Spizobactin 1,500,000 IU / 250 mg Chewable Tablets for Dogs

Krajina: Spojené kráľovstvo

Jazyk: angličtina

Zdroj: VMD (Veterinary Medicines Directorate)

Aktívna zložka:

Metronidazole, Spiramycin

Dostupné z:

Le Vet Beheer B.V.

ATC kód:

QJ01RA04

INN (Medzinárodný Name):

Metronidazole, Spiramycin

Forma lieku:

Chewable tablet

Typ predpisu:

POM-V - Prescription Only Medicine – Veterinarian

Terapeutické skupiny:

Dogs

Terapeutické oblasti:

Antimicrobial

Stav Autorizácia:

Authorized

Dátum Autorizácia:

2017-09-12

Súhrn charakteristických

Unlimited Renewal: November 2022
AN: 02383/2021 and 02395/2021
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Spizobactin 1,500,000 IU / 250 mg chewable tablets for dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
ACTIVE SUBSTANCES:
Spiramycin 1,500,000 IU
Metronidazole 250 mg
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.
Unlimited Renewal: November 2022
AN: 02383/2021 and 02395/2021
Page 2 of 7
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