Hypertonic 7.2% w/v Solution for Infusion

Country: Միացյալ Թագավորություն

language: անգլերեն

source: VMD (Veterinary Medicines Directorate)

active_ingredient:

Sodium Chloride

MAH:

Dechra Limited

ATC_code:

QB05BB01

INN:

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:

1998-12-18

SPC

Revised: June 2016
AN: 01539/2015
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Hypertonic 7.2% w/v solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance:
Sodium chloride
7.2% w/v
Approximate ionic content in millimoles per litre:
Sodium
1232 mmol/L
Chloride
1232 mmol/L
Excipients:
For a 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
This product is administered by intravenous infusion as adjunctive
therapy in
the treatment of circulatory shock (hypovolaemic or endotoxaemic) in
cattle,
calves, horses, dogs and cats.
4.3
CONTRAINDICATIONS
Do not administer to hypernatraemic animals.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Maintain aseptic precautions.
Adequate access to drinking water should be provided when using the
product.
Revised: June 2016
AN: 01539/2015
Page 2 of 4
Care should be taken to avoid the use of excessive doses (>8 ml/kg)
and
excessive dose rates (>60 ml/kg/hr).
The product should ideally be warmed to approximately 37°C prior to
administration.
Special precautions to be taken by the person administering the
veterinary
medicinal product to animals
Not applicable.
4.6
ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
Excessive doses and/or dose rates can cause hypernatraemia,
hypotension,
bradycardia, bronchoconstriction and hyperventilation.
Sodium overload may occur particularly in animals with cardiac or
renal
impairment, and it should be noted that sodium excretion may be
impaired
post-surgery/trauma. It should also be noted that hypernatraemia may
occur in
animals that are dehydrated.
A risk of thrombosis with intravenous infusion should be considered.
4.7
USE DURING PREGNANCY AND LACTATION OR LAY
Use under veterinary supervision.
4.8
INTERAC