Vetivex 11 (Hartmann's) solution for infusion for cattle, horses, dogs and cats

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Sodium (S) - lactate ; Sodium chloride; Potassium chloride; Calcium chloride dihydrate

Available from:

Dechra Regulatory B.V.

ATC code:

QB05BB01

INN (International Name):

Sodium (S) - lactate ; Sodium chloride; Potassium chloride; Calcium chloride dihydrate

Dosage:

3.2, 6, 0.4, 0.2 milligram(s)/millilitre

Pharmaceutical form:

Solution for infusion

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic area:

electrolytes

Authorization status:

Authorised

Authorization date:

2013-08-09

Summary of Product characteristics

1
_[Version 8, 10/2012] _
_ _
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
VETIVEX 11 (Hartmann’s) solution for infusion for cattle, horses,
dogs and cats [UK, IE]
VETIVEX Ringer Lactate Solution for infusion for cattle, horses, dogs
and cats [BE, FR, NL]
INFUSOLEC solution for infusion for cattle, horses, dogs and cats [DE,
DK, SE]
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 ml dose contains:
ACTIVE SUBSTANCES:
Sodium (S)-Lactate
3.20 mg
Sodium Chloride
6.00 mg
Potassium Chloride
0.40 mg
Calcium Chloride
0.20 mg
(equivalent to Calcium Chloride Dihydrate: 0.27 mg)
Sodium: 131 mmol/litre
Potassium: 5 mmol/litre
Calcium: 2 mmol/litre
Bicarbonate (as lactate): 29 mmol/litre
Chloride: 111 mmol/litre
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, horses, dogs and cats.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
This veterinary medicinal product is administered by intravenous
infusion for the treatment of
dehydration and metabolic acidosis in cattle, horses, dogs and cats.
It may be used to correct volume
depletion (hypovolaemia) resulting from gastrointestinal disease or
shock.
4.3
CONTRAINDICATIONS
Do not use in animals with:
-
hyperkalaemia
-
hypercalcaemia
-
hypernatraemia
-
hyperlactataemia
-
hyperhydration
-
metabolic alkalosis
-
oedema (hepatic, renal, or cardiac)
-
Addison’s disease
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
3
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.
A risk of thrombosis with intravenous infusion should be considered.
Maintain aseptic precautions.
This veterinary medicinal product should be warmed to approximately 37
o
C prior to the administration
of large volumes, or if the administration rate is high, in order to
avoid hypothermia.
This veterinary medicinal produ