VR OPTIGENTIN-S ANTIBIOTIC CORTICOSTEROID OPHTHALMIC GEL

Maa: Australia

Kieli: englanti

Lähde: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Aktiivinen ainesosa:

GENTAMICIN AS GENTAMICIN SULFATE; PREDNISOLONE ACETATE

Saatavilla:

JUROX PTY LIMITED

INN (Kansainvälinen yleisnimi):

gentamicin as sulfate(3mg/mL)+prednisolone as acetate(9mg/mL)

Lääkemuoto:

MISC. AURAL, OPHTHALMIC, ORO/NASO PHARYNGEAL

Koostumus:

GENTAMICIN AS GENTAMICIN SULFATE ANTIBIOTIC Active 3.0 mg/ml; PREDNISOLONE ACETATE STEROID-GLUCOCORTICOID Active 9.0 mg/ml

Kpl paketissa:

5mL

luokka:

VM - Veterinary Medicine

Valmistaja:

JUROX

Terapeuttinen ryhmä:

CAT | DOG | HORSE | BITCH | CASTRATE | CAT - QUEEN | CAT - TOM | COLT | DONKEY | ENDURANCE HORSE | FILLY | FOAL | GELDING | HIGH

Terapeuttinen alue:

OPHTHALMIC PREPARATIONS

Käyttöaiheet:

INFECTION - OCULAR | EYE INFECTIONS | OCULAR INFECTIONS

Tuoteyhteenveto:

Poison schedule: 4; Withholding period: WHP: Not to be used on horses producin g meat for human consumption.; Host/pest details: CAT: [INFECTION - OCULAR]; DOG: [INFECTION - OCULAR]; HORSE: [INFECTION - OCULAR]; Poison schedule: 4; Withholding period: ; Host/pest details: CAT: [INFECTION - OCULAR]; DOG: [INFECTION - OCULAR]; HORSE: [INFECTION - OCULAR]; For the treatment of bacterial infections of the eye, susceptible to gentamicin in the dog, cat and horse.NOT FOR USE IN FOOD PRODUCING ANIMALS. Initial treatment of corneal ulcers should not include corticosteroids. See leaflet for more details.

Valtuutuksen tilan:

Registered

Valtuutus päivämäärä:

2023-07-01

Pakkausseloste

PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
BIT
OPTIGENTIN@·S
ANTIBIOTIC, CORTICOSTEROID, OPHTHALMIC GEL
COMPOSITION
Each mL contains 5 mg gentamicin sulfate (equivalent to 3 mg
gentamicin
base)
and
10 mg prednisolone acetate (equivalent to 9 mg prednisolone),
In a
non-Irritant gel
base and Incorporates
04
mg benzalkonium
chloride
as Its preservative
PROPERTIES:
Gentarnicinis
one
01
the aminoglycoside antibiotics and
by
nature of
its
irreversible inrubitmn o! protein syrunes.s.
is bactericidal.
ItIS
active against
Gram-positive organisms and most Gram-negative bacilli, IncludlnQ
strains
01
_Pseudomonas_
and
_Proteus_
which may be resistant
to other antibiotics
Its
wide
spectrum. of
antibacterial
cover
makes
it
an effective topical
treatment in both primary and secondary bacterial
infections of the eye and
surrounding
tissues.
This preparation contains the corticosteroid,
prednisolone acetate,
which
is
advantageous
in the reduction
01
ocular
inflammation associated with
severe eye infections
The gel
base
used provides the desired stability of individual
components
With
lack
of
irritancy,
and film-spread of
active ingredients to the entire
corneal
surface.
INDICATIONS:
OPT1GENTlN-S is 'Indicated for the treatment of
bacterial
Infections of
the
eye,
susceptible
to gentamiCin in the dog,
cat
and horse.
DIRECTIONS FOR USE:
NOT FOR USE IN FOOD PRODUCING ANIMALS.
USE RESTRICTED TO SITUATIONS WHERE SENSITIVITY
INDICATES NO OTHER ALTERNATIVE
ANTIBIOTIC.
INITIAL TREATMENT
OF CORNEAL
ULCERS SHOULD NOT INCLUDE
CORTICOSTEROIDS.
SIMILARFY,
THIS OPHTHALMIC PREPARATION SHOULD NOT
BE
EMPLOYED IN
INSTANCES OF DEEP OCULAR ULCERATION WHEN VASCULARLSATION IS ABSENT.
REMISSION OF
CASES OF
VIRAL
ORIGIN SHOULD
BE
APPARENT
PRIOR
TO
COMMENCING OPT1GENTIN·S THERAPY.
One or two
drops
of the gel
should be instilled into the conjunctival sac three
or four
times daily.
To
meet
specific,
individual
cases,
the application frequency should
gradually
be reduced.
Therapy should not
be prematurely Withdrawn.

Valmisteyhteenveto

MATERIAL SAFETY DATA SHEET
PRODUCT NAME: OPTIGENTIN-S ANTIBIOTIC, CORTICOSTEROID OPHTHALMIC GEL
Issue Date: 29JAN08
QAF140
Page 1 of 3
STATEMENT OF HAZARDOUS NATURE
NOT CLASSIFIED AS HAZARDOUS ACCORDING TO CRITERIA OF NOHSC AUSTRALIA
COMPANY DETAILS
Company:
Jurox Pty Limited,
Address:
85 Gardiners Road, Rutherford NSW 2320
Telephone:
[phone] or 1800 023 312
Emergency Telephone No.:
[phone] or 1800 023 312
IDENTIFICATION
Product Name:
Optigentin-S Antibiotic, Corticosteroid Ophthalmic Gel
Other Names:
Manufacturer’s Product Code:
60530
UN Number:
None Allocated
Dangerous Goods Class:
None Allocated
Subsidiary Risk:
None Allocated
Hazchem Code:
None Allocated
Poisons Schedule Number:
4
Use:
Antibiotic, corticosteroid, ophthalmic gel for the topical
treatment of gentamicin-sensitive ocular infection in dogs and
cats.
PHYSICAL PROPERTIES / DESCRIPTION
Appearance:
Slightly viscous clear liquid, containing an easily re-
suspendable white powder.
Boiling Point/Melting Point:
Vapour Pressure:
Specific Gravity:
~1.02
Flashpoint:
Non-flammable
Flammability Limits:
Solubility in Water:
Miscible
pH:
4.0 – 5.0
OTHER PROPERTIES
INGREDIENTS
CHEMICAL ENTITY
CAS NUMBER
PROPORTION
Prednisolone Acetate
52-21-1
1.0%
Gentamicin Sulphate
1405-41-0
0.5%
Water
7732-18-5
to 100%
MATERIAL SAFETY DATA SHEET
PRODUCT NAME: OPTIGENTIN-S ANTIBIOTIC, CORTICOSTEROID OPHTHALMIC GEL
Issue Date: 29JAN08
QAF140
Page 2 of 3
HEALTH & HAZARD INFORMATION
HEALTH EFFECTS
ACUTE
Swallowed:
May lead to nausea, vomiting and diarrhoea. Sensitisation reactions
may occur in susceptible individuals.
Eye:
Mild irritant.
Skin:
Mild irritant. Absorbed through the skin. May lead to sensitisation
reaction in susceptible individuals.
Inhaled:
Does not present an inhalation problem.
CHRONIC
Due to the presence of Prednisolone Acetate, prolonged or repeated
exposure may lead to
electrolyte imbalance, oedema and delayed wound healing. Due to the
presence of Gentamicin
Sulphate, prolonged or repeated contact may lead to hearing
impairment, renal failure