SYNULOX 50 MG VETERINARY

Land: Israel

Sprache: Englisch

Quelle: Ministry of Health

Wirkstoff:

AMOXICILLIN AS TRIHYDRATE; CLAVULANIC ACID AS POTASSIUM

Verfügbar ab:

ZOETIS ISRAEL HOLDING B.V., ISRAEL

ATC-Code:

J01CA04

Darreichungsform:

TABLETS

Zusammensetzung:

AMOXICILLIN AS TRIHYDRATE 40 MG; CLAVULANIC ACID AS POTASSIUM 10 MG

Verabreichungsweg:

PER OS

Verschreibungstyp:

Required

Hergestellt von:

HAUPT PHARMA LATINA S.R.L, ITALY

Therapiebereich:

AMOXICILLIN

Anwendungsgebiete:

For the treatment of diseases, due to susceptible microorganisms including skin diseases, urinary tract infections, respiratory diseases, enteritis, soft tissue infections, dental infection in dogs and cats.

Berechtigungsdatum:

2020-12-31

Gebrauchsinformation

VETERINARY MEDICINE PACKAGE LEAFLET
This medicine is dispensed with a veterinarian’s prescription only
For animal use only
1. NAME, FORM AND STRENGTH OF THE VETERINARY
MEDICINE
Synulox 50 mg Veterinary, tablets
Synulox 250 mg Veterinary, tablets
Synulox 500 mg Veterinary, tablets
2. ACTIVE INGREDIENTS
Each Synulox 50 mg Veterinary tablet contains:
Amoxicillin 40 mg
Clavulanic acid 10 mg
Each Synulox 250 mg Veterinary tablet contains:
Amoxicillin 200 mg
Clavulanic acid 50 mg
Each Synulox 500 mg Veterinary tablet contains:
Amoxicillin 400 mg
Clavulanic acid 100 mg
Each tablet contains clavulanic acid in the form of potassium
clavulanate
and amoxicillin in the form of amoxicillin trihydrate in a palatable
base.
For the list of inactive ingredients, see section 13.
3. WHAT IS THE MEDICINE INTENDED FOR?
For the treatment of diseases, due to susceptible microorganisms,
including skin diseases, urinary tract infections, respiratory
diseases,
enteritis, soft tissue infections, dental infections in dogs and cats.
SYNULOX VETERINARY is active
in vitro
against a wide range of aerobic
and anaerobic bacteria, including:
Gram-positive:
Staphylococci
(including
β
-lactamase
-
producing strains)
; Clostridia;
Actinomyces; Peptostreptococcus spp; Streptococci; Enterococci.
Gram-negative:
Bacteroides spp.
(including
β
-lactamase
-
producing strains)
;
Escherichia coli
(including
β
-lactamase
-
producing strains)
; Salmonellae
(including
β
-lactamase
-
producing strains)
; Bordetella bronchiseptica;
Campylobacter spp; Fusobacterium necrophorum; Klebsiellae;
Pasteurellae; Proteus spp
.
Therapeutic group: antibiotic preparation from the penicillin group
ATCVET CODE: QJ01CR02
4. CONTRAINDICATIONS
As with other penicillins, Synulox Veterinary should not be
administered
orally to rabbits, guinea pigs, hamsters or gerbils. Caution is
advised
when administering the preparation to other small herbivores.
5. SIDE EFFECTS
Very rarely hypersensitivity reactions (allergic skin reactions,
anaphylaxis)
may occasionally occur. If an allergi

Fachinformation

Synulox Tablets LPD CC 14.03.2022
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Synulox 50 mg Veterinary
Synulox 250 mg Veterinary
Synulox 500 mg Veterinary
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_Active ingredients:_
mg per 50 mg
tablet
mg per 250 mg
tablet
mg per 500 mg
tablet
Amoxicillin
40.0
200
400
(as Amoxicillin Trihydrate)
45.9
229.5
460
Clavulanic acid
10.0
50
100
(as Potassium Clavulanate)
11.9
59.5
119.2
For the full list of all other excipients see section 6.1.
3.
PHARMACEUTICAL FORM
Synulox Veterinary are presented as circular, pink TABLETS with a
break line on one face
and “Synulox” engraved on the other. Each tablet contains
clavulanic acid as
potassium clavulanate and amoxicillin as Amoxicillin Trihydrate. in a
palatable base.
4.
CLINICAL PARTICULARS
4.1.
TARGET SPECIES
Synulox 50 mg Veterinary - cats and dogs.
Synulox 250 mg Veterinary - cats and dogs.
Synulox 500 mg Veterinary – dogs only.
4.2.
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment of diseases, due to susceptible microorganisms
including skin
diseases, urinary tract infections, respiratory diseases, enteritis,
soft tissue infections,
dental infection in dogs and cats.
4.3.
CONTRAINDICATIONS
The product should not be given to rabbits, guinea pigs, hamsters or
gerbils.
Caution is advised in their use in any other very small herbivores.
4.4.
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None. SPECIAL PRECAUTIONS FOR USE
i)
Special precautions for use in animals
Do not use this product on animals known to be sensitive to
penicillin.
Inappropriate use of the product may increase the prevalence of
bacteria
resistant to amoxicillin/clavulanic acid.
In animals with hepatic and renal failure, the dosing regimen should
be
carefully evaluated.
Synulox Tablets LPD CC 14.03.2022
Use of the product should be based on susceptibility testing and take
into
account official and local antimicrobial policies.
Narrow spectrum antibacterial therapy should be used for first line
treatment where susc