Stomorgyl 2 (2 kg)
ATC code
Species
Dogs and cats.
Indications
For the treatment of periodontal and related oral conditions in dogs and cats.
Dose 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 5 to 10 days.
Equivalent to: 1 tablet/2 kg bodyweight once daily for 5-10 days.
Do not break or crush the tablets.
Adverse reactions
Digestive tract disorders (vomitus, diarrhoea, anorexia) may occur very rarely.
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).
Dispensing
POM-V - Prescription Only Medicine – Veterinarian
TRUSTED SOURCE
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
STOMORGYL 2
Film-coated Tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Spiramycin 150,000 IU
Metronidazole 25mg
Colorants: Ponceau 4R 0.06mg Titanium dioxide E171 0.20mg
For 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)
For the treatment of periodontal and related oral conditions 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.
4.5 Special precautions for use
i. Special precautions for use in animals
None.
ii. Special precautions to be taken by the person administering the veterinary medicinal product to the 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)
None known.
4.7 Use during pregnancy, lactation or lay
Safety in pregnant dogs and cats has not been demonstrated.
4.8 Interaction with other medicinal products and other forms of interaction
The product should not be used concurrently with other antibiotics of the macrolide group.
4.9 Amount(s) 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 5 to 10 days.
Equivalent to: 1 tablet/2 kg bodyweight once daily for 5-10 days. Do not break or crush the tablets.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
No signs of toxicity were seen in cats receiving 5 times the recommended dose, or in dogs receiving 8 times the recommended dose.
4.11 Withdrawal period(s)
Not applicable.
5. PHARMACOLOGICAL PROPERTIES
Pharmacotherapeutic group:
Antibacterials for systemic use, combinations of antibacterials
ATCVet code: QJ01RA04
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.
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Aluminium Oxide, hydrated
Sorbitol
Dextrin, white
Gelatin
Citric Acid Monohydrate
Magnesium Stearate Wheat Starch Film coating:
Ponceau 4R (E124)
Titanium Dioxide (E171)
Hypromellose 6 m Pa s
Polyethylene Glycol 20000
6.2 Major incompatibilities
None known.
6.3 Shelf life
3 years.
6.4 Special precautions for storage
Do not store above 250C. Store in a dry place. Protect from light.
6.5 Nature and composition of immediate packaging
Opaque, white, non-plasticised polyvinylchloride-acetochloride blister pack with aluminium foil backing containing 10 tablets per strip. Each box contains five blister strips.
6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products, if appropriate
Any unused product or waste material should be disposed of in accordance with national requirements.
7. MARKETING AUTHORISATION HOLDER
Boehringer Ingelheim Animal Health UK Ltd
Ellesfield Avenue
Bracknell
Berkshire
RG12 8YS
8. MARKETING AUTHORISATION NUMBER
Vm 08327/4083
9. DATE OF FIRST AUTHORISATION
30 June 1993
10. DATE OF REVISION OF THE TEXT
November 2018
ANY OTHER INFORMATION REQUIRED BY THE SECRETARY OF STATE
Not applicable
Approved 01 November 2018
| Art. Nr. | 08327/4083 |
|---|---|
| EAN | 3661103000129 |
