APPENDIX I
SUMMARY OF PRODUCT CHARACTERISTICS
Name of the veterinary medicinal product
STOMORGYL P.A.
Qualitative and quantitative composition
One 80 mg tablet contains:
Active ingredient(s):
Spiramycin ............................................................ 100,000 IU
Metronidazole .................
....................................... 16.67 mg
For the full list of excipients, see section “List of excipients”.
Pharmaceutical form
Tablets.
Clinical information
Target species
Dogs and cats.
Indications for use, specifying target species
In cats and dogs:
- Treatment of oral conditions due to bacteria sensitive to spiramycin and metronidazole.
Contraindications
Do not use in case of hypersensitivity to imidazoles and/or spiramycin and/or excipients.
Specific warnings for each target species
None.
Special precautions of administration
Special precautions when administering to an animal
None.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
People with known hypersensitivity to imidazoles and/or spiramycin should avoid contact with the veterinary drug.
In case of accidental ingestion, seek medical advice.
Wash hands after use.
Other precautions
None.
Adverse effects (frequency and severity)
A few very rare cases of digestive disorders (vomiting, diarrhoea, anorexia) may be observed after treatment.
Brown urine may be observed.
The frequency of side effects is defined as follows:
very common (side effects in more than 1 in 10 treated animals)
common (between 1 and 10 animals out of 100 treated animals)
uncommon (between 1 and 10 animals out of 1,000 treated animals)
rare (between 1 and 10 animals out of 10,000 treated animals)
very rare (less than 1 in 10,000 treated animals, including isolated cases).
Use during pregnancy, lactation or laying
The results of studies conducted in laboratory animals did not show any teratogenic or foetotoxic effects.
In the absence of a study in the destination animal, the use of this proprietary medicinal product in pregnant dogs or cats in early gestation must subject to a risk/benefit assessment by the veterinarian.
In the absence of animal studies, avoid administering the proprietary medicinal product during lactation.
Medicinal interactions and other forms of interaction
Do not combine with lincosamides and bactericidal antibiotics active on bacteria in the multiplication phase.
Dosage and application type
Oral route.
100,000 IU of spiramycin (as base) and 16.67 mg metronidazole per kg of body weight per day, i.e. one tablet per kg of body weight per day for 6 to 10 days.
In severe cases, the dosage can be doubled.
To ensure proper dosing, the body weight of the animals should be determined as accurately as possible, to avoid under-dosing.
Overdose (symptoms, emergency action, antidotes), if needed
Neurological symptoms (tremors, seizures, ataxia) may occur after high doses or prolonged periods of treatment.
Waiting time
Not applicable.
Pharmacological properties
Pharmacotherapeutic group: Antibacterials for systemic use, spiramycin in combination with another antibacterial.
ATC-vet code: QJ01RA04.
Pharmacodynamic properties
The product is a combination of two antibiotics: spiramycin and metronidazole.
Spiramycin is a bacteriostatic antibiotic belonging to the macrolide family. Like the other macrolides, spiramycin inhibits protein synthesis and binds to bacterial ribosomes (50S ribosomal subunit) which leads to inhibition of bacterial protein synthesis. Spiramycin exerts bacteriostatic activity at concentrations below the minimum inhibitory concentration (MIC) of pathogenic microorganisms, which induces a delayed antibacterial effect.
It is active against Staphylococcus, Streptococci, Bacillus, Actinomyces, Neisseria, Listeria, Corynebacteria, Clostridia, Bacteroides, Haemophilus, Treponema, Leptospira, Toxoplasma, Mycoplasma.
Metronidazole is a bacteriostatic antibiotic derived from nitroimidazole.
It is active against all anaerobic cocci and bacilli, Gram-negative, against Bacteroides, Fusobacteria, Spirochetes and anaerobic bacilli, sporogenic Gram-positive. It is active against many protozoa (Trichomonas, Entamoeba, Histomonas).
A synergy in the metronidazole/spiramycin combination was highlighted in many anaerobic microbes and protozoa involved in oral infections in carnivores.
Pharmacokinetic characteristics
After oral administration, plasma concentrations of spiramycin reach their maximum between 2 and 4 hours after administration (Cmax = 2.29 IU/mL after repeated administration) and salivary concentrations between 4 and 8 hours. Salivary concentrations are approximately 3 times higher than plasma concentrations (Cmax = 2.86 IU/mL after repeated administration).
The maximum plasma concentrations for metronidazole are reached 1 hour after administration in saliva and are of the same order of magnitude as the plasma concentrations (Cmax = 7.07 μg/mL after repeated administration).
The volume of distribution (Vd) is 7.84 L/kg for spiramycin and 0.7 L/kg for metronidazole. The terminal plasma half-life (t1/2) is 8.10 hours for spiramycin and 5.69 hours for metronidazole, respectively. The plasma clearance is 0.823 L/h/kg for spiramycin and 0.081 L/h/kg for metronidazole. The main route of elimination is bile for spiramycin, while metronidazole is eliminated by faeces and urine.
Pharmaceutical information
List of excipients
Aluminum oxide hydrate
Sorbitol
Magnesium stearate
Gelatine
Dextrin
Citric acid monohydrate
Wheat starch
Major incompatibilities
None known.
Shelf life
Shelf life of veterinary medicinal product as packaged for sale: three years.
Special precautions for storage
No special precautions for storage.
Nature and composition of primary packaging
PVC-aluminium blister
Special precautions to take when disposing of unused veterinary medicinal products or waste derived from the use of this products
Empty packaging and any remaining product must be disposed of according to practices in force regarding the disposal of waste products.
Marketing authorisation holder
BOEHRINGER INGELHEIM ANIMAL HEALTH FRANCE
29 AVENUE TONY GARNIER
69007 LYON
FRANCE
Marketing authorisation number(s)
FR/V/2266226 4/1988
Box of 3 blisters of 10 tablets
Box of 5 blisters of 10 tablets
Not all sizes may be marketed.
Date of first authorisation/renewal of authorisation
22/06/1988-11/03/2013.
Date of text update
08/03/2021.
