Stomorgyl 20 Film-coated Tablets

Land: Storbritannia

Språk: engelsk

Kilde: VMD (Veterinary Medicines Directorate)

Aktiv ingrediens:

Metronidazole, Spiramycin

Tilgjengelig fra:

Boehringer Ingelheim Animal Health UK Ltd

ATC-kode:

QJ01RA04

INN (International Name):

Metronidazole, Spiramycin

Legemiddelform:

Film-coated tablet

Resept typen:

POM-V - Prescription Only Medicine – Veterinarian

Terapeutisk gruppe:

Cats, Dogs

Terapeutisk område:

Antimicrobial

Autorisasjon status:

Authorized

Autorisasjon dato:

1993-06-30

Preparatomtale

Revised: May 2024
AN: 02154/2023
Page 1 of 4
PARTICULARS TO APPEAR ON THE OUTER PACKAGE (CARTON)
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
Stomorgyl 20 Film-coated tablets
2. STATEMENT OF ACTIVE AND OTHER SUBSTANCES
Each tablet contains 469 mg spiramycin of standard potency (3,200
IU/mg), and
250 mg metronidazole in an inert carrier.
Colorants: Ponceau 4R, 0.06 mg; Titanium dioxide E171, 0.20 mg.
3. PHARMACEUTICAL FORM
Pink circular coated tablets.
Film-coated tablets.
4. PACKAGE SIZE
Each box contains 5 blister strips of ten tablets.
5. TARGET SPECIES
Cats and dogs.
6. INDICATION(S)
For the treatment of periodontal and related oral conditions in dogs
and cats.
Metronidazole has antimicrobial activity against most anaerobes,
including
_Bacteroides_, _Fusobacterium_ and spirochaetes. Spiramycin has a
therapeutic
spectrum including Gram-positive aerobes such as staphylococci,
streptococci
and _Bacillus_, but also including anaerobes such as _Actinomyces_,_
Clostridium_ and
_Bacteroides_. Antimicrobial synergy has been shown _in vitro_ for
many of these
organisms.
7. METHOD AND ROUTES OF ADMINISTRATION
DOSAGE AND ADMINISTRATION
By oral administration.
For dogs and cats, 23.4 mg spiramycin and 12.5 mg metronidazole/kg
bodyweight, equivalent to 1 tablet/20 kg bodyweight, once daily for 5
to 10 days.
8. WITHDRAWAL PERIOD
9. SPECIAL WARNINGS, IF NECESSARY
STOMORGYL 2 may be more suitable for cats.
Revised: May 2024
AN: 02154/2023
Page 2 of 4
CONTRA-INDICATIONS AND ADVERSE REACTIONS
Do not use in animals with a known hypersensitivity to spiramycin or
metronidazole.
The tablets should not be crushed or divided.
Digestive tract disorders (vomitus, diarrhoea, anorexia) may occur
very rarely
(less than 1 animal in 10,000 animals treated, including isolated
reports).
OVERDOSE
No signs of toxicity were seen in cats receiving 5 times the
recommended dose,
or dogs receiving 8 times the recommended dose.
STANDARD OPERATOR WARNINGS
Wash hands after use. In case of accidental ingestion obtain medical
advice if
needed.
Should dire