NOAH Compendium

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Date: Wednesday, May 15, 2024 6:44

Release 2.22
Stomorgyl 2, 10, 20 Film-coated Tablets
 
Species: Cats, Dogs
Therapeutic indication: Pharmaceuticals: Antimicrobials: Oral preparations: Tablets
Active ingredient: Metronidazole, Spiramycin
Product:Stomorgyl 2, 10 and 20 Film-Coated Tablets
Product index: Stomorgyl
Incorporating:
Qualitative and quantitative composition
Three strengths are available:
Stomorgyl 2: Spiramycin 150,000 IU and Metronidazole 25 mg
Stomorgyl 10: Spiramycin 750,000 IU and Metronidazole 125 mg
Stomorgyl 20: Spiramycin 1,500,000 IU and Metronidazole 250 mg
Colourants: Ponceau 4R 0.06 mg Titanium dioxide E171 0.20 mg
For the full list of excipients, see below.
Pharmaceutical form
Film-coated tablet. Pink circular convex scored tablet.
Clinical particulars
Target species
Dogs and cats.
Indications for use
For the treatment of periodontal and related oral conditions in dogs and cats.
Contra-indications
Do not use in animals with a known hypersensitivity to spiramycin or metronidazole.
Special warnings for each target species
None
Special precautions for use in animals
None
Special precautions to be taken by the person administering the 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.
Adverse reactions
None known.
Use during pregnancy, lactation or lay
Safety in pregnant dogs and cats has not been demonstrated.
Interactions
The product should not be used concurrently with other antibiotics of the macrolide group.
Amounts to be administered and administration route
By oral administration. For dogs and cats, 23.4 mg spiramycin and 12.5 mg metronidazole/kg bodyweight, once daily for up to 5 to 10 days.
Stomorgyl 2: 1 tablet/2 kg bodyweight once daily for 5-10 days.
Stomorgyl 10: 1 tablet/10 kg bodyweight once daily for 5-10 days.
Stomorgyl 20: equivalent to 1 tablet/20 kg bodyweight once daily for 5-10 days.
Do not break or crush the tablets.
Overdose
No signs of toxicity were seen in cats receiving 5 times the recommended dose, or in dogs receiving 8 times the recommended dose.
Pharmaceutical particulars
Excipients
Aluminium Oxide (hydrated), Sorbitol, Dextrin (white), Gelatin, Citric acid monohydrate, Magnesium stearate, Wheat starch, Ponceau 4R (E124), Titanium dioxide (E171), Hypromellose 6 m Pa s, Polyethylene glycol 2000.
Major incompatibilities
None known.
Shelf life
Shelf life of the product as packaged for sale: 3 years.
Special precautions for storage
Do not store above 25 °C. Store in a dry place. Protect from light.
Immediate packaging
Packs of 5 blister strips each containing 10 tablets.
Disposal
Any unused product or waste materials derived from such products should be disposed of in accordance with local requirements.
Marketing Authorisation Number
Vm 08327/4083-85
Significant changes
Legal category
Legal category: POM-V
GTIN
GTIN description:Stomorgyl 2 Film-coated Tablets
GTIN:3661103000129
GTIN description:Stomorgyl 10 Film-coated Tablets
GTIN:3661103000136
GTIN description:Stomorgyl 20 Film-coated Tablets
GTIN:3661103000143