Barilux HD

Ország: Málta

Nyelv: angol

Forrás: Malta Medicines Authority

Aktív összetevők:

BARIUM SULFATE

Beszerezhető a:

Sanochemia Diagnostics Deutschland GmbH Stresemannallee 4c, D-41460 Neuss, Germany

ATC-kód:

V08BA01

INN (nemzetközi neve):

BARIUM SULFATE 96.805 % (W/W)

Gyógyszerészeti forma:

POWDER FOR ORAL SUSPENSION

Összetétel:

BARIUM SULFATE 96.805 % (W/W)

Recept típusa:

POM

Terápiás terület:

CONTRAST MEDIA

Engedélyezési státusz:

Withdrawn

Engedély dátuma:

2006-08-28

Betegtájékoztató

Instructions for use and pharmaceutical information 

Read the entire package insert/instructions for
use thoroughly before you allow administration 
of the drug by your 
doctor or his authorized personnel. 

This drug is intended especially for use in
radiological examinations, therefore it is to be used 
only on instruction and under 
supervision of your doctor. Your doctor will decide the
preparation or dilution if necessary. 
-  Keep the package insert in case you want to read
it again later. 
-  If you have any questions turn to your doctor or pharmacist
please. 

The package insert includes:  1. What is Barilux® HD and what it
is used for? 

2. What do you have to pay attention for before using Barilux®
HD? 

3. How to take Barilux® HD? 

4. What kinds of side effects are possible? 

5. How to store Barilux® HD? 

Barilux® HD 
Active constituent: Barium sulfate 

Composition: The active ingredient is barium sulfate. 

Powder for preparation of a suspension: 100g powder contains
96.25g barium sulfate. 

Other ingredients: Sorbitol (Ph. Eur.), sodium citrate 2 H
2
O, dimethicone (350 cST), 
saccharin sodium, 3-ethoxy-4-hydroxy
benzaldehyde, polysorbate 20  

Barilux® HD is obtainable in packs of 23 cups containing
340g powder each for preparation 
of a suspension for oral use. 

1. 1. What is Barilux® HD and what it is used for? 

1.1 
Barilux® HD is a
radiological contrast agent. Barium sulfate coats the   wall
of the 
gastrointestinal tract and causes a higher absorption of 

X-rays entering the body. 

1.2 by: 
Sanochemia Diagnostics Deutschland GmbH 
Stresemannallee 4c  ·  D-41460 Neuss 
Phone: [phone] 
Fax: [phone] 
e-mail: [e-mail]  ·  www.sandiag.com 

produced by: 
AH Ehrlich GmbH & Co. KG 
Zeppelinstr. 4  ·  D-88410 Bad Wurzach 

1.3 
Barilux® HD is 
-  
 f

Termékjellemzők

Page 1 of 6 
SUMMARY OF PRODUCT CHARACTERISTICS 

1. 
NAME OF THE MEDICINAL PRODUCT 

Barilux® HD 
Active constituent: barium sulfate 

2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

Therapeutically active constituents:  
100g powder contains 96.805g barium sulfate 
(For list of excipients: see Section 6.1) 

3. DOSAGE 
FORM 

Powder for oral suspension 

4. CLINICAL 
DATA 

4.1 INDICATIONS 

Oral use 
- 
Radiological examination of the oesophagus 

and gastrointestinal tract using double 
 contrast 

4.2. 
DOSAGE AND METHOD OF ADMINISTRATION 

Dosage: 
The quantity and nature of the contrast medium and the
nature of administration are very variable 
and depend upon the examination technique, the nature of
the illness, and individual patient 
characteristics. High-density (HD) preparations
are especially suitable for evaluating the mucosal 
surface. 

The attending physician will adapt the dosage for infants and
children according to the age and 
body weight of the child, and also the
particular paediatric radiological procedure. There are no 
particular dosage recommendations for older patients. 

For Barilux® HD, the following dosages are recommended. 
For examination of the oesophagus,
stomach and duodenum, oral administration of 
90-180ml suspension is recommended. 
Complete filling of the stomach with Barilux® HD is not
recommended because of the suspension’s 
high density. For this purpose, lower 
density contrast medium suspensions, (e.g., 
Barilux® GI) are more suitable. 

Page 2 of 6 
Nature and duration of use: 
For oral use. 

Preparation of suspension: 
The ready-to-use suspension is prepared by adding
drinking water. It is recommended that 340g 
Barilux® HD be mixed with 68ml water at room temperature and
shaken briefly. Allow to stand for 
a short time and shake once more. This gives 153ml of prepared
suspension c