Maxibar 98.45% w/w powder for oral suspension

Šalis: Airija

kalba: anglų

Šaltinis: HPRA (Health Products Regulatory Authority)

Veiklioji medžiaga:

Barium sulfate

Prieinama:

Bracco Imaging spa

ATC kodas:

V08BA; V08BA01

INN (Tarptautinis Pavadinimas):

Barium sulfate

Dozė:

98.45%w/w percent weight/weight

Vaisto forma:

Powder for oral suspension

Recepto tipas:

Product subject to Restricted Prescription (C)

Gydymo sritis:

Barium sulfate containing X-ray contrast media; barium sulfate with suspending agents

Autorizacija statusas:

Marketed

Leidimo data:

1992-11-03

Pakuotės lapelis

PACKAGE LEAFLET: INFORMATION FOR THE USER
MAXIBAR
™
98.45 % W/W POWDER
FOR 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 X-ray examination.
•
If you get any side effects, talk to your doctor, or other
healthcare professionals helping you with your X-ray
examination. This includes any possible side effects not
listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Maxibar is and what it is used for
2.
What you need to know before you use Maxibar
3.
How to use Maxibar
4.
Possible side effects
5.
How to store Maxibar
6.
Contents of the pack and other information
1. WHAT MAXIBAR IS AND WHAT IT IS USED FOR
Maxibar belongs to a group of medicines called ‘contrast media’.
It is used when you have an X-ray of your digestive system. It
contains a chemical that helps the X-ray show up. This gives a
clearer ‘picture’ of your digestive system on the X-ray.
Maxibar 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 MAXIBAR
DO NOT USE MAXIBAR IF YOU:
•
are allergic to barium sulfate or any of the other ingredients of
this medicine (see section 6)
•
know that you have a hole in your bowel or stomach
(gastrointestinal perforation)
•
know that you have an abnormal passage connecting your
esophagus (tracheo-esophageal 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 necrotising
enterocolitis
•
have a severe intestinal paralysis
•
are a baby and have problems swallowing
•
have recently had

Prekės savybės

Health Products Regulatory Authority
03 April 2019
CRN008PXS
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Maxibar 98.45% w/w powder for oral suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Barium sulfate 98.45% w/w
Excipient(s) with known effect:
Sorbitol 2 g per 340 g dose; andSodium 259 mg per 340 g dose.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for oral suspension.
A white to off-white bulky powder for oral suspension with a slightly
sweet fruit taste, intended for suspension in water.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
This medicinal product is for diagnostic use only.
'Maxibar' is for use as a radiopaque agent during X‑ray
visualisation of the upper gastro-intestinal tract (oesophagus,
stomach
and duodenum). It is designed for optimal use in double contrast X-ray
examinations.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Maxibar is recommended for oral administration.
The powder must be reconstituted prior to administration (see section
6.6).
The administered dose of Maxibar will depend on the patient in
question and the section of the gastrointestinal tract to be
viewed.
ADULTS: Instructions for reconstitution are shown in section 6.6 but
the actual administered dose should be determined, from
experience, by the radiologist.
ELDERLY: The dosage should be determined, from experience, by the
radiologist. There are no special dosage recommendations.
CHILDREN: The dosage will be dependent on the size, age, health state
and anatomic 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 t of the gastrointestinal tract
– known or suspected tracheo-esophageal fistula
– gastrointestinal haemorrhage
– gastrointestinal ischaem