Spizobactin 3,000,000 IU / 500 mg Chewable Tablets for Dogs

In many cases of endodontic/periodontal disease the primary treatment is non-medicinal
and does not require antimicrobial medication.
Antimicrobial treatment of periodontal disease should be accompanied or preceded by
endodontic therapy and/or professional dental cleaning especially if the disease is
advanced. Dog owners are encouraged to routinely brush their dog's teeth to remove
plaque to prevent or to control periodontal disease.

Special precautions for safe use in the target species:
The combination of spiramycin and metronidazole should not be used as first-line empirical
treatment.
Whenever possible, metronidazole and spiramycin should only be used based on
susceptibility testing of the pathogens.
Use of the product should be in accordance with official, national and regional antimicrobial
policies.
Limiting the duration of treatment is necessary because damage to the germ cells cannot be
excluded with the use of metronidazole, and because in long-term studies with high doses,
an increase of certain tumours was seen in rodents. The chewable tablets are flavoured. In
order to avoid any accidental ingestion, store tablets out of reach of the animals.
Special precautions to be taken by the person administering the veterinary medicinal
product to animals:
Metronidazole has confirmed mutagenic and genotoxic properties in laboratory animals as
well as in humans. Metronidazole is a confirmed carcinogen in laboratory animals and has
possible carcinogenic effects in humans. However, there is inadequate evidence in humans
for the carcinogenicity of metronidazole.
Metronidazole may be harmful for the unborn child. Pregnant women should be careful
when handling this veterinary medicinal product.
Spiramycin and metronidazole may in rare cases induce hypersensitivity reactions, e.g.
contact dermatitis.
Direct contact with the skin or mucous membranes of the user should be avoided because
of the risk of sensitization. People with known hypersensitivity to the active substances or to
any of the excipients should avoid contact with the veterinary medicinal product.
Personal protective equipment consisting of impervious gloves should be worn when
handling the veterinary medicinal product to avoid skin contact and hand-to-mouth contact
with the veterinary medicinal product.
Metronidazole may cause adverse (neurological) effects if ingested by a child. To avoid
accidental ingestion, particularly by a child, unused part-tablets should be returned to the
open blister space and inserted back into the carton.
AN: 00121/2025 & 001235/2025
In case of accidental ingestion, seek medical advice immediately and show the package
leaflet or the label to the physician.
Wash hands thoroughly after handling the tablets.
Special precautions for the protection of the environment:
Not applicable.