Hypertonic 72 mg/ml Solution for Infusion

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Sodium Chloride

Available from:

Dechra Limited

ATC code:

QB05BB01

INN (International Name):

Sodium Chloride

Pharmaceutical form:

Solution for infusion

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Cats, Cattle, Dogs, Horses

Therapeutic area:

Replacement Agent

Authorization status:

Authorized

Authorization date:

2017-11-16

Summary of Product characteristics

Unlimited Renewal: March 2022
AN: 02991/2021
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Hypertonic 72 mg/ml solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains:
Active substance:
Sodium chloride
72 mg
Approximate ionic content in millimoles per litre:
Sodium
1232 mmol/litre
Chloride
1232 mmol/litre
Excipients:
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for infusion.
Clear, colourless solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle, calves, horses, dogs and cats.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
In all target species:
As adjunctive therapy in the treatment of circulatory shock
(hypovolaemic or
endotoxaemic).
4.3
CONTRAINDICATIONS
Do not use in animals with:

Hypertonic hyperhydration (characterised by oedema);

Renal insufficiency;

Severe electrolyte disturbances;

Uncontrolled haemorrhage;

Pulmonary oedema;

Retention of water and sodium chloride;

Cardiac insufficiency;

Hypertension;

Hypertonic dehydration (characterised by thirst).
Unlimited Renewal: March 2022
AN: 02991/2021
Page 2 of 6
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Excessive administration of chloride may, due to the electrolytes’
interaction
with the body’s bicarbonate buffer system exert an acidifying
effect.
Therefore, in clinical instances accompanied by acidosis and
hyperchloraemia, special care has to be taken if this veterinary
medicinal
product is to be infused.
Sodium chloride administration may aggravate a pre-existing
hypokalaemia.
Animals treated with this veterinary medicinal product should be
closely
observed for possible deterioration of the clinical condition as a
consequence
of treatment.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Do not use unless the solution is clear, free from visible particles,
and the
container is undamaged.
Maintain aseptic precautions.
Administration of the solution must be accompanied by an opp