E-Z-CAT oral suspension

País: Reino Unido

Língua: inglês

Origem: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredientes ativos:

Barium sulfate

Disponível em:

Bracco UK Ltd

DCI (Denominação Comum Internacional):

Barium sulfate

Forma farmacêutica:

Oral suspension

Via de administração:

Oral

Classe:

No Controlled Drug Status

Tipo de prescrição:

Valid as a prescribable product

Resumo do produto:

BNF:

Folheto informativo - Bula

E-Z-CAT
4.9 % W/V ORAL SUSPENSION
barium sulfate
PACKAGE LEAFLET: INFORMATION FOR THE USER
E-Z-CAT
™
4.9 % W/V ORAL SUSPENSION
barium sulfate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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,
radiographer or nurse helping you with your examination
which is usually called a CT or CAT scan.
•
This medicine has been prescribed for you only. Do not pass
it on to others. It may harm them, even if their signs of illness
are the same as yours.
•
If you get any side effects, talk to your doctor, radiographer
or nurse. This includes any possible side effects not listed in
this leaflet. See section 4
IN THIS LEAFLET:
1.
What E-Z-CAT is and what it is used for
2.
What you need to know before you use E-Z-CAT
3.
How to use E-Z-CAT
4.
Possible side effects
5.
How to store E-Z-CAT
6.
Contents of the pack and other information
1. WHAT E-Z-CAT IS AND WHAT IT IS USED FOR
E-Z-CAT belongs to a group of medicines called ‘contrast media’.
It is used when you have an examination called a CT or CAT
scan where X-rays are used. It contains a chemical that helps
the X-ray show up.
E-Z-CAT will be given to you as a drink.
This medicine is for diagnostic use only. It only helps to diagnose
a problem. It cannot be used to treat any diseases.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE E-Z-CAT
DO NOT USE E-Z-CAT IF YOU:
•
are allergic to barium sulfate or any of the other ingredients of
E-Z-CAT (listed in section 6)
•
know that you have a hole in your bowel or stomach
(gastrointestinal perforation)
•
know that you have an abnormal passage connecting your
stomach with your bowel (gastrointestinal fistula)
•
suffer from bleeding in your bowel or stomach
•
suffer from insufficient blood supply (ischaemia) of the bowel
wall
•
have an enlarged bowel - a condition called megacolon or
toxic megacolon
•
have an inflamed condition of the bowel called ne

Características técnicas

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
E-Z-CAT 4.9 % w/v oral suspension
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
_Active Constituent: _
Barium sulfate 4.9187 % w/v (4.6 % w/w)
_ _
_Excipients with known effect: _
_ _
Sorbitol, liquid (crystallising) (E420). Each 225 mL dose contains 16
g sorbitol.
Approximately 196mg sodium per 225 mL dose.
Approximately 57 mg potassium per 225 mL dose.
Methyl parahydroxybenzoate (E218).
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Oral suspension.
White, milky, viscous suspension.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
This medicinal product is for diagnostic use only.
E-Z-CAT is indicated for the opacification of the gastro-intestinal
tract prior to
computerised axial tomography.
E-Z-CAT is indicated in adults and children.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
E-Z-CAT is for oral administration.
_ _
The suspension is diluted with water to obtain a desired
concentration.
Recommended dilutions are shown in section 6.6.
Method of Administration
ADULTS AND THE ELDERLY:_ _350 - 450 mL of diluted suspension 30
minutes prior to the
scan and the same volume 5 minutes prior to the scan, or, as directed
by the
physician.
_ _
CHILDREN: The dosage will be dependent on the size, age, health state
and anatomical
region to be imaged of the child. Individual requirements should be
determined, from
experience, by the radiologist.
4.3
CONTRAINDICATIONS
_Immune System Disorders _
Hypersensitivity to barium sulfate or to any of the excipients listed
in section 6.1.
_Gastrointestinal Disorders _
Patients with any of the following:
-
a known or suspected, perforation of the gastrointestinal tract
-
known or suspected tracheo-esophageal fistula
-
gastrointestinal haemorrhage
-
gastrointestinal ischemia
-
megacolon or toxic megacolon
-
necrotising entercolitis
-
severe ileus
should not receive E-Z-CAT.
E-Z-CAT should not be used for infants with swallowing disorders.
_Surgical and Medical Procedures _
Barium sulfate shou