NOROCLAV INJECTION FOR CATTLE AND DOGS

Država: Irska

Jezik: engleski

Izvor: HPRA (Health Products Regulatory Authority)

Kupi sada

Preuzimanje Svojstava lijeka (SPC)
15-10-2016

Aktivni sastojci:

AMOXICILLIN (AS AMOXICILLIN TRIHYDRATE), CLAVULANIC ACID (AS POTASSIUM CLAVULANATE PH.EUR.)

Dostupno od:

Norbrook Laboratories Limited

ATC koda:

QJ01CR02

INN (International ime):

AMOXICILLIN (AS AMOXICILLIN TRIHYDRATE), CLAVULANIC ACID (AS POTASSIUM CLAVULANATE PH.EUR.)

Doziranje:

140/35 Mg/Ml

Farmaceutski oblik:

Suspension for Injection

Tip recepta:

POM

Terapijska grupa:

Bovine, Canine

Područje terapije:

Amoxicillin and enzyme inhibitor

Terapijske indikacije:

Antibacterial

Status autorizacije:

Authorised

Datum autorizacije:

2002-09-27

Svojstava lijeka

                                SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Noroclav Injection for Cattle and Dogs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
Amoxycillin (as Amoxycillin trihydrate)
14.0% w/v
Clavulanic acid (as Potassium clavulanate)
3.5% w/v
EXCIPIENTS:
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
A suspension for injection.
An off-white suspension.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle and Dogs.
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 30/09/2016_
_CRN 7024420_
_page number: 1_
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Noroclav Injection has a broad-spectrum of bactericidal activity against the bacteria commonly found in cattle and
dogs.
(a)
_In vitro _Noroclav Injection is active against a wide range of clinically important bacteria including:
Gram-positive: Staphylococci (including beta-lactamase producing strains), Streptococci, Corynebacteria, Clostridia,
_Bacillus anthracis_, _Actinomyces bovis_.
Gram-negative: _Escherichia coli _(including beta-lactamase producing strains), _Salmonella _spp (including beta-
lactamase producing strains), _Campylobacter _spp, _Klebsiella _spp, _Proteus _spp, _Pasteurellae _spp, _Fusobacterium_
_necrophorum_, Bacteroides (including beta-lactamase producing strains), _Haemophilus _spp, _Moraxella _spp and
_Actinobacillus lignieresi_.
(b)
Noroclav Injection is indicated for the treatment of diseases including:
Cattle:
Respiratory infections
Soft tissue infections (e.g. joint/navel ill, abscesses etc.)
Metritis
Mastitis.
Dogs:
Respiratory tract infections
Urinary tract infections
Skin and soft tissue infections (e.g. abscesses, pyoderma, anal sacculitis and gingivitis.)
4.3 CONTRAINDICATIONS
The product sh
                                
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