Polibar 96.5 % w/w powder for rectal suspension

Država: Irska

Jezik: angleščina

Source: HPRA (Health Products Regulatory Authority)

Aktivna sestavina:

Barium sulfate

Dostopno od:

Bracco Imaging spa

Koda artikla:

V08BA; V08BA01

INN (mednarodno ime):

Barium sulfate

Odmerek:

96.5 percent weight/weight

Farmacevtska oblika:

Powder for rectal suspension

Tip zastaranja:

Product subject to Restricted Prescription (C)

Terapevtsko območje:

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

Status dovoljenje:

Marketed

Datum dovoljenje:

1992-10-13

Navodilo za uporabo

POLIBAR
96.5 % W/W POWDER FOR RECTAL SUSPENSION
barium sulfate
PACKAGE LEAFLET: INFORMATION FOR THE USER
POLIBAR
96.5 % W/W POWDER
FOR RECTAL SUSPENSION
barium sulfate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU HAVE 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, pharmacist, or
nurse. This includes any possible side effects not listed in this
leaflet. See Section 4.
IN THIS LEAFLET:
1.
What Polibar is and what it is used for
2.
What you need to know before you have Polibar
3.
How Polibar will be given to you
4.
Possible side effects
5.
How to store Polibar
6.
Contents of the pack and other information
1. WHAT POLIBAR IS AND WHAT IT IS USED FOR
Polibar 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.
Polibar will be given to you as an enema (into your back
passage).
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 HAVE POLIBAR
DO NOT HAVE POLIBAR 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
(gastrointestinal perforation)
•
know that you have an abnormal passage connecting your
stomach with your bowel (gastrointestinal fistula)
•
suffer from bleeding in your bowel
•
suffer from insufficient blood supply (ischaemia) of the bowel
wall
•
have an enlarged bowel - a condition called megacolon or
toxic megacolon
•
have a severe inflamed condition of the bowel called
necrotising enterocolitis
•
suffer from poor movement of your bowel - a condition called
colonic

Lastnosti izdelka

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Polibar 96.5 % w/w powder for rectal suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Barium sulfate 96.5 % w/w
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for rectal suspension (enema).
White powder, free from grittiness, intended for suspension in water.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
This medicinal product is for diagnostic use only.
Polibar is for use as a radiopaque agent during X-ray visualisation of
the gastrointestinal tract.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Polibar is for rectal (enema) administration.
The powder must be reconstituted prior to administration (see section
6.6).
The administered dose of Polibar 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 of the gastrointestinal tract
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