NOROCLAV INJECTION FOR DOGS AND CATS

País: Austràlia

Idioma: anglès

Font: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Compra'l ara

Informació per a l'usuari (PIL)

20-06-2017

Fitxa tècnica (SPC)

20-06-2017

ingredients actius:

AMOXYCILLIN AS AMOXYCILLIN TRIHYDRATE; CLAVULANIC ACID AS POTASSIUM CLAVULANATE

Disponible des:

NORBROOK LABORATORIES AUSTRALIA PTY LIMITED

Designació comuna internacional (DCI):

amoxycillin as trihydrate(140mg/mL) + others

formulario farmacéutico:

PARENTERAL LIQUID/SOLUTION/SUSPENSION

Composición:

AMOXYCILLIN AS AMOXYCILLIN TRIHYDRATE ANTIBIOTIC Active 140.0 mg/ml; CLAVULANIC ACID AS POTASSIUM CLAVULANATE ANTIBIOTIC Active 35.0 mg/ml

Unidades en paquete:

10mL; 12 x 10mL; 12 x 50mL; 50mL

clase:

VM - Veterinary Medicine

Grupo terapéutico:

Área terapéutica:

ANTIBIOTIC & RELATED

indicaciones terapéuticas:

Resumen del producto:

Poison schedule: 4; Withholding period: WHP: N/A; Host/pest details: CAT: [ACTINOBACILLUS LIGNIERESII, ACTINOMYCES BOVIS, BACILLUS ANTHRACIS, BACTEROIDES SPP., BORDETELLA BRONCHISEPTICA, CAMPYLOBACTER SPP., CLOSTRIDIUM SPP., CORYNEBACTERIA, ESCHERICHIA COLI (E. COLI), FUSOBACTERIUM NECROPHORUM, HAEMOPHILUS SPP., KLEBSIELLA SPP., MORAXELLA SPP., PASTEURELLA SPP., PEPTOSTREPTOCOCCUS SPP., PROTEUS SPP., SALMONELLA, STAPHYLOCOCCI, STREPTOCOCCI]; DOG: [ACTINOBACILLUS LIGNIERESII, ACTINOMYCES BOVIS, BACILLUS ANTHRACIS, BACTEROIDES SPP., BORDETELLA BRONCHISEPTICA, CAMPYLOBACTER SPP., CLOSTRIDIUM SPP., CORYNEBACTERIA, ESCHERICHIA COLI (E. COLI), FUSOBACTERIUM NECROPHORUM, HAEMOPHILUS SPP., KLEBSIELLA SPP., MORAXELLA SPP., PASTEURELLA SPP., PEPTOSTREPTOCOCCUS SPP., PROTEUS SPP., SALMONELLA, STAPHYLOCOCCI, STREPTOCOCCI]; Ready-to-use broad spectrum antibiotic for dogs and cats.Do not use orally or parenterally in rabbits or guinea pigs. Use of this product may occasionally result in local tissue reaction.

Estat d'Autorització:

Registered

Data d'autorització:

