STOMORGYL 10 VETERINARY

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

METRONIDAZOLE; SPIRAMYCIN

Available from:

BEIT-EREZ HAVAT MILATIN LTD

Pharmaceutical form:

TABLETS

Composition:

METRONIDAZOLE 125 MG; SPIRAMYCIN 750000 IU

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

BOEHRINGER INGELHEIM ANIMAL HEALTH FRANCE SCS, FRANCE

Therapeutic indications:

Infection due to sensitive aerobic and anaerobic bacteria, specially infections of oral cavity: stomatitis, gingivitis, periodontal disease, pyorrhoea halltosis. In dogs and cats.

Authorization date:

2023-07-31

Patient Information leaflet

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CONTRAINDICATIONS:
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ingredients in this medicine.
The active ingredients are listed in section 2 and the additional
ingredients are listed
in section 13.
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Summary of Product characteristics

Page 1 of 3
VETERINARY PHYSICIAN’S PRESCRIBING INFORMATION
STOMORGYL 10 VETERINARY
1. TRADE NAME OF MEDICINAL PRODUCT
STOMORGYL 10 VETERINARY
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains: Spiramycin 750,000 IU and Metronidazole 125 mg
EXCIPIENTS: Colorants: Cochnieal Red A and Titanium dioxide.
For the full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
Film-coated tablet. Pink circular convex scored tablet.
4. CLINICAL PARTICULARS
4.1 TARGET SPECIES: Dogs and cats.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES:
Infection due to sensitive aerobic and anaerobic bacteria, especially
infections of oral cavity:
stomatitis, gingivitis, periodontal disease, pyorrhoea halitosis. In
dogs and cats.
4.3 CONTRAINDICATIONS:
Do not use in animals with a known hypersensitivity to spiramycin or
metronidazole.
4.4 SPECIAL WARNINGS (FOR EACH TARGET SPECIES): None known.
4.5 SPECIAL PRECAUTIONS FOR USE:
Special precautions for use in animals: None.
Special precautions to be taken by the person administering the
veterinary medicinal product
to animals: In case of accidental ingestion obtain medical advice if
needed. Wash hands after
use. Should direct skin contact occur, wash affected area. Should
accidental eye exposure
occur, flush the eyes immediately with water and seek medical
attention if needed.
4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS): Some very rare
cases of digestive
disorders (vomiting, diarrhea, anorexia) may be observed after
treatment.
A brown coloration of the urine may be observed.
The frequency of adverse reactions is defined using the following
convention:
-
very common (more than 1 in 10 animals treated- displaying adverse
reaction(s))
-
common (more than 1 but less than 10 animals in 100 animals treated)
-
uncommon (more than 1 but less than 10 animals in 1,000 animals
treated)
-
rare (more than 1 but less than 10 animals in 10,000 animals treated)
-
very rare (less than 1 animal in 10,000 animals treated, including
isolated reports).
REPORTING OF SUSPECTED ADV