UISCE-JECT, 100 % v/v, solvent for parenteral use

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Water for injections

Available from:

Duggan Veterinary Supplies Limited

ATC code:

QV07AB

INN (International Name):

Water for injections

Pharmaceutical form:

Solvent for parenteral use

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic area:

Solvents and diluting agents, incl. irrigating solutions

Authorization date:

2017-09-15

Summary of Product characteristics

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
UISCE-JECT 100 % v/v, solvent for parenteral use
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
Water for Injections
100% v/v
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solvent for parenteral use.
A clear, colourless sterile solvent.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
As required
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For use as a sterile solvent for the preparation of veterinary
medicinal products
intended for parenteral administration where water is a component of
the preparation
and
for
reconstituting
or
diluting
veterinary
medicinal
products
for
parenteral
administration immediately before use.
4.3
CONTRAINDICATIONS
None.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Use only as a solvent for a veterinary medicinal product for which
sterile water is
authorised for use for preparation, reconstitution or dilution.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
None.
2
Special precautions to be taken by the person administering the
veterinary medicinal
product to animals
None
4.6
ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
None
4.7
USE DURING PREGNANCY, LACTATION OR LAY
Can be used during pregnancy and lactation.
4.8
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
None
4.9
AMOUNTS TO BE ADMINISTERED AND ADMINISTRATION ROUTE
For parenteral use.
Refer to
recommendations of veterinary
medicinal product for which
water for
injections is used as solvent.
4.10 OVERDOSE (SYMPTOMS, EMERGENCY PROCEDURES, ANTIDOTES), IF
NECESSARY
Not Applicable
4.11 WITHDRAWAL PERIOD(S)
Zero days.
The withdrawal period of the product for which this product is used as
solvent should
be referred to.
5.
PHARMACOLOGICAL PROPERTIES
Not applicable
Pharmacotherapeutic group: non-therapeutic products; solvents and
diluting agents,
incl. irrigating solutions.
ATCvet code: QV07AB
6.
PHARMACEUTICAL PARTICULARS
6.1
LIST OF EXCIPIENTS
None.
6.2
INCOMPATIB