Dioralyte Citrus

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

POTASSIUM CHLORIDE; DISODIUM HYDROGEN CITRATE; GLUCOSE; SODIUM CHLORIDE

Available from:

Sanofi Malta Limited

ATC code:

A07CA

INN (International Name):

POTASSIUM CHLORIDE; DISODIUM HYDROGEN CITRATE; GLUCOSE; SODIUM CHLORIDE

Pharmaceutical form:

POWDER FOR ORAL SOLUTION

Composition:

POTASSIUM CHLORIDE; DISODIUM HYDROGEN CITRATE 0.53 g; GLUCOSE; SODIUM CHLORIDE

Prescription type:

OTC

Therapeutic area:

ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE AGENTS

Authorization status:

Authorised

Authorization date:

2005-10-28

Patient Information leaflet

19/09/2013 08:42 - VISTAlink folder 1119736 - Page 1/2
417164 - PB DIORALYTE SACHETS 20ER

This document has been digitally signed by the following people within
the VISTAlink system,
following the sanofi-aventis group guidelines.

Plant:
KOELN GERMANY
Packaging material code:
417164
Packaging material name:
PB DIORALYTE SACHETS 20ER
Second packaging material code:
VISTAlink folder number:
1119736
VISTAlink PDF version:
1
Reason
Signed by
Date
Market regulatory validation
Arthur Munano (UK regulatory
team)
18/09/2013 16:54:07
Plant final technical validation
Andrea Schmitz (Cologne
packaging team)
19/09/2013 08:41:40
Plant ready to print
Andrea Schmitz (Cologne
packaging team)
19/09/2013 08:42:02
19/09/2013 08:42 - VISTAlink folder 1119736 - Page 2/2
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DOCUMENT OUTLINE * 0000 [/PIL_MA082_01001.html#1] * CTD TOC * m1 TOC

Summary of Product characteristics

 
Page 1 of 5 
SUMMARY OF PRODUCT CHARACTERISTICS 

1.  NAME OF THE MEDICINAL PRODUCT 

DIORALYTE


CITRUS 

2.  QUALITATIVE AND QUANTITATIVE COMPOSITION  

Glucose 
3.56 g/sachet  

Sodium chloride 
0.47 g/sachet  
Potassium chloride 
0.30 g/sachet  
Disodium hydrogen citrate 
0.53 g/sachet  

3.  PHARMACEUTICAL FORM 

Powder for oral solution 

4.  CLINICAL PARTICULARS 

4.1  THERAPEUTIC INDICATIONS 

Oral correction of fluid and electrolyte loss in infants, children
and adults. Treatment of watery 
diarrhea of various aetiologies including gastro-enteritis, in
all age groups. 

4.2  POSOLOGY AND METHOD OF ADMINISTRATION 

Route of administration: Oral 

RECONSTITUTION 
The contents of each sachet should be dissolved in 200 ml
(approximately 7 fl oz) of drinking water. 
Use fresh drinking water for adults and children.  
For infants, and where drinking water is unavailable,
the water should be freshly boiled and cooled. 
The solution should be made up immediately before use and
may be stored for up to 24 hours in a 
refrigerator, otherwise any solution remaining an hour after
reconstitution should be discarded. The 
solution itself must not be boiled. 

A  basic  principle  of  treatment  of  diarrhea  is  to  replace  lost  fluid  and  electrolytes  and  then  to 
maintain  sufficient  fluid  intake  to  replace  fluid  loss  from  stools.  The  amount  of  reconstituted 
Dioralyte  administered  should  be  adapted  to  the  age  and  weight  of  the  patient  and  the  stage  and 
severity of the condition.  

Page 2 of 5 
Severe  dehydration  may  need  to  be  corrected  by  parenteral  fluids  initially,  followed  by  oral 
maintenance if indicated. If the loss of fluid in the diarrhea is excessive, medical advic