FLUNIXIN SOLUTION FOR INJECTION COMEX VETERINARY

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

FLUNIXIN AS MEGLUMINE

Available from:

COMEX LTD

Pharmaceutical form:

SOLUTION FOR INJECTION

Composition:

FLUNIXIN AS MEGLUMINE 50 MG/ML

Administration route:

I.V, I.M

Prescription type:

Required

Manufactured by:

NORBROOK LABORATORIES LIMITED, NORTHERN IRELAND

Therapeutic indications:

In the horse: the product is indicated for the alleviation of inflammation and pain associated with musculo-skeletal disorders especially in acute and chronic stages and for the alleviation of visceral pain associated with colic. In cattle: the product is indicated for the control of acute inflammation associated with respiratory disease.

Authorization date:

2021-10-31

Patient Information leaflet

_THIS LEAFLET HAS BEEN REVIEWED AND APPROVED BY THE MINISTRY OF
HEALTH: 13.1.2020_
_SUMMARY OF PRODUCT CHARACTERISTICS _
_VETERINARIAN PRESCRIPTION ONLY MEDICINE _
_FOR ANIMAL USE ONLY _
1.
NAME FORM AND STRENGTH OF THE VETERINARY MEDICINE
Flunixin Solution for Injection Comex Veterinary, 50mg/ml, I.M, I.V
2.
ACTIVE INGREDIENTS
Each ml contains:
Flunixin (as Meglumine) 50 mg
Excipients:
Phenol
5 mg/ml (preservative)
Sodium Formaldehyde Sulphoxylate Dihydrate 2.5 mg/ml (anti oxidant)
For a full list of excipients, see section 13 “further
information”
3.
INDICATIONS FOR USE
Horses:
For the alleviation of inflammation and pain associated with
musculo-skeletal disorders
especially in acute and chronic stages.
For the alleviation of visceral pain associated with colic.
Cattle:
Control of acute inflammation associated with respiratory disease.
THERAPEUTIC GROUP:
NSAID- non steroidal anti-inflammatory drug
4.
CONTRAINDICATIONS
Do not use where there is hypersensitivity to the product or to one of
the excipients.
Do not exceed the stated dose or the duration of treatment.
Use is contra-indicated in animals suffering from cardiac, hepatic or
renal disease
Use is contra-indicated in animals where there is the possibility of
gastro-intestinal ulceration or
bleeding.
Do not administer to pregnant mares.
Do not use the product within 48 hours before expected parturition in
cows.
5.
ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
Flunixin meglumine is a non steroidal anti-inflammatory drug (NSAID).
Untoward
effects include gastrointestinal irritation, ulceration and,
especially in dehydrated or
hypovolaemic animals, potential for renal damage.
Side effects can be reported to the Ministry of Health by clicking on
the link "Reporting
adverse events due to drug treatment" found on the home page of the
Ministry of
Health website (www.health.gov.il) which refers to the online form for
reporting
adverse events, or by entering the link:
_https://sideeffects.health.gov.il_
6.
TARGET SPECIES:
Cattle, Horses
7.
AMOUNTS TO BE ADMINISTE

Summary of Product characteristics

SIDE 1/1
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your earliest convenience
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CUSTOMER...................... Comex
COUNTRY......................... Jerusalem
PRODUCT ......................... Flunixin Injection
VOLUME ......................... Insert
RESOURCE CODE............. (405)026472
REVISION LEVEL.............. I03
PHARMA CODE................ 627
BARCODE......................... n/a
DIMENSIONS .................. 148 x 210mm
KEYLINE (DIE) REF. ......... A5, Single-sided
CLIENT ARTWORK APPROVAL - PROOF 3 - NORBROOK DESIGNER: EAMON
MCALLISTER (28/10/2015)
CUSTOMER APPROVAL (PLEASE SIGN)
SIGNATURE:
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DATE:
Artwork Department
Station Works, Newry, Co. Down, BT35 6JP
Tel: +44
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28 3026 4435
E-mail: [e-mail]
COLOURS USED:
PMS Black
PRESENTATION
Flunixin Veterinary is clear colourless solution for intravenous
administration containing 50 mg flunixin, as flunixin meglumine
USP and 5mg phenol Ph. Eur. as preservative, per ml.
IN HORSES, FLUNIXIN MAY BE USED ALSO AS AN INTRAMUSCULAR INJECTION.
USES
Flunixin meglumine is a relatively potent non-narcotic, non-steroidal
analgesic with anti-inflammatory, anti-endotoxic and
anti-pyretic properties.
In horses, Flunixin Injection is indicated for the alleviation of
inflammation and pain associated with musculo-skeletal
disorders and for alleviation of visceral pain associated with colic.
In cattle, Flunixin Inje