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

국가: 아일랜드

언어: 영어

출처: HPRA (Health Products Regulatory Authority)

유효 성분:

Water for injections

제공처:

SP Veterinaria, S.A.

ATC 코드:

QV07AB

INN (국제 이름):

Water for injections

복용량:

100 percent volume/volume

약제 형태:

Solvent for parenteral use

처방전 유형:

POM: Prescription Only Medicine as defined in relevant national legislation

치료 그룹:

All Species

치료 영역:

Solvents and diluting agents, incl. irrigating solutions

치료 징후:

Water

승인 상태:

Authorised

승인 날짜:

2017-09-15

제품 특성 요약

Health Products Regulatory Authority
21 September 2017
CRN000TWD
Page 1 of 4
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.
Health Products Regulatory Authority
21 September 2017
CRN000TWD
Page 2 of 4
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 OR IMMUNOLOGICAL PROPERTIES
Not applicable.
Pharmacotherapeutic group: non-therapeutic products; solvents and
dilu