2023-07-01

Informació per a l'usuari

DRAFT VIAL LABEL TEXT
NOROCLAV Injection For Dogs and Cats
Text appearing above and below the header and footer lines is not
included in the label.
24/01/01
Page 1 of 6
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
NOROCLAV INJECTION
FOR DOGS AND CATS
AMOXYCILLIN (AS TRIHYDRATE) 140 MG/ML
CLAVULANIC ACID (AS POTASSIUM CLAVULANATE) 35 MG/ML
10 mL/50 mL
[Norbrook logo]
Info
PEST
✔
Verified
DRAFT VIAL LABEL TEXT ANCILLARY PANEL
NOROCLAV Injection For Dogs and Cats
Text appearing above and below the header and footer lines is not
included in the label.
24/01/01
Page 2 of 6
READ THE ENCLOSED LEAFLET BEFORE USING THIS PRODUCT
Store at 2-8
°
C (Refrigerate). Do not freeze.
Norbrook Laboratories Australia Pty Limited
NRA:
52730 / 0201
[B]
Exp.
DRAFT LEAFLET TEXT
NOROCLAV Injection For Dogs and Cats
Text appearing above and below the header and footer lines is not
included in the label.
24/01/01
Page 3 of 6
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
NOROCLAV INJECTION
FOR DOGS AND CATS
AMOXYCILLIN (AS TRIHYDRATE) 140 MG/ML
CLAVULANIC ACID (AS POTASSIUM CLAVULANATE) 35 MG/ML
PRODUCT SUMMARY
EXTENDED SPECTRUM OF ACTIVITY - clavulanate extends the antibacterial
spectrum of amoxycillin
by making it active against resistant (
β
-lactamase producing) strains of _Staphylococci, E. coli,_
_Salmonella_ and _Campylobacter_ species. Furthermore, _Klebsiella_
species is added to the range
of susceptible species.
KILLS BACTERIA RAPIDLY - increases the likelihood of rapid clinical
cure.
EXCELLENT ABSORPTION AND PENETRATION - ensures sufficiently high
levels of NOROCLAV
Injection to achieve clinical success.
HIGHLY EFFECTIVE – the formulation of NOROCLAV Injection increases
the high cure rtes
achieved with amoxycillin alone.
DESCRIPTION
NOROCLAV Injection for Dogs and Cats is an off-white suspension
containing 140 mg/mL
amoxycillin as amoxycillin trihydrate (Ph. Eur) and 35 mg/mL
clavulanic acid as potassium
clavulanate (Ph. Eur).
INDICATIONS
NOROCLAV Inj

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Fitxa tècnica

PRODUCT NAME: NOROCLAV INJECTION FOR DOGS AND CATS
PAGE: 1 OF 4
THIS REVISION ISSUED: SEPTEMBER, 2009
MATERIAL SAFETY DATA SHEET
Issued by: Norbrook Laboratories Australia Pty Ltd
Freecall: 1800 665 866
POISONS INFORMATION CENTRE: 13 1126 FROM ANYWHERE IN AUSTRALIA, (0800
764 766 IN NEW ZEALAND)
SECTION 1 - IDENTIFICATION OF CHEMICAL PRODUCT AND COMPANY
NORBROOK LABORATORIES AUSTRALIA PTY LTD
FREECALL: 1800 665 866
UNIT 7/1 TRADE PARK DRIVE
TULLAMARINE, VIC 3043 AUSTRALIA
SUBSTANCE:
Oil based antibiotic injection.
TRADE NAME:
NOROCLAV INJECTION FOR DOGS AND CATS
APVMA CODE:
52730
PRODUCT USE:
Broad spectrum antibiotic for use against the bacteria commonly found
in dogs and
cats.
CREATION DATE:
SEPTEMBER, 2009
THIS VERSION ISSUED:
SEPTEMBER, 2009
and is valid for 5 years from this date.
SECTION 2 - HAZARDS IDENTIFICATION
STATEMENT OF HAZARDOUS NATURE
This product is classified as:
Not classified as hazardous according to the criteria of SWA.
Not a Dangerous Good according to the Australian Dangerous Goods (ADG)
Code.
RISK PHRASES:
Not Hazardous - No criteria found.
SAFETY PHRASES:
S36, S24/25. Wear suitable protective clothing. Avoid contact with
skin and eyes.
SUSDP CLASSIFICATION:
S4
ADG CLASSIFICATION:
None allocated. Not a Dangerous Good under the ADG Code.
UN NUMBER:
None allocated
EMERGENCY OVERVIEW
PHYSICAL DESCRIPTION & COLOUR
: Off-white to cream coloured oily suspension.
ODOUR:
No odour.
MAJOR HEALTH HAZARDS:
no significant risk factors have been found for this product. This is
an antibiotic preparation.
Any person with a history of allergies to this class of substances
should avoid all contact with this product as it may
cause sensitisation. This is also a physiologically active product and
so contact should be minimised, especially if the
user is taking a form of medication, as interactions can sometimes
give unexpected and undesired results.
POTENTIAL HEALTH EFFECTS
INHALATION:
SHORT TERM EXPOSURE:
Available data indicates that this product is not harmful. In addition
product is unlikely to
cause any

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