Stomorgyl 2 Film-Coated Tablets
Revised: February 2010
(ATCVet code amended)
|
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 |
|
|
Merial Animal Health Limited PO Box 327 Sandringham House Sandringham Avenue Harlow Business Park Harlow, Essex, CM19 5TG UK |
|
8. |
MARKETING AUTHORISATION NUMBER(S) |
|
|
Vm 08327/4083 |
|
9. |
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION |
|
|
30th June 2003 |
|
10. |
DATE OF REVISION OF THE TEXT |
|
|
February 2010 (ATCVet code amended) |
|
11. |
ANY OTHER INFORMATION REQUIRED BY THE SECRETARY OF STATE |
|
|
Not applicable |
Page 4 of 4