EFFYDRAL TABLETS

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM BICARBONATE, CITRIC ACID, AMINOACETIC ACID, LACTOSE MONOHYDRATE PH.EUR.

Available from:

Zoetis Ireland Limited

ATC code:

QB05XA

INN (International Name):

SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM BICARBONATE, CITRIC ACID, AMINOACETIC ACID, LACTOSE MONOHYDRATE PH.EUR.

Dosage:

Unknown

Pharmaceutical form:

Tablets Effervescent

Prescription type:

LM-Licensed Merchant

Therapeutic group:

Bovine

Therapeutic area:

Electrolyte solutions

Therapeutic indications:

Electrolytes

Authorization status:

Authorised

Authorization date:

2013-12-09

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Effydral Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains :
When one Effydral tablet is dissolved in 1 litre of water, the resulting isotonic oral rehydration solution has the following
composition:
*
Total alkali expressed as bicarbonate equivalents
** 90 mmol lactose is equivalent to 180 mmol glucose
For a full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Effervescent tablet.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Calves
Active substance
Sodium chloride
2.34 g
Potassium chloride
1.12 g
Sodium hydrogen carbonate 6.72 g
Anhydrous citric acid
3.84 g
Lactose monohydrate
32.44 g
Glycine
2.25 g
Constituent
(mmol/l)
Sodium
120
Potassium
15
Chloride
55
Bicarbonate + citrate 80*
Lactose
90**
Glycine
30
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 03/09/2015_
_CRN 7021914_
_page number: 1_
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Effydral solution corrects dehydration, electrolyte loss and metabolic acidosis, particularly when these disturbances arise as
a consequence of diarrhoea.
Effydral has been specially developed for the treatment of diarrhoea in calves.
4.3 CONTRAINDICATIONS
If the gastro-intestinal tract is completely obstructed, great care should be taken when administering oral solutions.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
For oral administration only.
Always use clean water and equipment when preparing Effydral solution. Replace with fresh solution every 24 hours.
Follow the instructions for use exactly. Use of a too-dilute Effydral solution will have a reduced efficacy while use of a
to