Effydral Effervescent Tablet

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Citric Acid Anhydrous , Glycine, Lactose Monohydrate, Potassium Chloride, Sodium Bicarbonate, Sodium Chloride

Available from:

Zoetis UK Limited

ATC code:

QA07CQ02

INN (International Name):

Citric Acid Anhydrous , Glycine, Lactose Monohydrate, Potassium Chloride, Sodium Bicarbonate, Sodium Chloride

Pharmaceutical form:

Effervescent tablet

Prescription type:

AVM-GSL - Authorised Veterinary Medicine – General Sales List

Therapeutic group:

Cattle, Pigs

Therapeutic area:

Replacement Agent

Authorization status:

Expired

Authorization date:

1993-03-01

Summary of Product characteristics

Revised: August 2020
AN: 00685/2020
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Effydral Effervescent Tablet
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCES:
QUANTITY (G/TABLET)
Sodium Chloride
2.34
Potassium Chloride
1.12
Sodium Bicarbonate
6.72
Citric Acid Anhydrous
3.84
Lactose Monohydrate
32.44
Glycine
2.25
When one Effydral tablet is dissolved in 1 litre of water the
resulting isotonic oral
rehydration solution has the following composition:
CONSTITUENT
QUANTITY (MMOL/L)
Sodium
120
Potassium
15
Chloride
55
Bicarbonate + citrate
80*
Lactose
90**
Glycine
30
* total alkali expressed as bicarbonate equivalents
** 90 mmol lactose is equivalent to 180 mmol glucose
EXCIPIENT(S):
For full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Effervescent tablet
White round tablet with a smooth surface
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Effydral has been specially developed for the treatment of
Revised: August 2020
AN: 00685/2020
Page 2 of 5
diarrhoea in calves and pigs.
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.
4.3
CONTRAINDICATIONS
If the gastro-intestinal tract is completely obstructed, care should
be taken when
administering oral solutions.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Wash hands after use.
4.5
SPECIAL PRECAUTIONS FOR USE
(i)
Special precautions for use in animals
Solutions should be prepared using clean water and feeding utensils
should be kept clean. Replace with fresh solution every 24 hours.
If Effydral is administered in too concentrated a solution to an
animal, free
access to drinking water should be provided.
Whenever possible adequate colostrum should be fed to animals.
Avoid over feeding of milk or milk replacer.
For oral administration only.
In very severe cases of dehydration accompanied by shock, additional
intravenous fluid therapy may be required