Aqupharm 1 (9 mg/ml) solution for injection/infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Sodium chloride

Available from:

Ecuphar NV

ATC code:

QB05BB01

INN (International Name):

Sodium chloride

Dosage:

9 milligram(s)/millilitre

Pharmaceutical form:

Solution for injection/infusion

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic area:

electrolytes

Authorization status:

Authorised

Authorization date:

2016-11-11

Summary of Product characteristics

_[Version 8.2,01/2021] _
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Aqupharm 1 (9 mg/ml) solution for injection/infusion (UK(NI), IE)
Aqupharm Sodium Chloride 9 mg/ml solution for injection/infusion (FR,
BE, HU, NL)
Aqupharm Natriumklorid 9 mg/ml solution for injection/infusion (FI)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Sodium Chloride
9 mg
The solution provides
Sodium: 150 mmol/litre
Chloride: 150 mmol/litre
EXCIPIENTS:
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection/infusion.
Clear, colourless particle free solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle, horses, sheep, goats, pigs, dogs, cats and rabbits.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Correction of water: sodium imbalances.
Treatment of metabolic alkalosis.
Rehydration in disease conditions which result in excessive loss of
water and sodium chloride, and
during and after surgery.
Vehicle solution for the administration of other compatible drugs.
4.3
CONTRAINDICATIONS
Do not use in cases of:
-
sodium and water retention (due to cardiac, hepatic or renal failure,
or enteropathy)
-
hypernatraemia
-
hyperchloraemia
-
hyperhydration.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Maintain aseptic precautions.
Use with caution in animals with cardiac or renal impairment as sodium
overload may occur. It should
be noted that sodium excretion may be impaired post-surgery/trauma.
Use with caution in animals with hypokalaemia.
Serum electrolyte levels, water and acid-base balance and the clinical
condition of the animal should be
closely monitored during the treatment in order to prevent overdose,
particularly in cases of renal or
metabolic changes.
A risk of thrombosis with intravenous infusion should be considered.
This product should not be used for longer than is necessary to
correct and sustain circulating volume.
Inappropri