Dogs.

For the adjunct treatment of mechanical or surgical periodontal therapy in the treatment of multi-bacterial infections of periodontal and related (peri)oral conditions - e.g. gingivitis, stomatitis, glossitis, periodontitis, tonsillitis, dental fistula and other fistulous wounds in the oral cavity, cheilitis and sinusitis - in dogs caused by micro-organisms susceptible to spiramycin/metronidazole, such as Gram-positive bacteria and anaerobes (see also Special warnings for each target species, Special precautions for use in animals and Special precautions to be taken by the person administering the veterinary medicinal product to animals).

Do not use in cases of hepatic disorders.

Do not use in cases of hypersensitivity to active substances or to any of the excipients.

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.

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.

Official, national and regional antimicrobial policies should be taken into account when the veterinary medicinal product is used.

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.

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. Do not handle the product if you are known to be hypersensitive to the active substances or to any of the excipients.

Impervious gloves should be worn during administration of the product to avoid skin contact and hand-to-mouth contact with the 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.

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.

Vomiting has rarely been observed in dogs.

Hypersensitivity can occur in rare cases. In cases of hypersensitivity reactions, treatment should be stopped.

Spermatogenesis disorders may occur in very rare cases.

Hematuria could be observed in very rare cases.

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).

Spiramycin has not been found to be teratogenic or embryo or foetotoxic. Studies in laboratory animals have shown inconsistent results with regard to teratogenic/embryotoxic effects of metronidazole. Therefore, use of this product during pregnancy is not recommended. Metronidazole and spiramycin are excreted in milk and use during lactation is therefore not recommended.

Do not use concomitantly with bactericidal antibiotics.

Macrolides, such as e.g. spiramycin act antagonistic to penicillins and cephalosporins.

The product should not be used concurrently with other antibiotics of the macrolide group.

Metronidazole may have an inhibitory effect on the degradation of other drugs in the liver, such as phenytoin, cyclosporine and warfarin.

Phenobarbital may increase hepatic metabolism of metronidazole resulting in decreased serum concentration of metronidazole.

For oral use.

75,000 IU spiramycin + 12.5 mg metronidazole per kg body weight, in more severe cases 100,000 IU spiramycin + 16.7 mg metronidazole per kg body weight, administered daily for 6-10 days depending on the severity of the disease.

In severe cases one can start with the higher dose and go back in the course of treatment on to the lower dose.

The daily dose may be given once daily or divided equally for twice daily administration.

The treatment should always be continued for 1-2 days after resolution of symptoms in order to prevent relapses. The tablets are to be administered either deep in the mouth (on the base of the tongue) or given with a small amount of food containing the tablet, to ensure all the tablet is consumed.

To ensure administration of the correct dosage, body weight should be determined as accurately as possible to avoid underdosing. The following table is intended as a guide to dispensing the product at approximately the standard dose rate of 75,000 IU spiramycin + 12.5 mg metronidazole per kg body weight:

Tablets can be divided into 2 or 4 equal parts to ensure accurate dosing. Place the tablet on a flat surface, with its scored side facing up and the convex (rounded) side facing the surface.

Halves: press down with your thumbs on both sides of the tablet.

Quarters: press down with your thumb in the middle of the tablet.

If neurological signs occur, treatment should be discontinued and the patient should be treated symptomatically.