
1
BILISCOPIN®
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I GIVEN BILISCOPIN?
BILISCOPIN contains the active ingredient iotroxate meglumine.
BILISCOPIN is a contrast agent used during an X-ray
examination of the liver, bile ducts and gallbladder or other areas
where bile flows.
For more information, see Section 1. Why am I given BILISCOPIN? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I AM GIVEN BILISCOPIN?
Do not use if you have ever had an allergic reaction to BILISCOPIN or
any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR, RADIOGRAPHER OR NURSE IF YOU HAVE ANY OTHER
MEDICAL CONDITIONS, TAKE ANY OTHER MEDICINES, OR ARE
PREGNANT OR PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING.
You may be asked to change your diet for the day prior and to not eat
(fast) the evening before your procedure. It is important
that you still drink fluids as normal.
For more information, see Section 2. What should I know before I am
given BILISCOPIN? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with BILISCOPIN and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW AM I GIVEN BILISCOPIN?
BILISCOPIN is given by a small needle into a vein usually in your hand
or arm by the doctor, radiographer or nurse. It is a drip
infusion and will be given slowly over 30 to 60 minutes.
More instructions can be found in Section 4. How am I given
BILISCOPIN? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE RECEIVING BILISCOPIN?
THINGS YOU
SHOULD DO
Tell your doctor, radiographer or nurse if you:
•
experience violent yawns, tickling in the throat, hoarseness, asthma
(tight chest, difficulty
breathing), swollen mouth or swollen eyelids, red rash or red flushed
skin, hives, coughing, runny
nose or sneezing
•
experience any of the severe symptoms of loss of consciousness o

Scheda tecnica

191217_Biliscopin PI
1
AUSTRALIAN PRODUCT INFORMATION
BILISCOPIN
® FOR INFUSION (Iotroxate meglumine)
1
NAME OF THE MEDICINE
Iotroxate meglumine.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 mL Biliscopin for infusion contains 0.105 g iotroxate
meglumine.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Biliscopin
for
infusion
is
a
radiocontrast
medium
for
cholangiography
and
cholecystography.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Biliscopin for infusion is indicated for radiological examination of
the hepatic and biliary
ducts
and
gallbladder
when
examination
by
oral
technique
is
unsuccessful
or
inappropriate.
4.2
DOSE AND METHOD OF ADMINISTRATION
General information
Contrast media should not be used in case of occurrence of particulate
matter or defective
container.
The
infusion
bottle
should
not
be
attached
to
the
infusion
set
until
immediately
before
the
examination.
Contrast
medium
solution
not
used
in
one
examination session must be discarded.
Dietary suggestions
In cholegraphy the diagnostic yield can be increased by ensuring that
the bowels are
empty of faecal
matter and gas by avoiding stimulation of the gall bladder. Patients
should
therefore
be
put
on
a
minimum, low-residue, non-gas forming diet 24 hours
before the examination. Easily digestible foods
and clear liquids, e.g. tea without milk,
fruit juice or clear fat-free soup can be given. The patient
should not be given eggs,
rusks, fruit, pulpy goods, paste or milk products. If a laxative is
prescribed,
it should be
taken about 20 hours before the examination.
Patient should fast on the day of the examination, which is best
carried out in the
morning.
After
administration of Biliscopin for infusion, the patient should not eat
or
smoke until the examination is
complete, but is allowed to drink water or weak tea if
thirsty.
Hydration
Adequate hydration must be assured before and after contrast medium
administration.
Disorders of
the water and electrolyte balance must be corrected before the