Spizobactin 3,000,000 IU / 500 mg chewable tablets for dogs

Země: Irsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktivní složka:

Spiramycin ; Metronidazole

Dostupné s:

Le Vet Beheer B.V.

ATC kód:

QJ51RF01

INN (Mezinárodní Name):

Spiramycin ; Metronidazole

Dávkování:

3,000,000, 500 international unit(s)/milligram

Léková forma:

Chewable tablet

Druh předpisu:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapeutické skupiny:

Dogs

Terapeutické oblasti:

spiramycin, combinations with other antibacterials

Terapeutické indikace:

Antibacterial

Stav Autorizace:

Authorised

Datum autorizace:

2017-09-15

Charakteristika produktu

1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Spizobactin 3,000,000 IU / 500 mg chewable tablets for dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
ACTIVE SUBSTANCES:
Spiramycin
3,000,000 IU
Metronidazole
500 m
_g_
EXCIPIENT(S):
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Chewable tablet.
Light brown with brown spots, round and convex flavoured tablet with a
cross-shaped break line on
one side.
Tablets can be divided into 2 or 4 equal parts.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the adjunct treatment of mechanical or surgical periodontal
therapy in the treatment of multi-
bacterial infections of periodontal and related (peri)oral conditions
– e.g. gingivitis, stomatitis,
glossitis, periodontitis, tonsillitis, dental fistula and other
fistulous wounds in the oral cavity, cheilitis
and sinusitis - in dogs caused by microorganisms susceptible to
spiramycin / metronidazole, such as
Gram-positive bacteria and anaerobes (see also section 4.4 and 4.5)
_._
4.3
CONTRAINDICATIONS
Do not use in cases of hepatic disorders.
Do not use in cases of hypersensitivity to active substances or to any
of the excipients.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
In many cases of endodontic/periodontal disease the primary treatment
is non-medicinal and does not
require antimicrobial medication.
Antimicrobial treatment of periodontal disease should be accompanied
or preceded by endodontic
therapy and/or professional dental cleaning especially if the disease
is advanced. Dog owners are
encouraged to routinely brush their dog's teeth to remove plaque to
prevent or to control periodontal
disease.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
The combination of spiramycin and metronidazole should not be used as
first-line empirical
treatment.
Whenever possible, metronidazole and spiramycin should only be used
based on susceptibility testing
of the pathogens.
Official, national and regional an